Kids 5-11 Appear Safely Protected By Small Doses of COVID Vaccine, Pfizer Says

An anonymous reader quotes a report from Ars Technica: Small doses of Pfizer's COVID-19 mRNA vaccine in children ages 5 to 11 appeared to produce strong antibody responses and comparable side effects to those seen in older age groups, according to the first top-line results from a Phase 2/3 clinical trial released by Pfizer and its partner BioNTech early Monday. The trial data involved 2,268 children ages 5 to 11 years, and these children were given a series of two 10-microgram doses of the vaccine, 21 days apart. The dosage is just a third of the 30-microgram doses given to people ages 12 and above. One month after the second dose, researchers measured the children's levels of antibodies able to neutralize the SARS-CoV-2 virus in a lab experiment. The geometric mean titer of antibody in the 5 to 11 year olds was 1,197.6 (95 percent confidence interval of 1,106.1 to 1,296.6), which is comparable to the geometric mean titer of 1,146.5 seen in people ages 16 to 25. Pfizer described the vaccine as being well tolerated in children, with side effects generally comparable to what's seen in people ages 16 to 25. But the company did not provide further data on the side effects. It also did not provide any further data on vaccine efficacy, though experts expect that comparable neutralizing antibody levels will provide comparable levels of protection against infection, hospitalization, and death. The company said it plans to submit the data to the FDA as soon as possible. It also aims to submit the data for emergency use authorization to the FDA by the end of the month. 'Once data is submitted to the FDA, it will take regulators several weeks to review the data and make a decision,' the report adds. 'That places the earliest estimates for vaccine authorization and availability for the 5-to-11 group at the end of October.'

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