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🌏 | Russia applies for registration of domestic corona vaccine to EU authorities


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Russia applies to EU authorities for registration of domestic coronavirus vaccine

 
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RDIR Governor Kirill Dmitriev said at a Reuters Next meeting last week that he would file a formal application for Sputnik V approval with EU authorities in February.
 

[Reuters] – Russia's Foreign Direct Investment Fund (RDIR) has released a new domestic coronavirus vaccine “Sput ... → Continue reading

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EU authorities

Sputnik V COVID-19 vaccine

Sputnik V(British: Sputnik V,Russian: Satellite V) Is(English editionCOVID-19 vaccine developed by the company on August 2020, 8Ministry of Health of RussiaByGam-COVID-Vac(Russian: Gam-KOVID-Vak, tr. Gam-KOVID-Vak) Registered as[2][3].. this is,AdenovirusViral vectorIt is a vaccine. On February 2021, 2, the results of the interim analysis of the clinical trialLancetPublished in a magazine and unusualSide effects91.6% effectiveness was shown[4].

Gam-COVID-Vac was finally announced on September 2020, 9Phase I-II studyBased on preliminary results ofロシアApproved for use in[5].. The rapid approval of Gam-COVID-Vac in early August has been criticized by the mass media, and the decision is valid amid lack of solid scientific research to confirm the safety and efficacy of the vaccine. Caused controversy in the scientific community as to whether it was[2][3][6][7][8].

Urgent mass distribution of vaccines in December 2020ロシア,アルゼンチン,ベ ラ ル ー シ,ハンガリー,Eur-lex.europa.eu eur-lex.europa.eu,United Arab EmiratesStarted in multiple countries, including. As of February 2021, 2 countries have approved the emergency use of Sputnik V.[9]Ordered for immediate distribution of over 10 billion doses of vaccine worldwide[10].

Technology

Gam-COVID-Vac isImmune responseTo stimulateCOVID-2Full length ofSpike proteinTwo humans containing the gene encoding (S)Adenovirus(common coldBased on virus)Virus 2 vectorIs a vaccine[11][12][13].. The Gam-COVID-Vac vaccine is a government-sponsored Gamareya Epidemiology and Microbiology Institute(English editionDeveloped by the team.This groupEbola virus,MERS coronavirusAlso worked on the vaccineMDRASLed by associate member Denis Logunov[14].

RecombinantAdenovirusSerotypeBoth 26 and 5 are used as vaccine vectors.these areBiotechnologyDerived from SARS-CoV-2 S proteincDNAincluding.BothDeltoid muscleAd26 vaccine is used on day 21 and Ad5 vaccine is used to boost the immune response on day XNUMX[12][15][16].

Vaccines should be frozen (storage temperature 2-8 ° C or 36-46 ° F)freeze dryingThere is a dosage form (Gam-COVID-Vac-Lyo, storage temperature 2-8 ° C or 36-4 ° F).The first dosage form was developed for large-scale use and is cheaper and easier to manufacture.The production of lyophilized preparations is convenient for storage and transportation, but requires much more time and resources. Gam-COVID-Vac-Lyo isHard-to-reach areas of RussiaSpecially developed for vaccine delivery to[5]..Alexander Ginzburg, director of the Gamalaya Institute, estimates that it will take 9-12 months to vaccinate most of Russia's population, assuming that domestic resources are sufficient.[17][18].

Clinical research

Phase I-II

Phase I safety trials began on June 6[2].. On September 9, data on 4 subjects from the Phase I-II study was released with safetyImmune responsePreliminary evidence of[5]..The results were argued by international vaccine scientists to be incomplete, suspicious, and unreliable because many test subjects reported the same data.[19]The authors replied that the sample size was as small as 9 and that dose setting measurements could only take discrete values ​​(800, 1600, 3200, 6400).Coupled with the observation that these values ​​tend to reach steady state after 3-4 weeks, the authors are not unlikely to see the same results for multiple participants between days 21-28. Claims[20].

Phase III

Israel, early November 2020(English editionProfessor Zeev Rotstein, director, said in Moscow(English editionHadassa branch in Japan said it was cooperating in a phase III clinical trial[21].

