By LAURAN NEERGAARD

AP – Moderna Inc. said it would ask U.S. and European regulators Monday to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection — ramping up the race to begin limited vaccinations as the coronavirus rampage worsens.

Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the U.S. and Europe. U.S. hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.

Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. in December. British regulators also are assessing the Pfizer shot and another from AstraZeneca.

Moderna created its shots with the U.S. National Institutes of Health and already had a hint they were working, but said it got the final needed results over the weekend that suggest the vaccine is more than 94% effective.

Of 196 COVID-19 cases so far in its huge U.S. study, 185 were trial participants who received the placebo and 11 who got the real vaccine. The only people who got severely ill — 30 participants, including one who died — had received dummy shots, said Dr. Tal Zaks, the Cambridge, Massachusetts, company’s chief medical officer.

When he learned the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. “We have already, just in the trial, have already saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.”

Moderna said the shots’ effectiveness and a good safety record so far — with only temporary, flu-like side effects — mean they meet requirements set by the U.S. Food and Drug Administration for emergency use before the final-stage testing is complete. The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster “conditional” clearance.

WHAT COMES NEXT

The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.

First up on Dec. 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. Moderna said its turn at this “science court” is expected exactly a week later, on Dec. 17.

RATIONING INITIAL DOSES

If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the U.S. by year’s end. Recipients will need two doses, so that’s enough for 10 million people.

Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the U.S.

Shipments are set to begin to states within 24 hours of FDA clearance. And this week, a different panel of U.S. experts, established by the Centers for Disease Control and Prevention, will meet to decide how those initial supplies will be given out. They’re expected to reserve scarce first doses for health care workers and, if the shots work well enough in the frail elderly, for residents of long-term care facilities.

As more vaccine gradually becomes available in coming months, other essential workers and people at highest risk from the coronavirus would get in line. But enough for the general U.S. population isn’t expected until at least spring.

Outside the U.S., Zaks said significant supplies from Moderna would be available later, “in the first quarter” of next year.

“Obviously we are doing everything in our power to increase the capacity and accelerate the timelines,” he said.

Britain’s government said Sunday it has ordered 7 million doses from Moderna.

The U.K. also has ordered 40 million doses of the Pfizer-BioNTech vaccine, although it’s not clear how much of the companies’ limited December supply could go toward that order — if British health authorities clear the shots. Still, British hospitals are gearing up to receive some doses as early as next week.

Both Moderna’s and Pfizer’s vaccines are made with the same technology, using 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.

ASTRAZENECA CONFUSION

AstraZeneca and Oxford University last week announced confusing early results of their vaccine candidate from research in Britain and Brazil.

That vaccine appears 62% effective when tested as originally intended, with recipients given two full doses. But because of a manufacturing error, a small number of volunteers got a lower first dose — and AstraZeneca said in that group, the vaccine appeared to be 90% effective.

Experts say it’s unclear why the lower-dose approach would work better and that it may just be a statistical quirk.

A larger U.S. study of the AstraZeneca candidate still is underway that should eventually give the FDA a better picture of how well it works. The FDA has said any COVID-19 vaccine would have to be at least 50% effective.

Meanwhile Britain’s government will have to decide whether its U.K. data is sufficient for an early rollout there.

STILL IN THE PIPELINE

Johnson & Johnson also is in final-stage testing in the U.S. and several other countries to see if its vaccine candidate could work with just one dose.

Both the J&J and AstraZeneca vaccines work by using harmless cold viruses to carry the spike protein gene into the body and prime the immune system.

The different technologies have ramifications for how easily different vaccines could be distributed globally. The AstraZeneca shots won’t require freezer storage like the Pfizer and Moderna vaccines.

Candidates made with still other technologies are in late-stage testing, too. Another U.S. company, Novavax Inc., announced Monday that it has finished enrolling 15,000 people in a late-stage study in Britain and plans to begin recruiting even more volunteers for final testing in the U.S. and Mexico “in the coming weeks.”

Vaccines made by three Chinese companies and a Russian candidate also are being tested in thousands of people in countries around the world.

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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 ANNE D’INNOCENZIO

NEW YORK (AP) — After months of slumping sales and businesses toppling into bankruptcy, Black Friday is offering a small beacon of hope.

In normal times, Black Friday is the busiest shopping day of the year, drawing millions of shoppers eager to get started on their holiday spending.

But these are not normal times: The economy is tanking and crowds are expected to be dramatically diminished as coronavirus cases spike and shoppers do more of their purchases online.

Many retailers closed their doors on Thanksgiving Day but are beefing up their safety protocols to reassure wary customers that they can still come back the next day. For those who can’t be reassured, stores are moving their doorbuster deals online and ramping up curbside pickup options as a last grasp at sales before the year ends and they head into the dark days of winter with the pandemic still raging.

