By MATTHEW PERRONE and MIKE STOBBE, AP Medical Writers
WASHINGTON (AP) – Federal health officials said Sunday that doses of Pfizer COVID-19 vaccine seemed safe and effective for children under 5, a key step toward a long-awaited decision to start vaccinating. the youngest American children.
The Food and Drug Administration released its analysis of the Pfizer shooting ahead of a meeting Wednesday where outside experts will vote on whether the shots are ready for the country’s 18 million babies, toddlers and preschoolers. Children under the age of 5 are the only group that does not yet meet the requirements for vaccination against COVID-19 in the US
Late last week, the FDA released a similar analysis of Moderna injections for children under 6.
If regulators clarify the features of one or both companies, vaccinations could begin as early as next week with drug manufacturers ready to quickly deliver government-ordered doses. Parents have been pressuring federal officials for months to have the opportunity to protect their youngest children as more adults take off their masks and abandon other public health precautions.
Although only about 3% of COVID cases in the United States are in the 6-month to 4-year-old age group, hospitalization and mortality rates in this group are higher than those of older children. , according to the FDA analysis, one of the reasons why experts have said that protecting this group is important.
The FDA said children who received Pfizer injections during testing developed high levels of anti-virus antibodies that were expected to protect them against coronavirus. This is the basic threshold required for FDA approval. But additional testing found key differences, with stronger results for Pfizer.
The Pfizer vaccine, given as a series of three injections, appeared to be 80% effective in preventing symptomatic COVID-19, although this calculation was based on only 10 cases diagnosed among study participants. The figure could change as the Pfizer study continues.
Moderna’s two-dose series was only 40% to 50% effective in preventing milder infections, although injections from both companies were tested at different times during the pandemic, when different variants were circulating. Modern has started testing a reinforcement for children.
On Wednesday, the FDA will ask an independent group of vaccine experts to discuss the data of the two companies before voting. The FDA is not required to follow the group’s recommendations, but the process is considered a key step in public verification of traits.
The FDA is expected to make its official decision shortly after Wednesday’s full-day meeting. The next step: The Centers for Disease Control and Prevention, which recommends how to use vaccines, will convene its own panel of experts to discuss which children need vaccinations.
It is unclear how much demand there will be initially for the shootings. A recent survey suggests that only 1 in 5 parents of young children would vaccinate their children immediately. Vaccines have been available since November for older U.S. students, but less than a third of those ages 5 to 11 have received the two recommended doses, according to government figures.
For the little ones, each company offers different dose sizes and number of doses, from 6 months to 4 years for Pfizer and up to 5 years for Moderna.
Pfizer and its partner BioNTech plan to offer two injections three weeks apart, followed by a third, at least two months later, each tenth of the dose given to adults. Pfizer is currently the only company with a COVID-19 vaccine for older children in the United States.
Modern is seeking FDA approval for two injections, each a quarter of its adult dose, about four weeks apart.
Currently, the FDA allows the Moderna vaccine to be used only in adults. But some countries allow full-size doses for teens and medium-sized doses for children ages 6 to 11, a step the FDA is also considering.
More than 30,000 U.S. children under the age of 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in this age group, according to U.S. health officials.
The government allowed pharmacies and states to start ordering child-sized doses last week, with 5 million initially available, half made by Pfizer and half by Moderna.
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