Moderna files emergency authorization for kids' COVID-19 vaccine

Moderna (MRNA) filed a request for emergency use authorization (EAU) for its COVID-19 vaccine for use in kids between 6 months and under 6 years Thursday.

The request is for the approval of two doses of 25 micrograms of the mRNA vaccine.

Moderna's clinical data showed the vaccine was 51% effective for the younger cohort of the age group, from six months to under 2 years, and 37% effective for the older group. The company said this is about the same as adult vaccine efficacy of two doses against Omicron.

By comparison, Pfizer (PFE)/BioNTech (BNTX) had extended its study of its vaccine in a similar age group to add a third dose of 10 micrograms due to low efficacy results in December 2021.

Moderna had previously indicated it would file by the end of the month, and is the first vaccine company to submit its filing for the still-unprotected age group.

Parents have been anxiously awaiting a vaccine option for the youngest age group as the virus continues to circulate, and a new variant, BA2.12.1, begins to increase in prevalence around the country. This, juxtaposed against relaxed masking around the country, has been cause for concern among parents of young children.

It's why, despite concerns about vaccine hesitancy and ongoing anti-vax sentiment for childrens' vaccines, Moderna's chief medical officer Dr. Paul Burton said he's gotten extremely positive reactions about the company's vaccine.

"The sentiment among parents and caregivers and doctors and nurses has been incredibly strong," Burton said.

The age group remains the highest risk among vulnerable individuals whose medical needs have been unmet by any protection, he added. In addition, young kids are reservoirs of the virus and can continue to spread it if their bodies aren't fighting it as they would with a vaccine.

"There is a public health and an unmet need," he said.

Competing vaccines

Recent reports suggest the FDA could hold onto the Moderna filing until Pfizer/BioNTech also complete their submission before moving forward with the EUAs.

In a separate interview Wednesday, former U.S. Surgeon General Dr. Jerome Adams told Yahoo Finance the idea behind that strategy is to compare both vaccines and determine which is better.

When asked if that meant it was possible for only one vaccine to be authorized or recommended, Adams said it's unclear.

"That's the question we don't know the answer to yet, because we haven't seen the data just yet," he said.

"They [the FDA] also don't want to approve a vaccine and then three weeks later approve a different vaccine and say, 'Actually we changed our mind, this one's better.' So they're trying to balance that with the real concern that many parents have about a world where their under-five-year-olds are out there around people unmasked and unvaccinated," Adams said.

To that, Burton replied that he has no direct knowledge of the strategy, but he senses the FDA understands the urgency of getting the vaccine approved.

"My sense is they will want to get this out," Burton said, noting it would be bad to only have one option for kids.

"I don't know that that makes medical sense. Every day we delay is another day they can either get COVID and get Long COVID. Giving people choices is most important," Burton said.

He added that trying to polarize people now, especially "where we are now politically," doesn't make sense.

Adams pointed to the companies for the ongoing delay, rather than the FDA, as neither company — even with Thursday's announcement — has fully completed their filing with the agency.

The FDA's Dr. Peter Marks said the agency is waiting the complete data and filing from both companies in order to move forward with the advisory committee and authorization process.

Moderna said in its statement Thursday the submission will be complete by next week.

"We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers," Moderna CEO Stéphane Bancel said in the statement.

Pfizer has indicated it will file next month, but it remains unclear when the submission will be complete.

Follow Anjalee on Twitter @AnjKhem

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