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Moderna (MRNA) to File EUA for Use of mRNA-1273 in Children

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Moderna (MRNA - Free Report) announced data from an interim analysis of its phase II/III study — KidCOVE — evaluating its COVID-19 vaccine, mRNA-1273, in two age groups — six months to under two years and two years to under six years of age. Please note that the study also evaluated the vaccine in a third age group — 6 to under 12 years of age. The company had announced interim data from this age group in November 2021.

Data from the recent interim analysis of the KidCOVE study showed that immunization with two 25 µg doses of mRNA-1273 28 days apart generated a robust neutralizing antibody response in both age groups — six months to under two years and two years to under six years of age.

Moderna is planning to file for emergency use authorization of two 25 µg doses of mRNA-1273 as a primary series of COVID-19 vaccination in children six months to under six years of age to the FDA, European Medicines Agency (EMA) and other global regulators in the coming weeks.

Data readout from the interim analysis of the KidCOVE study in November last year showed that immunization with two 50 µg doses of mRNA-1273 28 days apart generated a robust neutralizing antibody response in the age group of 6 to under 12 years.

In its press release, Moderna announced that it has initiated EUA submission for the use of two 50 µg doses of mRNA-1273 28 days apart as a primary series of COVID-19 vaccination in children aged 6 to under 12 years.

A EUA for the use of mRNA-1273 in adolescents has been under review with the FDA since late last year. The company’s EUA request for adolescents included data from the study that evaluated two 100 µg doses of mRNA-1273 28 days as a primary series. In December 2021, the company started evaluating the potential of a lower 50 µg dose for primary vaccination in adolescents.

The press release stated that Moderna had updated its EUA request for the use of mRNA-1273 in adolescents (aged 12 to 17 years) to include additional follow-up data. The additional data submission may result in authorization for the COVID-19 vaccine soon. Moderna has already gained authorization for the use of its vaccine in adolescents in several other countries including the European Union, UK, Australia, Canada and Switzerland

Potential authorizations for children and adolescents for mRNA-1273 in the United States will likely boost anticipated revenues from the vaccine in 2022.

Shares of Moderna have declined 29.6% in the year so far compared with the industry’s 12.2% decrease.

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We note that two 100 µg doses of mRNA-1273 28 days apart have gained “full” approval from the FDA for use in adults as COVID-19 vaccine in January 2022. The vaccine is available under the tradename of Spikevax.

Spikevax’s booster dose has gained authorization for emergency/conditional/temporary use in adults in many countries.

Although Moderna is continuously developing its COVID-19 vaccine for new age groups, it lags Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) Comirnaty. Pfizer and BioNTech’s Comirnaty is approved for use in individuals 16 years of age and older. The COVID-19 vaccine was also granted EUA for use in individuals five years and older. A third dose or booster dose of Pfizer and BioNTech’s vaccine is also authorized in individuals 12 years of age and older, and immunocompromised individuals five years of age and older.

We note that Moderna, Pfizer and BioNTech are also developing their Omicron-based COVID-19 vaccine candidates.

Pfizer and BioNTech’s COVID-19 vaccine is the leader in this segment, followed by Moderna. However, several other companies are developing or commercializing COVID-19 vaccines. Novavax (NVAX - Free Report) is one of the COVID-19 vaccine developers with the potential to gain significantly in 2022.

NVX-CoV2373 is also authorized for emergency use in adults in other highly populated markets like Australia, Canada, Europe and Indonesia. However, the vaccine is yet to be authorized in the United States. Novavax’s EUA filing with the FDA, which seeks authorization for the use of NVX-CoV2373 in adults, is currently under review. Earlier this month, Novavax secured a EUA in India for NVX-CoV2373 in adolescents.

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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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