Currently in progressPhase III clinical trialTargeted 40,000 volunteers in MoscowRandomized double blindA placebo-controlled, multicenter clinical trial scheduled to run until May 2021[22].. Belarus from 2020 to 2021[23], UAE[24],India[25], Venezuela was also conducting Phase III clinical trials[26].. February 2021, 2, interim analysis results of the Moscow testLancetPublished in the magazine, the efficacy rate after the second vaccination was 2% (91.6% confidence interval 95-85.6), anomalous.Side effectsIt was shown that there was no[27]..The study began on September 2020, 9 with a frozen liquid vaccine, and data analysis was performed up to the second database lock on November 7, 2020.Subjects over the age of 11 (oldest 24 years) in this study showed virtually comparable efficacy (2%) at all ages.The lowest age subject was 60 years old[4][28].

Sputnik-AstraZeneca COVID-19 Vaccine Trial

December 2020, 12, Russian Direct Investment Fund, Gamalaya National Center, AstraZeneca,(English editionIs one of the components of the Sputnik V vaccine developed by the Gamareya Center and developed by AstraZeneca and the University of Oxford.AZD1222Signed an agreement aimed at developing and implementing a clinical research program to evaluate immunogenicity and safety when used in combination with one of the components of a vaccine[29]..The research program will run in multiple countries for six months and will involve 6 volunteers in a single research program. February 1, 100Republic of AzerbaijanMinistry of HealthVaccine developed by AstraZenecaAnd announced that it would start clinical trials in combination with the Sputnik V vaccine by the end of February 2021.[30][31].

composition

This vaccine is composed of two components[1]..Both active ingredients have different serotypes (the first ingredient isSerotype 26, The second component isSerotype 5) Modification (Recombinant) It is a replication-deficient adenovirus,COVID-2 Of(English editionModified to contain the expressed gene[1].

Other ingredients (Excipients) Is quantitatively and qualitatively the same for both components.[1].

According to the official data sheet, otherAdjuvantNo further components or ingredients should be included in the vaccine, including[1].

History

In May 2020, the Gamalaya Institute for Epidemiology and Microbiology announced that it had developed a vaccine with no serious side effects. By August 5, Phase I and Phase II of the two clinical trials (2020 subjects each) were completed.Only one of them uses this formulation and was later approved for marketing under limited conditions.[32][33]..This vaccineWorld's first artificial satelliteNamed after the product "Sputnik V"[3][7][34].

During preclinical and clinical trials, 1 subjects who received one or two doses of the Gam-COVID-Vac vaccine contained a potent neutralizing antibody that inactivated viral particles, SARS-CoV- Produced antibodies against 2 spike proteins[2].. August 2020, 8, RussiaMikhail MurashkoHealth MinisterIt is,Vladimir PutinAt a government briefing attended by the president, he announced that he had approved widespread use of the vaccine.National registration of vaccinesRussian Federation GovernmentIt was implemented "conditionally" with post-marketing measures based on the Cabinet Order.Vaccine registration certificates will not be widely available in Russia until January 2021, 1, before which they may be provided to "a minority population of vulnerable groups" such as healthcare workers and the elderly. There was a statement, a spokeswoman for the Ministry of Health said.[3]..The license for registration number ЛП-006395 (LP-006395) was issued by the Russian Ministry of Health on August 8.This announcement was made before vaccine candidates entered Phase III clinical trials, but there are "conditional" marketing practices in other countries as well.[35][36].. On August 8, registration number ЛП-26 (LP-006423) was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".[2][3][7][37][5].

The commercial release of Gam-COVID-Vac was scheduled for September 2020. In October, Health Minister Mikhail Murashko said, "Gam-COVID-Vac will be provided free of charge to all Russian citizens after mass production begins."[38][39]..The Russian Ministry of Health then registered the upper limit of the factory shipping price of the two ingredients as 2 rubles.Essential medicinesAdded to the national list of[40]..Also in Russia(English editionIt was also proposed to include this vaccine in[40].

According to Russian media, mass production of Gam-COVID-Vac started by August 8.By that time, the Russian Federation has already received applications for a billion doses of vaccine from 15 countries. Each of the three facilities can produce about 20 million doses per month, which could double capacity by winter.By the end of 10, the Gamareya Institute was planned to produce 3-100 million doses, according to an interview with a spokeswoman for the organization.[41][42].

Scientific evaluation

August 2020, 8,whoA WHO spokeswoman said, "Pre-adaptation of any vaccine involves a rigorous review and evaluation of all required safety and efficacy data."[8].. "You can't use a vaccine or medicine without going through all these steps," said WHO's assistant director.[43].