“Black Friday is still critical,” said Neil Saunders, managing director of GlobalData Retail. “No retailer wants it to be tarnished. It’s still vital to get their consumers spending and get consumers into the holiday mood.”

Macy’s Herald Square in New York featured such deals as 50% off handbags and 60% off women’s and men’s coats, but there was just a trickle of shoppers at around 7 a.m., an hour after the store opened. There was no one in line at the service area where customers pick up their online orders. Workers could be seen sanitizing door knobs and windows. The scene looked similarly empty at the nearby Manhattan Mall.

At the Garden State Plaza mall in Paramus, New Jersey, parking spots were easy to find shortly after the mall opened at 7 a.m. Inside, there was a line at video game store GameStop and several police officers to control the crowd.

Things were quiet at a Walmart in Saddle Brook, New Jersey. The nation’s largest retailer has been offering its best deals online this month to deter any crowds from showing up on Black Friday.

The U.S. Centers for Disease Control and Prevention has labeled shopping in crowded stores during the holidays a “higher risk” activity and says people should limit any in-person shopping, including at supermarkets.

Instead, the health agency recommends shopping online, visiting outdoor markets or using curbside pickup, where workers bring orders to you in the parking lot.

The day after Thanksgiving has been losing its luster as the unofficial start to the holiday shopping season for the past several years, with more stores were offering holiday discounts throughout the month. Still, Black Friday has remained the busiest day of the year, according to ShopperTrak, and is expected to hold that title again this year.

The National Retail Federation, the nation’s largest retail trade group, has taken an optimistic view, predicting that shoppers will be looking for reasons to celebrate. The trade group expects sales for the November and December period to increase between 3.6% and 5.2% over 2019 compared with a 4% increase the year before. Holiday sales have averaged gains of 3.5% over the past five years.

“After all they’ve been through, we think there’s going to be a psychological factor that they owe it to themselves and their families to have a better-than-normal holiday,” said NRF Chief Economist Jack Kleinhenz. “There are risks to the economy if the virus continues to spread, but as long as consumers remain confident and upbeat, they will spend for the holiday season.”

Retailers were successful in convincing shoppers to spend early by pushing big discounts in mid-October. And shoppers have shown their willingness to spend for other holidays like Easter and Halloween.

Online sales could realize even bigger gains heading into the holidays. Black Friday is projected to generate $10 billion in online sales, a 39% bump from the year ago period, according to Adobe Analytics, which measures sales at 80 of the top 100 U.S. online retailers. And Cyber Monday, the Monday after Thanksgiving, will remain the biggest online shopping day of the year with $12.7 billion in sales, a 35% jump.

The pandemic has already benefited Amazon, which continues to seal its dominance in the online space as jittery shoppers click on their devices instead of venturing into stores. Likewise, big box chains like Walmart and Target that were allowed to stay open during the spring lockdowns fared far better than department stores and other non-essential retailers that were forced to close. That disparity helped speed up bankruptcy filings of more than 40 chains, including J.C. Penney and J.Crew, and resulted in hundreds of stores closings.

Plenty of clothing chains like Abercrombie and Fitch have warned of more difficult days ahead, including the possibility of even more store closures. A&F said Tuesday it expects sales declines to deepen to 5% to 10% for the holiday quarter.

“There are a lot of unknowns as we head into what’s our traditionally highest volume weeks of the year,” Scott Lipesky, chief financial officer at Abercrombie & Fitch told analysts on its earnings call. “With COVID numbers rising, there is the potential for a change in apparel demand and customer willingness to enter physical stores. “

Department stores and other clothing stores that haven’t yet recovered from the closures during the spring will have a hard time making up for lost sales, says Ken Perkins, president of Retail Metrics LLC , a retail research firm.

For the fiscal third quarter, mall-based retailers saw their profits down 20% while big box stores and other retailers that operate outside a traditional mall posted a 19% increase, according to RetailMetrics’ tally of roughly 100 retailers. For the fiscal fourth quarter, mall-based retailers are expected to see profits down 31%, while off-mall stores should see profits up 1%.

By MICHAEL RUBINKAM

In Pennsylvania, if you’re having friends over to socialize, you’re supposed to wear a mask — and so are your friends. That’s the rule, but Barb Chestnut has no intention of following it.

“No one is going to tell me what I can or not do in my own home,” said Chestnut, 60, of Shippensburg. “They do not pay my bills and they are not going to tell me what to do.”

As governors and mayors grapple with an out-of-control pandemic, they are ratcheting up mask mandates and imposing restrictions on small indoor gatherings, which have been blamed for accelerating the spread of the coronavirus. But while such measures carry the weight of law, they are, in practical terms, unenforceable, and officials are banking on voluntary compliance instead.

Good luck with that.

