U.S. FDA advisers overwhelmingly back authorizing Pfizer COVID-19 vaccine

Tags: FDAUSAVaccine
By December 15, 2020 Retrieved

(Reuters) –A panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted overwhelmingly to endorse emergency use of Pfizer’s coronavirus vaccine, paving the way for the agency to authorize the shot for a nation that has lost more than 285,000 lives to COVID-19.

The FDA is widely expected to authorize emergency use in days. Distribution and inoculations in the United States are expected to begin almost immediately thereafter.

The committee voted 17-4 that the known benefits of the vaccine outweighed the risks of taking the shot for individuals 16 and older, with 1 member of the panel abstaining.

Pfizer had asked that the two-dose vaccine be approved for use in people aged 16 to 85. Several advisory panel members discussed whether 16 and 17 year olds should be included in the recommendation. In the end, they voted on the question as put them by the FDA, which included 16 to 17 year olds.

The FDA said during the panel meeting that there was not enough data to support or contradict use of the vaccine in pregnant women. The agency recommends they make the decision on their own with advice from their doctors.


Source: Reuters

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