The vaccine, made by Pfizer and BioNTech, is already available for people 12 and older.
Pfizer said on Monday that its COVID-19 vaccine is in the works for children ages 5 to 11 and it will soon seek US authorization for this age group.
The vaccine, made by Pfizer and its German partner BioNTech, is already available for people 12 years of age and older. But now that there has been a surge in pediatric infections due to children back in school and the extra-infectious delta variant, many parents are anxiously waiting to be vaccinated for their young children.
“Over the past nine months, hundreds of millions of people 12 years of age and older from around the world have received our COVID-19 vaccine. We look forward to expanding the protection afforded by the vaccine to this young population, especially Subject to regulatory authorization from the U.S. as we track the spread of the delta variant and it poses a substantial risk to children,” Pfizer CEO Albert Boerla said.
For elementary school-aged children, Pfizer tested a much lower dose — a third of the amount that is now in each shot given. Dr. Bill Gruber, senior vice president at Pfizer, told the Associated Press that even after their second dose, children ages 5 to 11 developed the same levels of coronavirus-fighting antibodies as teenagers and young adults.
Dr. Ugur Sahin, CEO and co-founder, said, “The safety profile and immunogenicity data vaccinated at low doses in children aged 5 to 11 years are consistent with those we found in other older populations with our vaccine at higher doses. But I’ve seen it.” BioNTech K.
According to the American Academy of Pediatrics, while children have a lower risk of serious illness or death than older people, more than 5 million children in the US have tested positive for COVID-19 and at least 460 have died. Has been. Cases in children have increased dramatically as the delta variant has swept across the country.
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Pfizer said it conducted a low-dose study in 2,268 kindergarteners and elementary school-aged children. What the FDA called an immunity “bridging” study: evidence that young children developed antibody levels that have already been shown to be protective in teens and adults. That’s what Pfizer said Monday in a press release, not a scientific publication. Studies are still ongoing, and there have not yet been enough COVID-19 cases to compare rates between those who were vaccinated and those given a placebo – something that may offer additional evidence.
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The study is not large enough to detect any extremely rare side effects, such as heart swelling that sometimes occurs after the second dose, mostly in younger men. The FDA’s Marks said the pediatric study should be large enough that there is no high risk to young children. Pfizer’s Gruber said that once the vaccine is authorized for young children, they, like everyone else, will be carefully monitored for rare risks.
A second US vaccine maker, Moderna, is also studying its shots in elementary school-aged children. Pfizer and Moderna are also studying babies as young as 6 months old. Results are expected later in the year.
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news comes a day later U.S. Food and Drug Administration (FDA) advisory panel on Friday endorsed emergency approval for pfizer-biontech COVID-19 Vaccination The booster shot at least six months after the second dose in people 65 years of age and older and those at high risk of occupational exposure and severe COVID-19.
The vote was 18-0. The vote will now go to the FDA to issue a final decision.
The panel voted earlier Friday afternoon to deny the license of Pfizer’s booster vaccine in people 16 years and older by a vote of 2-16.
Granthshala News’ Kayla Rivas and