The Food and Drug Administration (FDA) is expected to determine whether or not to give full approval of Pfizer’s COVID-19 vaccine as soon as next month.
As the Delta variant rapidly rages through the country, causing spikes in new COVID-19 cases, the FDA is reportedly accelerating its timeline to fully approve the Pfizer vaccine, which was the first shot available.
Currently, the Pfizer - as well as the Johnson & Johnson and Moderna - vaccines have been given emergency use authorization.
Under the current timeline, the FDA hopes to have full approval by Labor Day (Monday, Sept. 6). It has been described as being one of the agency’s highest priorities.
The FDA announced late last week that it has taken an “all-hands-on-deck approach” and was “moving forward as rapidly as possible” on Pfizer’s application.
With full approval, it is expected that more COVID-19 vaccines could be administered, as it could assuage some concerns among those who are hesitant to get a shot in the arm due to it currently only having emergency use authorization.
According to the New York Times, “full approval typically requires the FDA to review hundreds of thousands of pages of documents — roughly 10 times the data required to authorize a vaccine on an emergency basis.”
The FDA can usually complete a priority review within six to eight months and had already working on an expedited timetable for the Pfizer vaccine.
Moderna, the second most widely used COVID-19 vaccine, filed for final approval of its vaccine in June, though it is still submitting data and it is unclear when it will be finished. Johnson & Johnson has not yet applied but reportedly plans to do so later this year.
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