While many are undoubtedly heeding public health advice — downsizing Thanksgiving plans, avoiding get-togethers, wearing masks when they’re around people who don’t live with them — it’s inevitable that a segment of the population will blow off new state and local restrictions and socialize anyway. Experts say that could put greater stress on overburdened hospitals and lead to an even bigger spike in sickness and death over the holidays.

“When this started in early March, we weren’t staring at Thanksgiving and Christmas, and we didn’t have the disease reservoir that we have. And that, to me, is the biggest concern in the next few weeks,” said Dr. David Rubin, the director of PolicyLab at Children’s Hospital of Philadelphia. He called the risk of a Thanksgiving spike “extremely high.”

“I think you’re seeing a lot of resistance here,” Rubin said. “I can’t speculate on what people are going to do, but I can say that to the degree that there isn’t a collective buy-in here, it sort of blunts the impact of the measures themselves.”

The nation is averaging 172,000 new virus cases per day, nearly doubling since the end of October, according to Johns Hopkins University. Hospitalizations, deaths and the testing positivity rate are also up sharply as the nation approaches Thanksgiving.

In response, elected officials are imposing restrictions that, with some exceptions, fall short of the broad-based stay-at-home orders and business shutdowns seen in the spring.

Utah and Vermont have banned all social gatherings. So have local governments in Philadelphia and Dane County, Wisconsin. In Kentucky, no more than eight people from two households are permitted to get together; in Oregon, the gathering limit is six. California has imposed an overnight curfew. More states are requiring masks, including those with GOP governors who have long resisted them. The nation’s top health officials are pleading with Americans to avoid Thanksgiving travel.

There’s some evidence the holiday will be quieter.

Tamika Hickson, who co-owns a party rental business in Philadelphia, said Thanksgiving was a bust even before her city moved to prohibit indoor gatherings of any size.

“Nobody’s calling,” Hickson said. “A lot of people lost a lot of loved ones, so they’re not playing with this. And I don’t blame them.”

AAA projects Thanksgiving travel will fall by at least 10%, which would be the steepest one-year plunge since the Great Recession in 2008. But that still means tens of millions of people on the road. On social media, people defiantly talk about their Thanksgiving plans, arguing that nothing will stop them from seeing friends and family.

More than 1 million people thronged U.S. airports on Sunday, according to the Transportation Security Administration — the highest number since the beginning of the pandemic.

Dr. Debra Bogen, the health director for Allegheny County, Pennsylvania, which includes Pittsburgh, said that too many have been ignoring public health guidance and that the result has been unchecked spread of the virus.

“For the past few weeks, I’ve asked people to follow the rules, curtail gatherings and parties, stay home except for essentials, and wear masks. I’m done asking,” Bogen said at a news conference, her frustration palpable. She announced a stay-at-home advisory that she said would turn into an order if people didn’t comply.

Some people are underestimating the risk to themselves and their friends and families, said Baruch Fischhoff, a Carnegie Mellon University psychologist who has written about COVID-19 risk analysis and communications. Others doubt what health officials are telling them about the virus. And still others are simply irresponsible.

Fischhoff said the lack of a cohesive national pandemic strategy; patchwork and seemingly arbitrary restrictions at the state and local level; and ineffective, politicized and contradictory public health messaging have sown confusion and mistrust.

“It has been a colossal, tragic failure of leadership from the very beginning that we didn’t find the common ground in which we were working to protect the weakest among us. And once you’ve lost that coordination, you’re scrambling to get it back and that’s the tragic mess that we’re in now,” he said.

In York County, Pennsylvania, 51-year-old retail worker Kori Jess tested positive for the virus last week. Long a mask skeptic, her personal experience with COVID-19 has changed her opinion — to a point. She said it’s appropriate to wear a mask when circumstances warrant, but she still doesn’t like the idea of government mandating them.

“I’m so torn,” Jess said. “I like that people are fighting for their freedoms, but I understand why people are wearing masks.”

In upstate New York, some sheriffs say they have no intention of enforcing Democratic Gov. Andrew Cuomo’s recent mandate barring private gatherings of more than 10 people.

“There is no need to hide cars and sneak around during your attempt to gather with family. We are not going to exhaust our limited resources obtaining search warrants and counting the turkey eaters in your house,” Madison County Sheriff Todd Hood said in a Facebook post. He encouraged people in the largely rural area to use common sense to keep themselves safe.

Kim Collins is among those planning a slimmed-down Thanksgiving. In a typical year, Collins would have as many as 20 people at her home in South Orange, New Jersey. This year, her extended family is staying put. “My husband’s having a hard time with the fact that his mom, who’s on her own, won’t be here,” she said.

But Collins wasn’t optimistic that others would be so careful. She said plenty of people are going through “mental gymnastics” to justify their holiday get-togethers. “I think that a lot of people aren’t great at the honor system,” she said. ___

Associated Press reporters Deepti Hajela in New York City and Michael Hill in Albany, New York, contributed to this story.