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UPDATE 2-As coronavirus soars, U.S. cheers Britain's vaccine approval

Wed, 02nd Dec 2020 19:34

(Adds new CDC quarantine guidelines, record deaths in several
states)

By Daniel Trotta and Maria Caspani

NEW YORK, Dec 2 (Reuters) - U.S. health experts on Wednesday
welcomed British emergency approval of Pfizer Inc's COVID-19
vaccine, a sign that U.S. regulators may soon follow suit in a
bid to bring the surging pandemic under control.

As U.S. coronavirus hospitalizations jumped to their highest
since the onset of the global pandemic, Britain gave emergency
use approval to the vaccine developed by Pfizer and
German partner BioNTech SE, the first country to do
so.

Britain said it would start inoculating high-risk people
early next week, a move that could make Americans more confident
about the prospect of an expected mass vaccination campaign
reminiscent of the anti-polio campaigns of the 1950s and 1960s.

"This should be very reassuring. An independent regulatory
authority in another country has found this vaccine to be safe
and effective for use," U.S. Health Secretary Alex Azar told Fox
Business Network on Wednesday.

U.S. COVID-19 hospitalizations hit a record for a fourth
consecutive day on Tuesday, approaching 100,000, according to a
Reuters tally. At the same time, exhausted healthcare
professionals are short-staffed, with many of their colleagues
falling sick.

Another 2,624 U.S. deaths were reported on Tuesday, the
fifth-highest daily total on record, raising the cumulative
death toll above 270,000 since the pandemic began. At least four
states - Illinois, Kansas, Minnesota and Oklahoma - reported a
record increase in deaths on Wednesday.

Although China and Russia also have moved ahead with
inoculation campaigns with their own vaccines, Britain's medical
standards more closely align with those of the United States.

"It's got major significance being that it's the first
Western country to approve the vaccine for a roll-out and start
administering it to the public," said Kirsten Hokeness, an
immunology and virology expert and chair of Science and
Technology at Bryant University in Smithfield, Rhode Island.

"It's going to put a little pressure on us to rapidly
evaluate the data," Hokeness said.

A U.S. Food and Drug Administration (FDA) panel of outside
advisers will meet on Dec. 10 to discuss whether to recommend
emergency use authorization of the Pfizer vaccine. Moderna's
vaccine, which employs similar technology as Pfizer's
and was also nearly 95% effective in preventing illness in a
pivotal clinical trial, is expected to be reviewed a week later.

Of particular interest is how Britain manages the Pfizer
vaccine's requirement to be stored at minus-70 degrees Celsius
(-94 Fahrenheit). Moderna's can be kept at more normal
refrigerator temperatures.

But the British experience is unlikely to factor into U.S.
regulatory approval, which instead will focus on the clinical
trial data.

'THE SINGLE MOST IMPORTANT TOOL'

While some U.S. health officials described a timeline that
assumed FDA authorization would come within days of the Dec. 10
meeting, others have said it could take weeks.

"Surely we want a vaccine available as soon as it is deemed
safe. We want to make sure that we can provide accurate
information to the public," said Dr. Lisa Costello, a professor
of pediatrics at the West Virginia University School of Medicine
who is helping advise West Virginia's state government on
vaccine distribution.

Virginia Governor Ralph Northam expressed confidence in the
safety of the vaccines at a news conference on Wednesday.

"As a doctor, I am confident that all protocols have been
followed and no corners have been cut," he said.

Pfizer, Moderna and AstraZeneca Plc have already
started manufacturing their vaccines and say distribution could
begin almost immediately after approval. AstraZeneca, however,
may have to conduct an additional trial to gain U.S. approval
after a dosing error led to better results in recently released
data than for its planned regimen.

Moderna, which has millions of doses ready to be shipped,
expects its vaccine could be approved for emergency use within
24 to 72 hours after the FDA advisory committee meeting on Dec.
17, Chief Executive Stéphane Bancel said on Wednesday.

Beyond regulatory hurdles, vaccinations face opposition from
significant numbers of Americans who reject medical science and
fear vaccines as harmful.

Similarly, many Americans still refuse to follow basic
public health guidance on wearing masks and avoiding crowds,
even as the pandemic killed 10,000 people and infected 1.1
million last week alone in the United States.

"A vaccine will be the single most important tool we have to
fight COVID, but it's not going to turn things around
overnight," Dr. Tom Frieden, former director of the U.S. Centers
for Disease Control and Prevention, wrote on Twitter.

"We must do much better at knocking the virus down with
nuanced, well-timed closures and measures such as rapid testing,
isolation, and contact tracing."

In hopes of increasing compliance, the U.S. Centers for
Disease Control and Prevention (CDC) on Wednesday added new
guidelines for shorter quarantines after coronavirus exposure.

The health agency said seven days with a negative COVID-19
test and 10 days without a test would work for individuals
showing no symptoms after exposure to the virus. But it still
recommends a 14-day quarantine period as the best way to reduce
its spread.

(Reporting by Daniel Trotta, Nathan Layne, Doina Chiacu, Maria
Caspani, Caroline Humer, Lisa Shumaker, Peter Szekely, Susan
Heavey, Mrinalika Roy and Trisha Roy;
Editing by Bill Berkrot and Rosalba O'Brien)

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