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FDA authorizes Pfizer, Moderna Covid-19 vaccines for babies, toddlers

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“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect children up to 6 months of age,” FDA Commissioner Robert Califf said in a statement† “As we have seen in older age groups, we expect the vaccines for younger children to protect against the most serious consequences of COVID-19, such as hospitalization and death.”

In addition to authorizing the mRNA vaccines for the youngest children, the FDA approved Moderna’s Covid-19 vaccine for children ages six to 17. For all ages, the FDA has determined that a third dose of Moderna’s injection should be given to children with certain immune systems at least a month after they receive their second injection. The Pfizer-BioNTech vaccine was already approved for children as young as five years old.

The CDC’s panel of expert advisors will consider whether the administration of the injections should be recommended in meetings Friday and Saturday. Once CDC director Rochelle Walensky signs a recommendation, kids are expected to get shots Tuesday.

Children under 6 years of age who receive the Moderna vaccine will receive two doses of 25 micrograms four weeks apart. The Pfizer vaccine consists of two doses of 3 micrograms three weeks apart, followed by a third dose at least eight weeks later.

Some members of the FDA advisory panel worried that parents could be confused by the products’ different dosing schedules, especially since the Pfizer-BioNTech vaccine doesn’t offer much protection after two doses, while Moderna’s primary series is complete with two doses.

“I’m very concerned that many of these kids won’t get the third dose,” Jeannette Yen Lee, a professor of biostatistics at the University of Arkansas for Medical Sciences, said of the Pfizer vaccine. “It’s a struggle to get people for two,” she added, noting that booster uptake for older populations is also low.

Actual efficacy against the Omicron variant in the 6-month to 5-year-old age group for Moderna’s vaccine ranged from 36 percent to 51 percent, and efficacy estimates were “generally consistent” with rates seen in observational studies at adults during the same variant waves, the FDA said.

Preliminary analyzes of the Pfizer vaccine showed 80 percent efficacy in children under 5 years of age against disease, although only 10 Covid cases were reported among study participants before the data cut-off date in April, raising confidence in that figure was limited.

Some FDA advisors expressed concern that parents will compare the efficacy rates suggested by the companies and base the product they choose solely on those numbers. Michael Nelson, head of UVA Health’s asthma, allergy and immunology division, urged manufacturers to quickly collect data on the prospect of vaccinating these children against Covid while receiving other routine childhood vaccinations.

“If we don’t get a quick answer to the co-administration question, it will be a barrier to completing the three-dose series for [the Pfizer] vaccine and probably for the Moderna vaccine,” he said. “Having to get it into isolation is going to be a big challenge for families and children here in the US”

The Biden administration is persuading parents to vaccinate their young children soon. Summer vacations – and young children receiving different levels of schooling before age 5 – along with misinformation about vaccines can weigh on early emergence. Many young children also got Covid during the Omicron peak, which could convince parents to hold off immunizing until they are further away from their natural infections.

To date, states, territories, pharmacies and other federal partners have ordered about 2.5 million doses of the Pfizer vaccine — half of what has been offered so far — and 1.3 million doses of Moderna, or about a quarter of what has been made available for pre-order, Assistant HHS Secretary for Preparedness and Response Dawn O’Connell said Thursday.

Recent poll by the Kaiser Family Foundation suggests that about 20 percent of parents are eager to vaccinate their children under 5 as soon as they are allowed, while nearly 40 percent plan to “wait and see” how the vaccine works and another 40 percent are reluctant to vaccinate at all.

Only 29 percent of U.S. children ages 5 to 11 are fully vaccinated against Covid, compared with nearly 56 percent of 12- to 15-year-olds and 67 percent of 16- and 17-year-olds, according to CDC data ending on 30th of April .

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