Pfizer and BioNTech's coronavirus vaccine is safe and provokes a strong antibody response in 5- to 11-year olds, the companies said Monday
Pfizer and BioNTech's coronavirus vaccine is safe and provokes a strong antibody response in 5- to 11-year olds, the companies said Monday, releasing their first results for this age group.
Pfizer and BioNTech plan to file the data in a "near-term" submission for emergency use with the Food and Drug Administration, the latest sign that the Delta variant's rise and increasing Covid-19 cases among young children have alarmed health officials. The companies said they will also ask the European Medicines Agency and other regulators to update their authorizations "as soon as possible.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S., underscoring the public health need for vaccination," Pfizer CEO Albert Bourla said in a statement. "These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
The request was intended to increase the likelihood of identifying rare but potentially serious side effects in younger children, given cases of heart inflammation called myocarditis detected in predominantly males under 30 who received one of the two messenger RNA vaccines — the Pfizer-BioNTech and Moderna shots.
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