“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
With the coronavirus on the rise in the US and the world, regulators are pushing for a quick decision.
“Help is on the way,” said Dr. Anthony Fauci, America’s leading infectious disease expert on the eve of the Pfizer announcement, adding that it is too early to abandon masks and other protective measures. “We really need to redouble public health measures while we wait for that help to come.”
Friday’s filing would set off a chain of events as the FDA and its independent advisers debate whether vaccines are ready. If so, another government group will have to decide how the limited initial supplies for the eagerly awaiting Americans will be rationed.
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How much vaccine is available and when is it a moving target, but initial supplies will be scarce and rationed. About 25 million doses of the Pfizer vaccine may be available 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 COVID-19 vaccine from its competitor Moderna Inc. is not far behind. Its first data suggests that the shots are as strong as those from Pfizer, and that company also hopes to seek emergency authorization within a few weeks.
This is what happens next:
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of FDA’s scientific advisers.
So far, what is known is based solely on statements by Pfizer and BioNTech. Of the 170 infections detected to date, only eight occurred among people who had received the real vaccine and the rest had received a fake injection. On the safety side, the companies cite the results of 38,000 study participants who have been tracked for two months after their second dose. That’s a milestone set by the FDA because historically, side effects from vaccines don’t show up later.
“We’ll dig into this data,” said Dr. Paul Offit, FDA advisor, Children’s Hospital of Philadelphia.
Think of it as science tested. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for one-day advisers debate on any signs of safety issues and how the new vaccine technology works before a verdict is delivered.
They will recommend not only whether the FDA should allow wider use of the vaccine in general, but, if so, for whom. For example, is there sufficient evidence that the vaccine works as well for older and sicker adults as it does for younger, healthier people?
Still no guarantee. “We don’t 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 an emergency green light, “that vaccine is still under investigation. It is not yet approved,” Dr. Marion Gruber, chief of the FDA’s vaccine office, told the National Academy of Medicine this week.
That means anyone who is offered an emergency vaccine must obtain a “fact sheet” outlining the potential benefits and risks before giving the vaccine, he said.
There will be many unknowns. For example, the 95 percent protection rate is based on people who developed symptoms and were later tested for the virus. Can those vaccinated become infected but have no symptoms, capable of spreading the virus? How long does the protection last?
That’s why the 44,000-person study needs to keep running – somewhat difficult considering ethically – participants who received sham injections at some point must be offered a real vaccine, complicating the search for answers.
And for now at least, pregnant women won’t qualify because they weren’t screened. Pfizer recently began testing the vaccine in children as young as 12 years old.
A Pfizer vaccine decision will not affect other COVID-19 vaccine candidates in the pipeline, which will be evaluated separately.
Preparing the vaccine is more complex than making typical drugs, yet the millionth dose to be released at Pfizer’s Kalamazoo, Michigan factory must be as pure and potent as all before and after doses.
That means the FDA’s decision is not based on the study data alone, but on its determination that the vaccine is being manufactured correctly.
The Pfizer-BioNTech vaccine, and Moderna injections, are manufactured using 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 the virus embeds.
That messenger RNA, or mRNA, signals the body to produce a harmless spike protein, training immune cells to recognize it if the real virus does eventually appear.
ENTER THE ARMS OF THE PEOPLE
Another government group, advisers to the Centers for Disease Control and Prevention, decides who is first in line to receive meager doses. Health and Human Services Secretary Alex Azar said he hopes a decision can be made at the same time as the FDA.
The Trump administration’s Operation Warp Speed has worked with states to align how many doses they would need to cover the populations that were offered the vaccine first.
Pfizer will ship those supplies as requested by states, only after FDA gives its approval.
The company’s 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.”