The U.S. Food and Drug Administration (FDA) has officially endorsed Pfizer and BioNTech’s COVID vaccine. That paves the way for emergency use authorization as the agency moves quickly to make the first coronavirus vaccine available in the U.S.
FDA endorses Pfizer/ BioNTech’s COVID vaccine
FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said they will now “rapidly work toward finalization and issuance of an emergency use authorization” for Pfizer and BioNTech’s COVID vaccine.
According to Fox News, the first shipments of the vaccine could start arriving as early as today, within hours of the decision from the FDA. The first people could receive the vaccine soon afterward. Pfizer and BioNTech’s vaccine will only be available in a limited number of doses at first. Frontline healthcare workers and patients at high risk for serious illness from COVID-19 will receive the first vaccine doses.
Pfizer announced last month that its COVID-19 vaccine was 95% effective at preventing the virus and doesn’t have any serious side effects. However, the U.K. is adding a warning to the vaccine after allergic reactions in two healthcare workers who have a history of allergic reactions to food, medications or vaccines.
Sanofi and GlaxoSmithKline run into problems
In other vaccine news, Sanofi and GlaxoSmithKline reported problems with their vaccine candidate. They announced in a joint statement that initial results from a phase 1/2 trial indicated that it brought only a low immune response in older adults.
The companies said that was probably due to insufficient antigen concentration. The vaccine candidate did bring a stronger immune response in adults between the ages of 18 and 49 that was comparable to what has been observed in patients who have recovered from COVID-19.
Sanofi and GlaxoSmithKline are planning a phase 2b trial in February. The phase 3 trials were previously set to take place this month, but they have been delayed. They now expect the phase 3 trials to take place by the second quarter of next year. Sanofi and GlaxoSmithKline are now planning to make the vaccine available starting in the middle of next year through the fourth quarter.
The phase 1/2 trial looked at the vaccine candidate in 441 American adults, who received either one or two doses of the vaccine or a placebo 21 days apart.
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