The US Medicines Agency (FDA) said Monday that Pfizer’s anti-Covid vaccine is safe and effective in children under five years old, before a meeting to decide the matter, AFP reported.
The FDA has scheduled an expert meeting for next Wednesday to decide whether or not to recommend the Pfizer vaccine (given in three injections for children aged six months to five years) and the Moderna vaccine (two injections for children aged six months to five years).
According to an FDA report published this Monday, children under five are the only age group not yet eligible for Covid vaccination in the United States and most countries, but their hospitalization and death rate is “higher than any other age group.” than in children and adolescents aged 5 to 17 years”.
Under the proposed plan, the first two injections of Pfizer are given three weeks apart, and the third is given eight weeks after the second. Your dosages will be lower than those used for children over five years of age, as well as for people aged 12 and over.
Pfizer and Moderna had already aired their findings in press releases, but the FDA had to review the data and conduct its own assessment, having released a favorable review for Moderna last Friday.
The review of Pfizer was also favorable, based on the levels of infection-blocking antibodies in the study participants and a similar side-effect profile in older age groups.
About 4,500 children participated in the study. A preliminary estimate put the vaccine’s effectiveness at 80.3%, but the FDA noted that this percentage was based on a few positive cases – just 10, compared to the 21 sought for a more accurate estimate.
There are nearly 20 million American children under the age of five, representing 6% of the population.
If, as expected, FDA-appointed experts recommend both vaccines, the matter immediately moves to another panel convened by the Centers for Disease Control and Prevention (CDC), which will have the final word.
Last week, White House officials advanced that the rollout of millions of doses of these vaccines in pharmacies and doctors’ offices could begin as early as June 21.
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