Recommendation of Approval of BioNTech and Pfizer COVID-19 vaccine voted 17-4 with a member abstaining by a key FDA panel on Thursday. This is the final step before the FDA finally confirms the distribution of the first doses in the U.S.
This would be a significant moment if the Food and Drug Administration accepts this non-binding recommendation of the Advisory Committee. COVID-19 has killed around 290,000 and infected over 15.4M people in the United States. This committee was to key approve flu and various other vaccines safe. The FDA often follows this committee’s recommendation and hence their decisions were of extreme significance.
James Hildreth, a committee member told NBC on Saturday that the FDA might grant EUA of the vaccine as soon as on Friday. A EUA allows administering a vaccine or drug to a limited setting or population, like hospitalized patients while the agency resumes evaluating safe data. After the voting, Albert Bourla, CEO Of, Pfizer said that the vote pleased the company and they are ready to distribute this vaccine and help combat COVID-19 when the FDA will issue the authorization.
Specialty Of Pfizer Vaccine
Pfizer vaccine uses mRNA technology which is a new method to vaccines that utilizes genetic material for provoking immune responses. The clinical trial has proved the vaccine as 95% effective. Pfizer vaccine storage requires a temperature of -94 Fahrenheit presenting significant logistical challenges to inner cities and rural areas that do not have the appropriate health-care infrastructure. Moderna vaccine requires a temperature of -4 Fahrenheit for storing.
Dr. Slaoui, Trump’s COVID-19 vaccine czar has declared that the country can distribute vaccine doses for immunizing 100M Americans which is one-third of the country’s population by February end. He has further stated that the entire country’s population can be vaccinated by June against COVID-19. Pfizer mentioned last week that its production lines in Europe and the U.S. are fully complete and it is confident that it can supply targeted doses.