Municipal Summit Governor plans to extend the prefecture's "emergency response measures"
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In addition, we confirmed common issues such as actively promoting vaccination with the new corona vaccine, and the governor and the mayor of the mayor actively exchanged opinions.
The "Prefecture / Municipal Mayor Summit" was held where the governor and the mayors of the prefecture gathered together, and Governor Arai was at the meeting of the countermeasures headquarters tomorrow ... → Continue reading
Nara TV Broadcasting
"Nara TV Broadcasting," a TV station in the ancient city of Nara, will provide you with the latest news about the prefecture, topics on the Great Buddha and deer, and information on delicious gourmet food.
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COVID-19 vaccine(Covid 19 vaccine,British: COVID-19 vaccine) IsNew Coronavirus Infection (COVID-19) OfCauseウ イ ル スIsSARS coronavirus 2For (SARS-CoV-2)Human capitalToAcquired immunityAimed to providevaccine.New coronavirus vaccine,New corona vaccineAlso called.
As of May 2021,VaccinationVaccines from multiple methods and manufacturers exist, from started to under development (mRNA vaccine,DNA vaccine,Viral vector vaccine,Inactivated vaccine,RecombinantProteinvaccine,peptideVaccines, etc.).
Globally2020 The end2021 From the beginning, vaccinations with multiple COVID-19 vaccines by multiple pharmaceutical companies have begun.An overview of the vaccination status of each country shows that while some countries have succeeded in concluding vaccine procurement contracts at an early stage and have already been vaccinated on a large scale, some countries have been delayed in vaccination and vaccination has hardly progressed. Exists ("" in the later sectionVaccine security and inoculation statusSee).
Vaccines already by multiple pharmaceutical companiesClinical trialIt has already been done, and inoculation is being carried out all over the world.Efficacy is different for each vaccine ("EffectivenessSee).
For the inoculation status of each country and each region, see "Vaccine security and inoculation status"checking.
Some pharmaceutical companies that have yet to develop vaccines are still striving to develop a new type of COVID-19 vaccine.As of May 2021, 5, none of the Japanese pharmaceutical companies have succeeded in obtaining approval for their COVID-18 vaccine.
Background to the start of development and acceleration of development
Prior to the COVID-19 pandemicSevere acute respiratory syndrome(SARS)Middle East respiratory syndromeCauses diseases such as (MERS)CoronavirusIt was said that the development of various vaccine technologies could be accelerated in early 2020 because the knowledge about the structure and function of the vaccine was established... January 2020, 1, SARS-CoV-10Gene sequenceThe data isGISAIDShared through, by March 3, the same year, of the worldPharmaceuticalThe industry has announced its commitment to COVID-19 in a big way.
2020 eraAs COVID-19 spread rapidly on a global scale, research institutes and drug manufacturers in each country embarked on the development of new vaccines and the reassessment of existing vaccines developed for other viruses. It was.who(WHO)2020 Published a list of 5 plans in progress worldwide by May.Eight of these plans are already at that pointWestern,People's Republic of ChinaWas in the clinical trial stage in (China)..In addition, WHO is a framework for joint investment and purchase by each country in vaccine development.COVAX(Kobax)Was launched.
As of June 2020, it was reported that "for the first vaccine to be developed, there is a possibility of developing a type of vaccine that prevents aggravation and death rather than infection prevention."..Others have pointed out that the vaccine is not effective for the elderly..
Some companies are looking for new manufacturing methods for the production of vaccines for COVID-19. This is the traditionalChicken eggsbyInfluenza vaccineThis is because there is a risk that the productivity will be low and it will take time if the production method of is applied, and the virus injected into the egg may be mutated to reduce the effectiveness of the vaccine... In particular,DNA vaccine,mRNA vaccineDevelopment will proceed.
As of May 2020, WHO,Coalition for Epidemic Infectious Diseases Innovation (Coalition for Epidemic Preparedness Innovations, CEPI) ,andGates Foundation(GF) Was investing funding and organizational resources in anticipation of the need for several vaccines to prevent the continuation of COVID-19 infection..CEPI organizes a $ 20 billion global fund for rapid investment and development of vaccine candidatesShowed in September 2020 that clinical data to assist in licensing may be available by the end of the year. On May 9, 2020, a teleson hosted by WHO (Long time special program), $ 40 billion pledges from 81 countries..At the same time, WHOII/Phase III clinical trialAlso announced the development of an international "solidarity trial" for the simultaneous evaluation of multiple vaccine candidates that have reached.
2020 year 11 month,バーレーンIs in ChinaShino FarmGiven the urgent marketing approval of the company vaccine,United Arab Emirates(UAE) followed. In December, with Bahrain英国Is ricePfizerApproved for emergency use of company vaccine, UAE andカナダApproved for general use.
Status of clinical trials
In Phase III clinical trials, some COVID-19 vaccines are as high as 19% for the prevention of symptomatological COVID-95 infectionsEffectivenessIs shown. As of February 2021, 4 vaccines are available in at least one countryRegulatory authorityFrom for the general publicApproveding. Two typesRNA vaccine(Pfizer-BioNTech Vaccine,Moderna vaccine), 7 types of conventional typeInactivated vaccine(BBIBP-CorV,CoronaVac,Covaxin,,CoviVac,,), 5 typesViral vectorvaccine(Sputnik Light,Sputnik V,Oxford-AstraZeneca,Combidisia,Johnson & Johnson), 2 typesProtein subunit vaccine(EpiVac Corona,)..In total, as of March 2021, 3 vaccine candidates have been developed at various stages, with 308 cases.Under clinical researchOf these, 24 are Phase I trials, 33 are Phase I / II trials, and 16 are Phase III trials..
Production / distribution plan
In many countries, such as the elderlycomplicationsPlans are being implemented to give priority to those who are at the highest risk of infection and those who are at high risk of exposure to the virus, such as healthcare workers,..In addition, provisional use of a single dose is being considered to extend the vaccine to as many people as possible until the availability of the vaccine improves... As of May 2021, 5, according to official reports from health organizations in each country, 19 billion COVID-13 vaccines were administered worldwide...AstraZeneca-Oxford is expected to produce 2021 billion times in 30, Pfizer-BioNTech 13 billion times, Sputnik V, China National Pharmaceutical, Sinovac and Johnson & Johnson each 10 billion times.Moderna aims to administer 2021 million doses in 6 and Combidisia targets 5 million doses.. By December 2020, more than 12 billion vaccines have been pre-ordered from each country, High-income countries, which make up 14% of the world's population, buy about half of them.
For middle- and low-income countries that do not have sufficient economic power to procure vaccines from Western companiesPeople's Republic of China,Russian Federation,IndiaExports a large amount of vaccine, and it has been pointed out that it intends to expand its diplomatic influence...The Japanese government is providing the purchased AstraZeneca vaccine free of charge to Taiwan, Vietnam, Indonesia, Thailand, the Philippines, Malaysia and Brunei..
Vaccination has already started all over the world.For the inoculation status in each country and region including Japan, see "Vaccine security and inoculation status"checking.
Efforts to accelerate vaccination by giving various incentives and benefits to those who have been vaccinatedOr a "vaccine" that proves that you have been inoculatedpassportThere is also a movement to issue..According to new guidance, fully vaccinated individuals can now participate in all indoor and outdoor activities without masks and without physical distance..
SARS and MERS
As of 2003, avian infectious bronchitis virus (infectious bronchitis virus),Canine coronavirusVaccines have been manufactured against several animal diseases caused by the coronavirus, such as feline coronavirus...Affect humansCoronavirusBranch Ofウ イ ル スPrevious projects for developing vaccines againstSevere acute respiratory syndrome(SARS) andMiddle East respiratory syndrome(MERS) was targeted. SARSAnd MERSVaccines against non-humanWith animalsHas been tested.
According to studies published in 2005 and 2006, the identification and development of new vaccines and medicines to treat SARS was a priority for governments and health agencies around the world at the time... As of 2020, there are no cures or preventative vaccines that have been proven safe and effective against human SARS..
There is no established vaccine for MERS.. When MERS became widespread, existing SARS studies were thought to have the potential to provide useful templates for developing vaccines and treatments for MERS-CoV infection... As of March 2020, completed Phase I clinical trials in humans (DNAOne MERS vaccine (based), And three other vaccines are in progress, all of whichAdenovirusvectorTwo types (ChAdOx2-MERS, BVRS-GamVac) and one MVA vector type (MVA-MERS-S)..
2020 COVID-19 vaccine development
From the end of 19 to the beginning of 2019, when COVID-2020 began to spread worldwide, there were no vaccines to prevent human coronavirus infection... After the detection of COVID-2019 coronavirus in December 12, COVID-19Gene sequenceWas released on January 2020, 1, triggering an urgent international response to expedite the development of preventative vaccines in case of an outbreak..
As of August 2020,who(WHO) is the causative virusSARS coronavirus 2He said he did not expect a vaccine against (SARS-CoV-2) to be available within 18 months... The global surge in COVID-2020 infection rates in early 19 stimulated international alliances and government efforts to urgently organize resources for the rapid production of multiple vaccines.In March, four vaccine candidates were included in the human evaluation ("Clinical trials started in 2020Refer to the table).
In April 2020, WHO will spend a total of 4 billion to develop three or more vaccines with different technologies and distributions.U.S. dollarEstimated.. By April 2020, "almost 4 companies and research institutes in 19 countries" will be in this virtualgold RushWas working on..Also in April, CEPI selected six vaccine candidates for COVID-4 for development through Phase II-III trials by the International Union, with three final vaccines. Estimates that it must be streamlined through regulation and quality assurance to obtain a license..Another analysis shows that 10 vaccine candidates require initial development at the same time, and 10 vaccine candidates require initial development at the same time before some of them are selected as the final path to licensing. I'm estimating.
July 2020, UK National Cyber Security Center (National Cyber Security Center), The United States and Britain of their respective governments and militaryIntelligence agencyAnd the security organization, Communications Security Establishment of Canada (Communications Security Establishment),United States Department of Homeland SecurityDirectorate General of National Protection and Programs (Cybersecurity Infrastructure Security Agency),US National Security Agency(NSA) is Russia's national supporthackerClaimed that it may have attempted to steal COVID-19 treatment and vaccine research from academic and pharmaceutical institutions in other countries.Russia denied it.
During 2020, the major changes in the overall COVID-19 vaccine development efforts from the beginning of the yearMultinational pharmaceutical industryIncreasing joint research with governments and many countries focusing on COVID-19 vaccineBiotechnologyCorporate diversity and growth.. According to CEPI, the general geographical distribution of COVID-19 vaccine development is:North AmericaOrganization accounts for about 19% of the world's COVID-40 vaccine researchAsiaとAustralia30% in Europe, 26% in Europe,South AmericaAnd there are several projects in Africa.
When vaccine development startsDistributed computingOf the projectFolding @ homeDue to the growing interest in, the computing power will be about 2020 in late March 3. EFLOPS, Achieved about 2020 EFLOPS in mid-April 4Became the world's first exaflop computing systemBESTSELLERSAll ofSuper computerAcquired the ability to exceed the total of.
Some organizations are forming international partnerships to accelerate vaccine development and prepare for distribution, some of which began raising US $ 2020 billion in early May 5, unprecedented in history. Promoting cooperation, accelerating research, and international communication on a scalewho(WHO) is also included.. WHO also has Covid-19 Vaccines Global Access to coordinate global vaccine development (COVAX)GAVIAnd in collaboration with CEPI Access to COVID-19 Tools (ACT) Accelerator Is the pillar of the vaccine.. In July, WHO announced that 7 countries, which make up up to 60% of the world's population, have agreed on a WHO COVAX program for the fair and equitable distribution of the final licensed vaccine. COVAX aims to accelerate the development and production of the COVID-165 vaccine and ensure that "access to licensed vaccines is provided fairly to all countries."Specifically, by the end of 19, participating countries will protect front-line healthcare workers and high-risk people and vaccinate the most vulnerable 2021% of the population.Guarantee that you will receive a guaranteed amount (provide up to 20 billion doses equally).
CEPI, in collaboration with international health authorities and vaccine developers, has created an additional US $ 20 billion fund.A global partnership between public, private, philanthropic and civil society organizations that has funded research and clinical trials of eight vaccine candidates for the foreseeable future (8-2020). The goal is to support some candidates for full development..United Kingdom, Canada,ベルギー,ノルウェー,スイス,Germany, NetherlandsHas already donated US $ 9 million, A private charity specializing in vaccine research and distributionBill & Melinda Gates Foundation(Gates Foundation) has donated US $ 2 million.
