By Lauran Nergaard, AP Medical writer
Pfizer said that on Friday it is asking US regulators to allow emergency use of its COVID-19 vaccine, which is starting the clock on a process that could give limited shots early next month And may eventually end the epidemic – but not until after a long, hard winter.
Pfizer Inc. And its German partner BioNTech announced that the vaccine appeared to be 95% effective in preventing mild to severe COVID-19 disease in a large, ongoing study.
The companies said safety and a good safety record meant the vaccine should qualify for emergency use authorization, something the Food and Drug Administration could give before the final test was fully completed. In addition to Friday’s FDA submission, they have already launched “rolling” applications in Europe and the UK and intend to deliver similar information soon.
Pfizer CEO Albert Borla said in a statement, “Our work to deliver a safe and effective vaccine has never been more urgent.”
As coronoviruses grow in the US and around the world, there is pressure on regulators to make faster decisions.
“Help is on the way,” top American infectious disease specialist Dr. Anthony Fauci said on the eve of Pfizer’s announcement, adding that it is too early to drop masks and other protective measures. “We really need to double down on public health measures because we are waiting for help to come.”
Friday’s filing advances the debate of the FDA and its independent advisors, if the shots are prepared. If so, still another government group will have to decide how the initial limited supply is waiting for Americans.
How much vaccine is available and when there is a targeting, but the initial supply will become scarce and rationed. Globally, Pfizer has estimated that it may provide 50 million doses by the end of the year.
According to information submitted for the National Academy of Medicine this week, about 25 million may be available for US use in December, 30 million in January, and 35 million more in February and March. The recipient will require two doses, three weeks apart.
Not far behind is Competitor Modern Inc.’s COVID-19 vaccine. Its initial data suggests the shots are as strong as Pfizer’s, and the company also expects emergency authorization within weeks.
Here’s what happens next:
The public’s first opportunity is to see how strong the evidence will be in early December at a public meeting of FDA’s scientific advisors.
So far, what is known is based only on the statements of Pfizer and BioNotech. Of the 170 infections detected so far, only eight were people who had received the actual vaccine and the rest had received a dummy shot. On the safety side, the companies cite results from 38,000 study participants who have been tracked for two months after their second dose. This is a milestone FDA set because historically, vaccines do not crop up later than side effects.
“We will exercise these data,” FDA consultant at Children’s Hospital Philadelphia Dr. Paul Offit said.
Think of it like science on a test. A few days before the meeting, the FDA will release its internal analysis. This sets the stage for consultants’ day-long debate about any signs of safety concerns and how the new vaccine technology works before making a decision.
They would advise whether the FDA should or should not allow widespread use of the vaccine, but if so for whom. For example, does the adequate proof vaccine work for older, sick adults as well as younger, healthier people?
There is still no guarantee. “We don’t know what the vote means,” said former FDA vaccine chief Norman Biler.
Use completely completely uniform
If there is an emergency green light, “the vaccine is still considered investigable. It is not yet approved,” Dr. Marion Gruber, head of the FDA’s vaccine office, told the National Academy of Medicine this week.
This means that anyone who offered emergency vaccination should receive a “fact sheet” describing the potential benefits and risks before undergoing the shot.
There will be many unknowns. For example, the 95% safety rate is based on people who developed symptoms and then were tested for the virus. Can the vaccine be infected but have no symptoms, capable of spreading the virus? How long does conservation last?
The 44,000-person study therefore needs to be ongoing – morally difficult thoughts, given dummy shots at some point, complicating the search for answers to participants, offering the actual vaccine.
And at least for now, pregnant women will not qualify because they were not studied. Pfizer recently began testing the vaccine in children under 12 years old.
A decision on Pfizer’s vaccine would not affect other COVID-19 vaccine candidates in the pipeline, which would be judged separately.
The bruising vaccine is more complex than typical pharmaceutical formulation, yet Pfizer’s tenth dose to get out of Kalamazoo, Michigan, the factory must have the same purity and potency before and after every dose.
This means that the FDA’s decision is not just based on study data, but on the determination that the vaccine is being made correctly.
The Pfizer-BioNTech vaccine – and Modern’s shots – are built with brand-new technology. They are not actual coronaviruses. Instead, they create a piece of genetic code for the “spike” protein that studs the virus.
This messenger RNA, or mRNA, instructs the body to make some harmless spike proteins, by training immune cells to identify whether the actual virus eventually comes along.
Into People ARMS.
Another government group – advisors to the Centers for Disease Control and Prevention – decide who is first in line for rare doses. Health and Human Services Secretary Alex Azar said he hoped the decision could be taken at the same time as the FDA.
The Trump administration’s Operation Tana Moti has worked with states to first determine how many people will need to cover the population offered the vaccine.
Pfizer will ship those supplies as ordered by the states – only after the FDA has given OK.
The company estimates how much it will ship each month, only forecasts, Beiler warned.
“It’s not like pizza,” he said. Manufacturing is so complex that “what you thought is not necessary.”
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