The Food and Drug Administration said Sunday that Pfizer’s COVID-19 vaccine appears to be safe for children under 5, the only age group not yet eligible for vaccination in the United States.
The agency released its review ahead of a Wednesday meeting where outside experts will vote on whether the vaccine is ready for the country’s youngest population.
The FDA released a similar analysis of Moderna’s vaccine for children under 6 last week.
Vaccinations could begin as early as next week if regulators clear shots from one or both drug companies.
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According to the FDA review, hospitalizations and deaths related to COVID-19 among children 6 months to 4 years old are higher than among children in other age groups, although babies, toddlers and preschoolers make up only about 3% of cases in the United States.
The agency said children who received injections from Pfizer in clinical trials developed high levels of anti-virus antibodies believed to offer protection against COVID-19, the baseline threshold required for authorization. from the FDA.
Pfizer’s vaccine was given in three doses and was found to be 80% effective in preventing symptomatic COVID-19. However, this data was based on only 10 cases diagnosed among study participants and may change as Pfizer’s study continues.
Meanwhile, Moderna’s two-dose vaccine was only about 40% to 50% effective in preventing milder infections.
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The two companies’ vaccines were tested at different times during the pandemic, with different variants circulating at the time of each study. Moderna has started testing a booster shot for toddlers.
The FDA will ask an independent panel of vaccine experts on Wednesday to debate the two companies’ data before the vote, although the agency is not bound to make a decision based on the panel’s recommendations.
A formal decision is expected shortly after Wednesday’s meeting. Next, the Centers for Disease Control and Prevention will host its own expert panel to discuss which toddlers need COVID-19 vaccines.
For younger children, each drug company offers different dose sizes and number of times. Pfizer’s vaccines will be available for children 6 months to 4 years old and Moderna’s up to 5 years old.
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Pfizer and its partner BioNTech should offer two doses three weeks apart and a third at least two months later. Each shot will be one-tenth the dose given to adults. Pfizer is the only company that currently has a COVID-19 vaccine designed for older children in the US
Moderna’s vaccine would include two shots given about four weeks apart, each one a quarter of the company’s adult dose.
More than 30,000 U.S. children under the age of 5 have been hospitalized with the virus and nearly 500 COVID-19 deaths have been reported in the same age group, according to U.S. health officials.
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The federal government allowed pharmacies and states to begin placing orders for vaccines for young children last week. There are 5 million doses initially available, with each company producing half of the injections.
Despite the potential FDA clearance for vaccines, vaccine demand is expected to be quite low. A recent survey suggests that only 1 in 5 parents of young children would have their children vaccinated immediately. Vaccines have been available for older American children since November, but less than a third of children aged 5 to 11 have received the recommended two doses, according to government data.
The Associated Press contributed to this report.
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