From London, England, June 2020, 6G7andG2035 of the countriesHead of StateAmong private and government representatives from 52 countries, includingVirtualThe summit was adjusted and US $ 88 billion was raised.Global Alliance for Vaccines and Vaccinations (GAVI)By2025 Prepare for vaccines for 3 million children in developing countries by..The main donation is US $ 16 billion from the Gates FoundationAnd the UK government for five years, including £ 5m a year (about US $ 3 billion in June 3000).
As of December 2020, US $ 12 billion has been raised by ACT Accelerators, nine vaccine candidates have been funded by COVAX and CEPI, and 24 countries are working on final vaccine deployment plans..
Coalition for Epidemic Control Innovation (CEPI)
Coalition for Epidemic Infectious Diseases InnovationIs the Norwegian government, the Indian government,Bill & Melinda Gates Foundation, And charitable trust organizationsWelcome TrustFunded in 2017World Economic Forum(DavosPublic institutions, private institutions, which were established at the conference)CharityAnd a global collaboration between civil society.Japan OfMinistry of Health, Labor and WelfareHas also been involved in the foundation and contributed since 2017.
On January 2020, 1, CEPI began work on vaccine development by the following three research teams, with at least one vaccine.Clinical trialAnnounced that it will start by June.. He also conducted clinical trials on humans in the summer, and said that approval of the vaccine would be as early as this year.
- US drug/vaccine developmentModerna, Inc.(English) (MRNA.O) andNational Institute of Allergy and Infectious Diseases (NIAID) cooperation
- Pharmaceutical companyInovio Pharmaceuticals, Inc. (INO.O)
- HoweQueensland UniversityTeam
Inovio has MERS' most advanced vaccine candidate INO-4700, The virus could be designed within 3 hours after the DNA sequence of the virus was published. Up to $ 900 million (about 9 million yen) from CEPISubsidyIn the early summer of 2020Middle East-AfricaLocalPhase II clinical trialGoing intoWants to conduct large-scale clinical trials in China by the end of the year.
XNUM X Month X NUM X Day,ModernaIs a safety study of administering the COVID-19 vaccine under development to humans (Phase I study) For US allergiesInstitute of Infectious Diseases (NIAID) Shipped to.Clinical trials in humans are expected to begin within two months, but may take a year and a half to become generally available..
August 2020, 3,Osaka UniversityDrug discovery companyAngesIt is,DNAPlasmidUtilizing technologyDNA vaccineWas jointly developed with Osaka UniversityTakara BioAnnounced that it will manufacture.. The clinical trial will start on June 6, the same year, and will be conducted for 30 people by the end of July..
August 2020, 5,Shionogi PharmaceuticalIs a subsidiary of UMN PharmaNational Institute of Infectious DiseasesIn collaboration with, it announced that it is aiming to start clinical trials within the year. The clinical trial is scheduled to start in 2020 at the earliest. It is expected to be launched in the market in the fall of 2021, with the goal of producing 3,000 million people by the end of the same year..
August 2020, 6,Kyushu UniversityIs from Kyushu UniversityVenture companyJointly announced that it has succeeded in developing a protein that is a candidate for a vaccine for the new coronavirus... Aiming to start clinical trials of vaccine from 2021.
While the development of the vaccine was urgent as of August 2020, experts (at that time) were concerned that "the effect of preventing the infection itself is difficult to prove."Also, of the Institute of Medical Science, University of TokyoKen IshiiThe professor complains, "The more you hurry (vaccine development), the more you neglect to guarantee safety."..In response to this concern, Dr. Sotaro Mine, a postdoctoral fellow at the National Research Institute of the United States, who specializes in virology and immunology, said, "Animal experimentationBased on the results such as, "I think that it has (infection prevention effect)."It has said.
Even in Japan, "fever, etc. at the clinical trial stage"Side effectsCan be seen in some casesAs of December 2020, 12, "Pfizer / BioNTech vaccine has been reported to anaphylaxis in 20 people (27 people per million people) when inoculated to 6 people."According to a report on January 2020, 1, "Moderna's vaccine had anaphylaxis in 23 people (400 per million people) after 10 million people were vaccinated, and all patients recovered thereafter. Was reported.
In Japan, Pfizer submitted an application for approval to the Ministry of Health, Labor and Welfare on December 2020, 12, and domestic manufacturers and universities are developing it with the aim of putting it into practical use. It is a goal and has not been put into practical use yet., Was said.
On February 2021, 2, AstraZeneca filed an application for approval with the Ministry of Health, Labor and Welfare..
February 2021, 2, Pfizer's corona vaccine "CommunityWas approved, and was officially approved on February 2021, 2...The legal name of the vaccine is "Coronavirus-modified uridine RNA vaccine (SARS-CoV-2)"..
On May 2021, 5, special approval was approved for AstraZeneca's corona vaccine "Bakiszebria" and Moderna's corona vaccine "COVID-20 Vaccine Moderna", and officially approved on May 19, 2021. Was..The legal name for AstraZeneca's viral vector vaccine is "Coronavirus (SARS-CoV-2) vaccine (recombinant saladenovirus vector)"...However, although the Moderna vaccine was targeted for public inoculation following Pfizer (used at large venues described below), the AstraZeneca vaccine appears to be a side reaction in other countries.ThrombosisAlthough it was approved by the regulatory affairs, it was excluded from public inoculation due to the outbreak of..After that, on August 8, the same year, it was added to the target of public inoculation for people aged 3 and over in principle..
On July 2021, 7, Daiichi Sankyo announced that it would start clinical trials of the mRNA vaccine by the end of the year...Because other vaccinations have already started in JapanplaceboDue to ethical issues in comparison with other vaccines, a recessive trial will be conducted to compare the difference in efficacy with other vaccines..
On January 2020, 1, an official from the China Center for Disease Control and Prevention (CDC) said it had begun development of the vaccine... Aug. 1,GuangzhouRussiaConsulateChina announced that the new coronavirus genome was provided from China to Russia, and China and Russia started joint vaccine development.
The clinical trial of the developed vaccine was approved in China on March 3 (although it is unknown whether it is the same as above), with Chen Wei as the leader.Chinese PLA Military AcademyMilitary Medical Research InstituteResearchers start clinical trials.. On June 3China Central TelevisionAlso reported.
March 3, with the Institute of Biological Engineering, Academy of Military Medical SciencesIs a new type of coronavirus vaccine developed independently (Adenovirus(Media) started the first clinical trial to 108 people..The project manager is Chen Wei Major GeneralSo, using the replication defective human type 5 adenovirus as a medium, S antigen of the new virus is made..Seven Chen Wei teams have already been vaccinated to prevent infection..Maj. Gen. Chen has a PhD in viral vaccine research and has previously received anti-SARS virus preparations andEbolaHas been announced to have succeeded in developing a vaccine for.
On May 2020, 5, CanSino Biologics reported that it was the first in the world to confirm the effect on humans in a phase 25 clinical trial of a viral vector vaccine that started in March of the same year... Aug. 6,People's Republic of China Central Military CommissionIs a domestic vaccine "Ad5-nCoVUseChinese PLADecided to authorize only to.. From July 7, emergency use of the vaccine was started for medical professionals..
May 2020, 12, ChineseShino FarmThe company is a domestic vaccine "BBIBP-CorVThe efficacy of the vaccine was set at 79.34%, and the vaccine was approved before China on December 12, the same year.Mohammed bin Rashid Earl McTumAnnounced lower than the 86% announced by the United Arab Emirates..The following day, the 31st, China's National Pharmaceutical Products Administration approved China National's "BBIBP-CorV"..
In mid-August 2020, the Russian government approved the domestically manufactured vaccine and announced that it plans to start vaccination for medical professionals from October... Then on August 8thVladimir PutinThe presidentGamareya Memorial National Center for Epidemiology and MicrobiologyDomestic vaccine "Gam-COVID-VacAnnounced that it was the first in the world to approve (Sputnik V)..
The United States of America
United States Federal GovernmentWill invest more than $ 2020 billion in 100 to subsidize vaccine research and manufacturing and pre-purchase contracts.Operation Warp Speed(Ultra-high-speed operation) started.US Biomedical Advanced Research and Development Agency TheAstraZeneca(UK)SanofiWe also support vaccine development by pharmaceutical companies in other countries such as (France)..
January 2020, 1, major US pharmaceutical and daily necessitiesJohnson & Johnson (J & J) announced that it has begun development of the COVID-19 vaccine.EbolaApply the technology used to develop the vaccine. This vaccine is currentlyEur-lex.europa.eu eur-lex.europa.euとRwandaHas been administered in.. "We have already put a lot of researchers into vaccine development and are confident that we will be able to achieve some results within a month. We already have a mass production system for the global market, so once the vaccine is complete, We can ship 1 million units within a year. ".
August 2020, 3,National Institutes of HealthIt is,National Institute of Allergy and Infectious DiseasesAnd the mRNA vaccine developed by the biopharmacy company ModernaClinical trialAnnounced that it reached. The clinical trial isState of WashingtonSeattleBeginning in the city, From multiple clinical trial participants by May 5, the same yearantibodyI was able to confirm..We plan to supply 1 to 5 billion doses to the world in one year..
PfizerVaccine will be available in 2020. Aim to inoculate hundreds of millions of people by 2021. If the vaccine is completed in Japan, it will be supplied to Japan for 2021 thousand doses by June 6.Japanese GovernmentIs basically agreed with..Later, data from early clinical trials were released on November 2020, 11, with preventive efficacy exceeding 9%...In response to this, we will apply for approval to the US Food and Drug Administration by the end of November 2020..
The Novabax vaccine is targeted for production of 1 million doses a year.Production is in the United StatesFujifilmIn cooperation with a subsidiary, in JapanTakeda PharmaceuticalWill manufacture and sell from the drug substance.
The United Kingdom
AstraZeneca Oxford Universityと共同でワクチン開発を開始し、そ2020年4月より臨床試験を開始した。同年9月以降、翌21年にかけて10億回分の生産が可能と目され、5月の時点で既に4億回分（アメリカ3億回分、イギリス1億回分）の供給を9月から開始することが予定されていた..After that, the supply plan was increased to 20 billion times, and it was basically agreed with the Government of Japan that Japan would be supplied with 1 million times, of which 2,000 million times would be supplied by March 3,000... Regarding the clinical trial, it was confirmed that some participants were suspected of having a serious adverse reaction.May 9Was interrupted fromRevealed that it resumed on September 9th.
However, concerns have since been raised in each country regarding the AstraZeneca vaccine. On January 2021, 1 in FranceEmmanuel MacronThe president said that the company's vaccine is almost ineffective for the elderly aged 60-65 and over., The country's health authorities recommended not to inoculate elderly people aged 2 and over on February 2, and German, Italian and Swedish health authorities also recommended not to inoculate elderly people.. However,European Medicines Agency(EMA) recommended vaccination for adults of all ages.
Also in March 2021 after vaccination with AstraZeneca vaccinethrombusGermany, France, Italy, Spain, Denmark due to reports of adverse reactions such as, Iceland, Norway,Netherlands,ThailandThere were many countries that suspended inoculation. On March 3, WHO announced a comment to continue vaccination, as no causal relationship was found between the company's vaccine and the occurrence of blood clots...In response to this, inoculation was resumed in France and Germany..
AstraZeneca clinical trials confirmed 79% efficacy, announced March 2021, 3.. HoweverNational Institute of Allergy and Infectious DiseasesPointed out that it may have contained old, incomplete clinical trial data and requested that it provide up-to-date and accurate information.AstraZeneca also announced that it will provide the latest data within 48 hours..As a result, the effectiveness was corrected to 76%..
February 2020, 2 in FranceSanofiThe United StatesMinistry of Health and Welfare Announced that it aims to rapidly develop a recombinant vaccine for COVID-19 in collaboration with the Biomedical Advanced Research and Development Agency (BARDA) of (HHS)...Also supported by the Biomedical Advanced Research and Development Agency.
IndiaInoculation of two domestic vaccines was started on January 2, 2021.India has one of the world's largest vaccine manufacturers, the Serum Institute of India (SII), which exports but relies on imports from the US and EU for raw materials..
