Covid vaccine: FDA panel meets to vote on emergency approval for Pfizer jab

The Food and Drug Administration’s (FDA) independent panel has started its meeting to discuss Pfizer’s Covid-19 vaccine ahead of a vote to determine if the jab should receive emergency use authorisation. 

The non-binding decision made by the FDA’s Vaccines and Related Biological Products Advisory Committee, a group of independent infectious disease experts, on Thursday will likely be the last step before the health agency determines if it will approve the jab. 

Although the FDA is not required to adhere to the advisory panel’s recommendation, the agency will likely follow how the panel votes – which will take place at the end of the meeting on Thursday. 

Pfizer, in partnership with BioNTech, is seeking emergency use authorisation for its coronavirus vaccine. If granted, the company said 2.9 million doses of the vaccine could be shipped out to states within 24 hours of that authorisation – thus starting the country’s massive distribution campaign to get Americans vaccinated for Covid-19.

The meeting will entail experts weighing the benefits versus the risks of Pfizer’s vaccine on Americans aged 16 years old and above following data retrieved by human trials. At this time it will not be determined if the vaccine is safe for children under the age of 16. 

Pfizer’s vaccine, if approved by the FDA, would receive the first emergency authorisation for a coronavirus jab in the United States. Moderna, which is about one week behind Pfizer, has also sought emergency authorisation for its vaccine. 

This panel comes after the FDA released an analysis of Pfizer’s vaccine data on Tuesday. In the analysis, the federal agency found Pfizer data showed it was 95 per cent effective against Covid-19 – which further built the case for why the vaccine should receive emergency use authorisation. 

One purpose of the independent panel was to provide transparency to the public about the safety and efficacy of a Covid-19 vaccine so Americans would feel comfortable to receive the jab if it were approved. It was anticipated for the panel to likely endorse the vaccine. 

What would emergency use authorisation mean for Pfizer? 

It would allow for the vaccine to be distributed to the public as the FDA continues to review data retrieved by the ongoing human trials, but this authorisation would not allow for the commercial use of the vaccine until it received full approval. 

The panel’s vote will likely happen towards the end of the day on Thursday, and an emergency use authorisation by the FDA could follow as early as Friday. 

“We’ll have to see what the scientific and medical discussion is today,” FDA Commissioner Dr Stephen Hahn told NBC’s Today  show on Tuesday. “But our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter.”

This authorisation would allow for Pfizer to ship out 2.9 million doses to states as early as this weekend, and officials would then start vaccinating healthcare professionals and those living in long-term care facilities – two groups the Centres for Disease Control and Prevention (CDC), as well as other health agencies, has recommended to be vaccinated first. 

An additional 2.9 million doses of the Pfizer vaccine would be sent 21 days following the first shipment. 

Americans have eagerly awaited emergency authorisation for a coronavirus vaccine at a time when coronavirus cases, hospitalisations, and deaths are surging across the US. On Wednesday, the US reported a record 3,011 deaths from Covid-19 in a single day – the most the country has seen since the start of the pandemic. 

The country has recorded more than 15.3 million coronavirus cases and over 289,000 deaths, according to Johns Hopkins University.