FDA panel recommends emergency approval of Pfizer-BioNTech vaccine in the US

The decision follows the deadliest day in the US pandemic

A pharmacist undergoes training as they prepare for the distribution of the Pfizer vaccine in New York City, December 10, 2020. Handout via REUTERS

A Food and Drug Administration panel has recommended granting an emergency use authorisation (EUA) for the Pfizer-BioNTech Covid-19 vaccine in the United States, a day after the country recorded its deadliest day of the pandemic.

The vaccine advisory panel voted 17-4 in favour of recommending the use of the vaccine, with one abstention.

The panel held a day-long meeting discussing safety, efficiency and other concerns, ultimately recommending approval.

Members ruled that the Pfizer-BioNTech vaccine is safe for people over the age of 16, and healthcare workers and nursing home residents will receive the first vaccines.

The Pfizer-BioNTech Covid-19 vaccine has already been approved in the UK, Bahrain, and Saudi Arabia, with the first immunisations already under way in Britain.

The US is dealing with the world's deadliest coronavirus outbreak and has the most cases globally.

Around 200,000 Americans are infected each day, while hospitals struggle with capacity issues. Both Johns Hopkins University and the Covid Tracking Project reported on December 9 that more than 3,000 Americans had died from Covid-19, bringing the death toll to more than 290,000.

The next hurdle for the Pfizer-BioNTech vaccine in the US is the official Food and Drug Administration decision on issuing the EUA. This could happen as early as Friday, according to CNBC.

The agency is expected to follow the recommendation of the vaccine advisory panel.

When the agency issues the EUA, the vaccines may be shipped domestically but public health officials will not be able to immunise yet.

The final step in the authorisation journey will take place when the Centres for Disease Control and Prevention advisory committee votes on whether to offer the vaccine to the public.

Pfizer-BioNTech has a standing order with the US government to manufacture 100 million vaccines. Initial hopes were to meet that order by the end of the year, however supply-chain issues may result in fewer doses sent out by year's end.

The New York Times reported that this summer, the Trump administration passed on an offer by Pfizer to provide more vaccines for Americans.

The Food and Drug Administration panel will meet on December 17 to discuss the EUA approval of a Covid-19 vaccine by Moderna.