Vastavam web: A US government advisory panel has recommended emergency approval for the Pfizer-BioNTech coronavirus vaccine, underlining that the shot’s potential benefits outweigh its risks. 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 Pfizer and its German partner BioNTech. “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 drug now needs to be formally approved by the FDA. 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. The Pfizer vaccine has already been approved for the public in the UK and, Canada.
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 Emergency Use Authorisation (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.