The FDA 53-page briefing document gives a green signal to Pfizer-BioNTech COVID-19 vaccine. A US roll-out of the vaccine is expected post-approval from an outside panel of scientific advisers who will review the FDA report on Thursday.
As COVID cases continue to surge in the US, Food & Drug Administration-FDA is all set to take a momentous decision in its history. In its 53-page briefing document that has been recently published, the vaccine meets the standard when it comes to emergency use authorization.
In the US, the hospitals are preparing themselves to receive the COVID-19 vaccine shipments. One may expect the vaccine roll-out decision by the weekend. All this may well take an actual shape post a review of the FDA report by an outside panel of scientific advisers. The analysis shall take place with the manufacturers of the vaccine, Pfizer & BioNTech. A favourable recommendation is expected by the panellists, which will, in turn, help the FDA to grant emergency authorization for vaccine distribution. With the way things are moving, the authorization might come as early as Friday this week.
There is a lot of positivity surrounding the report which suggests that the two-dose vaccine has started to show effective results in the first dose itself. Once approval is received by the FDA, effective dose authorization can be put in place which will allow some adults to receive the vaccine. However, the agency will continue to evaluate the date and monitor results simultaneously. Alex Azar, Health and Human Service Secretary has been quoted as saying that once the panel formally votes OK to the vaccine, it will not take much time before FDA announces its authorization. That said, he further added that the vaccine will be in line with the FDA’s gold-standard process.
The authorization will come as a step that otherwise takes a decade to get completed. Pfizer in its final analysis of the phase 3 trial had a sample of 43000 participants and found that the vaccine was 95% effective in fending off the disease. As per the US officials, they shall distribute the vaccine within 24 hours of the authorization coming-in. However, it will take months to immunize everyone who wants to get vaccinated. As Drug Makers & State Authorities are gearing up to get the vaccine distributed post the approval by the FDA, the process is expected to start in about a week time. The first doses are expected to be shipped within hours of a decision with a target to distribute 6.4 million doses in the first week itself. The FDA report in the analysis was unable to determine whether people who had suffered from COVID-19 got benefited from the vaccination. Many questions remain unanswered like how long the protection will last and whether the vaccine will prevent people who are infected despite vaccination from spreading the dreaded disease.
It is well to be noted that the US has approached Pfizer for 100 million doses last week, but was informed that the supply may not be available until June.
