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When can kids under 5 get vaccinated? Pfizer shifts trial to three doses

When can kids under 5 get vaccinated? Pfizer shifts trial to three doses

Pfizer Inc. and BioNTech SE plan to study a three-dose regimen of their Covid-19 vaccine in young children 6 months to 4 years old, the companies said in a statement. The vaccine partners amended their clinical trial protocol following a request by an external, independent data monitoring committee that found that the two-dose regimen did not prompt a strong immune response in blood tests among those ages 2 to less than 5 years old. No safety concerns were identified in the age group. If three doses prove successful, Pfizer and BioNTech will approach the U.S. Food and Drug Administration for an emergency-use authorization for the regimen in that age group in the first half of 2022. The additional shot will be a 3-microgram dose. The change “reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile, the companies said in a statement. Pfizer and BioNTech also plan to test a third dose, but at a 10 microgram formulation, in children 5 to under 12 years of age, they said in the statement. “Control of omicron may only be possible with three or more doses, said Kathrin Jansen, Pfizer’s head of vaccine research and development, in an investor event on Friday. Pfizer fell 2.6% in pre-market trading in New York, while BioNTech’s American depositary receipts fell 2.9%. Download.

science 2021-12-18 Livemint