FDA advisory panel recommends approval of Pfizer vaccine
The Pfizer/BioNTech covid-19 vaccine is close to being granted Emergency Use Authorization, having already been approved in the UK, Bahrain and Canada.
An FDA advisory panel has voted in favour of approving the Pfizer/BioNTech coronavirus vaccine for use in the US. The group of outside advisors made the decision after a day-long hearing on Thursday in which the vaccine’s clinical trial results were scrutinised. This is not the official granting of Emergency Use Authorization but that is expected to follow in the coming days.
The FDA advisory board’s decision was not unanimous with 17 voting in favour, four against, and one abstention. The dissenting votes came after a dispute over who should be allowed access to the vaccine, with the final verdict recommending approval for emergency usage for people aged 16 and over.
When will the Pfizer vaccine be approved for use in the US?
Although the FDA has not officially granted approval, the findings of their advisory panel will almost certainly be followed. That is the first of two regulatory bodies who must vote in favour of the vaccine before it can be rolled out nationwide. The other, an advisory committee to the US Centers for Disease Control and Prevention (CDC), is expected to vote on Sunday on the matter.
Before that vote, the CDC’s Advisory Committee on Immunization Practices will hold a virtual meeting on Friday to discuss data presented by Dr William Gruber, Pfizer’s senior vice president of vaccine clinical research and development. In clinical trials the vaccine has been shown to have an effectiveness of 95% in preventing the coronavirus and found no evidence of any severe side effects.
Kristen Nordlun, spokesperson for the FDA, told CNN: “We anticipate being able to vote on the use of this vaccine on Sunday.”
When will the Pfizer vaccine be available for Americans?
With today’s news it appears like the pharmaceutical effort to develop an effective coronavirus vaccine has been successful, but attention will now turn to the logistical issue of getting it to those who need it most. Federal officials have said that an initial shipment of 6.4 million doses is ready to leave warehouses within 24 hours of approval being granted. However each recipient requires two shots, to be administered three weeks apart, so that full number will not be available straight away.
General Gustave Perna, chief operating officer for Operation Warp Speed, has revealed that 2.9 million doses will be sent out in the first wave with the same number held in storage for the second dose. Another 500,000 is to be held in reserve in case more are urgently needed.
Those first shipments will be reserved for healthcare workers and nursing home residents, but Pfizer have projected that it will be able to provide a total of 25 million doses to the US before the end of 2020. Moving into the New Year, it expects another 75 million doses to be available for Americans by March.