Pharmaceutical company Pfizer has formally asked US regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month.
The companies said protection plus a good safety record meant the vaccine should qualify for emergency use authorisation, something the Food and Drug Administration (FDA) can grant before the final testing is fully complete.
In addition to the FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible,” FDA Commissioner Stephen Hahn said in a statement.
The meeting of the Vaccines and Related Biological Products Advisory Committee will discuss the safety and effectiveness of the vaccine candidate.
The FDA is not obligated to abide by its advisory panel recommendations, but typically does.
Reuters has reported, citing a source, that an FDA panel tentatively plans to meet between December 8 and 10 to discuss the vaccine.
Mr Hahn said the agency had been preparing for the review of emergency use authorisation for COVID-19 vaccines for several months and stood ready to do so as soon as a request was submitted.
The FDA intended to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.
With the coronavirus surging around the US and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Anthony Fauci, the top US infectious disease expert, said on the eve of Pfizer’s announcement, adding that it was too early to abandon masks and other protective measures.
“We need to actually double down on the public health measures as we’re waiting for that help to come.”
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.
Globally, Pfizer has estimated it could have 50 million doses available by year’s end and up to 1.3 billion doses by the end of 2021.
About 25 million may become available for US use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week.
Recipients would need two doses, three weeks apart.
The US government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates that pan out, and has promised shots will be free.
Not far behind is competitor Moderna Inc’s COVID-19 vaccine.
Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorisation within weeks.
Here’s what happens next.
Making the data public
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
So far, what’s known is based only on statements from Pfizer and BioNTech.
Of 170 infections detected to date, only eight were among people who had received the actual vaccine and the rest had gotten a dummy shot.
On the safety side, the companies cite results from 38,000 study participants who had been tracked for two months after their second dose.
That’s a milestone FDA set because historically, vaccine side effects do not crop up later than that.
“We’ll drill down on these data,” said FDA adviser Paul Offit of the Children’s Hospital of Philadelphia.
Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis.
That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.
They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom.
For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?
There’s still no guarantee.
“We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.
Emergency use isn’t the same as full approval
If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.
That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.