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🌏 | Pfizer vaccine, strong antibody response to elderly people over 80 years old = English study


Pfizer vaccine, strong antibody response to elderly people over 80 years old = English study

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Pfizer and Germany's Biontech announced on the 1st the latest clinical trial data that the preventive effect of the new coronavirus vaccine jointly developed is 91.3%.

[London, XNUMXst Reuters] – According to data released by a research team led by the University of Birmingham, US Pharmaceuticals ... → Continue reading


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COVID-19 vaccine

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 providevaccineIs. As of March 2021, 3VaccinationThere are multiple types of vaccines, from started to under development[1].

Prior to the COVID-19 pandemicSevere acute respiratory syndrome(SARS)Middle East respiratory syndromeCauses diseases such as (MERS)CoronavirusBecause the knowledge about the structure and function of2020We were able to accelerate the development of various vaccine technologies at the beginning[2].. 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[3].

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), 5 types of conventional typeInactivated vaccine(BBIBP-CorV,CoronaVac,Covaxin,(English edition,(English edition), 4 typesViral vectorvaccine(Sputnik V,Oxford-AstraZeneca vaccine,Vaccine made by Cansino Biologics,Johnson & Johnson Vaccine), 2 typesProtein subunit vaccine(EpiVac Corona,(English edition)[4]..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.[5][4][6][7].

Production / distribution plan

In many countries, such as the elderlycomplicationsPlans are being implemented to prioritize and phase out those who are at the highest risk of infection and those who are at high risk of exposure or infection, such as healthcare workers.[8].. As of March 2021, 3, based on official reports from health agencies in each country, 30 million COVID-5 vaccines were administered worldwide.[9]..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[10][11].. By December 2020, more than 12 billion vaccines have been pre-ordered from each country[12], High-income countries, which make up 14% of the world's population, buy about half of them[13].

WesternFor middle- and low-income countries that do not have the financial power to procure sufficient corporate vaccinesPeople'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.[14].

Inoculation status

Vaccination has already started all over the world, and the "vaccine" that proves that it has been vaccinatedpassportThere is also a movement to issue[14]..Regarding the inoculation status, "#Vaccine security / inoculation status"reference.


2020 eraAs the COVID-19 infection spread at a rapid pace, research institutes and drug manufacturers in each country set out to develop new vaccines and reassess existing vaccines developed for other viruses. ..who(WHO)2020Published a list of 5 plans in progress worldwide by May.Eight of these plans are in Europe, the United States and ChinaClinical trialIs in the stage of[15]..In addition, WHO is a framework for joint investment and purchase by each country in vaccine development.COVAX(Kobax)Was launched[16].

Regarding the first vaccine to be developed, it is possible to develop a type of vaccine that prevents aggravation and death rather than infection prevention.[17].. Others have pointed out that the vaccine is not effective for the elderly.[18].

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.[19].. In particular,DNA vaccine,mRNA vaccineIs under development[20].

WHO,Coalition for Epidemic Infectious Diseases Innovation (Coalition for Epidemic Preparedness Innovations, CEPI) ,andGates Foundation(GF) Is investing funding and organizational resources in anticipation of the need for several vaccines to prevent the continuation of COVID-19 infection[21]..CEPI organizes a $ 20 billion global fund for rapid investment and development of vaccine candidates[22]Showed 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[23]..At the same time, WHO also announced the development of an international "solidarity trial" for the simultaneous evaluation of multiple vaccine candidates that have reached Phase II / III clinical trials.[24].

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[25][26], UAE andカナダApproved for general use[27][28][29].



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.[30]..Affect humansCoronavirusBranch Ofウ イ ル スPrevious projects for developing vaccines againstSevere acute respiratory syndrome(SARS) andMiddle East respiratory syndrome(MERS) was targeted. SARS[31]And MERS[32]Vaccines 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.[33][34][35].. As of 2020, there are no cures or preventative vaccines that have been proven safe and effective against human SARS.[36][37].

There is no established vaccine for MERS[38].. 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.[36][39].. As of March 2020, completed Phase I clinical trials in humans (DNAOne MERS vaccine (based)[40], And three other vaccines are in progress, all of whichAdenovirusvectorTwo types (ChAdOx2-MERS, BVRS-GamVac) and one MVA vector type (MVA-MERS-S).[41].

2020 COVID-19 vaccine development

There is no vaccine to prevent human coronavirus infection[21].. After the detection of COVID-2019 coronavirus in December 12[42], 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.[43][44][45].

2020 year 2 month,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.[46].. 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.[24]In March, four vaccine candidates were included in the human evaluation ("Clinical trials started in 2020Refer to the table)[43][47].

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[24][48].. By April 2020, "almost 4 companies and research institutes in 19 countries" will be in this virtualgold RushWas working on[49]..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[5][21][47]..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[50].

Developmental status

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[5].. 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 researchAsiaAustralia30% in Europe, 26% in Europe,South AmericaAnd there are several projects in Africa[43].

