Federal health officials said Sunday that child-sized doses of Pfizer’s COVID-19 vaccines appear safe and effective for children under five, a major step toward a long-overdue decision to begin vaccinating young American children.
The Food and Drug Administration published its analysis of Pfizer’s dose before a meeting Wednesday where outside experts will vote on whether the shots are ready for the 18 million children, toddlers and preschoolers. Children under five are the only group not yet eligible for COVID-19 vaccination in the United States
Late last week, the U.S. Food and Drug Administration published a similar analysis of Moderna shots for children under six.
If regulators remove the shots by one or both companies, vaccinations could begin as soon as next week as drug companies prepare to ship government-ordered doses quickly. Parents have been lobbying federal officials for months to allow them to protect their young children as more adults ditch masks and forego other public health precautions.
While only about 3% of COVID cases in the United States fall in the 6 months to 4 year age group, hospitalization and death rates in this group are higher than those of older children, according to a U.S. Food and Drug Administration analysis — one reason why Experts say that protecting this group is important.
The US Food and Drug Administration said that children who received Pfizer shots during testing developed high levels of anti-viral antibodies that are expected to protect them from the Corona virus. This is the basic threshold required to win an FDA license. But additional testing revealed key differences, with stronger results for Pfizer.
The Pfizer vaccine, given as a series of three shots, has been shown to be 80% effective in preventing symptoms of COVID-19, although that calculation was based on only 10 diagnosed cases among study participants. The number could change as the Pfizer study continues.
Moderna’s dual-dose series was only 40% to 50% effective in preventing milder infections, although the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing the booster for young children.
On Wednesday, the Food and Drug Administration will ask an independent panel of vaccine experts to discuss the two companies’ data before voting. The FDA is not required to follow the group’s recommendations, but the process is seen as an essential step in screening the shots publicly.
The Food and Drug Administration is expected to make its official decision shortly after Wednesday’s all-day meeting. Next step: The Centers for Disease Control and Prevention, which recommends how the vaccines should be used, will convene its expert panel to discuss which children need vaccinations.
It is not clear how much demand this will initially be on the footage. A recent study suggests that only one in five parents of young children will get their children vaccinated right away. Vaccines have been available since November to older US schoolchildren, but less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.
For younger children, each company offers different dose sizes and number of shots, from 6 months to 4 years for Pfizer and up to 5 years for Moderna.
Pfizer and partner BioNTech plan to offer two shots three weeks apart, followed by a third at least two months later — each one-tenth of the adult dose. Pfizer is currently the only company with a COVID-19 vaccine for older children in the United States.
Moderna is seeking FDA clearance for two doses, each a quarter of the adult dose, about four weeks apart.
The U.S. Food and Drug Administration currently allows Moderna vaccine to be used for adults only. But some countries allow full-size doses for teens and half-size shots for children ages 6 to 11 — a move the FDA is considering as well.
More than 30,000 American children under the age of 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to US health officials.
The government allowed pharmacies and states to start placing orders for high-volume doses last week, with 5 million doses initially available – half made by Pfizer and half by Moderna.
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