Moderna beats Pfizer to the punch, files EUA for Covid-19 vaccine for youngest children
Covid-19 vaccines for the youngest group of children (under the age of six) may soon be available — potentially in the next month — as Moderna announced on Thursday morning that it has submitted an EUA request to the FDA.
The FDA still needs to review the application, which is based on data unveiled late last month showing a robust neutralizing antibody response in the 6 month to under 6 years age group after a two-dose series of the vaccine, along with a favorable safety profile. The FDA still needs to set up an advisory committee of outside experts to review the data.
How long that review may take is still up in the air. But the FDA’s vaccine chief Peter Marks told a Senate committee on Tuesday that a vaccine for this youngest age group is a top priority, and a schedule is coming within a week.
The FDA previously scheduled and then postponed an adcomm meeting to review Pfizer/BioNTech vaccine data on two doses for this same youngest age group, but the companies decided to pull back at the last minute without being entirely clear, as an application was not submitted and new data were not made public.
More recently, Pfizer said it’s going for a third dose and expects to release data on its vaccine in this group of infants and children before the end of the quarter, although the New York Times reported recently that application could come as soon as next month.
As far as the timeline for when these Moderna vaccines may be available, Marks also told a Senate committee on Tuesday that the FDA will be releasing plans for holding the adcomm meeting, and providing a timeline on its review within the next week.
The timing remains a big question mark and is dependent on how quickly the FDA can review the application, which typically (outside a pandemic) would take the agency six to 10 months to review, but will likely be condensed to weeks in this case. The agency may also opt to hold a joint Pfizer-Moderna VRBPAC meeting to allow its outside advisors to review all of the data together.
Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia and a member of the adcomm that would meet to discuss the Moderna and Pfizer data, told Endpoints News via email, “Nothing on the schedule until June.” But he also clarified that he didn’t know what would be discussed in June. The Moderna VRBPAC meeting may not have been scheduled yet.
If authorized, the Moderna vaccines will likely be made available at no cost to Americans as the trial on which the EUA is based was funded by the US government and conducted in collaboration with the NIH’s National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
Moderna CEO Stéphane Bancel said in a statement, “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.”
Similar to Pfizer, Moderna said it’s also currently studying booster doses for the two oldest pediatric cohorts, and the company is designing a study to evaluate the potential for a booster for those aged 6 months to under 6 years too.
The company said it is evaluating booster doses of the original vaccine, as well as a bivalent booster candidate, known as mRNA-1273.214, which includes both Omicron-specific mRNA and mRNA-1273. Moderna also recently unveiled promising data for another bivalent booster, known as mRNA-1273.211 and which includes mutations found in the Beta variant of concern, and which bested the company’s original booster in terms of neutralizing titers against all variants of concern, including Omicron.
The news, which follows similar results for the Pfizer/BioNTech Covid-19 vaccine when combined with Beta, bodes well for the booster season coming in the fall.