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Pfizer and its partner Biontech said the coronavirus vaccine was safe and produced strong antibody responses in children aged 5 to 11 in a large-scale trial, findings that could pave the way for immunization of schoolchildren in a few months.
The long-awaited results offer one of the first glimpses of the effectiveness of the Covid vaccine in young children. As pressure mounted to vaccinate children in the United States, a new school year began just as the delta variant led to a significant increase in cases.
In a trial with 2,268 participants, two doses of the vaccine at a concentration of 10 micrograms – one-third of the adult dose – produced antibody levels similar to those seen in the 16 to 25-year-old trial that received the adult dose, and side effects were similar.
According to a statement from Pfizer and Biotech, the two companies plan to send the data as part of a short-term request for emergency use authorization from the United States Food and Drug Administration, and to also share with regulators in Europe.
The United States Food and Drug Administration is expected to decide whether or not to authorize a booster dose of Pfizer-Biontech vaccine in the following days. An advisory committee unanimously approved a third dose for people over 65, in addition to those at high risk of serious complications, on Friday after voting against Pfizer’s demand to allow the doses to be used. reminder for all people 16 years of age and over.
Although the FDA often follows its advisers, it is not obligated to do so, and it can always choose to support boosters for a larger group. Now, only certain immunocompromised people are officially authorized to receive a third emergency dose.
The companies said preliminary data from other branches of the Pfizer-BioNTech pediatric trial, which are testing the vaccine in children under five, could arrive in the fourth quarter.
Greater experience
Data for children 5 to 11 years old were from a core group of patients participating in the trial. At the request of US regulators, Pfizer and Biontech presented a plan to add 2,250 more children aged 5 to 11 to pediatric studies, a Pfizer spokesperson said.
Safety is an important measure for young children, who are infected more frequently and help spread the virus, but are less likely to develop serious complications than older adults. In rare cases, mRNA vaccines have been linked to carditis and endocarditis, and the risk appears to be higher in young men.
The companies did not provide specific figures on side effects, nor did the two companies disclose whether children who received the vaccine had lower rates of Covid disease than those who received a placebo, which is the data that the trial planned to collect. as a secondary objective.
A spokesperson for Pfizer said the experiment was still ongoing and some data was still withheld. The companies said in the statement that they intend to submit the full data from the experiment for publication in a scientific journal.
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