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FDA Issues EUA for Pfizer COVID-19 Vaccine for Children
The dose is one-third of the dose given to people 12 years and older.
The FDA has issued an emergency use authorization for Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The vaccine is two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
In addition, the U.S. government has purchased 50 million more doses of the companies’ COVID-19 vaccine, to prepare for the pediatric vaccine rollout after FDA grants EUA, Pfizer and BioNTech said in a news release. The companies expect to deliver all of these doses by April 30, 2022.
In the United States, COVID-19 cases in children 5 through 11 years of age make up 39% of cases in people younger than 18 years of age. According to the CDC, about 8,300 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths have been reported in those less than 18 years of age.
Related: FDA Advisory Committee Recommends Pfizer Vaccine for Children
The authorization was supported by data from a study that enrolled 4,700 children 5 through 11 years of age in the United States, Finland, Poland and Spain. In studies, the immune response was comparable to that of older participants.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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