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An emergency approval for the Pfizer-BioNTech coronavirus vaccine has been recommended by a US government advisory panel, stressing that the potential benefits of the shot outweigh its risks. The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 with 1 abstention on Thursday after an eight-hour public hearing to recommend the vaccine developed by Pfizer and its German partner BioNTech.
There is a clear advantage, and theoretical risks are all we have on the other side, said committee member Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital. The potential advantages of the vaccine outweigh its risks, he said.
“It’s a huge milestone,” said another member, Ofer Levy, an expert in paediatric infectious diseases and head of the Boston Children’s Hospital precision vaccine programme. The drug now needs to be approved by the FDA formally. While the FDA is not necessarily required to accept the advisory body’s recommendations, it is expected to do so next week as administration gears to ship and provide Americans across the country with millions of doses of coronavirus vaccines, with priority being given to the vulnerable population.
In the UK and Canada, the Pfizer vaccine has already been approved for use by the public. A bright light in a needlessly dark time is today’s approval by the Food & Drug Administration of the Pfizer-BioNTech COVID-19 vaccine. The scientists and researchers who developed this vaccine are grateful to us. And we are grateful to the scientists and experts in public health who have evaluated this vaccine’s safety and efficacy, free from political influence. In a statement, President-elect Joe Biden said the integrity of science led us to this point.
The challenge now is to scale up the vaccine’s manufacturing and distribution. We are putting an experienced team together to do just that. We need the Trump administration to buy the doses it has negotiated with Pfizer and Moderna before I take office and to operate quickly to scale production for the US population and the world. And, Biden said we will need Congress to fund our distribution efforts.
In the first 100 days of his administration, Biden vowed to distribute 100 million shots. According to FDA Commissioner Stephen M Hahn, following the VRBPAC meeting, FDA career staff will take into account the input of the Committee as they continue their review of the Emergency Use Authorisation (EUA) request to determine whether the standards for safety and effectiveness have been met, as well as to refine the instructions for use and the information material to be provided to those receiving it.
On Thursday, the COVID-19 Tracking Project said the US set records for all three metrics measuring the severity of the pandemic this week, recording a total of 1.4 million new cases and 15,966 fatalities. Yesterday, states and territories reported 3,088 COVID-19 deaths, a record no one wanted to see and this week’s average number of deaths per day exceeded 2,000, exceeding the highest average we saw in the first deadly surge in the spring. More than 106,000 individuals with COVID-19 are currently hospitalised, it said.
The deadly virus has infected over 15.5 million people, according to Johns Hopkins University, and claimed more than 292,000 lives in the United States, both of which are the highest figures in the world. A separate group of independent advisers to the Centers for Disease Control and Prevention, the Immunization Practices Advisory Committee, is scheduled to look at the information after the vaccine is authorised by the FDA.