Domestic pharmaceutical companies distribute in JapanCompanyJointly developed by SII and manufactured by SIIKobaksin'Developed by AstraZeneca and by Barrat BiotechLicense productionTo "Kobi ShieldThe former did not show data to prove its effectiveness at the approval stage...Efficacy of 81% was evaluated in subsequent clinical trials.
Taiwan(Republic of China) Then,(Chinese: Vaccine seedling biologic,Hsinchu Prefecture)ButNational Institutes of HealthDeveloped with the cooperation ofIn response, an emergency use authorization was issued in July 2021. Inoculation started on August 7, 2021Tsai EnglishPresidentWas vaccinated early in the morning of the same day.
Tsai Ing-wen states that in the past it was difficult to import vaccines except for private procurement and grants from Japan and the United States due to China's obstruction..
Southeast Asian countries
Eur-lex.europa.eu eur-lex.europa.euNanogen Pharmaceutical BiotechnologyVietnam Army Medical University"Nanocovacs" is under development in collaboration with, in February 2021Second stage clinical trial, Started the final stage clinical trial on June 6.
Iran's supreme leaderAlly HarmenayThe vaccine that was inoculated on June 2021, 6 was urgently approved in the same month among several vaccines being developed in Iran, according to Iranian state media..
キ ュ ー バ
Type of vaccine
As of January 2021, nine different technology platforms (many candidate technologies remain undefined) are under research and development to create an effective vaccine against COVID-1..
Most of the vaccine candidate platforms in clinical trials are major COVID-19 infectionsantigenCoronavirus asSpike proteinAnd its variants.. The platform developed in 2020Nucleic acidTechnology (Nucleoside modified messenger RNAandDNA),Non-replicating viral vector,peptide,Recombinant protein,Attenuated virus,and so on.
Many vaccine technologies being developed for COVID-19 use a "next generation" strategy to improve the accuracy of the COVID-19 infection mechanism, unlike vaccines already used to prevent influenza. doing..Some synthetic vaccines utilize 2P mutationsSpike proteinImmobilizes the prefusion structure and stimulates the immune response before the virus attaches to human cells..Vaccine platform under development increases the flexibility of antigen manipulation for healthcare professionals, the elderly, children, pregnant women, It can be expected to have an effect of targeting the infection mechanism of people who are susceptible to COVID-19 infection, such as those who have decreased infection..
RNA vaccineToRNAIs included and when introduced into the organizationMessenger RNAActs as (mRNA), causing cells to make foreign proteins,Adaptive immune responseStimulate and respondPathogen,cancer cellTeach the body how to identify and destroy. RNA vaccineNucleoside modified messenger RNAIs often used, but not always. Delivery of mRNA protects RNA strands and aids absorption into cellsLipid nanoparticlesAchieved by co-formulating the molecule..The development of this technologyUniversity of PennsylvaniaImmunologist,Drew WeissmanとKariko Catalinby.
RNA vaccine is the first COVID-19 vaccine approved in the United States and the European Union.. As of January 2021, this type of licensed vaccine isPfizer-BioNTech VaccineとModerna vaccineIs. As of February 2021, in the EU, CureVac RNA vaccine awaits approval.
Severe allergic reactions are rare. In December 2020, the first 12 doses of Pfizer-BioNTech COVID-19 vaccine resulted in 1,893,360 severe allergic reactions, 175 of which.AnaphylaxisMet.. Only 2020 reports of anaphylaxis were reported in 12 doses of the modelna COVID-2021 vaccine in December 1 and January 19..Lipid nanoparticlesIs most likely involved in an allergic reaction.
Adenovirus vector vaccine
These vaccines contain DNA encoding the SARS-CoV-2 proteinAdenovirus-Non-replication using a shellViral vectorIs an example of.. Vaccines using viral vectors against COVID-19 have the non-replicating nature of producing only antigens that elicit a systemic immune response rather than producing new viral particles.
Sputnik V uses the same Ad26 as the Johnson & Johnson vaccine for the first time and the same Ad1 as Combidisia for the second time, with the same efficacy as a single dose, 5 A complete study has been conducted to see if a single dose has the same effect.
Inactivated virus vaccine
Subunit vaccineOne or more without introducing the entire particle of the pathogenantigenTo present.Antigens are oftenProtein subunitHowever, any molecule can be used as long as it is a fragment of a pathogen..
As of April 2021, only this type of vaccine has been approved.Peptide vaccine OfEpiVac CoronaとThere are two.For vaccines that are pending approval,Novavax COVID-19 vaccineWhen,(Conjugate vaccine),There is.Was previously in clinical trials but was discontinued because subsequent HIV tests revealed that it could cause false results..
Self-propagating RNA vaccine
It is a vaccine that proliferates or replicates by itself, called a self-proliferating RNA vaccine or a self-replicating RNA vaccine.It is a next-generation RNA vaccine that proliferates proteins that increase RNA in the body after inoculation and increases RNA by itself. In the case of VLP Therapeutics Japan vaccine, it grows by itself, so if there are 127g of replicon particles, it is calculated that a vaccine that can be inoculated to the entire population of Japan can be made.In addition, it is said that it can be stored for 4 to 1 months in an environment of 2 ° C... VLP Therapeutics Japan,Osaka City University,National International Medical Research Center,Institute for medical infrastructure, health and nutrition,Oita UniversityEtc. are under development..In addition, Elixirgen Therapeutics, Inc. (Elixirgen Therapeutics) in Baltimore, Maryland, USA has developed a self-replicating RNA vaccine "EXG-5003", and in Japan, Fujita Medical University (Toyoake City, Aichi Prefecture). Phase 1/2 clinical trials have been started at.
Oral vaccines and nasal vaccines are also being developed and researched.
Lifetime immunityVaccines are also being researched and developed with the aim of acquiring the vaccine, which is a smallpox vaccine researched and developed by the Tokyo Metropolitan Institute of Medical Science.Vaccinia virusSARS-CoV-2 gene incorporated into a further attenuated DIs strainLive vaccine,, Institute of Industrial Science, University of TokyoMeasles virusIs researching and developing a live genetically modified vaccine using .
Scientists investigated whether existing vaccines for unrelated diseases could activate the immune system and reduce the severity of COVID-19 infection...For tuberculosisBCG vaccineThere is experimental evidence that has a non-specific effect on the immune system, but there is no evidence that this vaccine is effective against COVID-19..
Vaccine efficacy(Vaccine efficacy) is a control study comparing the risk of illness in vaccinated subjects to the risk of illness in unvaccinated subjects...0% efficacy means that the vaccine does not work (placeboSame as).A 50% efficacy means that vaccinated people are half as infected as unvaccinated people.
It is not easy to compare the efficacy of different vaccines because clinical trials were conducted with different populations, regions and different virus variants... Vaccine for COVID-1967% may be enough to delay the pandemic, but this is necessary for the vaccine to prevent infectionSterilization immunityIt is premised on giving (the action of the immune system to eliminate the virus before infection).Vaccine efficacy reflects disease prophylaxis and may be highly infectious in asymptomatic individuals, making it an inadequate indicator of SARS-CoV-2 infectivity..US Food and Drug Administration(FDA) andEuropean Medicines Agency(EMA) has set a cutoff value of 19% for the efficacy required for approval of the COVID-50 vaccine...A realistic mass vaccination rate of 75% is targeted and actualBasic reproduction numberThe efficacy required for the COVID-19 vaccine is expected to be 70% or more to prevent the epidemic and 80% or more to extinguish the epidemic without taking measures such as social distance. ing.
In the calculation of efficacy, symptomatological COVID-19 is commonly referred to as PCR (Polymerase chain reaction) The test is positive andAlthough defined as having at least one or two symptoms in the defined list of, the exact specifications will vary from study to study.By countrySARS-CoV-2 mutant strainBecause of the different prevalence of, the study site also affects the reported efficacy.The following range is 95% unless otherwise statedConfidence intervalAnd all values are for all subjects regardless of age.Efficacy for severe COVID-19 is of paramount importance, hospitalization and death are public health burdens, and prevention is prioritized...The vaccines that have been approved and approved have shown the following efficacy.
|vaccine||Effectiveness of COVID-19 by severity||Clinical trial location||Reference|
|Mild or moderate[Note 1]||Serious symptoms without hospitalization or death[Note 2]||Serious symptoms with hospitalization and death[Note 3]|
|Moderna vaccine||~ 94% (89–97%)[Note 4]||~ 100%[Note 5]||~ 100%||United States|||
|Pfizer BioNTech Vaccine||~ 95% (90–98%)[Note 6]||Not reported||Not reported||Multinational|||
|Sputnik Light||~ 79%||Not reported||Not reported||Russia|||
|Sputnik V vaccine||~ 92% (86–95%)||~ 100% (94–100%)||~ 100%||Russia|||
|Oxford-AstraZeneca Vaccine||~ 81% (60–91%)[Note 7]||~ 100% (72–100%)||~ 100%||Multinational|||
|~ 76% (68–82%)[Note 8]||~ 100%||~ 100%||United States|||
|BBIBP-CorV||~ 79%||~ 100%||~ 100%||Multinational|||
|CoronaVac||~ 78%||~ 100%||~ 100%||Brazil|||
|Nova Bucks Vaccine||~ 89% (75–95%)||~ 100%[Note 9]||~ 100%[Note 9]||United Kingdom|||
|~ 60% (20–80%)||~ 100%[Note 9]||~ 100%[Note 9]||South Africa|
|Johnson & Johnson Vaccine||~ 66% (55–75%)[Note 10][Note 11]||~ 85% (54–97%)[Note 12]||~ 100%[Note 13]||Multinational|||
|~ 72% (58–82%)||~ 86% (-9–100%)||~ 100%||United States|
|~ 68% (49–81%)||~ 88% (8–100%)||~ 100%||Brazil|
|~ 64% (41–79%)||~ 82% (46–95%)||~ 100%||South Africa|
|Covaxin||~ 78% (61-88%)||~ 100%||~ 100%||India|||
|Convidicea||~ 66%||~ 91%||Not reported||Multinational||[Unreliable medical source?]|
- ^ Mild symptoms: fever, dry cough, tiredness, myalgia, joint pain, sore throat, diarrhea, nausea, vomiting, headache, olfaction, tastelessness, stuffy nose, epistaxis, conjunctivitis, rash, cold, dizziness Such.Moderate symptoms: mild pneumonia.
- ^ Serious symptoms that do not lead to hospitalization or death of an individual are any of the following serious respiratory symptoms measured at rest at any time during the observation period (pneumonia, deep vein thrombosis, dyspnea): , Hypoxia, persistent chest pain, loss of appetite, confusion, or fever above 38 ° C, but not persistent or severe enough to lead to hospitalization or death).Respiratory rate of 30 beats / minute or higher, heart rate of 125 beats / minute or higher, oxygen saturation (SpO2) of 93% or lower (indoor air above sea level), or oxygen partial pressure / inspiratory oxygen partial pressure (PaO2 / FiO2) Is less than 300mmHg.
- ^ Serious symptoms that cause hospitalization or death include those requiring hospital treatment or death: dyspnea, hypoxia, persistent chest pain, loss of appetite, confusion, 38 ° C or higher Fever, dyspnea, renal failure, multiple organ failure, sepsis, shock.
- ^ Mild / Moderate COVID-19 symptoms observed in the Moderna vaccine trials, were only counted as such for vaccinated individuals if they began more than 14 days after their second dose, and required presence of a positive RT-PCR test result along with at least two systemic symptoms (fever above 38ºC, chills, myalgia, headache, sore throat, new olfactory and taste disorder) or just one respiratory symptom (cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia) ).
- ^ Severe COVID-19 symptoms observed in the Moderna vaccine trials, were defined as symptoms having met the criteria for mild / moderate symptoms plus any of the following observations: Clinical signs indicating of severe systemic illness, respiratory rate ≥ 30 per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2 / FIO2 <300 mm Hg; or respiratory failure or ARDS, (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure <90 mmHg, diastolic BP <60 mmHg or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit or death. in the trials, compared with 30 severe cases reported in the placebo group (incidence rate 9.1 per 1000 person-years).
- ^ Mild / Moderate COVID-19 symptoms observed in the Pfizer-BioNTech vaccine trials, were only counted as such for vaccinated individuals if they began more than 7 days after their second dose, and required presence of a positive RT-PCR test result along with at least one of the following symptoms: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; or vomiting.