International organization

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[23].. 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[5][51][52].. 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.[53]Guarantee that you will receive a guaranteed amount (provide up to 20 billion doses equally)[54][55].

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[5][48]..United Kingdom, Canada,ベルギー,ノルウェー,スイス,Germany, NetherlandsHas already donated US $ 9 million[23][56], A private charity specializing in vaccine research and distributionBill & Melinda Gates Foundation(Gates Foundation) has donated US $ 2 million[57][58].

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)By2025Prepare for vaccines for 3 million children in developing countries by[59]..The main donation is US $ 16 billion from the Gates Foundation[60]And 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.[61][62].

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[63].Japan OfMinistry of Health, Labor and WelfareHas also been involved in the foundation and contributed since 2017[64].

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[64][65].. He also conducted clinical trials on humans in the summer, and said that approval of the vaccine would be as early as this year[66].

  1. US drug/vaccine developmentModerna, Inc.(English) (MRNA.O) andNational Institute of Allergy and Infectious Diseases (NIAID) cooperation
  2. Pharmaceutical companyInovio Pharmaceuticals, Inc. (INO.O)
  3. HoweQueensland UniversityTeam

In addition, the US company has joined the vaccine development plan,SARS,MERSIdentified from survivors ofMonoclonal antibodyWhether (mAbs) is effective against this virus[67].

Inovio has MERS' most advanced vaccine candidate INO-4700[68], 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 into[69][70]Wants to conduct large-scale clinical trials in China by the end of the year[71].

February 2, UKGlaxoSmithKline (GSK) isPandemicEstablished with a vaccineAdjuvantAnnounced to participate in the collaboration of CEPI to provide the basic technology of (antigenicity enhancer)[72].

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.[73].


August 2020, 3,Mitsubishi Tanabe PharmaAnnounced that it will start developing vaccines using plant-derived particles manufactured by a Canadian subsidiary.[74].

August 2020, 3,Osaka UniversityDrug discovery companyAngesDeveloped a vaccine for this virus in collaboration with Osaka University,Takara BioAnnounced that it will manufacture[75][76][77].. The clinical trial will start on June 6, the same year, and will be conducted for 30 people by the end of July.[78][79].DNAPlasmidUtilizing technologyDNA vaccineIt is said that the manufacturing process can be completed in a shorter time than other methods of vaccines.

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.[80][81].

Daiichi Sankyo,Tokyo UniversityThe Institute of Medical Sciences aims to start clinical trials of vaccines from March 2021 at the earliest.[81].

August 2020, 6,Kyushu UniversityIs from Kyushu UniversityVenture company(Fukuoka City) announced that it has succeeded in developing a protein that is a candidate for a vaccine for the new coronavirus.[82][83].. Aiming to start clinical trials of vaccine from 2021[83].

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."[81]..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, "Based on the results of animal experiments, I think that it has (infection prevention effect)." Masu "[84]It has said.

Even in Japan, "fever, etc. at the clinical trial stage"Side effectsCan be seen in some cases[81]As 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."[85]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[86].

In Japan, Pfizer applied for approval to the Ministry of Health, Labor and Welfare on December 2020, 12, and domestic manufacturers and universities are mainly developing five vaccines with the aim of putting them into practical use, all of which are in 18. The goal is to start clinical trials in Japan, and it has not been put into practical use yet.[87], Was said.

On February 2021, 2, AstraZeneca filed an application for approval with the Ministry of Health, Labor and Welfare.[88].

February 2021, 2, Pfizer's corona vaccine "CommunityWas approved, and was officially approved on February 2021, 2.[89][90]..The legal name of the vaccine is "Coronavirus-modified uridine RNA vaccine (SARS-CoV-2)".[91].

March 2021, 3 About Moderna's vaccine, the contact company in JapanTakeda PharmaceuticalApplied to the Ministry of Health, Labor and Welfare for approval[92].


On January 2020, 1, an official from the China Center for Disease Control and Prevention (CDC) said it had begun development of the vaccine.[93].. Aug. 1,GuangzhouRussiaConsulateChina announced that the new coronavirus genome was provided from China to Russia, and China and Russia started joint vaccine development[94].

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[95].. On June 3China Central TelevisionAlso reported[96].

March 3, with the Institute of Biological Engineering, Academy of Military Medical Sciences(English editionIs a new type of coronavirus vaccine developed independently (Adenovirus(Media) started the first clinical trial to 108 people[97]..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[97]..Seven Chen Wei teams have already been vaccinated to prevent infection[97]..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[96].

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.[98][99].. Aug. 6,Central Military CommissionIs a domestic vaccine "Ad5-nCoVUseChinese PLADecided to authorize only to[100].May 7Started emergency use of vaccine for medical professionals[101].

May 2020, 12, ChineseShino FarmIs 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[102]..The following day, the 31st, China's National Pharmaceutical Products Administration approved China National's "BBIBP-CorV".[103].

