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Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, setting the clock on a process that could lead to limited first shots as early as next month and eventually to end of the pandemic, but not until after a very, hard winter.
The action comes just days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears to be 95 percent effective in preventing mild to severe COVID-19 disease in a large ongoing study.
The vaccine is among seven Canada has pre-ordered.
The companies said the protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the U.S. Food and Drug Administration can guarantee before the final test is fully completed. In addition to the FDA presentation on Friday, the company has already started rolling applications in Europe, the UK and Canada and plans to present similar information soon.
With the coronavirus on the rise in the United States and around the world, the pressure is on regulators to make a quick decision.
“Help is on the way,” said Dr. Anthony Fauci, the leading US expert on infectious diseases, on the eve of Pfizer’s announcement, stressing that it is too early to abandon masks and other protective measures. “We need to effectively double down on public health measures while we wait for help to arrive.”
Friday’s filing sets off a chain of events as the FDA and its independent consultants debate whether the shots are ready. If so, yet another government group will have to decide how to ration the initial limited supplies for eagerly awaited Americans.
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. According to information presented this week to the National Academy of Medicine, approximately 25 million doses of Pfizer vaccine could be available in December, 30 million in January and another 35 million in February and March. Recipients will need two doses, three weeks apart.
Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests that the shots are as strong as Pfizer’s and that the company plans to seek emergency clearance within weeks.
“We will analyze this data”
The first chance for the public to see just how strong Pfizer’s evidence really is will come in early December at a public meeting of FDA science advisors.
So far, what is known is based only on the statements of Pfizer and BioNTech. Of the 170 infections detected to date, only eight were among the people who had received the actual vaccine and the rest had received a sham injection. On the safety side, the companies cite the results of 38,000 study participants who were monitored for two months after their second dose. This is an FDA-set milestone because historically, vaccine side effects don’t show up later.
“We will analyze this data,” said Dr. Paul Offit, an FDA adviser, of Children’s Hospital of Philadelphia.
A few days before the meeting, the FDA will release its own internal analysis. This sets the stage for consultants’ daily debate on any signs of safety concerns and how new vaccine technology works before issuing a verdict.
They’ll recommend not only whether the FDA should allow wider use of the vaccine in general, but if so, for whom. For example, is there enough evidence that the vaccine works for older, sick adults as well as for younger, healthier people?
There is no guarantee yet.
“We don’t know what the vote will be,” former FDA vaccine chief Norman Baylor said.
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