- ^ When the dosing interval is 12 weeks or more. At intervals of less than 6 weeks, efficacy was approximately 55% (33-70%).
- ^ The dosing interval is 4 weeks.Efficacy is said to be "prevention of symptomatological COVID-19".
- ^ a b c d No cases were detected in the study.
- ^ For medium.
- ^ Efficacy reported 28 days post-vaccination for the Johnson & Johnson single shot vaccine. A lower efficacy was found for the vaccinated individuals 14 days post-vaccination.
- ^ The source does actually say negative 9.
- ^ No hospitalizations or deaths were detected 28 days post-vaccination for 19,630 vaccinated individuals in the trials, compared with 16 hospitalizations reported in the placebo group of 19,691 individuals (incidence rate 5.2 per 1000 person-years) and 7 COVID-19 related deaths for the same placebo group.
Vaccine effectivenessIn a real-world study of (vaccine effectiveness), certain vaccines have shown COVID-19 infection, symptoms, hospitalization, and death in large populations of vaccinated individuals under non-ideal routine conditions. Measure how much you could prevent.
- イ ス ラ エ ルでは、2020年12月20日から2021年1月28日までの期間にモデルナまたはファイザー-バイオンテックのワクチンを接種した715,425人のうち、2回目の接種から7日後からの期間に、317人（0.04%）のみが軽度/中等度のCovid-19症状で発病し、16人（0.002%）のみが入院したことが確認された.
- Centers for Disease Control and PreventionPfizer-BioNTech and Moderna Covid-19 vaccines provide highly effective protection, according to the report...In the actual environment, the effectiveness of the complete immunity (more than 2 days after the second administration) mRNA vaccine is 2% and partial immunity (14) against SARS-CoV-90 infection regardless of the symptom status. The vaccine efficacy was 1% at least 14 days after the second dose and before the second dose.
- 104 healthcare workers working in 15,121 UK hospitals were all COVID-19 before the surveyantibodyWas negative, but from December 2020, 12 to February 7, 2021Lineage B.1.1.7Twice a week during the period when was circulating as the dominant mutant strainReverse transcription-polymerase chain reaction (RT-PCR) testで追跡調査を行った。この研究では、ワクチンを接種した90.7%のコホート（母集団）と、ワクチンを接種しなかった9.3%のコホートの陽性結果を比較し、ファイザー-バイオンテック社のワクチンは、全ての感染症（無症候性を含む）を、1回目の接種から3週間後には72%（58-86%）減少させ、2回目の接種から1週間後には86%（76-97%）減少させたことがわかった.
- From January 2021th to March 1th, 17, during the period when strain B.3 was circulating as a dominant mutant strain.イ ス ラ エ ルA study of the general population of Pfizer found that the Pfizer vaccine reduced asymptomatic COVID-19 infections by 94% and symptomatic COVID-19 infections by 97%..
- America'sMayo ClinicA study of preoperative patients showed that the mRNA vaccine was 80% protective against asymptomatic infections..
- Director of China Disease Control CenterGao FuAdmitted at a meeting held on April 2021, 4, that Chinese vaccines were "not very protective."Private companyShinobuCompany developedCoronaVacVaccineBrazilA clinical trial in Japan found that the efficacy rate was only 50.4%.トルコAnother study conducted in Japan showed 83.5% effectiveness.State-ownedShino FarmAccording to the company, the efficacy rates of the two vaccines are 2% and 79.4%..
|vaccine||Effectiveness of COVID-19 by severity||Survey country||Refs|
|Pfizer-BioNTech||~ 86% (76-97%)||Not reported||United Kingdom|||
|~ 90% (68-97%)||~ 100%[I]||United States|||
|~ 94%||~ 97%||Israel|||
|Moderna||~ 90% (68-97%)||~ 100%[I]||United States|||
|CoronaVac||Not reported||~ 67% (65-69%)||~ 80% (73-86%)||Chile|||
|Sputnik V||Not reported||~ 98%||Not reported||Russia|||
Induced by current COVID-19 vaccineantibodyMedium or completely to the responseResistanceIf a SARS-CoV-2 mutant with SARS-CoV-XNUMX appears, it may be necessary to change the vaccine...Studies have shown that many vaccines developed for early strains are less effective against some mutants of symptomatological COVID-19... As of February 2021, the U.S. Food and Drug Administration (FDA) believes that all FDA-approved vaccines maintain a protective effect on circulating strains of SARS-CoV-2..
Mutant strains are concerned about the risk of escaping from neutralizing antibodies acquired by recoverers and vaccinated individuals, but a study by the National Institute of Infectious Diseases and the Japan Medical Research and Development Organization conducted a study of new coronavirus infection (COVID). -19) It was discovered that the total amount of neutralizing antibody in the recoverer declines with time, but an antibody that cross-binds to the mutant strain is acquired, and the quality of this antibody (neutralizing specific activity / crossability) improves with time. bottom.This phenomenon will be an important finding in vaccine strategies for mutant strains. .
Alpha strain (Strain B.1.1.7)
In December 2020, a new mutant strain, strain B.12, was identified in the United Kingdom...Initial results showPfizer-BioNTech VaccineとModerna vaccineBoth suggest protection against UK mutants.
In one studyOxford-AstraZeneca VaccineShowed 1.1.7-42% efficacy against B.89 and 1.1.7-71% efficacy against mutant strains other than B.91...According to preliminary data from clinical trialsNovavax vaccine~ 96% for the original mutant strain, ~ 1.1.7% for B.86,South AfricaIt has been shown to have a symptomatological improvement effect of ~ 1.351% against B.501 (2.V60 mutant strain)..
Beta strain (Strain B.1.351 / 501.V2 mutant)
Moderna has begun testing a new vaccine to tackle South African strain B.1.351 (501.V2 mutant).. On February 2021, 2, Pfizer announced that the neutralizing activity of B.17 was reduced to two-thirds, but said that the vaccine's disease-preventing effect on this mutant could not yet be claimed... From patients vaccinated with Modelna and Pfizer against B.1.351serumDecreased neutralization activity was subsequently confirmed in several studies.. On April 4, Pfizer-BioNTech's latest information on a vaccine trial in South Africa showed that the vaccine was so far 1% effective (that is, no cases occurred in vaccinated subjects).Placebo control groupStates that 9 of the 6 infections were B.1.351..
January 2021 in South AfricaAd26.COV2.S vaccineJohnson & Johnson, who conducted a clinical trial in South Africa, reported that the level of protection against moderate to severe COVID-19 infection was 72% in the United States and 57% in South Africa..
September 2, "Financial Times』\ Paper is from South Africa Oxford UniversityInterim study data from a study conducted in collaboration with AZD1222 reported that the Oxford-AstraZeneca vaccine (AZD1.351) showed reduced efficacy against B.XNUMX...The study found that in a sample size of 2,000 people, the AZD1222 vaccine provided "minimal protection" in all cases except the most severe cases of COVID-19... On February 2, the South African Health Minister canceled about a million vaccine deployment plans while reviewing the data and waiting for advice on how to proceed..
Gamma strain (lineage P.1)
Strain P.1 (20J / 501Y.V3), the first mutant identified in Brazil, may have partially escaped the effects of Pfizer-BioNTech vaccination..
Strain B.1.617 (Delta strain / Kappa strain)
In October 2020, a new double mutant was discovered in India and named strain B.10. Almost undetected until January 1.617 and in AprilAntarcticaとSouth American continentSpread to at least 20 countries on each continent except..Among the approximately 15 defined mutations, this is the spike mutation D111D (synonymous), G142D., P681R, E484Q, L452RAnd the latter two are easyantibodyMay cause to avoid(* There is no mutation in G1.617.2D and E142Q in strain B.484 described later, but instead there is a mutation in T478K).
The Delta strain has a high viral load and is said to be highly infectious.Even if the vaccine is given, the risk of infection is higher than that of the conventional strain, while the risk of aggravation is kept low due to the effect of the vaccine.In addition, it has been pointed out that even if the vaccinated person is infected, even if it is mild or asymptomatic, it may proliferate in large quantities in the body like the non-vaccinated person and become a source of virus infection..
Clinical trials and approval status
In the Phase I study, safety and preliminary doses were tested mainly in dozens of healthy subjects, and in the Phase II study, immunogenicity and dosage were tested following the success of the Phase I study. level(BiomarkerEfficacy based on), and side effects of candidate vaccines are evaluated, usually in hundreds of people.Phase I–II trials consist of preliminary safety and immunogenicity trials, usually randomized, placebo-controlled trials to determine more accurate and effective doses.Phase III trials typically involve more subjects at multiple institutions,Control groupAt the optimal dose, includingAdverse effectsTest the effectiveness of vaccines to prevent disease while monitoring (“intervention trials” or “pivotal trials”)..Vaccine safety, efficacy, and in Phase III trialsDefinitions may vary depending on the company's trials, such as the degree of side effects, the definition of infection or dose, and whether the vaccine prevents moderate or severe COVID-19 infection..
Plans for ongoing clinical trials, if accumulating data in the trial provides positive or negative early insight into the effectiveness of the treatment.May be changed as..Indications for ongoing Phase II-III clinical trials for candidate vaccines can shorten study duration, reduce subject numbers, expedite early termination or success decisions, avoid duplication of research efforts, and Strengthen coordination on plan changes for solidarity trials between international hubs.
List of approved or approved vaccines
|Vaccine candidate drug, developer, investor||Developing country||Vaccine type (technology)||Inoculation interval||Storage temperature||Current phase (number of subjects)||Number of approvals||Number of emergency use permits|
|Oxford AstraZeneca COVID-19 Vaccine (Vaxzevria, Kobi Shield) [A]|
OxfordDe University,AstraZeneca, CEPI
|英国||Adenovirus vector (ChAdOx1)||2 times|
|2 8℃||Phase III (30,000)||2||143|
|Pfizer-BioNTech COVID-19 Vaccine (Cominati, Tojinameran)|
|USA, Germany||RNA (modRNATheLipid nanoparticlesDisperse to)||2 times|
|-70 ± 10 ℃||Phase III (43,448)||5||93|
|Sputnik V COVID-19 vaccine (Gam-COVID-Vac)||ロシア||Adenovirus vector (, Ad5 and Ad26 types)||2 times|
|-18 ℃ (freezer)||Phase III (40,000)||2||6|
|Moderna COVID-19 vaccine |
|米 国||RNA (modRNATheLipid nanoparticlesDisperse to)||2 times|
|-20 ± 5 ℃ (freezer)||Phase III (30,000)||2||50|
Shino Farm: Beijing Biological Products Institute
|Chugoku||Inactivated COVID-2 (Vero cell)||2 times|
|2-8 ℃||Phase III (48,000)||4||50|
|Johnson & Johnson COVID-19 Vaccine |
Janssen Pharma,Johnson & Johnson,BIDMC
|United States, Netherlands||Adenovirus vector (, Ad26)||1 times||2-8 ℃||Phase III (40,000)||0||46|
|Chugoku||Inactivated COVID-2 (Vero cell)||2 times|
|2-8 ℃||Phase III (33,620)||1||32|
|India||Inactivated COVID-2 (Vero cell)||2 times|
|2-8 ℃||Phase III (25,800)||0||14|
|Chugoku||Adenovirus vector (, Ad5)||1 times||2-8 ℃||Phase III (40,000)||1||5|
|ロシア||Subunit (peptide)||2 times|
|2-8 ℃||Phase III (40,000)||1||2|
Anhui Zhifei Longcom Biopharmaceutical Co. Ltd.
|Chugoku||Subunit vaccine()||3 times|
|Phase III (29,000)||0||2|
Shino Farm: Wuhan Biological Products Research Institute
|Chugoku||Inactivated COVID-2 (Vero cell)||1 times[Source required]||Phase III (51,600)||0||2|
The Chumakov Center at the Russian Academy of Sciences
|ロシア||Inactivated COVID-2||2 times|
|2-8 ℃||Phase III (3,000)||0||1|
Research Institute for Biological Safety Problems
|Eur-lex.europa.eu eur-lex.europa.eu||Inactivated COVID-2||2 times|
|2-8 ℃||Phase III (3,000)||0||1|
|Sputnik Light||ロシア||Adenovirus vector (, Ad26 type)||1 times||2-8 ℃||Phase III (7,000)||0||3|
|(English: MVC-COV1901）||Taiwan||Subunit vaccine(S-2P protein + CpG 1018)||2 times|
|2-8 ℃||Phase III (5,120)||0||1|
- ^ Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by.