In February 2021, China's National Drug AdministrationSinovac BiotechCompanyCoronaVacApproved two domestic vaccines from CanSino Biologics[104][105].


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.[106].. 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).[107].

On November 2020, 11, Russia announced the first interim results of a final third-stage clinical trial in which Sputnik V was 11% more effective in preventing the onset.[108].

The United States of America

January 2020, 1, U.S. infectious disease drug manufacturer,(English edition(Novavax Inc.) said it has begun developing a vaccine to prevent infection with the virus.[109][110].

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.euRwandaHas been administered in[111].. "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. "[112].

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[113], From multiple clinical trial participants by May 5, the same yearantibodyI was able to confirm[114]..We plan to supply 1 to 5 billion doses to the world in one year.[81].

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[81]..Later, data from early clinical trials were released on November 2020, 11, with preventive efficacy exceeding 9%.[115]..In response to this, we will apply for approval to the US Food and Drug Administration by the end of November 2020.[115].

The 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[81].

The United Kingdom

AstraZeneca Oxford Universityと共同でワクチンを開発し、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[116]..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.[81].. Regarding the clinical trial, it was confirmed that some participants were suspected of having a serious adverse reaction.May 9Was interrupted from[117]Revealed that it resumed on September 9th[118].

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.[119], 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.[120]. However,European Medicines Agency(EMA) recommended vaccination for adults of all ages[119].

In March 2021, cases of side reactions such as thrombus after inoculation with AstraZeneca vaccine were reported, so Germany, France, Italy, Spain and Denmark.[121], Iceland, Norway[122],Netherlands[123],Thailand[124]There 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.[125]..In response to this, inoculation was resumed in France and Germany.[126].

AstraZeneca clinical trials confirmed 79% efficacy, announced March 2021, 3[126].. 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[127]..As a result, the effectiveness was corrected to 76%.[128].


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).[129].


IndiaInoculation of two domestic vaccines started on January 2, 2021, and export preparations are in progress."Kobaksin" developed by Indian companies and government agencies, and Indian companies developing AstraZenecaLicense productionAlthough it is a "Kobi Shield", the former did not show data to prove its effectiveness at the approval stage.[130]..Efficacy of 81% was evaluated in subsequent clinical trials[131].

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.[5]..Most of the vaccine candidate platforms in clinical trials are the major COVID-19 infectionsantigenCoronavirus spike asproteinAnd its variants[5].. The platform developed in 2020Nucleic acidTechnology (Nucleoside modified messenger RNAandDNA),Non-replicating viral vector,peptide,Attenuated virus,and so on[2][21][43].

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[2][5]..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.[5][43].

RNA vaccine

RNA vaccineToRNAIs included and when introduced into the organizationMessenger RNAActs as (mRNA), causing cells to make foreign proteins,Adaptive immune responseTeach the body how to identify and destroy the corresponding pathogens and cancer cells. 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[132][133][134][135].

RNA vaccine is the first COVID-19 vaccine approved in the United States and the European Union[136][137].. As of January 2021, this type of licensed vaccine isPfizer-BioNTech Vaccine[138][139][140]Moderna vaccine[141][142]Is. As of February 2021, in the EU, CureVac(English edition RNA vaccine awaits approval[143].

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[144].. Only 2020 reports of anaphylaxis were reported in 12 doses of the modelna COVID-2021 vaccine in December 1 and January 19.[144].Lipid nanoparticlesIs most likely involved in an allergic reaction[144].

Adenovirus vector vaccine

These vaccines contain DNA encoding the SARS-CoV-2 proteinAdenovirus-Non-replication using a shellViral vectorIs an example of[145].. 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.[145]

As of 2021 month,This type of vaccineApproved asOxford-AstraZeneca Vaccine[146][147][148], RussianSputnik V[149],ChineseCombidisiaAndJohnson & Johnson VaccineIs[150][151].

Both the Combidisia and Johnson & Johnson vaccines are one-shot vaccines that can be stored for several months in normal refrigerated storage without the complexity of logistics.[152][153].

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

Inactivated vaccineIscultureHeat the virus particlesFormaldehydeIt is a vaccine that loses the ability to cause illness and causes an immune reaction by killing it by such methods.[154].

As of January 2021, in ChinaCoronaVac[155][156][157],BBIBP-CorV[158], IBP-CorV, IndiaCovaxin, Russian CoviVac[159]Is licensed.Vaccines in clinical trialsValneva vaccineThere is[160][161].

Subunit vaccine

Subunit vaccineIt is,PathogenPresents one or more antigens without introducing the entire particle of.Antigens are oftenProtein subunitHowever, any molecule can be used as long as it is a fragment of a pathogen.[162].

As of January 2021, only this type of vaccine has been approved.Peptide vaccine OfEpiVac Corona[163](English edition[164]There are two.For vaccines that are pending approval,Novavax COVID-19 vaccine[165]When,(Conjugate vaccine),(English editionThere is.(English editionWas previously in clinical trials but was discontinued because subsequent HIV tests revealed that it could cause false results.[166][167].

