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Beers and Woodcock does not report any relevant financial information. Bourla works for Pfizer.
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The FDA on Monday approved the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 12-15.
The vaccine, which was previously available to people aged 16 and over, remains the only COVID-19 vaccine available to a pediatric population. The FDA amended an Emergency Use Permit (EUA) issued in December to include the younger age group.
The FDA has approved the emergency use of Pfizer-BioNTech in children ages 12-15. Source: Adobe Stock.
FDA Deputy Commissioner Janet Woodcock, MDcalled the enlarged EEA “a significant step in the fight against the COVID-19 pandemic”.
“Today’s action is making it possible to protect a younger population from COVID-19, which brings us closer to returning to a sense of normalcy and ending the pandemic,” Woodcock said in a press release. “Parents and guardians can be assured that the agency has carried out a rigorous and thorough review of all available data, as we have done with all of our COVID-19 emergency vaccine approvals.”
Pfizer and BioNTech officially asked the FDA last month to expand the EEA based on Phase 3 data showing the vaccine is safe to use in children ages 12-15.
According to the American Academy of Pediatrics, more than 3.8 million children were diagnosed with COVID-19 on May 6, accounting for 14% of all US cases.
The expanded EEA “is a crucial step in offering life-saving vaccines to children and adolescents,” said AAP President Lee Savio Beers, MD, FAAP, said in a statement. “Our youngest generations have put themselves under severe stress over the past year, and the vaccine is a hopeful sign that they will be able to experience all of the activities that are so important to their health and development.”
Last week, President Joe Bidenannounced a three-point plan that would see 70% of the country at least partially vaccinated by July 4, including efforts to vaccinate children ages 12-15.
Biden said the White House would be “ready to go” if an EEA was issued and would make vaccines for children available in about 20,000 pharmacies and ship cans direct to pediatricians.
The CDC’s Advisory Committee on Immunization Practices has scheduled a meeting for Wednesday to vote on recommendations for vaccine use in the newly approved age group.
Pfizer CEO and Chairman Albert Bourla, DVM, PhD, said last week that the company also plans to file an application with the FDA for an EEA for vaccine use in children ages 2 to 5 and 5 to 11 in September.
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Amesh A. Adalja, MD
Amesh A. Adalja
FDA approval for younger age groups will be very important in removing barriers to face-to-face learning and will allow extracurricular activities to have less of a negative impact on school education as children can be vaccinated. This will also reduce the spread of the virus to some extent. However, it is important to remember that children are spared the serious consequences of disease and are not magnifying glasses for infection. There are many high-risk people around the world who have not yet been vaccinated.
Amesh A. Adalja, MD
Senior Scholar
Johns Hopkins Center for Health Safety
Disclosure: Adalja does not report any relevant information.
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