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Pfizer-BioNTech's COVID-19 vaccine appears to be safe and effective for children ages 6 months to 5 years, according to a company study released early Monday. The study of nearly 1,700 young children showed the vaccine to be as safe as a placebo and more than 80% protective during the omicron outbreak. No new safety issues were identified during the trial, the companies said in a news release, and the majority of reported adverse events were mild or moderate. (Weintraub, 5/23)

Pfizer and its German partner, BioNTech, said Monday that an early analysis showed their three-dose coronavirus vaccine regimen triggered a strong immune response in young children, proving 80 percent effective at preventing symptomatic infections in children 6 months to 4 years old. The results, along with other recent developments, signal that the long and frustrating wait for a vaccine for the youngest children, the last group to lack access, could be over within weeks. (Johnson, 5/23)

The 80 percent efficacy figure may change as the company gathers more data. It is based on 10 symptomatic cases of Covid that occurred seven days after the third dose of the vaccine as of April 29. A formal analysis will be performed once there are at least 21 positive cases in the clinical trial. The safety and immune response data are finalized, the company said. The first two doses of the vaccine are given three weeks apart, followed by a third dose at least two months later. The findings were announced in a news release, and the full data haven’t been made available for outside experts to review. (Miller and Lovelace Jr., 5/23)

Pfizer and its partner BioNTech said the number of children in the trial who fell ill with Covid was too small to make a definitive statement on efficacy. Only 10 children participating in the trial became ill with Covid after those in the vaccination group were given the third dose. The clinical trial’s protocol specified that analysis of vaccine efficacy required at least 21 Covid cases. The companies said that final data on efficacy, a secondary endpoint for the clinical trial, would be shared “once available.” (LaFraniere, 5/23)

The Phase 2/3 trial included 1,678 children who received a third dose during the period when the Omicron coronavirus variant dominated. Antibody levels tested one month after the third dose showed the vaccine produced a similar immune response as two doses in 16-to-25 year-olds, the companies said in a news release. The data has not yet been peer-reviewed or published. (Kounang, 5/23)