Pfizer seeks US approval for COVID vaccine booster
Aug. 25 (Reuters) – Pfizer Inc (PFE.N) said on Wednesday that a booster dose of its two-shot COVID-19 vaccine resulted in a three-fold increase in antibodies to the coronavirus, as the company looks to the United States. United. regulatory approval for a third injection.
The drugmaker and its German partner BioNTech (22UAy.DE) aim to complete the request for booster use in people aged 16 and over by the end of this week.
The US government has said it is preparing to deploy the third coup in mid-September to Americans who took their initial course more than eight months ago if the US Food and Drug Administration and the Centers for Disease Control and Prevention of the United States decides that the boosters are necessary. Read more
A committee of CDC external advisers is scheduled to meet on Monday to review the clinical data.
Pfizer said 306 people who received a third dose of its vaccine between five and eight months after their second injection had levels of neutralizing antibodies 3.3 times the levels seen after their second injection.
The study, details of which have not yet been released, also found that side effects from a third injection were similar to those from the second dose, including mild to moderate fatigue and headaches, said the society.
Scientists continue to debate whether the drop in antibody levels means COVID vaccine boosters need to be widely administered, but some countries are moving forward. Read more
Israel began rolling out boosters in early August for older citizens and this week extended training to people as young as 30, saying the shots helped increase protection against the highly Delta variant. infectious. Read more
US President Joe Biden said: “This is the best way to protect us from new variations that may arise.”
However, the director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, said the data on the benefits and safety of a COVID-19 vaccine booster is inconclusive. Read more
The health agency has once again called for a delay in the rollout of booster injections and is instead targeting higher vaccination rates in countries where many had not even received the first or second injection.
The WHO had called for a moratorium on recalls until at least the end of September.
Earlier this week, U.S. regulators granted full approval to Pfizer’s two-dose vaccine, which has so far been available under emergency use authorization.
The approval prompted some local governments, such as New York City and the state of New Jersey, as well as the U.S. military and some businesses to mandate vaccines.
A third dose of the Pfizer-BioNTech vaccine is not currently authorized for wide use in the United States.
However, under the amended emergency use authorization, a third dose was authorized for administration to persons 12 years of age or older who were immunocompromised.
Pfizer and BioNTech have said they intend to submit the results of their recall trial for publication in a medical journal and file the data with the European Medicines Agency and other regulatory authorities around the world. in the coming weeks.
Report by Mrinalika Roy and Manas Mishra in Bengaluru; Deena Beasley in Los Angeles; Editing by Arun Koyyur and Mark Porter
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