University College LondonGeneticistFrancois BallouxHe called the Kremlin's approval of Gam-COVID-Vac a "reckless and stupid decision."[2].(English editionVaccine Education Center DirectorPaul OffitThe professor characterized the announcement as a "political insult" and said that untested vaccines could be very harmful.[8].

(English edition OfBalram bhargavaHe said Russia put COVID-19 vaccine candidates on the fast track (priority approval process) in the early stages.[44].

Leeds UniversityStephen Griffin, an associate professor of medicine, said the SARS-CoV2 vaccine, which targets spike proteins, is solid and positive.Moreover, the Sputnik antigen is delivered via another treatment, i.e., using ineffective adenovirus rather than formulated RNA, thus perhaps giving flexibility in one or the other way. Provide and provide better response for specific age groups and ethnic groups.And he said it would be easier to store this vaccine.[45][Source invalid].

University of London Graduate School of Hygiene and Tropical Medicine"This data shows that the vaccine is reasonably effective. These results are consistent with the results of other vaccines," said Stephen Evans, a professor of the disease (COVID-19). ) Is a really big message for health scientists around the world to be able to deal with vaccines. "[45].

University of LeicesterJulian Tang, a clinical virologist at Tang, said: "Despite long-standing concerns about the widespread deployment of this Russian Sputnik V vaccine prior to data from Phase III trials, this approach is now somewhat justified.[46]. '

Reading UniversityProfessor of Virology, Ian Jones, and Professor and Director of Virology, London School of Hygiene and Tropical MedicinePolly Roy"The development of the Sputnik V vaccine has been criticized for its unsightly rush, omissions, and lack of transparency," he said of the Phase III results published in The Lancet magazine in February 2021. The results reported in were clear, and the proof of the scientific principles of vaccination meant that another vaccine could participate in the fight to reduce the incidence of COVID-2. "[47].

Wistar InstituteVaccine ScientistHildegund CJ Ertl"Great. Good safety profile, over 2021% efficacy for all ages, 2% for serious illness and death," he said in response to Phase III results published on February 2, 90. Effectiveness, can be stored in the refrigerator, low cost. What more do you want? "[48].

According to a preliminary examination by an expert[Who?], "Gam-COVID-Vacfreeze dryingThe formulation issmallpoxSimilar to a vaccine,Pfizer-BioNTechCompany andModernaOngoing required for each of the company's vaccinesCold chainorCold chain storageAvoid the need for.Enables remote transportation while reducing the risk of vaccine alteration.[49][50]'

Distribution, vaccination, and public awareness

Early recognition

January 2020(English edition CanadianIn a poll conducted on the subject, 14% of the respondents said they would not receive the Russian vaccine if they were provided free of charge, while the majority (68%) said they would not.AmericanWhen asked the same question, 59% said they would not receive the Russian vaccine, while 24% said they would get it for free.[51][52].

As of 2020 month,pollAccording to the report, only half of Russia's population is voluntarily vaccinated.[53].

  • UK and US officials said the Gam-COVID-Vac vaccine is likely to be rejected due to concerns that it does not adhere to the usual rigorous vaccine clinical trial process.[54]..is therepublic healthExperts say that the Russian government's prompt approval of Gam-COVID-Vac is a "cut-out" and if the vaccine proves unsafe or ineffective.Public trustStates that it may hurt[7]..ImmunologistPeter Openshaw"There is a great risk that confidence in the vaccine will be compromised if the approved vaccine is subsequently shown to be harmful," he said.[7].  

ロシア

In early December 2020, federal officials announced that they would begin large-scale free vaccination with Gam-COVID-Vac for Russian citizens.This vaccination will be on December 12, 2020MoscowStarted at 70 medical centers in[55].

Doctors and other healthcare professionals, teachers, social workers, etc. are at the highest risk of being exposed to illness and are given priority inoculation.[56]..The age of vaccinated people was initially limited to 60, but this limit was later lifted.[57].

Unvaccinated people were sent a text message stating, "You work for an educational institution and can get the COVID-19 vaccine for free."Subjects are asked general questions about their health status before vaccination with the vaccine removed from freezing approximately 15 minutes before use.Subjects will be given a leaflet warning of possible side effects, which suggests that side effects are often mild and last for at most 2-3 days.[58][59][60]..Vaccination is banned for people with certain underlying illnesses, pregnant women, and those who have had respiratory illnesses in the last two weeks.[56].