Other types

Several other vaccines currently in clinical trialsDNA plasmid vaccine[168][169][170][171][172][173], At least two(English editionvaccine[174][175],Conjugate vaccine, SARS-CoV-2 spike protein was expressed(English editionand so on[176].

Scientists investigated whether existing vaccines for unrelated diseases could activate the immune system and reduce the severity of COVID-19 infection.[177]..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.[178].


The efficacy of the new vaccine is in clinical trialsEffectivenessDefined by[180]..Efficacy is a comparison of the risk of a vaccinated subject getting sick and the risk of an unvaccinated subject getting sick.[180]..0% efficacy means that the vaccine does not work (same as placebo).A 50% efficacy means that vaccinated people are half as infected as unvaptized 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.[181].. Vaccine for COVID-19(English edition67% 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.[182].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.[183][184]..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[185].

In the calculation of efficacy, symptomatological COVID-19 is generally positive for PCR and(English editionAlthough 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 against severe COVID-19 is paramount, hospitalization and death are public health burdens, and prevention is prioritized[186]..The vaccines that have been approved and approved have shown the following efficacy.

vaccineEffectiveness of COVID-19 by severityClinical trial locationReference
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[187]
Pfizer BioNTech Vaccine~ 95% (90–98%)[Note 6]Not reportedNot reportedMultinational[188]
Sputnik V vaccine~ 92% (86–95%)~ 100% (94–100%)~ 100%Russia[189]
Oxford-AstraZeneca Vaccine~ 81% (60–91%)[Note 7]~ 100% (72–100%)~ 100%Multinational[190]
~ 76% (68–82%)[Note 8]~ 100%~ 100%United States[191]
BBIBP-CorV~ 79%~ 100%[192][Unreliable medical source?]~ 100%[192][Unreliable medical source?]Multinational[193][Unreliable medical source?]
CoronaVac~ 78%~ 100%~ 100%Brazil[194][195][196][Unreliable medical source?]
Nova Bucks Vaccine~ 89% (75–95%)~ 100%[Note 9]~ 100%[Note 9]United Kingdom[197][198]
~ 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[199]
~ 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~ 81%Not reportedNot reportedIndia[201][202][Unreliable medical source?]
Convidicea~ 66%~ 91%Not reportedMultinational[203][Unreliable medical source?]
  1. ^ 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.
  2. ^ 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.
  3. ^ 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.
  4. ^ 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) ).[187]
  5. ^ 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).[187]
  6. ^ 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.[188]
  7. ^ When the dosing interval is 12 weeks or more. At intervals of less than 6 weeks, efficacy was approximately 55% (33-70%).
  8. ^ The dosing interval is 4 weeks.Efficacy is said to be "prevention of symptomatological COVID-19".
  9. ^ a b c d No cases were detected in the study.
  10. ^ For medium.
  11. ^ 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.[199]
  12. ^ The source does actually say negative 9.
  13. ^ 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)[199] and 7 COVID-19 related deaths for the same placebo group.[200]

Mutant strain

Vaccine changes may be required if SARS-CoV-19 mutants emerge that are moderately or completely resistant to the antibody response elicited by the current COVID-2 vaccine.[204]..Studies have shown that many vaccines developed for early strains are less effective against some mutants of symptomatological COVID-19.[205].. As of February 2021, the U.S. Food and Drug Administration believes that all FDA-approved vaccines maintain a protective effect on circulating strains of SARS-CoV-2.[206].

B.1.1.7 Mutant strain

December 2020, a new variant in the UKB.1.1.7Was confirmed[207]..Early results suggest that both the Pfizer and modelna vaccines protect against UK mutants.[208][209].

In one studyOxford-AstraZeneca VaccineShowed 1.1.7-42% efficacy against B.89 mutants and 1.1.7-71% efficacy against non-B.91 mutants.[210]..According to preliminary data from clinical trialsNovavaxThe vaccine has been shown to improve symptoms by ~ 96% against the original variant, ~ 1.1.7% against B.86, and ~ 1.351% against the South African B.60 variant.[211].

501.V2 mutant strain

Moderna is from South Africa(English editionStarted testing a new vaccine to work on (also known as B.1.351)[212].. On February 2021, 2, Pfizer announced that the neutralizing activity of the 17.V501 mutant was reduced by two-thirds, but said that the vaccine's disease-preventing effect on this mutant could not yet be claimed.[213].. Decreased serum neutralizing activity from patients vaccinated with Moderna and Pfizer against B.1.351 has since been confirmed in several studies.[214][215].. According to the latest information from Pfizer / BioNTech's vaccine trial in South Africa on April 2021, 4, the vaccine was so far 1% effective (that is, no cases occurred in vaccinated subjects). Six of the nine infections in the placebo control group were stated to be B.100 mutants.[216].

January in South AfricaAd26.COV2.SJohnson & Johnson, who conducted clinical trials of the vaccine, reported that the level of protection against moderate to severe COVID-19 infection was 72% in the United States and 57% in South Africa.[217].

