By Daniel Trotta
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.
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.
“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.”
Reuters
