Pfizer announced On Monday that its COVID-19 vaccine is safe and effective for children aged 5 to 11 and will eventually seek United states authorization for this age group.
The vaccine, developed by Pfizer and its German partner BioNTech, is already accessible to anybody aged 12 and above. However, with children returning to school and the extra-contagious delta variant triggering a significant increase in pediatric illnesses, many parents are impatiently anticipating vaccines for their younger children.
“Hundreds of millions of people aged 12 and up from all around the world have gotten our COVID-19 vaccination during the last nine months. We are excited to expand the vaccine’s protection to this younger age group, related to regulatory approval, especially as we assess the emergence of the Delta variant and the significant potential threat to children “Albert Bourla, CEO of Pfizer, stated.
Pfizer examined a far smaller dose for primary school-aged children – one-third of the amount in each injection provided presently. Despite this, children aged 5 to 11 acquired coronavirus-fighting antibody levels comparable to teens and young adults after their second dosage, according to Dr Bill Gruber, a Pfizer senior vice president.
According to BioNTech CEO and cofounder Dr Ugur Sahin, “the safety profile and immunogenicity findings in children aged 5 to 11 years immunized at a lower dose are comparable with those we have observed with our vaccine among other older populations at a larger dose.”
Pfizer stated that the lower dose was examined in 2,268 kindergartners and primary school-aged children. The FDA demanded immunological “bridging” research, which demonstrated that the younger children produced antibody levels that had previously been shown to be protective in adolescents and adults. That’s what Pfizer said in a press statement on Monday, not in a scientific report. The research is still ongoing, and there haven’t been adequate COVID-19 occurrences to contrast rates between those who were vaccinated and those who were administered a placebo — something that could provide further information.
The research is too small to identify any exceedingly unusual adverse effects, such as heart inflammation, which happens sometimes after the second dosage, mostly in young men. According to Marks of the FDA, pediatric research should be significant enough to eliminate out any extreme risk to young children. According to Pfizer’s Gruber, once the vaccine is approved for younger children, they will be closely monitored for unusual effects just like everybody else.
Moderna, a second vaccine producer in the United States, is also testing its vaccines in primary school-aged children. Pfizer and Moderna are also examining infants as young as six months old. The results are expected later this year.
The announcement arrives shortly after a U.S. Food and Drug Administration (FDA) advisory panel on Friday recommended that the Pfizer-BioNTech COVID-19 vaccine booster shot be given at least six months after the second dose to people over 65, as well as those at high risk of occupational exposure and extreme COVID-19.
The vote was 18 to 0. The vote will now be presented to the FDA for a final decision.
Earlier Friday afternoon, the panel voted 2-16 to disapprove licensing of Pfizer’s booster vaccine in people aged 16 and above.
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Taking approval sounds like they won’t be held responsible if there’s any adverse effect.
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