FDA Panel Recommends Approval Of Pfizer’s Covid-19 Vaccine For Emergency Use; Greenlight Expected Soon

A panel of the Food and Drug Administration recommended that the agency authorize Pfizer-BioNTech’s coronavirus vaccine for emergency use.

The decision was non binding, but it is likely to lead to FDA approval of the vaccine, perhaps in the next few days. The FDA’s Vaccines and Related Biological Products Advisory Committee had a day-long discussion of the safety of the vaccine and any potential side effects, with medical experts weighing in on trial data. The vote was 17 in favor and four against, with one abstention. CNN carried the vote of the committee, which typically generates little fanfare.

The Trump administration has outlined plans to ship 2.9 million doses of the vaccine within 24 hours of approval. That will be matched by a similar amount for second doses for recipients. Plans are being made to distribute the vaccine to healthcare workers and those at long-term care facilities, with officials at the Centers for Disease Control expected to meet on Sunday to decide who to prioritize. The distribution of another 100 million doses is expected in the next few months.

President-elect Joe Biden has raised concerns about plans for distribution of the vaccine and inoculating hundreds of millions of Americans, and has called on Congress to provide funding for widespread production and distribution.

At the meeting, there was extensive discussion of potential side effects, including reports of allergic reactions. But Moncef Slaoui, who is leading the White House’s Operation Warp Speed, said that noticeable side effects of the Pfizer and another vaccine from Moderna have been limited to about 10% to 15% of volunteers who have taken the vaccine.

The FDA advisory committee question was of whether the benefits for use in those 16 years and older outweighed the risks. There was some disagreement as to whether the recommendation should be instead for those 18 years and older, given the lack of children in the trial group.

The UK and Canada already have approved the vaccine. Doses were first administered following the rollout in  the UK this week.

The panel’s recommendation comes as cases have spiked across the country, with hospital ICUs nearing capacity and California issuing new stay at home orders. On Thursday, Virginia’s governor Ralph Northam issued a new curfew order and mask mandate.