- ^ Long-term storage temperature. The Pfizer–BioNTech COVID-19 vaccine can be kept between -25 and -15 ° C (-13 and 5 ° F) for up to two weeks before use, and between 2 and 8 ° C (36) and 46 ° F) for up to five days before use.
- ^ Manufacturing partnership with the and Canadian Center for Vaccinology,, Nova Scotia
Vaccine candidates in human clinical trials
As of 2020, 11 of the vaccine candidates under clinical development are using adjuvants to increase immunogenicity..Immune adjuvantIs a substance that is added to vaccines to enhance the immune response to antigens such as COVID-19 virus and influenza virus...Specifically, adjuvants can be used to formulate COVID-19 vaccine candidates to increase their immunogenicity and efficacy to reduce or prevent COVID-19 infection in vaccinated individuals... The adjuvants used in the formulation of COVID-19 vaccines may be particularly effective in techniques using inactivated COVID-19 virus and recombinant protein-based or vector-based vaccines...Known as alumAluminum saltIs the first adjuvant used in an approved vaccine and is the adjuvant of choice in about 80% of adjuvanted vaccines...Alum adjuvant initiates diverse molecular and cellular mechanisms to enhance immunogenicity, including the release of inflammatory cytokines.
According to one expert, an effective vaccine against COVID-19 can save trillions of dollars in global economic impact, so the cost of billions of dollars looks small compared to that...In the early stages of a pandemic, it is not known if a safe, reliable, and affordable vaccine against the virus can be produced, and exactly how much it will cost to develop the vaccine. Was..Billions of dollars could be invested without success.
Once an effective vaccine is developed, billions of vaccines need to be produced and distributed worldwide. In April 2020, the Gates Foundation estimates that manufacturing and distribution will cost as much as US $ 4 billion...84-90% of vaccine candidates in Phase I clinical trialsDid not reach final approval during development, and 25.7% did not reach approval in Phase III clinical trials..Manufacturers' investments in vaccine candidates exceed US $ 10 billion, and millions of doses can be wasted if advanced manufacturing contracts are signed..
As of November 2020, companies subsidized under the US Operation Warp Speed program have set an initial price of $ 11 to $ 1 per flu vaccine. doing.. In December 2020, a Belgian politician briefly published a confidential price agreed between vaccine producers and the EU. :
|Manufacturer||vaccine||Price per dose in the EU|
|AstraZeneca||Oxford-AstraZeneca COVID-19 Vaccine||€ 1.78|
|Johnson & Johnson||Johnson & Johnson COVID-19 Vaccine||for US$8.50|
|Sanofi / GSK||€ 7.56|
|Pfizer / Biontech||Pfizer-BioNTech COVID-19 Vaccine||€ 12.00|
|R-Pharm||Sputnik V COVID-19 vaccine||for US$10.00|
|Moderna||Moderna COVID-19 vaccine||for US$18.00|
To deploy COVID-2021 vaccination after 19, 100-190 billion bottles (Vial) Global transportation and tracking may be required, and this effort is easily the largest everSupply chainBecomes an issue.. As of September 2020, Supply Chain and Logistics (logistics) Experts have expressed concern that the international and domestic networks for the distribution of licensed vaccines are not ready to respond in both quantity and urgency.The reason is mainly in 2020PandemicDue to resource deterioration during downsizing that reduces the lockdown and supply capacity of.. The COVAX (The COVID-19 Vaccines Global Access) partnership, global pharmaceutical companies, contract vaccine manufacturers, cross-border transportation, storage facilities, national health agencies, and many other organizations are facing global coordination. About issuesGAVI OfChief executive officer(CEO)States as follows. "Efficient delivery of billions of vaccines worldwide involves highly complex logistical and programmatic obstacles along the supply chain.".
As an example of emphasizing the size of the taskInternational Air Transport AssociationTransports only a single dose to people in more than 19 countries experiencing the COVID-200 pandemic, with 1 aircraft747A type freighter (introduced a precision vaccine cold storage device) is required... "In a fast-moving pandemic, if everyone isn't safe, no one is safe," GAVI said..
In contrast to multi-billion dollar investments in vaccine technology and early-stage clinical research, the vaccine's post-licensing supply chain has not received similar planning, coordination, security, or investment...The main concern isLow and middle income countriesVaccine distribution resources, especially for vaccination of children, are scarce or absent... In September, the COVAX partnership included 9 countries coordinating plans to optimize their COVID-172 vaccine supply chain.,UNICEF(UNICEF) will work with COVAX to prepare funding and supply chains for vaccination of children in 92 developing countries..
Logistics services for vaccination ensure the necessary equipment, staff and supply of licensed vaccines across international borders...At the core of logistics is the handling and monitoring of vaccines,Cold chainIncludes management, distribution safety within the vaccination network, etc... The purpose of the COVAX facility is to integrate manufacturing, transportation and overall supply chain infrastructure, centralize and equally manage logistics resources among participating countries...Includes logistics tools for vaccine forecasting and needs estimation, domestic vaccine management, potential waste, and inventory management.
- Individual vaccineVialThebarcodeVisibility and traceability
- Sharing of supplier audits
- Vaccine vial transport from manufacture to recipientEvidence preservationSharing
- Use of vaccine temperature monitoring tools
- Temperature stability test and guarantee
- New packaging and delivery technology
- Adjustment of supplies in each country (Personal Protective Equipment (PPE),, Syringe, needle, rubber stopper, freezer power supply, waste disposal, etc.
- Communication technology
- Environmental impact of each country
According to one vaccine developer, a lack of logistics at any stage could derail the entire supply chain...If the vaccine supply chain fails, the economic and human costs of a pandemic can be prolonged over the years..
As of August 2020, months after the establishment of safety and efficacy, many governments have more than US $ 8 billion, despite some vaccine candidates entering Phase III trials. Pre-ordered more than 50 billion vaccines at a cost..2021 vaccine pre-orders from the UK Government were 1 per person.. In September, CEPI provided financial support for basic and clinical research on nine vaccine candidates under a funding commitment to produce two billion doses of three vaccines approved by the end of 9. ing.2022 A total of 70-100 billion COVID-19 vaccines could be produced worldwide by now, but large pre-orders (called "vaccine nationalism") by rich countries are vaccines in poorer countries. It threatens the use.
After joining COVAX in October, China announced that it would produce 10 million vaccines by the end of 2020 and another 6 billion vaccines in 2021, but 10 billion people are home to it. It was unclear how many vaccines would be produced for the population of.Shino FarmThe company states that it may have a production capacity of over 2021 billion doses in 10.. Sinovac will complete its second production facility by the end of 2020CoronaVacIt says it aims to increase its production capacity from the previous 3 million doses to 6 million doses..
AstraZenecaThe CEO said: "The challenge is not the production of the vaccine itself,VialIs in filling.There are not enough vials in the world "In preparation for the high demand for vial manufacturing, an American glass maker invested $ 7 million for a vial factory in July.Although there are concerns about the availability of glass for vial production and the management of contaminantsShows rising manufacturing costs and diminished potential developer interests amid demand for affordable vaccines.
Vaccines must be handled and transported according to international regulations, maintained under different temperature controls by vaccine technology, and used for vaccination before they deteriorate during storage... The size of the COVID-19 vaccine supply chain is expected to be enormous to ensure global delivery to vulnerable populations...Priorities for preparing facilities for such distribution include optimization of temperature-controlled facilities and equipment, infrastructure, training of vaccination staff, and rigorous monitoring..RFIDThe technology is being implemented to track and certify vaccine dosages along the entire supply chain from manufacturer to vaccination..
2020 year 9 month,CompanyJohnson & JohnsonWith the companytechnology transferとAgreed to support the production of vaccine candidates, including production.. In October 2020, a partner scheduled to manufacture the first dose in December 10Lonza GroupBut in SwitzerlandAnnounced to manufacture vaccine candidate moderna..The newly constructed 2,000-square-meter facility will begin production at 3 million doses annually.The products manufactured here will be shipped frozen at -70 ° C to Laboratorios Farmacéuticos Rovi SA in Spain for the final stages of production...Lonza's base in Portsmouth, New Hampshire aims to begin producing US-specific vaccine ingredients as early as November..
Vaccines (and adjuvants) are inherently unstable to temperature changes and are throughout the supply chain.Cold chainRequires control and is usually kept at a temperature of 2-8 ° C (36-46 ° F).. The technology of the COVID-19 vaccine is diverse among several new technologies, so cold chain management presents new challenges, and some vaccines that are stable during freezing but are sensitive to heat should be frozen. Some vaccines are not, and some are stable above temperature...Freezing damage and lack of personnel training in the on-site inoculation process are major concerns...If multiple COVID-19 vaccines are approved, the cold chain of vaccines may have to address all of these temperature sensitivities between different countries, where climatic conditions and local resources for temperature maintenance change. Have sex.Shino FarmAnd Sinovac's vaccine is an example of an inactivated vaccine in Phase III trials that can be transported using existing cold chain systems, but CoronaVac itself does not need to be frozen..
The modRNA vaccine technology under development is difficult to control for mass production and degradation and may require storage and transportation at very low temperatures...As an example, Moderna's RNA vaccine candidates would have a limited shelf life if cold chain management was performed at sub-zero temperatures. BioNTech-Pfizer RNA candidates require storage below -70 ° C during transport storage from vaccine production to inoculation.
vaccineVialContains several doses of vaccine, but has a time limit after being punctured for the first dose and must be discarded after that, so it is suitable for local cold storage and management of the inoculation process. Need to pay attention.. Because COVID-19 vaccines are likely to be in short supply in many places during initial deployment, health authorities, agencies and vaccination staff are responsible for the supply of other well-supplied vaccines in general. It is required to avoid as much as 30% of corruption and disposal as much as possible..
Cold chains are also bikesDroneVaccine transport methods in local communities such as, the need for booster administration, the use of diluents, access to vulnerable people such as healthcare workers, children and the elderly are also challenges..
Supports long-term storage of vaccines in some countriesUltra low temperature freezerThe number ofSince the inoculation is in the summer, it is necessary to have cold storage equipment that can carry the vaccine in small portions from the freezer to the inoculation site, which is a heavy cost burden...Since many non-pharmaceutical specialists are involved at the end of the cold chain, there are cases where the low temperature cannot be maintained due to improper handling of equipment, resulting in disposal..
Air and land transportation
International air cargo coordination is an integral part of the time- and temperature-sensitive distribution of the COVID-19 vaccine, but as of September 2020, the air cargo network is not ready for multinational deployment... "Safe delivery of the COVID-19 vaccine will be the mission of this century for the global air cargo industry, but it cannot be achieved without careful prior planning, and the time is now. I. We urge governments to take the lead in facilitating cooperation across the logistics chain to prepare facilities, security arrangements, and border procedures for challenging and complex tasks. To "International Air Transport Association(IATA) Executive Director and CEOSaid in September 2020.
In 2020, due to a severe decrease in passenger air traffic, airlines will cut headcount to keep costs down (Layoff), Reducing routes, storing and selling aircraft, etc... As a leader in the procurement and supply of COVID-19 vaccine within the WHO COVAX facilityGAVI AllianceとUNICEFIs preparing for the largest and fastest vaccine deployment to date, with international air freight transport cooperation, customs and border control, and 1 aircraft to deliver a single vaccine to multiple countries. May require freighter.
Security and corruption
Widespread demand for COVID-2,000 vaccines across the supply chain, as pharmaceuticals are the world's largest market and are worth about $ 19 billion annually.Counterfeit goods,theft,Bad business law,Cyber attackVulnerable to..The lack of a harmonious regulatory framework between countries, such as poor technical capacity to identify and track counterfeit and genuine vaccines, restricted access, and ineffective capacity, is vaccinated. May threaten the lives of others and perpetuate the COVID-19 pandemic..Tracking system technology used in packaging materials is used by manufacturers to track vaccine vials throughout the supply chain., Also digital and to ensure the security of the vaccination teamBiometricsUsing the tool.
