First modification: 23/05/2022 – 16:44
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Washington (AFP) – Pfizer-BioNTech’s COVID-19 vaccine is safe and effective for children between six months and five years old when given three doses, the drugmaker said in a statement Monday.
The announcement comes at a time when the United States Drug Agency (FDA) has several meetings planned to analyze the authorization of the covid vaccine for the segment of younger children, who are not eligible for vaccination. In most countries.
Pfizer-BioNTech did a clinical trial in which they gave three 3-microgram doses and found that the vaccine elicited a strong immune response.
Side effects, according to the company, were similar between those who received the vaccine and the placebo. The efficacy of the vaccine was 80.3%, according to a preliminary estimate.
“We are pleased that our compound for toddlers, which we carefully selected to be one-tenth the adult dose, was well tolerated and produced a strong immune response,” Pfizer CEO Albert Bourla said in a statement. .
“We look forward to completing our submissions to regulators around the world soon in hopes of making this vaccine available to younger children as soon as possible.”
FDA experts have three meetings scheduled in June in which they will likely decide whether to authorize Pfizer’s Covid vaccines for children under five and Moderna’s for children under six, which is administered in two 25-microgram injections.
The agency originally planned to test Pfizer’s vaccine given in two doses in February, but data showed it did not elicit a strong enough immune response in children two to four years old.
The FDA then asked to see data from a third injection.
mild side effects
According to the new data, 1,678 children received a third dose at least two months after the second, at a time when the omicron variant was predominant.
An analysis of a subset of participants revealed that antibody levels were similar to those seen in 16- to 25-year-olds who received two doses. No new adverse events were identified, and most side effects were mild or moderate.
“According to Pfizer’s press release, all three doses of its covid vaccine appear to be very safe and highly effective in preventing not only severe illness, hospitalization, and death from covid, but also symptomatic covid at a time when the omicron was the dominant variant,” Celine Gounder, chief public health editor at Kaiser Health News, told AFP.
“However, we do know that protection against SARS-CoV-2 infection and milder symptomatic illness declines over time,” added Gounder, an infectious disease specialist and epidemiologist.
“Pfizer reports follow-up data only up to seven days after the third dose of the vaccine. It’s too early to say how three doses would work after several months or a year.”
“I wish the two-dose vaccine would have worked for Pfizer-BioNTech. It didn’t. But the three-dose series seems to have given these very young children the protection we want them to have,” Jeremy Faust of the Department of Health told AFP. Emergency Medicine at Brigham and Women’s Hospital in Boston.
Severe COVID-19 disease is very rare among children under five, an age group in which the United States has recorded 477 deaths from the virus since the start of the pandemic.
© 2022 AFP
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