Pfizer's data shows that its COVID vaccines were 57% effective against symptomatic disease in children ages 2-4, and were 50% effective in those 6 months to two years old, according to a person familiar with the data.
for two doses of its coronavirus vaccine to be authorized for emergency use in children between 6 months and 5 years old, even though the plan is for the vaccine to eventually be given as a three-dose series.
that two doses of the vaccine didn't produce an immune response that cleared the required threshold in children 2-4 years old, and that it is testing a third dose. Those results aren't expected until March, but giving two shots the go-ahead would allow parents to begin vaccinating their children — a months-long process — while data on the third dose is gathered. Two doses did clear the antibody threshold in children 6 months to 2 years old. No safety concerns were found in either age group.The results announced by Pfizer analyzed whether two doses of the vaccine — which were smaller than the ones given to adults — created an antibody response in small children that is roughly equivalent to that of people ages 16 to 25. But even though two shots didn't produce an antibody response matching that of 16-to-25-year-olds, it appears the doses do offer protection against hospitalizations and death, as well as some protection against infection. And clinical data on effectiveness has accumulated faster than anticipated, as the rapid spread of the Omicron variant has resulted in more cases among clinical trial participants.The initial argument against authorizing two doses was that, although they were somewhat effective, three doses would be necessary. But "people latched on to the idea that an ineffective two-dose vaccine might be authorized," University of Pittsburgh professor Walid Gellad said. "The way the information on potential pediatric vaccine authorization has been rolled out is a problem — it has led to confusion, uncertainty, concern about integrity of the process" he added.Pfizer's data shows that the vaccines were 57% effective against symptomatic disease in children ages 2–4, and were 50% effective in those aged 6 months to 2 years old, according to a person familiar with the data. But these are results against both Delta and Omicron. It's likely that effectiveness against Omicron alone is lower, and that effectiveness against hospitalization is higher. The data is based a small sample size, the person cautioned. Additionally, the antibody levels produced by two doses just missed the threshold for children ages 2 to 4, the person added, and are likely comparable to those elicited by two doses in older age groups. Because neutralizing antibodies help protect against hospitalization and death, we know that "the two-dose regimen, on its own, will help protect kids against hospitalization and serious disease," the person familiar said.This won't be the first time that federal health regulators have to consider using an unconventional process to get ahead of the virus. This tension was at the heart of last fall's booster debate as well, when some scientists felt that there wasn't yet enough data to justify the widespread recommendation of a third shot of the vaccine. Ultimately, the FDA and the CDC slowed down the booster authorization timeline that had been envisioned by the Biden administration, and the entire process was criticized as messy and confusing.to consider whether to recommend authorizing two doses of the vaccine. The FDA will then have to decide whether to authorize it, and the CDC will weigh in as well. If the board sees data showing that two doses are safe and effective, the challenge will be deciding whether to authorize two doses without having information on what happens with a third dose, board member Paul Offit told Axios. "They want us to have the option of giving parents the choice to do this, pending the third dose," Offit said. "It's unheard of, but then again, the pandemic is novel."
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