National infrastructure development
Although WHO has an "effective vaccine management" system in place, This includes building priorities for preparing national and quasi-national personnel and facilities for vaccine distribution, including:
- Training staff to handle time- and temperature-sensitive vaccines
- Robust monitoring capabilities to optimize vaccine storage and transport
- Temperature controlled equipment / equipment
- Facilitate takeoff and landing clearance
- Of flight attendantsquarantineExemption from requirements
- Promotion of flexible operation for efficient domestic expansion
- Grant landing priority to maintain vaccine temperature requirements
Vaccine expiration date
Made by Pfizer as an exampleTojinameran, Pfizer-Biontech, BNT162b2, Kominati intramuscular injection) is valid from the date of manufacture even when stored in an ultra-low temperature freezer (minus 90 ° C-60 ° C).6 months(However, in the 2021th edition of the package insert of the vaccine issued on September 9, 10, the expiration date for storage at minus 6 ° C-90 ° C is from 60 months.9 monthsHas been extended to), Made by Moderna that can be stored in a general low temperature freezer (mRNA-1273, COVID-19 vaccine modeler intramuscular injection), but the limit is about 2-3 months after arrival at the site.Inventories and distribution management with an eye on supply and demand are important.
By October 2021, in some developed countries, the second inoculation of residents will have reached a certain rate, the increase in the inoculation rate will reach a plateau, and there will be a surplus of vaccines that have been secured in advance. The outlook has come out.In Western countries, about 10 million doses are expected to expire by the end of 2, and in Japan, about 2021 million doses are expected to expire by the end of March 2.There is a call for the establishment of a framework for international compatibility with countries that lack surplus vaccines that are about to expire..
For Pfizer products, the expiration date has been extended to 9 months, but the expiration date is stamped for each product, and as a general rule, the expiration date of existing products will not be extended.However, Shimane PrefectureMatsueThen, according to the opinion of the city's vaccination committee by specialists, there is no problem with efficacy and safety, and it is a policy to continue vaccination as long as it is within the extended deadline..
There was a future risk to the manufacturer as no physical long-term safety could be confirmed.On the other hand, on February 2020, 2,Alex OtherThe U.S. Secretary of Health and Welfare has stated that the "Public Preparation and Emergency Preparedness Act" for medical measures against COVID-19 (Public Readiness and Emergency Preparedness Act) ”Was published.The subject was "any vaccine used to treat, diagnose, cure, prevent or alleviate infection with COVID-19, or SARS-CoV-2 or its mutant virus," and the declaration was "manufacturer in vaccine production." Claims for the negligence of the medical provider who prescribes the wrong dose or the negligence of the medical provider are excluded unless there is intentional tort. "..This declaration is valid in the United States until October 2024, 10.
Social MediaSo, it is said that the COVID-19 vaccine is already available when it was not available.Conspiracy theoryWas also seen.The patents cited in various SNS posts includeSARS coronavirusExisting patents on gene sequences and vaccines of other strains such as COVID-19 are referenced, but not on COVID-XNUMX..
The United States, which was selling a vaccine called "nCoV2020 spike protein vaccine" on May 5, 21.SeattleTo North Coast Biologics, based inUS Food and Drug Administration(FDA) announces that it has sent a notice of cancellation.
Some hoaxes about other vaccines include:
- infertilitybecome[Note 1]
- For corona vaccineRFID tag-MicrochipIs mixedGovernment manages humans by embedding tags and chips
- When you inoculate the corona vaccineBluetoothConnected to peripherals through
- Humans after vaccination with mRNA vaccineDNAIs modified
- 5G communicationConnected to
- The bodymagnetbecome
- Human immunodeficiency virusInfected with (HIV)
- The governmentGenetic manipulationTrying to
2021 year 7 month 19 dayYomiuri ShimbunOnline coverageThen, "English NPO"Anti-Digital Hate Center (CCDH)According to the survey, 65% of the hoaxes related to vaccines on SNS originate from 12 individuals and groups. "United States Attorney GeneralRobert F. KennedyAlso includes his son Robert F. Kennedy Jr.As a countermeasure,Facebook,TwitterSo, deletion of information denied by the Health Organization, retweets and "How niceMeasures such as suspension of function are being taken.
Misinformation in Japan
Chuo UniversityProject ProfessorKunihiko Takeda TheYouTubeAccording to the results of the UK vaccination, "If all 320 million Japanese high school students are vaccinated, there is a probability that 50 people will die or suffer side effects."However, in the United Kingdom, no deaths have been reported that have a causal relationship with the vaccination of Pfizer and AstraZeneca, and no corresponding side reactions have been reported, and Takeda's remarks are incorrect..
In February 2021, Israel, which is the most inoculated with the COVID-2 vaccine in the world, and in March the following March, China will prove the inoculation of the COVID-19 vaccine.Vaccine passportIs issued, Each country is said to follow this.
Some European countries as of April 4 (アイス ランド,エストニア,Cyprus,ジ ョ ー ジ ジ,ポーランド,ルーマニア), In Latin AmericaEur-lex.europa.eu eur-lex.europa.eu,ベリーズ,エクアドル,Indian OceanIsland countrySeychellesCountries such as Japan have begun to lift the ban on travel entry for vaccine passport holders.However, depending on the country, the vaccinated vaccinePharmaceutical manufacturerThere is a difference between valid and invalid depending on.
In Japan, from July 2021, 7, the fact of vaccination for overseas travelers will be announced.Officially certifiedStart accepting applications for issuance of certificates in each municipality.However, when returning to JapanquarantineThere is no relaxation of measures.
Vaccine security and inoculation status
The status of COVID-2021 vaccine in the world as of April 4, 10 is as follows..
Number of vaccinations per 100 people / Cumulative number of vaccinations
The status of COVID-2021 vaccine in the world as of April 9, 5 is as follows..
Number of vaccinations per 100 people / Cumulative number of vaccinations
As of September 2021, 9, the number of vaccinations per 5 people in Japan was 100, which rapidly exceeded 107.5 million in less than half a year from March..
イ ス ラ エ ル
As of March and April 2021, the COVID-3 vaccine per capita rate is the highest in the world.イ ス ラ エ ル.JewDiasporaFace political instability by leaking commitments from Pfizer executives to preferentially receive large doses of vaccines through a connection withNetanyahuMedia analyzed that it was the prime minister's recovery strategy.
On March 2021, 3, Lan Balichel, Israeli Corona Vaccine Specialist Team Representative and Chief Innovation Officer of Clarit, Israel's largest health organization, announcedJapan Press ClubAccording to what he said at the remote lecture hosted by、「昨年（2020年）の12月19日から高齢者優先で始まったワクチン接種は、16歳以上の全住民に対象が拡大され、イスラエル国民約920万人の60％がすでに接種済みで、50％が2回接種済み。特に50歳以上は80％が2回目の接種を受けており、高齢者はワクチンで守られているThe reason why Israel was able to procure the vaccine earliest in the world was "I had a pre-purchase contract with a vaccine maker before December of last year. If the infection increases further, Pfizer and others I had a contract with the manufacturer to give priority to the vaccine. ".."Instead, the condition was that data on infections would be shared worldwide, which means that Israel could become a'testbed'for vaccination and procure important vaccines faster.".
Regarding the method of vaccination in Israel, "In Israel, vaccine clinics have been opened in various places for vaccination.He said that he had hundreds of clinics all over Israel in a week.Clinics were set up by setting up tents in large hospitals and plazas, and the management of inoculated people was digitized 20 years ago.Electronic medical recordIn Israel, he said that the information on who received the vaccination and the date and time of the second vaccination was decided at the time of the first vaccination.digitalizationRevealed that the progress made was very helpful for efficient vaccination..."It was important to ensure transparency. We told the public what we knew and what we didn't understand as a clear message... ".
Regarding the method of promoting vaccination, he explained, "People who have been vaccinated are given a'green badge'." "If you receive a mark certifying that you have been vaccinated on your smartphone, you can eat inside the restaurant and participate in concerts and cultural events. On the other hand, those who have not been vaccinated can go to the restaurant. By applying different rules to those who have been vaccinated and those who have not, such as saying that they can only eat outside the restaurant, economic activities can be resumed with peace of mind and the number of vaccinations will be increased.IncentiveIt also became ".
The United States of America
As of July 2021, the United States has a tendency to level off with a vaccination rate of 7% of the total population.President of the United StatesJoe BidenWas a speech on July 7 of the same year,United States Federal GovernmentLocal authorities have called on vaccinated people to pay $ 100 to encourage vaccination, and have announced that federal officials and employees of trading companies will be required to disclose vaccination status..
in Japan,Vaccination methodAccording to the provisions of Article 7, Paragraph 2 of the Supplementary Provisions, Article 6, Paragraph 1 of the same ActTemporary inoculationIs done in the form of.
From February 2021, 2, the first regulatoryly approved Pfizer vaccine will be inoculated.Medical facilityIt was started for medical professionals in Japan (implemented by prefectures).Next, the municipalities took the lead in implementing the vaccinations, and from April onward, reservations for vaccinations were started for the elderly aged 4 and over.
From August 5TokyoCity center (Otemachi)WhenOsakaCountry established in (SDF) Was opened and the target area was expanded nationwide, and from June 6, the target age was expanded to 17 years or older.
Since June 6, occupational inoculation at companies and universities has started.
For the purpose of inoculating the majority of the people and inhabitants rapidly and quickly, the following problems have become apparent.
- Implementation method and reservation method are different for each municipality
- There are group vaccinations at schools and public facilities, individual vaccinations at local hospitals and clinics, and both, and the reservation method may differ depending on the local government (reservation on a special site, special site for medical institutions or own hospital site). , Direct reservation by phone (mixed local governments that can and cannot),Call centerCall to, local government will notify you by specifying location and date (egNiigataJoetsu City), Other)
- Reservation system (Internet, telephone) due to mass accessPunkConfusion such as
- Concerns about waste of vaccines due to double reservations with large-scale venues of countries (Self-Defense Forces) established in Tokyo and Osaka
- InoculateDoctor,nurseLack of
- Recalling nurses who retired due to childbirth, childcare, retirement age, etc.In addition,Dentist,medical internInoculation by is also done in some,Furthermorepharmacist,Medical studentWhile inoculation bySince inoculation is also a pure medical practice, there are high hurdles such as law revisions, and the Ministry of Health, Labor and Welfare is reluctant..
- In addition, other than nursesCo-medicalThen,Paramedic,Clinical technologistThe policy to enable inoculation by.
- In the case of occupational inoculation at companies and universities, it is necessary to secure medical staff to inoculate on their own, and it is a dedicatedIndustrial physicianCompanies at the level ofFaculty of medicineIn fact, it is capped by universities that have (especially the latter, which dispatches staff and provides venues for municipal inoculation)..
- Occurrence of disparity in inoculation rate of residents in each municipality (prefecture, municipality)
- In some less populated municipalities, vaccination of applicants over the age of 16 was almost completed in May (eg).FukushimaHinoemata Village). on the other hand,HokkaidoNemuroIn some cases, the completion of inoculation for people aged 65 and over is "early September"..
- In particular, to local governments that started inoculation for people aged 6 and over, which was expanded in June,Vaccine evasionProtest phone call seen by the faction (Electric convex) Occurrence.
- The target age of the large-scale venues of the Self-Defense Forces in Tokyo and Osaka has been expanded from June 6 to 17 years or older, which is the target age of the Moderna vaccine., Inoculation requires an inoculation ticket sent by the local government, and you cannot receive the inoculation unless the local government ships it..
- Internal management mistake
- Disposal of vaccines that can no longer be used due to mishandling (details will be described later in "#Vaccine misdisposal problem"reference)
- Due to inoculation mistakes due to management mistakes, needle stick accidents, and other mistakesMedical accident(Details will be described later.#Medical accidents associated with vaccination(See)
- After accidentally puncturing the inoculator's finger, replace only the needle without discarding the inoculation syringe to inoculate the inoculated person, accidentally puncture the inoculated person with a used syringe set, etc. ..Both are at risk of infectious diseases
- Second inoculation to the same person within 3 weeks (same day, next day, etc.)
- Misinoculation of low-concentration vaccine due to mistake in dilution
- Deceive local governments (health centers, municipal offices), etc. and ask for money and personal information related to vaccinationSuspicious phoneAnd individual visits
- About vaccineFalse information (hoax) OfSocial MediaRefraining from inoculation of young people due to diffusion in → The above-mentioned "Incorrect informationSee section
Securing vaccines in Japan
October 2020, 6- Katsunobu KatoThe Minister of Health, Labor and Welfare (at that time) announced that he would establish a mass production system for corona vaccines by the first half of 2021, and with the second supplementary budget of 2020 billion yen in 2, he would accelerate the development of the production system for vaccine development companies. Showed a policy to subsidize the cost to proceed.