August 2021, 2,Financial TimesPaper is from South Africa(English editionIn the provisional test data of the test conducted in collaboration with Oxford University,Oxford-AstraZeneca COVID-19 Vaccine Of(English editionReported that it showed a decrease in effectiveness against[218]..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.[219].. On February 2021, 2, the South African Health Minister canceled about one million vaccine deployment plans while reviewing the data and waiting for advice on how to proceed.[220][221].

P.1 mutant strain

First identified in Brazil(English editionThe mutant strain (also known as 20J / 501Y.V3) appears to have partially escaped vaccination with the Pfizer / BioNTech vaccine.[222].

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”)[223][224]..Vaccine safety, efficacy, and in Phase III trials(English editionDefinitions 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.[225][226][227].

Plans for ongoing clinical trials, if accumulating data in the trial provides positive or negative early insight into the effectiveness of the treatment.(English editionMay be changed as[228][229]..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[228][230].

List of approved or approved vaccines

Each countryRegulatory authorityOf 11 vaccinesEmergency use permissionIs giving.Six of these vaccines are at least oneWHO accredited strict regulatorApproved for emergency or general use by.

Vaccines approved by emergency license or general license
Vaccine candidate drug, developer, investorDeveloping countryVaccine type (technology)Inoculation intervalStorage temperatureCurrent phase (number of subjects)Number of approvalsNumber of emergency use permits
Oxford AstraZeneca COVID-19 Vaccine (Vaxzevria, Kobi Shield) [lower-alpha 1][232][233][234]
OxfordDe University,AstraZeneca, CEPI
英国Adenovirus vector (ChAdOx1)2 times

4-12 weeks

2-8 ℃Phase III (30,000)3169
Pfizer-BioNTech COVID-19 Vaccine (Cominati, Tojinameran)[27][235][236]
USA, GermanyRNA (modRNATheLipid nanoparticlesDisperse to)2 times

3-4 weeks

-70 ± 10 ° C[lower-alpha 2](Ultra low temperature freezer)Phase III (43,448)3470
Sputnik V COVID-19 vaccine (Gam-COVID-Vac)

Gamareya Memorial National Center for Epidemiology and Microbiology

ロシアAdenovirus vector (, Ad5 and Ad26 types)2 times

3 weeks

-18 ℃ (freezer)Phase III (40,000)062
Moderna COVID-19 vaccine [239][240]
米 国RNA (modRNATheLipid nanoparticlesDisperse to)2 times

4 weeks

-20 ± 5 ℃ (freezer)Phase III (30,000)3110
Shino Farm: Beijing Biological Products Institute
ChugokuInactivated COVID-2 (Vero cell)2 times

3-4 weeks

2-8 ℃Phase III (48,000)339
Johnson & Johnson COVID-19 Vaccine [242][243][244]
Janssen Pharma,Johnson & Johnson,BIDMC
United States, NetherlandsAdenovirus vector (, Ad26)1 times2-8 ℃Phase III (40,000)3110
ChugokuInactivated COVID-2 (Vero cell)2 times

2 weeks

2-8 ℃Phase III (33,620)124
BBV152 (Kobaksin)
(English edition,(English edition
IndiaInactivated COVID-2 (Vero cell)2 times

4 weeks

2-8 ℃Phase III (25,800)08
Ad5-nCoV (Combidisia)
(English edition, (English edition[248][lower-alpha 3]
ChugokuAdenovirus vector (, Ad5)1 times2-8 ℃Phase III (40,000)14
EpiVac Corona[250]
Vector Institute
ロシアSubunit (peptide)[250]2 times

3 weeks

2-8 ℃Phase III (40,000)11
(English edition(RBD-Dimer)[251]

Anhui Zhifei Longcom Biopharmaceutical Co. Ltd.

ChugokuSubunit vaccine()3 times

30 Day

Phase III (29,000)02
(English edition

Shino Farm: Wuhan Biological Products Research Institute

ChugokuInactivated COVID-2 (Vero cell)1 times[Source required]Phase III (51,600)02
(English edition[252]The Chumakov Center at the Russian Academy of SciencesロシアInactivated COVID-22 times

2 weeks

2-8 ℃Phase III (3,000)01
  1. ^ Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by.[231]
  2. ^ Long-term storage temperature. The Pfizer–BioNTech COVID-19 vaccine can be kept between for up to two weeks before use, and between for up to five days before use.[237][238]
  3. ^ Manufacturing partnership with the and Canadian Center for Vaccinology,, Nova Scotia[249]

Vaccine candidates in human clinical trials


As of 2020, 11 of the vaccine candidates under clinical development are using adjuvants to increase immunogenicity.[5].Immune adjuvantIs a substance that is added to vaccines to enhance the immune response to antigens such as COVID-19 virus and influenza virus.[253]..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.[253][254].. 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.[254]..Known as alumAluminum saltIs the first adjuvant used in an approved vaccine and is the adjuvant of choice in about 80% of adjuvanted vaccines.[254]..Alum adjuvant initiates diverse molecular and cellular mechanisms to enhance immunogenicity, including the release of inflammatory cytokines[253][254].


