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Pfizer and Moderna are expanding the size of their vaccine trials for children aged 5 to 11, seeking to better detect very rare heart problems in those vaccinated.
Major Vaccine Manufacturers Increase Number of Children Enrolled in School at Federal Food and Drug Administration’s Request, First reported by the New York Times.
The FDA has asked companies to include 3,000 children – or double the previous number of participants – in order to be able to adequately detect rare side effects such as myocarditis or pericarditis, inflammation of the heart, according to anonymous sources who spoke to The Times.
the side effect is very unlikely, appearing in just 12.6 cases per million seconds of doses, according to the U.S. Centers for Disease Control and Prevention (CDC). Last month, the FDA updated its vaccine fact sheets to include the possible increased risk.
Coronavirus cases are on the rise across the country as the highly contagious delta variant spreads, with cases and deaths predominantly among those unvaccinated.
The Pfizer-BioNTech vaccine has already been approved for children 12 years of age and older, and the Moderna vaccine is approved for those 18 years of age and older.
While schools are expected to reopen for in-person learning in the fall, the issue of student immunizations is a priority for parents, teachers and school staff.
Pfizer, which began vaccine trials in children 11 and under in March, said on its website that it expects the study results to be submitted to the FDA for clearance. emergency use for children 5-11 years old. in September or October. A spokesperson for Pfizer told HuffPost that the company has not provided any further updates to its schedules for testing vaccines for children.
Moderna, who also began vaccine trials in children under 12 in March, plans to apply for emergency clearance in late 2021 or early 2022, a spokesperson told The Times.
The FDA told HuffPost in a statement that the agency could not comment on “one-on-one interactions with sponsors,” but noted that it was working with companies to “ensure that the number of participants in clinical trials is of sufficient size to improve detection of safety signals. “
Moderna did not immediately respond to HuffPost’s request for comment.
In a letter to the editor of The Times earlier this month, the director of the Center for Biologics Evaluation and Research at the FDA, Peter Marks, wrote that COVID-19 vaccines authorized in the United States have been “under scrutiny. thoroughly “and” meet FDA requirements. rigorous standards.
“If we really want our lives to get back to normal, the fastest way to do it is simple,” wrote the director of the FDA, “get vaccinated now.”
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