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British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world’s first shot against the virus that’s backed by rigorous science and taking a major step toward eventually ending the pandemic.

The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.

“Help is on its way,” British Health Secretary Matt Hancock told the BBC, adding that the situation would start to improve in the spring.

“We now have a vaccine. We’re the first country in the world to have one formally clinically authorized but, between now and then, we’ve got to hold on, we’ve got to hold our resolve,” he said.

Other countries aren’t far behind: Regulators in the United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc. British regulators also are considering another shot made by AstraZeneca and Oxford University.

Hancock said Britain expects to begin receiving the first shipment of 800,000 doses “within days,” and people will begin receiving shots as soon as the National Health Service gets the vaccine.

Doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

A government committee will release details of vaccination priorities later Wednesday, but Hancock said nursing home residents, people over 80, and healthcare workers and other care workers will be the first to receive the shot.

Pfizer said it would immediately begin shipping limited supplies to the U.K. — and has been gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration, a decision expected as early as next week.

Pfizer CEO Albert Bourla called the U.K. decision “a historic moment.”

“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.

While the U.K. has ordered 40 million doses of the Pfizer vaccine, enough for 20 million people, it’s not clear how many will arrive by year’s end. Hancock said the U.K. expects to receive “millions of doses” by the end of this year, adding that the actual number will depend on how fast Pfizer can produce the vaccine.

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One concern about the Pfizer-BioNTech vaccine is that it must be stored and shipped at ultra-cold temperatures of around minus 70 degrees Celsius (minus 94 degrees Fahrenheit), adding to the challenge of distributing the vaccine around the world.

Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold, the company says.

“Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months,” the company said in a statement.

The company also says it has agreed to work with other vaccine makers to ensure there is sufficient supply and a range of vaccines, “including those suitable for global access.”

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot colored the race in the U.S. and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.

The shots made by U.S.-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn’t complete, early results suggest the vaccine is 95% effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO, recently told The Associated Press.

The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

Final testing must still be completed. Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.

The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects in pregnant women.

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Virginia bars must close by 10, while Tennessee bars across street in small border town remain open

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Bars on the Virginia side of the street in the small border town of Bristol are allowed to remain open only until 10 p.m. due to state COVID-19 restrictions while bars on the other side of the street, governed by the state of Tennessee, are free to serve customers until 2 a.m. 

The imaginary line on State Street separates the livelihoods of small business owners by just about 40 feet.

Residents and merchants on the Virginia side of the town – population 45,000 – argue the strict rule is being handed down by lawyers in northern Virginia, more attuned to the ways of Washington lawmakers, just across the Potomac River.

“It’s ridiculous. It’s two totally different areas of the country,” business owner J.J. Gillenwater said in a recent podcast

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. Gillenwater added that at 9:30 every night, he and other keepers must inform customers that they will soon be closing. Customer then make their way across the street to Tennessee , he said, where they are able to continue their night until 2 a.m.

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“We are consistently losing money because of these restrictions,”Gillenwater’s co-owner Blair Jones said. “Live entertainment has been curtailed which has impacted our late-night sales having to shut down at 10 p.m. It’s been a real killer for us.”

While the Tenn. Republican Gov. Bill Lee has lifted restrictions over time, Virginia Democrat Gov. Ralph Northam has extended an executive order restricting bars and restaurants from normal operations until at least the end of February. 

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Biden will honor 500K US COVID-19 deaths with candle lighting ceremony

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President Biden plans to mark 500,000 deaths from COVID-19 in the US with a candle lighting ceremony Monday, according to the White House.

The president will deliver a heartfelt speech at sundown at the White House’s Cross Hall to commemorate the grim death toll milestone, Biden’s press schedule said Sunday.

“The president will deliver remarks on the lives lost to COVID-19 in the Cross Hall,” the schedule states.

“[He will then] hold a moment of silence and candle lighting ceremony at sundown in the South Portico.”

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Biden will honor the lives lost to the illness — which on Sunday hovered just under 500,000, according to state health officials — alongside Vice President Kamala Harris and First Lady Jill Biden.

Biden and Harris also held a somber ceremony at the Lincoln Memorial a day before taking office last month to honor the 400,000 lives lost to the coronavirus.

“To heal, we must remember,” Biden said at the time.

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Dr. Fauci: Trump Let ‘Terrible Things’ Happen After Our COVID-19 Disagreements

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Dr. Anthony Fauci continues to open up about his experiences working under the Trump administration, revealing the moment he began to lose influence with former President Donald Trump.

In a wide-ranging interview with The Telegraph, the infectious disease specialist recalled a marked shift in his professional relationship with Trump in April or May of last year, once the president began to publicly side with anti-lockdown protesters and back states’ efforts to lift stay-at-home orders.

“My influence with [Trump] diminished when he decided to essentially act like there was no outbreak and focus on re-election and opening the economy,” Fauci, who is now serving as chief medical adviser to President Joe Biden, recalled Friday. “That’s when he said, “It’s going to go away, it’s magical, don’t worry about it.”’

Immediately thereafter, he added, “my direct influence on him was negligible. It became more conflictual than productive.”

Over the course of the past year, Fauci has enjoyed broad support from both Democrats and Republicans, and continues to be seen as a touchstone of scientific wisdom amid the ongoing pandemic.

But as the 2020 election drew to a close, Trump publicly lashed out at him and other medical experts even as the COVID-19 death toll continued to spike.

In an October phone call with campaign staffers, the former president deemed Fauci “a disaster.” Weeks later, he told supporters at a Florida rally he was considering firing Fauci “a little bit after” the election.

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In his interview with The Telegraph, Fauci didn’t touch on specific incidents but said having to correct the president’s numerous coronavirus falsehoods, often on live television, led to a gradual falling-out.

“When it became clear that in order to maintain my integrity and to get the right message [across] I had to publicly disagree with him, he did things — or allowed things to happen — that were terrible,” he said.

On the flip side, he offered faint praise for former Vice President Mike Pence, who “really tried his very best to address the outbreak.”

Elsewhere in the interview, Fauci ― who has worked alongside six presidents ― drew parallels between Trump’s handling of the coronavirus to the ways former President Ronald Reagan neglected to deal with the HIV/AIDS epidemic. Still, he said, they were “significant differences.”

Reagan “never did anything to obstruct what I was trying to do,” he recalled, while Trump “was putting as much stock in anecdotal things that turned out not to be true as he was in what scientists like myself were saying.”

“That caused unnecessary and uncomfortable conflict where I had to essentially correct what he was saying,” he added, “and put me at great odds with his people.”
(The Huffington Post)

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