Pfizer, BioNTech seek emergency use of COVID-19 shots in US
(AP) — Pfizer formally asked U.S. regulators Friday 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 the FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.
“Help
is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease
expert said on the eve of Pfizer’s announcement, adding that it’s 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.”
Friday’s filing sets 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 million 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 than 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.
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’d 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’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.
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,” 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.
A
decision on Pfizer-BioNTech’s vaccine won’t affect other COVID-19
vaccine candidates in the pipeline, which will be judged separately.
MANUFACTURING
Brewing
vaccine is more complex than typical drug manufacturing, yet the
millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must
be the same purity and potency as every dose before and after.
That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.
The
Pfizer-BioNTech vaccine — and Moderna’s shots — are made with
brand-new technology. They don’t contain the actual coronavirus.
Instead, they’re made with a piece of genetic code for the “spike”
protein that studs the virus.
That messenger RNA, or mRNA,
instructs the body to make some harmless spike protein, training immune
cells to recognize it if the real virus eventually comes along.
GETTING INTO PEOPLE’S ARMS
Another
government group — advisers to the Centers for Disease Control and
Prevention — decides who is first in line for scarce doses. Health and
Human Services Secretary Alex Azar said he hopes that decision can be
made at the same time as FDA’s.
The Trump administration’s
Operation Warp Speed has worked with states to line up how many doses
they’d need to cover the populations offered vaccine first.
Pfizer will ship those supplies as ordered by the states — only after FDA gives the OK.
Company projections of how much it will ship each month are just predictions, Baylor warned.
“It’s not like a pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought.”
AP video journalist Kathy Young contributed to this report.