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American pharmaceutical company Pfizer released astonishingly positive data regarding its covid-19 vaccine on Monday and by the end of November, the company hopes to apply for approval from regulatory authorities. However, experts warn that it will take some time maybe a month before the vaccine can be approved.
Health experts believe that the people of the United States should not hope for Pfizer’s covid-19 vaccine to be authorized by the Food and Drug Administration (FDA) before the 2nd half of December. The reason is that the first company that may get its vaccine over the line, Pfizer, may not be able to do it before the next week. Moreover, the FDA would require weeks to review and authorize the vaccine candidate.
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Dr. Larry Corey, who is at the front of the covid-19 vaccine trials network in the US, believes that the FDA will take around 10 days to review clinical trial data of Pfizer. The agency will also be required to review the manufacturing data of Pfizer to make sure that the facilities are up to the standard where the vaccine is being made.
Corey said that he is not sure how long will the review take but thinks that it could be around two weeks which according to him is a reasonable time period for such a review. Moreover, the FDA has decided to seek input from the advisory group named Vaccines and Related Biological Products Advisory Committee (VRBPAC). However, the FDA has to schedule any meeting with the VRBPAC 15 days in advance publicly, which can also slow things down a little.
Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia Dr. Paul Offit agrees with the December deadline and said that the FDA also has to seek the advice of the VRBPAC which would presumably be scheduled sometime in December.
Moreover, Pfizer’s report on Monday about its covid-19 vaccine being 90% effective was based on preliminary data. The FDA won’t grant an Emergency Use Authorization (EUA) based on that information. According to the FDA rules, a company can apply for EUA only after waiting for two weeks of giving a second dose of its vaccine to about half of the volunteers. Moreover, the doctors leading the clinical trials will need nearly 100 more proven cases of the coronavirus to show that the vaccine works.
Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said that Pfizer is about a week or more from reaching that. Moreover, the secretary of the US Department of Health and Human Services Alex Azar thinks that it will take the company a couple of weeks to get the vaccine authorized from the FDA.
Head of the Center for Biologics Evaluation and Research of FDA Dr. Peter Marks said that the FDA will not cut corners and will move swiftly in its processes. Dr. Marks who also leads vaccine decision-making for FDA added that the agency will not grant full approval rather it will use its EUA process.
Although the federal government has not given any directions regarding who will get vaccinated first, however, Centers for Disease Control and Prevention (CDC) and the National Academies of Sciences, Engineering, and Medicine have given recommendations that the most vulnerable people and frontline and emergency workers should be first vaccinated.
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