Vaccine moves closer to getting OK in US
WASHINGTON (AP) » U.S. regulators Tuesday released their first scientific evaluation of Pfizer’s COVID-19 vaccine and confirmed it offers strong protection, setting the stage for the government to green light the biggest vaccination effort in the nation’s history.
The analysis by Food and Drug Administration scientists comes ahead of a Thursday meeting where the FDA’s independent advisers will debate if the evidence is strong enough to recommend vaccinating millions of Americans. A final FDA decision and the first shots could follow within
just days.
They are among a whirlwind of developments that are expected to make multiple vaccines available by early next year, in the U.S. and beyond.
Britain on Tuesday began vaccinations with the shot made by Pfizer and German partner BioNTech. The FDA later this month will consider one developed by Moderna. Also Tuesday, a medical journal published early data suggesting a third vaccine candidate, AstraZeneca’s, also protects people, though not as much as the two other frontrunners.
The vaccines emerged from an all-out worldwide race and are reaching the market less than a year after the virus was even identified — a remarkable scientific achievement that shaved years off the usual process.
The encouraging developments come as the coronavirus continues surging across much of the world. The scourge has claimed
more than 1.5 million lives, including over 284,000 in the U.S., the highest toll of any country.
FDA scientists reanalyzed data from Pfizer’s huge, stillunfinished study and found that so far, the vaccine appears safe and more than 90% effective across patients of different ages, races and underlying health conditions. The FDA specifically confirmed it works well in older people, who are especially vulnerable to the virus.
Thursday’s public meeting will be closely watched by health authorities around the world and is considered key to bolstering confidence in the shots amid skepticism about vaccine safety among many Americans.
“We want people to see this discussion, to see the issues that are brought up, and have a vigorous discussion of the data elements by the outside experts,” FDA Commissioner Stephen Hahn said in an interview. “That will be an important part of showing what goes into our decision making.”
The FDA is expected to follow its committee ‘s advice, and first in line once vaccinations begin would be health care workers and nursing home residents.
Pfizer CEO Albert Bourla declined to predict how quickly FDA might issue a decision.
“They need to take as much time as they need to feel comfortable. It’s very important for the trust of the vaccine from the people,” he said.
Pfizer and BioNTech previously reported the shots appeared 95% effective at preventing mild to severe COVID-19 disease, based on the first 170 infections confirmed after participants’ second dose. Only eight of the infections were among volunteers who had been given the real vaccine; the rest were among those who had gotten a dummy shot.
Moderna has reported nearly identical protection in tests of its vaccine, which was developed with the U.S. National Institutes of Health.
A third option, from AstraZeneca and Oxford University, appears safe and about 70% effective, according to early test results from Britain and Brazil.