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 before after a long, hard winter.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine seems 95% effective in preventing mild to severe COVID-19 disease in a large, ongoing study.
The companies said protection plus a good safety record means the vaccine must qualify for authorization for emergency use, something the Food and Drug Administration can provide before the final test is completely completed. In addition to Friday̵
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
With coronavirus rising around the United States and the world, regulators are under pressure to make a quick decision.
“Help is on the way,” said Dr. Anthony Fauci, the top US expert in infectious diseases, just before Pfizer’s announcement, adding that it is too early to abandon masks and other protective measures. “We actually need to double public health measures as we wait for that help to come.”
Friday’s filing would trigger a chain of events as the FDA and its independent advisers discussed whether the shots are ready. In that case, another government group will have to decide how to ration the initial limited supply to tense waiting Americans.
How much vaccine is available and when is a moving target, but the initial supply will be scarce and rationed. Globally, Pfizer has estimated that it could have 50 million doses available by the end of the year.
About 25 million may become available for use in the United States 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 need two doses three weeks apart.
Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizers, and that company also expects to seek emergency clearance within a few weeks.
Here’s what happens next:
CREATION OF DATA PUBLIC
The public’s first chance to see how strong the evidence really is comes in early December at a public meeting with FDA scientific advisors.
So far, what is known is based solely on statements from Pfizer and BioNTech. Of the 170 infections found so far, only eight were among the people who had received the actual vaccine and the rest had received a dummy shot. In the area of safety, companies cite results from 38,000 study participants who have been tracked for two months after their second dose. It’s a milestone the FDA has set because vaccine side effects historically do not show up later than that.
“We are analyzing this data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.
Think of it as science on trial. A few days before the meeting, the FDA releases its own internal analysis. It sets the stage for the advisers’ daily debate on signs of safety concerns and how the new vaccine technology works before a verdict is handed down.
They will not only recommend whether the FDA should generally allow wider use of the vaccine, but if so, for whom. For example, is there enough evidence that the vaccine works just as well for older, sicker adults as for younger and healthier people?
There is still no guarantee. “We do not know what that vote will be,” said former FDA vaccine chief Norman Baylor.
EMERGENCY USE IS NOT THE SAME AS FULL APPROVAL
If there is a green light in an emergency, ”this vaccine is still considered for research purposes. It is not yet approved, “said Dr. Marion Gruber, head of the FDA’s vaccine office, to the National Academy of Medicine this week.
That means anyone offered an emergency vaccination should be given a “fact sheet” describing potential benefits and risks before going through with the shot, she said.
There will be many unknowns. For example, the protection rate of 95% is based on people who developed symptoms and then were tested for the virus. Can the vaccinated person become infected, but have no symptoms, able to spread the virus? How long does the protection last?
Therefore, the 44,000-person study needs to continue – something difficult ethically considered that participants who get dummy shots at some point should be offered real vaccine, which complicates the search for answers.
And at least for now, pregnant women do not qualify because they were not studied. Pfizer only recently began testing the vaccine in children as young as 12 years old.
A decision on Pfizer’s vaccine will not affect other COVID-19 vaccine candidates in the pipeline, which will be assessed separately.
Brewing vaccine is more complex than typical drug production, yet the million dose that rolls out of Pfizer’s Kalamazoo, Michigan factory must be the same purity and strength as each dose before and after.
This means that the FDA decision is not only based on study data, but on its decision that the vaccine is performed correctly.
The Pfizer BioNTech vaccine – and Moderna’s shots – are made with completely new technology. They do not contain the actual coronavirus. Instead, they are made with a piece of genetic code for the “spike” protein that studies the virus.
This messenger RNA, or mRNA, instructs the body to produce some harmless spike protein that trains immune cells to recognize it if the real virus eventually comes together.
TO GET IN 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 the decision can be made at the same time as the FDA.
The Trump administration’s Operation Warp Speed has worked with states to figure out how many doses they need to cover the populations offered vaccine first.
Pfizer will ship these supplies as ordered by the states – only after the FDA has given OK.
The company’s projections of how much it will send each month are only predictions, Baylor warned.
“It’s not like a pizza,” he said. Production is so complex that “one does not necessarily end up with what one thought.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.