COVID-19 Vaccine for Young Children: Moderna Seeks FDA Authorization

Strategic Insights -

Parents of children as young as six months old may soon be able to get their kids vaccinated against COVID-19, as Moderna has submitted an application to the FDA to authorize its vaccine for young children aged 6 months through five years. Clinical trials have shown the vaccine to be effective in preventing serious illness in this age group. The FDA is expected to make a final decision on the authorization by June.

Key Takeaways:

  • Moderna has submitted an application to the FDA to authorize its COVID-19 vaccine for young children aged 6 months through five years.
  • The vaccine has shown to be effective in preventing serious illness in clinical trials among this age group.
  • The FDA is expected to make a final decision on the authorization by June.
  • The vaccine will consist of two 25-microgram doses given four weeks apart, a quarter of the adult dose.
  • Moderna Chief Medical Officer Dr. Paul Burton stated that the vaccine provides a "good level of protection" and "can protect these kids" from serious illness.
  • The vaccine will be a relief for parents, as children under 5 have been hospitalized five times as often as they were during the earlier Delta variant wave of 2021 due to the Omicron surge.
  • Pfizer is also preparing to submit an application for authorization of its vaccine for kids under five, following a previous attempt that was withdrawn due to lack of effectiveness in clinical trials.
  • The FDA may authorize the two companies' vaccines for tots "one at a time, or hold off and authorize both at the same time," which might reduce confusion and ensure supplies are available more widely.
  • Moderna is also preparing to seek authorization for a booster dose for the age group, which could be available in the fall and be a so-called bivalent vaccine, targeting two strains of the coronavirus in a single shot.
  • Pfizer has submitted paperwork for authorization of booster shots for its vaccine for children aged five to 11, currently only available for ages 12 and up.

Statistics:

  • Children under 5 have been hospitalized roughly five times as often as they were during the earlier Delta variant wave of 2021 due to the Omicron surge.
  • By February, three-quarters of children and teens in the U.S. caught Covid at least once, though agency officials noted it remains unclear how long that protection from those previous infections will last or whether it's as robust as the protection provided by the vaccines.

Sources:

  • NBC News: "Moderna asks FDA to authorize Covid vaccine for children as young as 6 months"
  • NBC News: "FDA considers a Pfizer booster and a Moderna vaccine for children"
  • NPR: "FDA Considers A Pfizer Booster And A Moderna Vaccine For Children"
  • AP: "AP: CDC reports new cases of COVID-19 among children and teens"
  • Flickr: "Photo: Heather Hazzan for Self Magazine, Creative Commons (https://creativecommons.org/licenses/by/2.0/) License 2.0"