WASHINGTON — Pfizer and BioNTech say their COVID-19 vaccine is more than 90% effective at protecting young children from symptomatic infection, The Associated Press is reporting.
The data was posted on the U.S. Food and Drug Administration’s website Friday ahead of a committee meeting slated for next week. An initial review of the data is expected later Friday, according to the news agency.
In the study, 2,263 children ages 5 to 11 received either two 10 µg doses of the Pfizer-BioNTech vaccine or a placebo administered 21 days apart, the AP reported. The children’s doses, which were one-third the size of the 30 µg shots approved for adults, were nearly 91% effective, according to the data. The vaccine appeared to be safe for children, as well, the companies said.
The news came two days after the White House detailed plans to allow elementary-age children to get COVID-19 vaccine shots as soon as next month, pending authorization from the FDA and the Centers for Disease Control and Prevention.
On Thursday, Pfizer and BioNTech said a booster shot of its coronavirus vaccine was 95.6% effective at preventing symptomatic cases of COVID-19 in study participants ages 16 and older.
“In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster,” the drugmakers said in a news release Thursday. “These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.”
At least 10,000 trial participants ages 16 and older received a booster dose, which had a “favorable safety profile,” the companies said. The efficacy data was compiled “during a period when Delta was the prevalent strain” of the virus, according to the release. It has not yet been peer-reviewed.
Also on Thursday, CDC Director Rochelle Walensky endorsed an advisory committee’s recommendation to expand eligibility for COVID-19 vaccine booster shots for certain populations.
Walensky’s move came after the CDC Advisory Committee on Immunization Practices voted unanimously to recommend booster doses of COVID-19 vaccines made by Moderna, Johnson & Johnson and Pfizer, and also gave the green light to mixing and matching booster doses of the three authorized vaccines.
In a unanimous 15-0 vote, the advisory committee recommended the use of a single booster dose of the Moderna COVID-19 vaccine for emergency use in individuals ages 65 and older, people ages 18 to 64 who are at high risk of severe COVID-19, and people ages 18 to 64 who have frequent institutional or occupational exposure to the virus.
The committee also voted on whether to authorize the Johnson & Johnson booster for anyone 18 and over who had gone at least two months since getting the single-shot vaccine. That also passed by a 15-0 margin.
– The Associated Press contributed to this report.
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