October 2020, 6- Shinzo AbePrime Minister(At that time)Nico Nico Live Broadcast"We are negotiating with Moderna in the US and AstraZeneca in the UK so that we can get the vaccine at the end of the year at the earliest.".
2020 year 7 month,United States Federal GovernmentA senior official in charge of the vaccine strategy "Operation Warp Speed" said on June 2020, 6, "The top priority is to protect the American people. It will not prevent other countries from getting the surplus.".
On September 2020, 9, the Japanese government announced a policy to make all citizens free of charge for coronavirus vaccination without asking for their own expenses..
August 2021, 1,Yoshii KanThe Prime Minister (at that time)Taro KonoMinister for Regulatory Reform(At that time) the minister in charge of vaccination "Minister in charge of promoting new coronavirus vaccinationAppointed to..On January 1th, after approving the vaccine in mid-February, vaccination was started from the medical staff who participated in the safety survey from the end of February, and since then, the medical staff, the elderly aged 19 and over, and the elderly After giving priority to vaccinations for people working in facilities and facilities for persons with disabilities and those with a disease, it is assumed that vaccinations will be given to the general public in May and will be given to all citizens aged 2 and over by July. Schedule announced by the government.
As of January 2021, 1, the Government of Japan has signed contracts with three companies, Moderna, AstraZeneca, and Pfizer, on the premise of successful vaccine development..
According to a report on January 1, a pharmaceutical manufacturer headquartered in Ashiya City, Hyogo Prefecture,JCR PharmaAnnounced that it plans to manufacture 9,000 million doses (4,500 million people) of AstraZeneca's vaccine for Japan in Japan..
Prior to vaccination in each municipality in Japan, January 2021, 1KanagawaKawasaki City OfKawasaki City College of NursingAt the gymnasium of Kawasaki CityMinistry of Health, Labor and WelfareVaccination training was conducted by.
Also, on October 2021, 1,TokyoNerima-kuHowever, on a small scale for vaccination starting in the spring of 2021ClinicMainly vaccination in Japan, combined with large-scale vaccination in public facilitiesNerima Ward modelThe Ministry of Health, Labor and Welfare provided information to local governments nationwide as a precedent case..KyotoKyoto City,TochigiSano CityLocal governments all over the country have decided to introduce this "Nerima Ward model"...After that, from May 2021, when inoculation began in earnest in each local government nationwide, many local governments, mainly in urban areas, mainly used individual inoculation, and some combined inoculation. It has been adopted.
On February 2021, 2, the first flight of the American Pfizer vaccine for Japan will have a Pfizer manufacturing plant.ベルギーFrom Chiba prefectureNarita International AirportIn addition, freight flights by passenger planes (Boeing 787-9) Arrived.Transportation has been in regular service since before the COVID-19 epidemic.ANAWas in charge of..The second flight arrived on February 2, the third flight arrived on March 2, and the fourth flight arrived on March 21... Four airlifts (February 2th to March 12th) secured a maximum of about 3 million times and about 8 million people... On the 4th flight arriving on April 5, the aircraft will be even larger due to the increase in transportation volume (Boeing 777-300ER).
At a press conference on April 4, Prime Minister Suga said, "The government will work together to ensure that each local government can complete two vaccinations (for the elderly) with the end of July in mind."..Minister Kono did not show the basis for this policy at the House of Representatives Cabinet Committee on the 28th...In addition, the Ministry of Health, Labor and Welfare is also grasping the state of the body on the 26th. ".
In the week of April 4, 26 doses of vaccine will be distributed to all municipalities..
July 5, USAJohnson & Johnson(Janssen Pharma) Announced that it has applied to the Ministry of Health, Labor and Welfare for manufacturing and marketing approval of its single-dose vaccine..However, at the time of application, there is no supply contract with the Japanese government such as Pfizer Moderna AstraZeneca..
On June 6, the Ministry of Health, Labor and Welfare announced that Pfizer's new coronavirus vaccine has been released.Over 16 years oldWas subject to publicly funded inoculation, but from this dayOver 12 years oldInoculation target was expanded to.
In a party leaders' debate on June 6, Prime Minister Suga said that he would like to "realize all the necessary people from October to November" regarding vaccination..
In August, publicly funded vaccinations for Moderna vaccines were expanded to 8 years and older., AstraZeneca vaccine was added to the publicly funded vaccine for people over 40 years old in principle.
On August 8, the Ministry of Health, Labor and Welfare announced that it would suspend the use of about 26 million lots of the company's vaccine suspected of being contaminated with foreign substances after a series of foreign substances were found in some of the moderna vaccines after the 16th of the same month... As a result of an investigation by Moderna on September 9, it was found that the foreign matter was a piece of stainless steel mixed in due to a defect in the assembly of the manufacturing equipment, and the product in the lot in question was voluntarily collected by the company. ..In addition, if a product in a lot other than the lot to be collected contains rubber pieces, but it is thought that part of the rubber on the lid has been mixed in during the manufacturing or collection process. It is possible to continue inoculation.
Vaccination status (initial)
As of the end of January 2021, the delay in the start of vaccination in Japan was conspicuous while vaccination was already in full swing in developed countries.Of the major developed countries, Japan was the only country that had not been approved for the vaccine..
On February 2, the same year, there was a special approval from the Ministry of Health, Labor and Welfare for the Pfizer mRNA vaccine in Japan as well., The inoculation started on February 2th in Japan.The first official inoculator isTokyoMeguro OfNational Hospital Organization Tokyo Medical Center Of院長Met.Priority was started from inoculation to medical staff.. "In the future, vaccinations for medical professionals will be promoted at hospitals in each prefecture," he explained.
As of the end of March 2021, the number of vaccinations per 3 people in Japan was 100.OECDWas the lowest among the 37 countries of..As of April 4, the same year, more than 27% of the population was vaccinated more than once, which was lower than 1% of the whole Asia...After that, the vaccination rate rose rapidly over the period, and on September 9, the number of people who received the second vaccination reached 13% of the total population.Of these, 65% were older than 88 years old...As of October 10, the same year, the number of people who received the second vaccine was 4% of the total population, and 2% when the first was completed..
Initially in Japan, for 12 years old and over (AstraZeneca products are 40 years old and over in principle, 18 years old and over if necessary), Vaccination priority guidelines have been established in the following order.
- Medical staff, etc. (hospital,ClinicStaff,pharmacist,Emergency servicesMember,Health centerStaff etc.)
- Persons born before April 32, 1957 (elderly people aged 4 and over)
- Underlying diseases other than the elderly (Heart disease,Diabetes mellitus,BMI30 or more)Facilities for the elderlyWorkers such as
- Persons other than 1. --3 above
同年3月、まず医療従事者などへのワクチンの優先接種が本格的に開始。同年4月15日時点で、優先接種対象の医療従事者等480万人のうち2回目の接種を完了したのは約68万人（14％）、1回目完了が117万人（24%）であった。優先接種対象の医療従事者等にはには新型コロナウイルスの感染者に接する機会が多いQuarantine stationThe staff of the hospital and the health center were also included, but at this point the vaccine supply was insufficient., NHK interviews showed that quarantine station staff had not been vaccinated..
As of April 4, about one-third of medical professionals completed the first vaccination..
第2順位の65歳以上の高齢者に対しては4月12日に一部の自治体で接種が開始され、4月26日以降本格的に接種が開始された。第1順位の接種を受ける医療従事者の数が当初の想定より100万人多い470万人に増えたことや接種対象となる高齢者が約3600万人に上ること、日本で広く使われる注射器では1瓶から6回分を採取できないこと、ファイザーのワクチン増産が5月以降となることなどから、スケジュールの遅延が予想された..As mentioned above, vaccination of medical staff was delayed, so some local governments diverted the distributed vaccine for the elderly to local medical staff..
In addition, there have been a series of cases in which the mayors and staff of local governments inoculate the vaccine effectively against the surplus of vaccine due to cancellation, etc., and it is difficult to make reservations for vaccination especially for the elderly, which is confusing. While it is occurring, there are some opinions that are problematic from the perspective of fairness.However, Taro Kono, the minister in charge of administrative reform, who is in charge of promoting vaccination, said, "It is extremely unforgivable that valuable vaccines are being discarded. I want you to use it effectively at the discretion of the local government so that it will not be discarded. If there is criticism, I will take responsibility. ".
Regarding the problem of the number of inoculations per bottle caused by the syringe, Kyoto PrefectureUji Tokushukai HospitalIf the conditions are metInsulinPfizer vaccine can be inoculated 1 times from 7 bottle with a syringe. Also,TerumoDeveloped a syringe that can inoculate 1 times from 7 bottle and started production from the end of March of the same year.
On April 4, the same year, the governmentTokyoとOsakaAnnounced the establishment of an inoculation site for 1 people a day, and on the 1th, Prime Minister Yoshihide Suga instructed the establishment of an inoculation site by the Self-Defense Forces in Tokyo.The policy is from May 27th to 5 months.The place is TokyoOtemachi Joint Government Building, Osaka prefectureOsaka Prefectural International Conference Center(Osaka cityNakanoshima), Which was opened from May 5th in both Tokyo and Osaka...It was reported that the vaccine will be made by Moderna (assuming approval), which is under review for approval, instead of Pfizer, which has already been distributed to local governments, to prevent confusion in management...Also, TokyoMachida-shiThen.Soccer J League-FC Machida ZelviaIs the home stadium ofMachida City Athletics StadiumUse (facility naming rights name, Machida GION Stadium) as a mass inoculation venueEach local government is implementing or considering the establishment of an inoculation site using large-scale facilities such as the Kokugikan, stadium, and racetrack..
On May 5, Moderna and AstraZeneca vaccines were specially approved by the Minister of Health, Labor and Welfare.As a result, three new coronavirus vaccines were approved in Japan, but of these, the viral vector vaccine made by AstraZeneca is rare.ThrombosisSince cases of side reactions that develop the disease have been reported overseas, it was decided to forgo public inoculation in Japan for the time being.(Public inoculation has been resumed since then, as described below).On the 23rd of the same month, the SDF members and private nurses were vaccinated with the Moderna vaccine at the Osaka Prefectural International Convention Center, which is a large-scale inoculation venue operated by the SDF.From the following day, 24th, we started vaccination with Moderna vaccine for elderly people aged 65 and over at large-scale inoculation venues in Tokyo and Osaka..
To local governments nationwideMinistry of Internal Affairs and Communications・ As a result of a survey conducted by the Ministry of Health, Labor and Welfare, 5% of local governments answered that "the inoculation of elderly people is scheduled to be completed by the end of July" announced on May 21..
On June 6, the government announced that it would start inoculation in occupational areas at companies and universities from the 1st of the same month in order to reduce the burden on the region and accelerate inoculation.Use the same Moderna vaccine as the large-scale venue by the Self-Defense Forces in Tokyo and Osaka..Actually from the 13th of the same monthAll Nippon Airways(ANA Holdings), From 14thJapan Airlines,Yomiuri ShimbunSome companies such as start inoculation of occupational areas ahead of schedule..After that, as the application for occupational vaccination was made at a faster pace than expected, there was a possibility that the supply of the moderna vaccine to be used became insufficient, so the government suspended the application at 6:25 on June 17. Announced..The daily deliverable amount of Moderna vaccine for occupational inoculation has reached the upper limit, which isbottleneckThe main reason is that there is a possibility that there will be a shortage of vaccines.In addition, it was scrutinized that there were cases where companies applied for an amount larger than the number of employees, but in conclusion, on the 30th of the same month, Prime Minister Suga made a new application for occupational vaccination at the relevant ministerial meeting on progress such as vaccination. Announced that the application will be effectively suspended.At this time, we are considering supporting large-scale inoculations carried out by local governments not only by Moderna but also by Pfizer, but the prospect of vaccine supply is uncertain, and some local governments have begun to stop accepting reservations..
In addition, the Ministry of Health, Labor and Welfare has been adjusting the AstraZeneca vaccine, which had been postponed for use in public vaccination due to the risk of adverse reactions to the development of thrombosis, in the direction of allowing publicly funded vaccination for people aged 60 and over.However, on July 7, the same year, it was decided to add it to the target of publicly funded inoculation for people aged 30 and over in principle., Officially added from August 8rd.
