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Pfizer: Shot effective; US deaths over 250K
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Pfizer: Shot effective; US deaths over 250K

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Pfizer said Wednesday that new test results show its coronavirus vaccine is 95% effective, is safe and also protects older people most at risk of dying — the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.

And conditions inside the nation’s hospitals are deteriorating by the day as the coronavirus rages across the U.S. at an unrelenting pace and the death toll has surpassed 250,000.

The announcement from Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine. Anticipating that, a Food and Drug Administration advisory panel is on standby to publicly debate the data in early December.

The companies also have begun "rolling submissions" for the vaccine with regulators in Europe, the U.K. and Canada and soon will add this new data.

Pfizer and BioNTech had initially estimated the vaccine was more than 90% effective after counting a group of the earliest infections that occurred in its final-stage testing. With the new announcement, they have accumulated more infections — 170 — and said only eight of them occurred in volunteers who got the actual vaccine rather than a comparison dummy shot. One of those eight developed severe disease, the companies said.

"This is an extraordinarily strong protection," Dr. Ugur Sahin, BioNTech's CEO and co-founder, told The Associated Press.

Even if regulators agree, he dispelled any notion that an end to the pandemic is around the corner, warning "we are now awaiting a hard winter."

"The available vaccine doses are just too small to ensure that we could make a significant difference to the society" right away, Sahin said. But next year if several companies' vaccine candidates also work, "we might be able to get control of this pandemic situation late summer 2021."

The companies have not yet released detailed data on their study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters — leading experts to caution that people should focus less on the specific numbers and more on the overall promise.

Earlier this week, competitor Moderna Inc. also announced similar effectiveness of its own COVID-19 vaccine candidate, which is made with the same, brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along.

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For both, "there's every reason to be enormously optimistic," said Dr. Paul Offit of Children's Hospital of Philadelphia, one of FDA's advisers.

"When these vaccines roll out, you're only going to know it's effective for a limited period of time," he cautioned, adding that more follow-up information will come. "You don't want to oversell it, but you don't want to undersell it."

All eyes are on the progress of potential vaccines as the grim infection toll jumps in the U.S. and abroad as winter weather forces people indoors, in the close quarters that fuels viral spread.

Pfizer and BioNTech said the vaccine was more than 94% effective in adults over age 65, though it is not clear exactly how that was determined with only eight infections in the vaccinated group to analyze and no breakdown provided of those people's ages.

Meanwhile, overwhelmed hospitals are converting chapels, cafeterias, waiting rooms, hallways, even a parking garage into patient treatment areas. Staff members are desperately calling around to other medical centers in search of open beds. Fatigue and frustration are setting in among front-line workers.

“We are depressed, disheartened and tired to the bone,” said Alison Johnson, director of critical care at Johnson City Medical Center in Tennessee, adding that she drives to and from work some days in tears.

The number of people in the hospital with COVID-19 in the U.S. has doubled in the past month and set new records every day this week. As of Tuesday, nearly 77,000 were hospitalized with the virus.

Newly confirmed infections per day in the U.S. have exploded more than 80% over the past two weeks to the highest levels on record, with the daily count running at close to 160,000 on average. Cases are on the rise in all 50 states. Deaths are averaging more than 1,155 per day, the highest in months.

The out-of-control surge is leading governors and mayors across the U.S. to grudgingly issue mask mandates, limit the size of private and public gatherings ahead of Thanksgiving, ban indoor restaurant dining, close gyms or restrict the hours and capacity of bars, stores and other businesses.

New York City's school system — the nation's largest, with more than 1 million students — suspended in-person classes Wednesday amid a mounting infection rate, a painful setback in a corner of the country that suffered mightily in the spring but had seemingly beaten back the virus months ago.

Texas is rushing thousands of additional medical staff to overworked hospitals as the number of hospitalized COVID-19 patients statewide accelerates toward 8,000 for the first time since a deadly summer outbreak.

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