After an eight-hour public hearing on Thursday, the food and drug administration’s (FDA) vaccines and related biological products advisory committee (VRBPAC) voted 17 to 4 with 1 abstention to recommend the vaccine developed by American pharmaceutical giant Pfizer and its German partner BioNTech to combat the disease that has killed over 292,000 people in the US.
An emergency use authorisation (EUA) is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine. Thursday’s vote does not mean the vaccine will be authorised immediately, US media reported.
“There is a clear benefit, and all we have on the other side is theoretical risks,” said committee member Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia.
The vaccine’s potential benefits outweigh its risks, he said.
“It’s a huge milestone,” said another member Ofer Levy, a pediatric infectious disease expert and head of the precision vaccine programme at Boston Children’s Hospital.
The Pfizer vaccine has already been approved for the public in the UK, Canada, Bahrain and Saudi Arabia.
The recommendation comes a day after the US recorded more than 3,000 deaths in the latest 24-hour period – the highest total in a single day anywhere in the world.
The drug still needs to be formally approved by the FDA’s vaccine chief.
While the FDA is not necessarily mandated to accept the recommendations of the advisory body, it is expected to do so next week as the administration gears to ship and provide millions of doses of coronavirus vaccines to Americans across the country, with priority being given to the vulnerable population.
Several committee members expressed concern about reports of allergic reactions in two people who were vaccinated in Britain, which authorised Pfizer’s vaccine ahead of the US.
FDA staff said that, as with any vaccines, paperwork would accompany the Pfizer vaccine to warn against administering it to anyone with a history of severe allergic reactions to vaccines or allergies to any of the ingredients of the vaccine.
“Today’s approval by the food and drug administration of the Pfizer-BioNTech Covid-19 vaccine is a bright light in a needlessly dark time. We are grateful to the scientists and researchers who developed this vaccine,” President-elect Joe Biden said in a statement.
“And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” he said.
The challenge now is to scale up manufacturing and distribution of the vaccine.
“We are putting together an experienced team to do just that. Before I take office, we need the Trump administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the US population and the world. And, we will need Congress to fund our distribution efforts,” Biden said.
Biden has vowed to distribute 100 million shots in the first 100 days of his administration.
According to FDA commissioner Stephen M Hahn, after the VRBPAC meeting, FDA career staff will take the committee’s input into account as they continue their review of the EUA request to determine whether it has met the standards for safety and effectiveness, as well as refine the instructions for use and the informational materials to be provided to those receiving the vaccine.
“In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorised vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,” Hahn said in a statement.
Congressman Fred Upton said the vaccine is essential in the fight to end the Covid-19 pandemic and restore a sense of normalcy.
“While this is an exciting day, as folks await the vaccine, everyone should continue to follow the CDC guidelines and wear their masks, wash their hands, and avoid large crowds to help stop the spread,” he said.
The Covid-19 Tracking Project on Thursday said the US sets records in all three metrics that measure the pandemic’s severity this week, recording a total of 1.4 million new cases and 15,966 deaths.
“Yesterday, states and territories reported 3,088 deaths from Covid-19 — a record no one wanted to see — and the average number of deaths per day this week exceeded 2,000, surpassing the highest average we saw in the spring’s deadly first surge. More than 106,000 people are currently hospitalised with Covid-19,” it said.
According to Johns Hopkins University, the deadly virus has infected over 15.5 million people and claimed more than 292,000 lives in the US – both the figures highest in the world.
A separate group of independent advisors to the Centres for Disease Control and Prevention – the advisory committee on immunisation practices – are scheduled to take a look at the data after FDA authorises the vaccine.
A second vaccine, developed by Moderna and the National Institutes of Health, is also seeking emergency approval in the US.