Vaccine status (mid-late)
As mentioned above, despite various confusions, the vaccination rate in Japan has been steadily increasing, and as of October 10, the same year, the number of people who have been vaccinated for the second time is 4% of the total population, and 2 when the first time is completed. %Met.. British statistics voluntary organization "According to the survey, the inoculation rate (population ratio statistics of the number of inoculated people) up to the number of inoculations planned by the health authorities of each country (usually 2 times, 3 times depending on the country) is based on the statistics as of October 10, the same year. It surpasses 17%, 66.47% in the United Kingdom, 65.7% in Germany, and 65.15% in the United States, which is comparable to the world..
In addition, the issue of inoculation priority is left to the discretion of the local government, so there are differences in the response depending on the local government, but it is generally resolved by the latter half of the summer, and many local governments have relatively few applicants. The reservation status is such that vaccination can be done promptly..
On the other hand, the situation of securing vaccine supply has begun to make a big difference depending on the local government. According to a report on October 10, in Nagoya City, which has a population of more than 13 (the same year), reservation slots are not 100% filled at large venues, etc., and inoculation without reservation is possible at some times. On the other hand, in Kuwana City, Mie Prefecture, the supply of Pfizer vaccine supplied from Mie Prefecture has tapered, and since October 10, it has been impossible to respond to inoculation and reservations are not possible. , The disparity in inoculation response between local governments is emerging..Also, in Koriyama City, Fukushima Prefecture and Hiroshima City, Hiroshima Prefecture, the government and prefectures did not indicate that the supply quota for Pfizer vaccines would be secured until October of the same year. It has become.
While the inoculation rate is rising, the slump in the inoculation rate of young people has become a problem.In Osaka Prefecture, as of October 10th, the first vaccination rate for young people in their 15s and 20s has finally reached the 30% level..
Vaccine misdisposal problem
Until 2021, the supply was not sufficient for the total demand for vaccines not only in Japan but also from a global perspective, and as mentioned above, it was used correctly not only for promoting inoculation but also for moral reasons. There is a problem in being discarded without being done, KonoMinister for Administrative ReformAt a press conference on May 2021, 5, (at that time) made an unusual statement that it was "extremely unforgivable" for the disposal of surplus vaccines..
Even under such circumstances, due to the rapid inoculation of a large number of residents, the following erroneous disposals are occurring one after another due to various handling mistakes, erroneous procedures, and other causes.It is not a mistake, but the residents who booked the inoculation canceled without contact by the day of the inoculation, so there were cases where it was unavoidably discarded, so we are calling for caution..
Also, as mentioned above, some types of vaccines require strict temperature control such as cryogenic temperatures and have a short expiration date. For example, Pfizer products have an expiration date of 6 months even when stored in an ultra-low temperature freezer.(However, in the 2021th edition of the package insert of the vaccine issued on September 9, 10, the expiration date when stored at minus 6 ° C-90 ° C is9 monthsHas been extended to), Even if it is made by Moderna that can be stored in a general low temperature freezer, it is limited to about 2 to 3 months after arriving at the site.Inventories and distribution management with an eye on supply and demand will become important.
|Date and Time||Place||Number of waste||Cause||Source|
|XNUM X Year X NUM X Month to X NUM X Day||Kobe City||About 1200 times||The power plug of the cool box has fallen off (the extension cord is left on the aisle), and it is delivered naked without being put in the cold box.|||
|XNUM X Year X NUM X Month to X NUM X Day||TokyoHachioji City||About 258 times||Incorrect dilution procedure|||
|October 2021th, 5||Kawasaki City||For 150 people||After moving to a normal refrigerator, due to a temperature control error|||
|October 2021th, 6||Sakai City||For 210 people||Accidental operation of the breaker at night at the inoculation site|||
|October 2021th, 6||Kawasaki City||For 6396 people||Temperature rise using a cryogenic freezer to be recalled|||
|October 2021th, 7||Shinjuku ward||For 1644 people||Refrigerator temperature control error (cause unknown)|||
|October 2021th, 9||Shinagawa||2500 times||When I replaced the outlet to move the refrigerator, the preset set temperature was reset.|||
|October 2021th, 9||MieTsu City||4800 times||Accidental operation of the breaker at night at the inoculation site|||
|October 2021th, 9||EhimeSeiyo City||84 times||Inoculation facility Medical institution leaks water due to aging water pipes, floods, and power outages due to electric leakage|||
|October 2021th, 9||SaitamaKazo City||54 times||Refrigerator temperature control error (estimated to be out of order)|||
|October 2021th, 9||Saitama||156 times||Temperature rise due to erroneous operation of refrigerator switch|||
|October 2021th, 9||GunmaOta City||2890 times||Temperature rise due to opening of refrigerator door|||
|October 2021th, 10||IbarakiMito||666 times||Power outage due to defective high-voltage switchboard at inoculation facility medical institution, refrigerator temperature rises without emergency power generation and no auxiliary power supply|||
|October 2021th, 10||IbarakiTsukuba City||4800 times||For some reason, the breaker is cut off, the refrigerator is stopped, and the temperature rises.|||
|October 2021th, 10||SaitamaFujimino-shi||420 times||Temperature rises due to unplugged refrigerator|||
|October 2021th, 10||SaitamaTokorozawa||384 times||When moving from the cool box to the refrigerator, bottles with different lot numbers were mixed and the lot number could not be managed, so it was discarded.|||
|October 2021th, 10||HyogoTatsuno City||144 times||Temperature rise due to opening of refrigerator door|||
|October 2021th, 10||Nagoya city||For a total of 102 people this month||Since 88 people were canceled without permission, 66 people were forced to discard.|||
|October 2021th, 10||Sendai city||For 294 people||Estimated temperature rise due to refrigerator failure|||
|October 2021th, 10||NaraKashihara||For 110 people||Refrigerator temperature control error (cause unknown)|||
|October 2021th, 10||AkitaDaisen City||1128 times||Leave without putting in the cool box|||
|October 2021th, 10||Shizuoka City||204 times||Temperature rise due to opening of refrigerator door|||
|October 2021th, 10||NagasakiSasebo||340 times||Refrigerator temperature control error (under investigation of cause)|||
|October 2021th, 10||SaitamaKoshigaya||864 times||Incorrect operation when switching to auxiliary power supply due to rolling blackouts|||
|October 2021th, 10||HyogoNishinomiya||250 times||Something wrong with the auxiliary power supply|||
|October 2021th, 10||Karatsu City, Saga Prefecture||72 times||Temperature rise due to opening of refrigerator door|||
|October 2021th, 10||YamagataYurihonjo City||150 times||Refrigerator temperature control error (cause unknown)|||
|October 2021th, 10||Tsu City, Mie Prefecture||252 times||Temperature rise due to opening of refrigerator door|||
|October 2021th, 10||Nishinomiya City, Hyogo Prefecture||1760 times||Use by refrigerating the place that should be refrigerated according to the standard|||
Vaccination for pregnant women
It has been reported that pregnant women are more likely to become ill when infected with the new coronavirus than non-pregnant women of the same generation, and are at increased risk of preterm birth, pregnancy complications, and adverse effects on the foetation., Even those who are pregnant, breastfeeding, or planning to become pregnant can be vaccinated with the mRNA (messenger RNA) vaccine...However, based on the fact that "pregnant people have limited usage records, etc.", pregnant women are not required to apply the provisions of the obligation to make efforts under the Immunization Law., Excluded from priority inoculation.
A follow-up study of approximately 3 women vaccinated with mRNA during pregnancy reported that the frequency of side reactions such as fever and malaise was similar to that of non-pregnant women, with effects on the fetus and childbirth. I was not able to admit. Japan Obstetrics and Gynecology Association,Japan Obstetrician and Gynecologist Association, Issued a statement for pregnant women, that pregnant women who wish to be vaccinated can be vaccinated, that the advantages of receiving the vaccine are considered to outweigh the disadvantages, and consult with the doctor at the medical examination in advance. Mentioned things like.. The second report was issued on August 2021, 8, recommending that pregnant women be vaccinated at any time, and also vaccination of pregnant women's husbands or partners, who tend to be a source of infection to pregnant women. I asked.
On August 2021, 8, the Ministry of Health, Labor and Welfare stated, "If pregnant people and spouses (omitted) wish to receive the new corona vaccine as soon as possible and smoothly (omitted). ) Please give special consideration to each prefecture and municipality. ”.
Regarding the management of newborn babies born to pregnant women suffering from COVID-19, the Ministry of Health, Labor and Welfare's Guide to the Treatment of Coronavirus Infectious Diseases (COVID-19) (Version 5.2) does not specifically describe it.The guideline, which states that "contact between the new coronavirus-positive mother and the newborn baby is after the end of the mother's isolation period," adds concerns about the disadvantages of mother-child separation..
In Singapore, a 16-year-old training man died of heart failure, and the Ministry of Health recommends that he should refrain from strenuous exercise for a week after vaccination... In October 2021, about the Moderna vaccine in Japan, the Ministry of Health, Labor and Welfare said that in rare cases young men may have inflammation of the heart muscles, etc. We have begun to consider the recommendation of vaccination.Finland is also suspending moderna vaccinations for men under the age of 10.
As of October 2021, the Ministry of Health, Labor and Welfare has 10 medical workers who were vaccinated in advance for Pfizer products in Japan, and about 2 SDF personnel for Moderna products in parallel with the vaccination of elderly people. Was investigated for side reactions.Pain, headache, fever, pain at the inoculation site, etc. were observed...A report of suspected adverse reactions to the new corona vaccine has also been published on the Ministry of Health, Labor and Welfare website, and has been verified for thrombosis with thrombocytopenia, myocarditis / pericarditis, anaphylaxis, and deaths..
Medical accidents associated with vaccination
Carry out inoculation work directlynurse,DoctorThere is a shortage of nurses, and nurses who have retired from work for a while are being recalled, and inoculations are being carried out by dentists and residents...Inoculation by pharmacists, medical students, nursing students, etc. was also considered., Inoculation is also pureMedical practice (medical practice)Because of this, there are high hurdles such as law revisions, and the Ministry of Health, Labor and Welfare is reluctant.. AlsoParamedic,Clinical technologistInoculation by..Against such a background, it is relatively easy to handleIntramuscular injectionHowever, due to mistakes such as needlestick injuriesMedical accidentIs occurring with inoculation.In addition, various handling mistakes, including those caused by erroneous applications on the part of the inoculator, have caused inoculation troubles that do not meet the standards and regulations.
- Medical accident due to accidental puncture
- After accidentally stabbing the inoculator's finger, the inoculator is inoculated by replacing only the needle without discarding the inoculation syringe, and there is a risk of infection.
- Accidental puncture of a used syringe set into another inoculated person, risk of infection.
- There is a risk of needlestick accidents and infections in the fingers of inoculation nurses due to incorrect disposal procedures for used syringe sets..
- Misinoculation due to mishandling, etc.
- Second inoculation to the same person within 3 weeks (same day, next day, etc.)
- Misinoculation of low-concentration vaccine due to mistake in dilution.
- In the case of erroneous inoculation in Kanazawa City, 297 people who agreed to the antibody test out of 285 potential patients were tested for antibodies by blood sampling, and 8 people were judged to be equivalent to re-inoculation.Seventeen people with low antibody levels were asked to have another antibody test at a later date.In general, depending on the constitution, even if the new corona vaccine is inoculated, the increase in antibody level may be slow, so it is said that the number of erroneous inoculations cannot be specified..
- Mis-inoculation of subjects who should be vaccinated against influenza.It was the third inoculation of the new corona vaccine to the inoculated persons..
- Mis-inoculation of 11-year-old children under the inoculation age..In addition, children under the age of 12 who should be vaccinated with the Japanese encephalitis vaccine are erroneously inoculated.The child had a fever of 37.9 ° C due to a side reaction the next day..
- Vaccines that should be refrigerated before inoculation are frozen and used to inoculate 194 people.Violation of standards, impact unknown.
August 2021, 7,Imperial Household AgencyIs the emperorTokujinAnnounced that it had been vaccinated on the afternoon of the XNUMXth... (In addition,EmperorElderly people such as the coupleroyalIt is reported that the inoculation was started in June, following the implementation status of general elderly people.）
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