By LAURAN NEERGAARD

AP – 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 until after a long, hard winter.

The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.

“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 surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.

“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”

Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. Globally, Pfizer has estimated it could have 50 million doses available by year’s end.

About 25 million may become available for U.S. use 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.

Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.

Here’s what happens next:

MAKING THE DATA PUBLIC

The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.

So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.

“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.

Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.

They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?

There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.

EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL

If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?

That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

And at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.

A decision on Pfizer’s vaccine won’t affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

MANUFACTURING

Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.

That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.

The Pfizer-BioNTech vaccine — and Moderna’s shots — are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

GETTING INTO 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 that decision can be made at the same time as FDA’s.

The Trump administration’s Operation Warp Speed has worked with states to line up how many doses they’d need to cover the populations offered vaccine first.

Pfizer will ship those supplies as ordered by the states — only after FDA gives the OK.

Company 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.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

By CHRISTOPHER RUGABER

WASHINGTON (AP) — The number of Americans seeking unemployment aid rose last week to 742,000, the first increase in five weeks and a sign that the resurgent viral outbreak is likely slowing the economy and forcing more companies to cut jobs.

The Labor Department’s report Thursday showed that applications for benefits rose from 711,000 in the previous week. Claims had soared to 6.9 million in March when the pandemic first intensified. Before the pandemic, applications typically hovered about 225,000 a week.

The economy’s modest recovery is increasingly at risk, with newly confirmed daily infections in the United States having exploded 80% over the past two weeks to the highest levels on record. More states and cities are issuing mask mandates, limiting the size of gatherings, restricting restaurant dining, closing gyms or reducing the hours and capacity of bars, stores and other businesses. At least 15 states have tightened curbs on businesses to try to slow infections.

Evidence is emerging that consumers are losing confidence in the economic outlook and pulling back on shopping, eating out and other activities. Spending on 30 million credit and debit cards tracked by JPMorgan Chase fell 7.4% earlier this month compared with a year ago. That marked a sharp drop from two weeks earlier. Consumer sentiment also declined in early November and is down nearly 21% from a year ago, according to a University of Michigan survey.

The number of people who are continuing to receive traditional unemployment benefits fell to 6.4 million, the government said, from 6.8 million. That shows that more Americans are finding jobs and no longer receiving unemployment aid. But it also indicates that many jobless people have used up their state unemployment aid — which typically expires after six months — and have transitioned to a federal extended benefits program that lasts 13 more weeks.

The worsening viral outbreak coincides with the impending expiration of two federal unemployment programs at year’s end that could eliminate benefits for 9.1 million people, according to a report from The Century Foundation. Congress has so far failed to agree on any new stimulus package for jobless individuals and struggling businesses. The cutoff of aid will sharply reduce income for the unemployed, force a further reduction in their spending and perhaps weaken the economy.

One of those programs is Pandemic Unemployment Assistance, which made self-employed and contract workers eligible for unemployment aid for the first time. PUA was established by a multi-trillion-dollar aid package that Congress enacted in the spring.

The second measure in the stimulus package provided the additional 13 weeks of benefits for unemployed people who have used up their state benefits.

When those two programs expire on Dec. 26, the Century Foundation estimates that 12 million people will lose their benefits. About 2.9 million might be able to transition to a state extended benefit program that can last from six to 20 weeks, the report said. But the rest will lose benefits that average about $320 a week nationally.

The expiration of benefits will make it harder for the unemployed to make rent payments, afford food or keep up with utility bills. Most economists agree that because unemployed people tend to quickly spend their benefits, such aid is effective in boosting the economy.

Cutting off benefits with several million people still unemployed would be unusually early compared with previous recessions. In the Great Recession of 2008-2009, the government extended unemployment benefits to 99 weeks, and the additional aid lasted through 2013. When that program ended, about 1.3 million people lost benefits — a fraction of the number who would lose their aid at the end of this year.

“We’re still down 10 million jobs since the pandemic began,” said Elizabeth Pancotti, co-author of the Century Foundation report and a policy advisor at Employ America, a left-leaning think tank. “We’re heading into the winter, we’re seeing additional business closures, consumer demand is already falling….Cutting off benefits seems inhumane to me.”

In March and April, when the pandemic erupted in the United States, tens of millions of people applied for jobless aid. Though many of them have been rehired or have landed new jobs, those who haven’t found work began exhausting their six months of state aid as early as September.

Most of them would then shift to the Pandemic Emergency Unemployment Compensation program, which provides 13 additional weeks. Yet the Century Foundation estimates that 3.5 million people will have used up all of those 13 weeks before the year ends. An additional 950,000 people will have run out of the 39 weeks provided by the PUA program by then, too.