The Morning Call
Pfizer seeking emergency use of its vaccine in US
If FDA approves shots, some could arrive next month
Pfizer said Friday it is asking U.S. 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 and eventually an end to the pandemic — but not until after a long, hard winter.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
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 mil
lion doses available by year’s end.
About 25 million may become available for U.S. 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 will need two doses, three weeks apart. The U.S. 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 authorization within weeks.
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’d received the actual vaccine and the rest had gotten a dummy shot. Onthe safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.
“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.
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.
If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. 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.
There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?
That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.
“I’m curious,” said Barry Colvin, 52, of White Plains, New York, who is taking part in that study at NYU Langone Health.
But he’s not in a great hurry to find out which group he’s in. “You need to hang in there for a while to understand and answer a lot of the other questions that remain unknown.”
Additionally at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.