Moderna Seeks FDA Approval for Its COVID-19 Vaccine for Children Ages 5 and Below

Moderna on Thursday submitted a filing to the Food and Drug Administration (FDA) seeking approval for its COVID-19 vaccine for children aged under six.

According to Reuters, if approved, it would be the first COVID-19 vaccine shot against the virus available for those under five years old.

Moderna chief medical officer Paul Burton told Reuters that it represents an important area of "unmet need." Burton noted that there was no vaccine, "no other therapy" that children within the age range can have.

He said he thinks from a public health perspective that offering the COVID-19 vaccine to these children as quickly as possible "is the best thing."

In March, Moderna released trial data showing that its vaccine was safe and generated a similar immune response in young children as for adults.

The chief medical officer of Moderna did not reveal a time frame for when the FDA was expected to consider the authorization request.

Moderna COVID-19 Vaccine for Children

Moderna noted during the testing of the shots among two groups of children that they found a "robust neutralizing antibody response," as well as a "favorable safety profile," according to CBS News.

Moderna said its vaccine efficacy against infection was 51 percent among children younger than two and 37 percent among children from two to five years old.

In a statement, the vaccine maker noted that the efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses.

Aside from the COVID-19 vaccine for children, Moderna said it is also working on expanding its own booster shot studies to evaluate the third dose in children as young as six months old.

Spokespeople for both FDA and the Centers for Disease Control and Prevention (CDC) said they plan to have a meeting of their outside vaccine advisers before approving the Moderna shots.

In a statement, FDA spokesperson Abby Capobianco said the FDA could not reach a decision on any vaccine without a completed EUA request, which includes a comprehensive review of all the adverse events and replication of the key analyses.

COVID-19 Vaccines

Local health departments across the country are currently facing a dilemma such as how to address a declining demand for vaccines while avoiding the waste of unused millions of doses currently in state stockpiles, nearing expiration.

According to ABC News, federal data noted that states received 720 million doses, with more than 570 million of those vaccine shots have been administered.

C. Buddy Creech, director of the Vanderbilt Vaccine Research Program and associate professor of pediatric infectious diseases, told ABC News that it was a "tremendous loss of opportunity" not to have administered the vaccines to those who need them.

Creech said it was not only a financial loss but also a significant health loss for those who are not yet protected from COVID-19 and its risks.

Vaccine dose wastage can result from various issues, such as dropped vials and syringes; and improperly prepared, unused, or expiring vaccine doses.

This article is owned by Latin Post.

Written by: Mary Webber

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