In early December 2020, the Minister of HealthMikhail MurashkoSaid Russia has already vaccinated more than 10 high-risk people[61]..Of these, 4 are volunteers for the Sputnik V Phase III trial, and 6 other healthcare workers and doctors are also vaccinated.[62]..Kirill Dmitriev, head of the Russian Direct Investment Fund, said in an interview with the BBC that Russian health workers expect to vaccinate about 12 million people with the coronavirus in December.[63].

Until early December 2020, Generium (PharmstandardManaged by the company) and Binnopharm (managed by the company)AFK Sistema(Managed by the company) was producing Gam-COVID-Vac on a large scale.The vaccine is also expected to be produced by BIOCAD.According to Russian media, these suppliers will distribute 2020 vaccines by the end of December 12. December 50thTatyana Golikova(English editionAnnounced that approximately 690 million doses of Sputnik V vaccine will be distributed to the Russian private sector by the end of February 2021[64]..Mayor of MoscowSergey SobyaninHe is based in the newly opened Moscow(English editionAnnounced that it will be the leading manufacturer of Russian Sputnik V coronavirus vaccine.The plant is in full operation and will produce up to 1,000 million doses of vaccine per month.[65].

Overseas

(English editionAccording to (RDIF), as of December 2020, more than 12 billion doses of vaccine have been ordered. With dosing requests from more than 12 countries, supply to the global market is produced by partners such as India, Brazil, China, South Korea and Hungary.[66][67]..As of August 2020, at least 8 countries wanted to get the vaccine, Russian officials said.[68].

It's free in Russia, but in the international market it costs less than US $ 1 per dose (less than $ 10 for two doses required to vaccinate one person) from other manufacturers.mRNA vaccineIt will be much more affordable than.Kirill Dmitriev, head of the fund, told reporters that more than one billion doses of vaccine are expected to be produced outside Russia in 2021.[69][70].

Hadassa Medical Center in Israel to obtain 150 to 300 million dosesMemorandum of UnderstandingSigned[71]..Argentina agreed to buy 2500 million doses of vaccine[72]..The vaccine was registered and approved in Argentina in late December[73]..The state of Bahia, Brazil, has also signed a contract to conduct a phase III clinical trial of the Sputnik V vaccine, with plans to purchase 5,000 million doses and sell them in northeastern Brazil.[74].

(English editionThe company has signed a contract to manufacture more than 1 million doses of vaccine in India and submitted data for the mid-term study to Indian regulators on January 2021, 1 to recommend the transition to the late-term study. Are[75].. RDIF has announced plans to sell 1 million doses to India, 3,500 million doses to Uzbekistan, 3,200 million doses to Mexico and 2,500 million doses to Nepal and Egypt respectively.[76].

January 2021, 1 in ArgentinaAlberto FernandezThe president was the first Latin American leader to be vaccinated against the disease by the then-approved Sputnik V.[77][78].

Emergency use permission

As of December 2020, Belarus and Argentina(English edition OfEmergency use permissionGave[79].. On January 2021, 1, Hungary became the first European Union (EU) country to register this vaccine for emergency use, as well as the United Arab Emirates in the Gulf region.[80][81][82][83][84].

January 2021, 1, according to RDIF[85], Russian authoritiesEuropean UnionI applied for registration of Sputnik V in. February 2,European Medicines Agency(EMA) announced that it has not received an application for serial review or manufacturing and marketing approval of the vaccine.Developers are only interested in considering a sequential review of vaccines, but the EMA's Committee for Medicinal Products for Human Use (CHMP) and the COVID-19 EMA Pandemic Task Force (COVID-ETF) are for developers. You must first agree with the developer before submitting an application to start the sequential review process[86].

Algeria, Bolivia, Serbia, Palestinian Territories[75], Mexico is also allowed for emergency use[87].

On January 2021, 1, Iran approved the vaccine and was the supreme leader.Ally HarmenayAfter he banned vaccine imports from the United States and the United KingdomMohammad Javad The LeafForeign Minister said he would like to start purchasing and co-producing vaccines "in the near future"[88][89].

As of February 2021, 2 countries have approved the emergency use of Sputnik V[9].


References

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