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 The companies in a release said the booster was tested on 10,000
participants aged 16 and older who had received two doses in its
earlier trials. A booster administered about 11 months after the
second shot had a favourable safety profile and worked against the
highly contagious Delta variant of the coronavirus, they said. The
data has not been submitted for peer review.
The trial results come a day after the U.S. Food and Drug
Administration authorized booster doses U.S. FDA clears Moderna, J&J
COVID-19 boosters, backs use of different vaccine for boost of the
COVID-19 vaccines from Moderna Inc and Johnson & Johnson, and said
Americans could choose a different shot from their original
inoculation as a booster.
An panel of expert advisers to the U.S. Centers for Disease Control
and Prevention made a similar recommendation on Thursday, clearing
the way for a final approval from its director that would allow such
shots in the coming days.
The U.S. agencies previously authorized boosters of the Pfizer/BioNTech
shot at least six months after the first round of shots to increase
protection for people aged 65 and older, those at risk of severe
disease and those who are exposed to the virus through their work.
Dr. Walid Gellad, a professor at University of Pittsburgh's medical
school, said there seems to be a benefit of having the third dose to
prevent symptomatic COVID-19, but questioned if the booster was
helping younger people as well as older people.
"I'm just still very curious if this is primarily in people who are
much, much older. Because what we don't want to do is run out and
give boosters to 25-year-olds who had COVID before and got two doses
of the vaccine, just based on this press release," Gellad said.
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Pfizer had said its two-shot vaccine's efficacy wanes over time,
citing a study that showed 84% effectiveness from a peak of 96% four
months after a second dose. Some countries have already gone ahead
with plans to give booster doses.
The drugmakers said on Thursday the median time between the second
dose and the booster shot or the placebo in the study was around 11
months. There were only five cases of COVID-19 in the booster group,
compared with 109 cases in the group that received the placebo shot.
The median age of the participants was 53 years, with 55.5% of
participants between 16 and 55 years, and 23.3% at 65 years or
older.
Jefferies analyst Michael Yee said the trial results add to mounting
data that boosters could help in providing long-lasting protection
from symptomatic infection.
There were no reported cases of severe disease, suggesting robust
protection from infection with only the primary vaccination series,
Yee wrote in a note.
The companies said they would submit detailed results of the trial
for peer-reviewed publication to the FDA, the European Medicines
Agency and other regulatory agencies, as soon as possible.
(Reporting by Riham Alkousaa, Ankur Banerjee in Bengaluru and Mike
Erman in New York; Editing by Jason Neely, Bernadette Baum and Bill
Berkrot)
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