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Moderna Requests Authorization for COVID-19 Vaccine for Children Under 6

Moderna submits a request to the FDA for emergency use authorization of its COVID-19 vaccine in children 6 months to under 6 years of age.
Moderna Requests Authorization for COVID-19 Vaccine for Children Under 6

On Thursday, Moderna asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer, according to The Associated Press.

"Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread," writes Lauran Neergaard for AP.

Moderna seeks to be 1st with COVID shots for littlest kids (Lauran Neergaard - AP)

Excerpt from AP: Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers -- albeit not as effectively during the omicron surge as earlier in the pandemic. "There is an important unmet medical need here with these youngest kids," Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two kid-size shots "will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that."
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"Less-than-ideal clinical trial results and growing backlash against children's vaccinations writ large have complicated what was already a delicate decision-making process," writes Caitlin Owens for Axios.

"Moving quickly to authorize the shots for young children carries risks for regulators because dosing recommendations could still change, undermining vaccine confidence. But moving with extra caution further delays long-awaited protection against the virus for this youngest age group," according to Axios.

The high-stakes push to get COVID vaccines to young children (Caitlin Owens - Axios)

Excerpt from Axios: Young children generally aren't at high risk of severe COVID infections, but some do get seriously ill or, in rare instances, die. Plenty of parents remain anxious to vaccinate their children as soon as possible. At the same time, vaccine hesitancy is high among parents of young children, and only 27% of children ages 5 to 11 — the most recent age group to become eligible for vaccines — have been fully vaccinated, according to the American Academy of Pediatrics.
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"The Food and Drug Administration is expected to convene a public meeting of a panel of outside vaccine advisers within weeks to consider Moderna’s request," reports The Wall Street Journal. "An FDA official said at a recent congressional hearing the agency would move quickly once it had a completed application, and would release a schedule for advisory panel meetings within the next week."

Moderna Asks FDA to Clear Its Covid-19 Vaccine for Young Children (Peter Loftus - The Wall Street Journal)

Excerpt from The Wall Street Journal: [Moderna] said Thursday that it had submitted the request after a study showed the shot safely induced immune responses in the young age group. If the panel votes to recommend the shot, the FDA could authorize its use soon after, though the agency may seek additional data before making a decision. The FDA has delayed authorizing Moderna’s vaccine—mRNA-1273, or Spikevax—for adolescents to assess whether the shots heighten the risk of an inflammatory heart condition.
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