A review released Wednesday by the US Food and Drug Administration said the third dose of Pfizer’s two-dose COVID-19 vaccine boosts a person’s immunity against the virus, but said the current regimen still prevents serious illness. Provides adequate protection from
The FDA is considering Pfizer’s request to offer a third shot of its vaccine, which the drugmaker says is needed because its effectiveness declines between six and eight months after the second dose. Pfizer submitted a preliminary study to the FDA that suggested that the third dose of the vaccine, given to more than 300 people, increased immunity levels three to five times more than the earlier shots.
Pfizer also cited an Israeli study published on Wednesday New England Journal of Medicine, which showed that the infection rate was 11 times lower in people aged 60 and older who received the third dose of the vaccine. About 1 million people participated in the study.
Pfizer has applied for permission to offer a third dose as the highly contagious delta version of COVID-19 triggered a dramatic new surge of infections, hospitalizations and deaths around the world.
But the FDA said in its review that recent studies indicate that currently US-licensed or authorized COVID-19 vaccines still provide protection against serious COVID-19 illness and death in the United States.
The US government’s drug regulator’s Vaccine Advisory Committee will meet on Friday to discuss whether the agency should approve Pfizer’s request. The committee’s recommendation is non-binding, meaning the FDA can approve a third dose of Pfizer even if the committee recommends against it.
Both the FDA and the Centers for Disease Control and Prevention last month recommended a third shot of the Pfizer or Moderna vaccine for some people with weakened immune systems.
The FDA meeting will come days after an international group of vaccine experts published an essay the Lancet Medical Journal in opposition to providing booster shots of existing vaccines to the general public.
Experts say recent studies suggest that current vaccines in use around the world offer strong protection against the virus, including the delta variant, particularly against serious illness and hospitalization. .
The authors include two key officials in the FDA’s Vaccine Review Office who are stepping down before the end of the year. the new York Times It recently reported that Dr. Marion Gruber and Dr. Philip Krause are upset by the Biden administration’s recent announcement that booster shots will be offered to some Americans starting next month, before the FDA has the right amount of data. Have time to review.
The authors suggest that modifying vaccines to match specific COVID-19 variants is a better approach than providing additional doses of the original vaccine.
World Health Organization Director-General Tedros Adhanom Ghebreyesus has asked wealthy countries to skip COVID-19 vaccine booster shots for the rest of the year to ensure that low- and middle-income countries have greater access to the vaccine.
Some information for this report has been received from the Associated Press and Reuters.