(Adds Azar, medical experts, Moderna CEO)
By Daniel Trotta
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 soared 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, an example that should add confidence to a
vaccine skeptical U.S. population as American officials prepare
for massive vaccinations 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. Meanwhile, 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.
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,
offering an additional level of confidence.
"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.
An 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.
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 advisory committee meeting on Dec. 17,
Chief Executive Stéphane Bancel told the Piper Sandler
healthcare conference 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."
(Reporting by Daniel Trotta, Nathan Layne, Doina Chiacu, Maria
Caspani, Lisa Shumaker, Susan Heavey, Mrinalika Roy and Trisha
Roy;
Editing by Nick Zieminski and Bill Berkrot)
Astrazeneca (AZN)
