Moderna’s vaccine for kids under 6 now with FDA for authorization

Moderna announced Thursday that it has requested FDA authorization for its two-dose COVID-19 vaccines for children 6 months to 2 years, and 2 years to under 6 years.

If the Food and Drug Administration issues an emergency use authorization (EUA) for the vaccines, they will be the first such vaccines available to the age groups in the now nearly two-and-a-half-year-long pandemic. Parents of young, vaccine-ineligible children have been anxiously awaiting the availability of such vaccines, particularly as much of the country tries to move on from the pandemic even as the number of cases of the extremely contagious omicron subvariants continue to tick upward.

We are proud to share that we have begun our EUA submission for authorization for our COVID-19 vaccine for young children.

In March, Moderna announced top-line clinical trial results that the vaccines for the two young age groups met their primary goals in the trial: They both prompted high levels of neutralizing antibodies that matched or exceeded the levels seen in adults ages 18 to 25.

Moderna was able to calculate vaccine effectiveness against infections because the trial was ongoing during the omicron wave. The vaccine appeared to be effective in children from 6 months to 2 years, and from 2 years to 6 years.

Omicron rollercoaster

Results from home COVID-19 testing were included in the efficacy estimates. When they only included COVID-19 cases that were confirmed positive in a laboratory, the efficacy improved slightly for infants, rising to 51 percent (with a 95 percent confidence interval of 21 to 69) for 6 months to 2 years. The efficacy estimate remained at 37 percent for children under the age of 2 years.


The company noted that the efficacy estimates are similar to vaccine efficacy estimates in adults.

Parents will be watching how the FDA handles the submission now that it is with them. Last week, it was reported that FDA officials are considering delaying review of Modern's submission as they await data from Pfizer and BioNTech on their vaccine for young children. If the two vaccine options were made available to parents at the same time, it would be less confusing. Anthony Fauci, a top infectious disease expert, said that the FDA may wait until June to review and authorize the vaccines.

Pfizer and BioNTech announced in December that two doses of their vaccine for children under age 5 did not meet the primary goal of generating antibody levels comparable to levels seen in adults. The data on which is expected in June is being tested by the companies.

Massive impact

Plans to delay review of Moderna's vaccines have been criticized by parents and other experts. Scott Gottlieb is a Pfizer board member and former FDA commissioner.

Gottlieb doesn't expect the Pfizer-BioNTech vaccine to do better in terms of vaccine efficacy, and he doubts that their three-dose vaccine will show to be 50 percent effective against omicron infections in the trials.

There are questions about why the FDA would consider delaying Moderna's two-dose vaccine if Pfizer-BioNTech's three-dose regimen doesn't provide better protection. Gottlieb and other experts argue that the vaccines are needed to provide baseline protection in an age group of children who have not been exposed to severe disease.

Jeremy Faust, Harvard's emergency medicine doctor, said that getting protected sooner is what matters, and that will have a massive impact on how.