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.[255]..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[21][44][57]..Billions of dollars could be invested without success[56].

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.[256]..84-90% of vaccine candidates in Phase I clinical trials[43][257]Did not reach final approval during development, and 25.7% did not reach approval in Phase III clinical trials[257]..Manufacturers' investments in vaccine candidates exceed US $ 10 billion, and millions of doses can be wasted if advanced manufacturing contracts are signed.[21][56][57].

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[258].. In December 2020, a Belgian politician briefly published a confidential price agreed between vaccine producers and the EU.[259] :

ManufacturervaccinePrice per dose in the EU[260]
AstraZenecaOxford-AstraZeneca COVID-19 Vaccine€ 1.78
Johnson & JohnsonJohnson & Johnson COVID-19 Vaccinefor US$8.50
Sanofi / GSK€ 7.56
Pfizer / BiontechPfizer-BioNTech COVID-19 Vaccine€ 12.00
CureVac(English edition€ 10.00
R-PharmSputnik V COVID-19 vaccinefor US$10.00
ModernaModerna COVID-19 vaccinefor US$18.00

Supply chain

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[21][261][262].. 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[261][263][264].. 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)(English editionStates as follows. "Efficient delivery of billions of vaccines worldwide involves highly complex logistical and programmatic obstacles along the supply chain."[265].

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.[266].. "In a fast-moving pandemic, if everyone isn't safe, no one is safe," GAVI said.[52].

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.[261][263][267]..The main concern isLow and middle income countriesVaccine distribution resources, especially for vaccination of children, are scarce or absent.[52][268].. In September, the COVAX partnership included 9 countries coordinating plans to optimize their COVID-172 vaccine supply chain.[269],UNICEF(UNICEF) will work with COVAX to prepare funding and supply chains for vaccination of children in 92 developing countries.[270][271].


Logistics services for vaccination ensure the necessary equipment, staff and supply of licensed vaccines across international borders.[272]..The core of logistics includes vaccine handling and monitoring, cold chain management, and distribution safety within the vaccination network.[273].. 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.[52][267]..Includes logistics tools for vaccine forecasting and needs estimation, domestic vaccine management, potential waste, and inventory management[273].

Other logistics factors implemented internationally during the transportation of the COVID-19 vaccine include:[261][274][275] :

  • 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
  • Stockpiling
  • Adjustment of supplies in each country (Personal Protective Equipment (PPE),(English edition, Syringe, needle, rubber stopper, refrigerated fuel and 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.[276]..If the vaccine supply chain fails, the economic and human costs of a pandemic can be prolonged over the years.[264].

Manufacturing capacity

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[262][276][277]..2021 vaccine pre-orders from the UK Government were 1 per person[262].. 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[269].2022A 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[21][262][276].

Indian Serum Research InstitutePlans to produce at least one billion doses of vaccine, half of which will be used in India[262].

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[278].Shino FarmThe company states that it may have a production capacity of over 2021 billion doses in 10[279].. 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.[280].

AstraZeneca(English editionThe CEO said: "The challenge is not the production of the vaccine itself,VialIs in filling.There are not enough vials in the world "[281]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 contaminants[282]Shows rising manufacturing costs and diminished potential developer interests amid demand for affordable vaccines[52][262][264].

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.[262][276].. The size of the COVID-19 vaccine supply chain is expected to be enormous to ensure global delivery to vulnerable populations.[21][263]..Priorities for preparing facilities for such distribution include optimization of temperature-controlled facilities and equipment, infrastructure, training of vaccination staff, and rigorous monitoring.[263][265][270].RFIDThe technology is being implemented to track and certify vaccine dosages along the entire supply chain from manufacturer to vaccination.[283].

2020 year 9 month,(English editionCompanyJohnson & JohnsonWith the companytechnology transfer(English editionAgreed to support the production of vaccine candidates, including production[284].. In October 2020, a partner scheduled to manufacture the first dose in December 10Lonza GroupBut in Switzerland(English editionAnnounced to manufacture vaccine candidate moderna[285]..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.[285]..Lonza's base in Portsmouth, New Hampshire aims to begin producing US-specific vaccine ingredients as early as November.[285].

Cold chain

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)[275][286].. 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.[286]..Freezing damage and lack of personnel training in the on-site inoculation process are major concerns.[287]..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[286].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.[288][289].

