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FDA advisors review coronavirus vaccines for children as young as 6 months

Expert advisers to the Food and Drug Administration will meet on Wednesday to review scientific evidence about coronavirus vaccines for the country’s young children, the last group in the United States not yet eligible for shots.

The outside experts are expected to vote late Wednesday on whether FDA officials should approve vaccines from Pfizer, with German partner BioNTech, and Moderna. The Moderna vaccine would be for children 6 months to 5 years old and the Pfizer-BioNTech vaccine for children 6 months to 4 years old.

The FDA could act on the recommendation within days, potentially paving the way for admissions to be available next week for at least 19 million infants, toddlers and young children.

While families wait for a decision, these are probably the highest priority questions.

What happens if the FDA acts?

The Centers for Disease Control and Prevention plans to convene a panel of outside advisors Friday and Saturday to review the injections for young children. If the Advisory Committee on Immunization Practices recommends the use of the vaccine, CDC Director Rochelle Walensky is expected to act within hours to endorse that recommendation.

How effective are the vaccines?

The Moderna regimen — two doses, given four weeks apart — was found to be 51 percent effective in preventing disease in children between 6 months and 2 years old and 37 percent effective in children 2 to 5 years old.

The Pfizer-BioNTech regimen is three shots. The second dose is given three weeks after the first. The next shot comes two months later. The ultimate efficacy of that vaccine is unknown, but an early analysis — which is likely to change — suggested it was 80 percent effective against symptomatic diseases.

If the shots are allowed, when and where can kids get them?

At the beginning of next week, children can be vaccinated. Most are expected to get shots in the offices of pediatricians. For families without regular access to a pediatrician, the federal government will give money to states to run vaccination clinics.

Pharmacies can give the vaccines to children who are at least 3 years old, but outlets will initially have smaller supplies, as officials expect most parents to take their children to their doctor.

Biden administration officials have said they plan to make vaccines as accessible as possible so that parents can have their children vaccinated in locations they know and trust. In addition to the pediatric practices, there will be pop-up clinics at children’s museums, libraries and childcare locations.

There can be two vaccines. Will doctors offer both?

Some larger pediatric practices have ordered both Moderna and Pfizer-BioNTech vaccines. But others opt for just one brand, sometimes based on their experience giving that brand to older children.

This is a story in development. It will be updated.

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