The regulator has set an unofficial deadline for approving the drug before Labor Day, NYT notes.
The coronavirus vaccine of the American company Pfizer and its German partner Biotech can receive full approval from the US Food and Drug Administration as early as early September. This was reported by The New York Times, citing sources.
According to the newspaper, the regulator has set an unofficial deadline for approving the vaccine before Labor Day, which will be celebrated this year in the United States on September 6. According to doctors, obtaining a full-fledged permit with a drug approved so far only under an accelerated procedure for use in emergency circumstances will help to remove any concerns about the safety of the vaccine, as well as resolve any legal issues related to the introduction of mandatory vaccination for certain groups of people. The New York Times points out that the Pentagon is waiting for the regulator to give final approval to one of the coronavirus vaccines.
It is noted that Moderna applied for full approval of its vaccine in the United States in June but has not yet sent a full package of documents, and Johnson & Johnson has not yet sent an application at all but plans to do so this year. The difficulty in such an early full approval of the vaccine is that to issue a final permit, doctors need to study 10 times more documents than when approving the drug for use in emergency circumstances.
According to a survey by the American non-profit organization Kaiser Family Foundation, which deals mainly with health problems, three out of 10 people who have not been vaccinated are inclined to get vaccinated if they receive full permission from the medical regulator. At the same time, the organization noted that many of the respondents do not fully understand the entire process of certification of drugs and can use their current status as an excuse for refusing vaccination.