Pfizer said Friday it is asking US regulators to allow emergency use of its COVID-19 vaccine, starting the clock in a process that could bring in limited first shots as early as next month and ultimately ending the pandemic – but not until after a long, harsh winter.
The action comes days after Pfizer Inc and its German partner BioNTech announced their vaccine It appears to be 95% effective in preventing mild to severe COVID-19 in a large, ongoing study.
The companies said the protection plus a good safety record means that the vaccine must be eligible for emergency use permission, something the FDA can grant before the final test is fully completed. In addition to the FDA’s filing on Friday, they have already started “trading” applications in Europe and the UK and intend to provide similar information soon.
“Our work to provide a safe and effective vaccine has not been more urgent than ever,” Albert Burla, CEO of Pfizer, said in a statement.
As the Coronavirus spreads across the United States and the world, pressure is mounting on regulators to take a quick decision.
“Help is on the way,” said Dr. Anthony Fauci, the chief US infectious disease expert on the eve of Pfizer’s announcement, adding that it was too early to abandon masks and other protective measures. “We need to double down on public health measures while we wait for that help.”
The submission of the file on Friday will lead to a chain of events as the FDA and its independent advisors debate whether the footage is ready. If so, another government group has yet to decide how to distribute the limited primary supplies to anxiously awaiting Americans.
How much vaccine is available and when it is a moving target, but initial supplies will be scarce and fortified. Globally, Pfizer estimates that it may have 50 million doses available by the end of the year.
About 25 million could become available for use in the United States in December, 30 million in January and 35 million in February and March, according to information provided to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.
Not far from Moderna Inc.’s rival COVID-19 vaccine. His early data indicate The shots are as powerful as Pfizer, and that company also expects to request emergency permission within weeks.
Here’s what happens next:
Make the data public
The public’s first chance to see how powerful the evidence really is will come in early December at a public meeting of the FDA’s science advisors.
So far, what is known has only relied on statements from Pfizer and BioNTech. Of the 170 infections detected so far, only eight were among the people who received the actual vaccine while the rest got the placebo. In terms of safety, the companies cite results of 38,000 study participants who were tracked for two months after the second dose. This is a milestone set by the US Food and Drug Administration because historically, vaccine side effects do not appear afterward.
“We’re going to go over this data,” said FDA consultant Dr. Paul Offitt of Children’s Hospital in Philadelphia.
Think of it like science in experience. A few days before the meeting, the FDA will release its internal analysis. This sets the stage for the counselors’ day-long debate about any signs of safety concerns and how the new vaccine technology is working before a judgment is given.
They will recommend not only whether the FDA should allow the vaccine to be used more broadly in general but if so, who. For example, is there enough evidence that the vaccine also works in older adults, those with diseases such as younger, healthier people?
There is no guarantee yet. “We don’t know what that vote will be,” said Norman Baylor, the former head of vaccines for the Food and Drug Administration.
Emergency use is not the same as full consent
If there’s an emergency green light, “This vaccine is still being tested. This week, it hasn’t been approved yet,” said Dr. Marion Gruber, head of the FDA’s Vaccine Office, of the National Academy of Medicine this week.
This means, she said, anyone offering an emergency vaccine should have a “fact sheet” describing the potential benefits and risks before proceeding with the shot.
There will be a lot of unknowns. For example, a 95% protection rate is based on people who develop symptoms and then get tested for the virus. Can the pollinator become infected and have no symptoms capable of spreading the virus? How long is the protection period?
That’s why the 44,000-person study needs to continue – which is morally difficult to consider, as participants who are given mock shots must be given a real vaccine at some point, complicating the search for answers.
And at least for now, pregnant women will not qualify because they have not undergone the study. Pfizer only recently started testing the vaccine in children as young as 12 years old.
The decision regarding the Pfizer vaccine will not affect the other COVID-19 vaccine in the pipeline, which will be judged separately.
A fermentation vaccine is more complicated than manufacturing a typical drug, but the one millionth dose delivered at the Pfizer plant in Kalamazoo, Michigan should be of the same purity and efficacy as every before-and-after dose.
This means that the FDA’s decision depends not only on study data, but on determining that the vaccine is being manufactured correctly.
The Pfizer-BioNTech vaccine – and Moderna shots – are made with completely new technology. It does not contain the current Coronavirus. Instead, it is made with a piece of genetic code for the “spike” protein that inhibits the virus.
This messenger RNA, or mRNA, directs the body to make some harmless proteins, and train immune cells to recognize them if the real virus eventually appears.
Access to people’s weapons
Another government group – consultants to the Centers for Disease Control and Prevention – decides who is first in arranging the rare doses. Health and Human Services Secretary Alex Azar said he hopes the decision will be made at the same time as the Food and Drug Administration.
The Trump administration’s Warp Speed Operation has worked with states to determine the number of doses they need to cover the population exposed to the vaccine first.
Pfizer will ship these supplies as countries require – only after the FDA gives approval.
Baylor cautioned that the company’s forecast of the amount of shipment each month is only a forecast.
“It’s not like pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought”.
The Associated Press’s Department of Health and Science is supported by the Howard Hughes Medical Institute’s Science Education Division. AP is solely responsible for all content.