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.[264]..As an example, Moderna's RNA vaccine candidate requires cold chain management at sub-freezing temperatures, although it has a limited shelf life, and BioNTech-Pfizer's RNA candidate is in transit storage from vaccine production to inoculation. Requires storage below 70 ° C[290][291].

vaccineVialContains several doses of vaccine, but is only viable for 6 hours after being punctured for the first dose and must then be discarded for cold storage and management of the inoculation process in the field. Need to pay attention[21][292].. COVID-19 vaccines are likely to be in short supply in many places during initial deployment, so vaccination staff should avoid spoilage and disposal, which typically accounts for 30% of supply.[261][292]..Cold chains are also bikesDroneVaccine transport methods in local communities such as, the need for booster administration, the use of diluents, access to vulnerable groups such as healthcare workers, children and the elderly are also challenges.[21][270][293].

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.[263][266][294].. "Safe delivery of the COVID-19 vaccine will be the mission of this century for the global air cargo industry, but it will not happen without careful prior planning, and the time has come for that. I. We urge governments to take the lead in facilitating cooperation across the logistics chain, preparing facilities, security arrangements, and border procedures for challenging and complex tasks. I will be the secretary general and CEO of IATA.(English editionSaid in September 2020[294].

In 2020, airlines cut headcount due to severe decline in passenger air traffic (Layoff), Shrinked the network and kept the aircraft in long-term storage[263][294].. As the leaders in the procurement and supply of COVID-19 vaccines within the WHO COVAX facility, GAVI and UNICEF are preparing for the largest and fastest vaccine deployment to date and will cooperate with international air freight transport. , Customs and border control, and may require as many as 1 freighters to deliver a single dose of vaccine to multiple countries[270][294].

Security and corruption

Widespread demand for COVID-2,000 vaccines across the supply chain, as pharmaceuticals are the world's largest fraud market and are worth about $ 19 billion annually.Counterfeit goods,theft,Bad business law,Cyber ​​attackVulnerable to[267][295]..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[295][296]..Tracking system technology used in packaging materials is used by manufacturers to track vaccine vials throughout the supply chain.[267], Also digital and to ensure the security of the vaccination teamBiometricsUsing the tool[283][297].. April 2020,InterpolIt is,Organized crimeInfiltrate the vaccine supply chain, steal products by physical means,Information theftWarned that it may even provide counterfeit vaccines[298].

National infrastructure development

Although WHO has an "effective vaccine management" system in place[299], 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
  • Traceability
  • Security

Border processes for efficient handling and customs clearance within individual countries include:[272][299] :

  • 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


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. "[300]..This declaration is valid in the United States until October 2024, 10.

In Japan, as with other vaccines, if there is a health hazard due to a side reaction,Vaccination methodbased onNational relief systemWas targeted by[301].

Incorrect information

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.[302][303].

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[304].

Australian Institute for Strategic Policy(ASPI) claims that China and Russia are disseminating fake news or propaganda related to vaccines developed in the West.[305][306].

Vaccine passport

In February 2021, Israel, which is the most inoculated with the COVID-2 vaccine in the world, and in March of the following year, China issued a "vaccine passport" certifying the inoculation of the COVID-19 vaccine.[307], Each country is said to follow this.

European as of April 4st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, In the Pacific IslandsSeychellesCountries 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[308].

Also travel to get a vaccine passportVaccine tourismHas begun[309].

Vaccine security and inoculation status

World overview

The status of COVID-2021 vaccine in the world as of April 4, 10 is as follows.[310].

Number of vaccinations per 100 people / Cumulative number of vaccinations

As of the end of March 2021, the number of vaccinations per 3 people in Japan was 100.OECDLowest among 37 countriesIs[311][312].

Israeli situation

As of March and April 2021, the COVID-3 vaccine per capita rate is the highest in the world.イ ス ラ エ ル.

Lan Baricelle, Israeli Corona Vaccine Countermeasures Expert Team Representative and Chief Innovation Officer of Israel's largest health organization, Clarit, spoke at a remote lecture hosted by the Japan National Press Club on March 2021, 3. According to Israel[313], "The vaccination that started on December 2020th last year (12) with priority given to the elderly has been expanded to all residents aged 19 and over.920% of Israeli citizens of about 60 million have already been vaccinatedAnd 50% have been vaccinated twice.In particular, 2% of people over the age of 50 have been vaccinated for the second time, and the elderly are protected by the vaccine.[313]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. "[313].."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."[313].

Regarding the method of vaccination in Israel, "In Israel, vaccine clinics have been opened in various places for vaccination.[313]He said that he had hundreds of clinics all over Israel in a week.Clinics are set up by setting up tents in large hospitals and plazas, and the management of vaccinated people isDigitized 20 years ago officialElectronic 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.[313].

Also"Ensuring transparencyWas important.As a clear message what we know and what we do not understandI told the people without hiding[313].. ".

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. For example, you can only eat outside the storeBy applying different rules to those who have been vaccinated and those who have not, it is possible to resume economic activities with peace of mind and increase vaccinations.IncentiveAlso becameExplained[313].

Japan situation

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[314].

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."[315].

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."[316].

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.[317].

August 2021, 1,Yoshii KanThe Prime MinisterTaro KonoMinister for Regulatory ReformThe minister in charge of vaccination "Minister in charge of new coronavirus vaccinationAppointed to[318]..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[319].

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.[87].

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.[320].

Prior to vaccination in each municipality in Japan, January 2021, 1, Kanagawa PrefectureKawasaki City OfKawasaki City College of Nursing Ofgymnasiumso,Kawasaki City(Administrative organization)Ministry of Health, Labor and WelfareVaccination training was conducted by[321].

Also, on October 2021, 1,TokyoNerima-kuHowever, small scale for vaccination scheduled to start after April 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.[322].KyotoKyoto City,TochigiSano CityLocal governments all over the country have decided to introduce this "Nerima Ward model".[323][324].

On February 2021, 2, the United States for JapanPfizerThe first flight of the vaccine made is at the 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[325]..The second flight arrived on February 2, the third flight arrived on March 2, and the fourth flight arrived on March 21.[326][327][328][329].(February 2th to March 12th) 3 airlifts secure a maximum of about 8 million times and about 4 million peopleWas done[329].. On the 4th flight arriving on April 5, the aircraft will be even larger due to the increase in transportation volume (Boeing 777-300ER)[330].

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."[331]..Minister Kono did not show the basis for this policy at the House of Representatives Cabinet Committee on the 28th.[332]..In addition, the Ministry of Health, Labor and Welfare is also grasping the state of the body on the 26th. "[333].

In the week of April 4, 26 doses of vaccine will be distributed to all municipalities.[334].

On April 4, the first group of moderna vaccines for Japan will be launched from Belgium.KIXToJALArrived by plane[335].

Vaccination status

As of the end of January, vaccination is already in full swing in developed countries,The delay in starting vaccination in Japan was noticeable..Of the major developed countries, Japan was the only country that had not been approved for the vaccine.[336].

Finally, the Pfizer vaccine officially approved in Japan on February 2021, 2Inoculation started on February 2 in JapanAnd the first inoculationTokyoMeguro OfNational Hospital Organization Tokyo Medical Center Of院長Was done against.Priority was started from vaccination to medical staff[337].. "In the future, vaccinations for medical professionals will be promoted at hospitals in each prefecture," he explained.

2021As of late March, the number of vaccinations per 3 people in Japan was 100.OECDLowest among 37 countrieswas[338][339].. As of April 4, more than 27% of the population was vaccinated more than once, which is lower than 1% of the whole Asia.[340].

In Japan, for people over 16 years old[341], The order of vaccination was as follows[342].

  1. Medical staff, etc. (hospital,ClinicStaff,pharmacist,Emergency servicesMember,Health centerStaff etc.)[343]
  2. Persons born before April 32, 1957 (elderly people aged 4 and over)
  3. Underlying diseases other than the elderly (Heart disease,Diabetes mellitus,BMI30 or more)Facilities for the elderlyWorkers such as[343]
  4. Persons other than 1. --3 above

上述のように、3月に、まずは医療従事者などへのワクチンの優先接種が本格的に始まったわけだが、 2021年4月17日時点の情報で、優先接種の対象になっている医療従事者などのうち、2回の接種を終えたのはおよそ68万人と、わずか14%にとどまっていると判明。(その数の内訳を解説すると)接種対象となる医療従事者はおよそ480万人と見込まれているのだが、厚生労働省によると4月15日までに1回目の接種を受けたのは全体の24%にあたるおよそ117万人で、2回目の接種も終えた人は14%のおよそ68万人にとどまっていたのである。さらに、優先接種対象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 stationAnd staff such as health centers are also included[343], NHK interviewed 13 quarantine stations nationwide and found that no staff were inoculated at any of the quarantine stations.[344]As of April 4, about one-third of medical professionals completed the first vaccination.[340].

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日以降本格接種の開始が予定されているが、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ている[326][345][327](As mentioned above, since vaccination of medical staff has not progressed, some local governments may divert the distributed vaccine for the elderly to local medical staff.[346][347]).

(Due to the syringeNumber of inoculations per bottle(Regarding the problem) Uji Tokushukai Hospital in Kyoto Prefecture, if the conditions are metInsulinPfizer vaccine can be inoculated 1 times from 7 bottle with a syringe[348]. Also,TerumoDeveloped a syringe that can inoculate 1 times from 7 bottle and started production from the end of March[349].

April 2021, 4, the governmentTokyoOsakaOn the 1th, Prime Minister Yoshihide Suga announced the establishment of an inoculation site for 1 people a day.SDFInstructed to set up an inoculation site in Tokyo.The policy is from May 5th to 24 months.LocationOtemachi Joint Government BuildingIs scheduled.To prevent confusion in management, the vaccine will be made by Moderna (assuming approval), which is under review at the time of the press, instead of Pfizer, which has already been distributed to local governments.[350][351][352].

On the other hand, about the venue in Osaka,cityNakanoshima OfOsaka Prefectural International Conference CenterIt is decided that both Tokyo and Osaka will be opened from May 5th.[353].


[How to use footnotes]

注 釈


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