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FDA Authorizes PFE & MRNA's COVID Jabs for 6 Months & Older Kids

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The FDA has expanded the emergency use authorization (“EUA”) that was previously granted to mRNA-based COVID-19 vaccines of Moderna MRNA, and Pfizer PFE and BioNTech BNTX for use in the youngest population. Moderna’s Spikevax, and Pfizer and BioNTech’s Comirnaty are now authorized for immunization of all individuals six months or older against COVID-19 in the United States.

The FDA authorized a three-dose series of Pfizer and BioNTech’s Comirnaty for use in children six months through four years of age. Moderna’s Spikevax gained EUA as a two-dose series for use in children aged six months to five years.

The FDA also authorized the use of Moderna’s COVID-19 vaccine in two more populations — children aged 6 through 11 years old and adolescents aged 12 through 17.

The Centers for Disease Control and Prevention (CDC) has recommended mRNA-based vaccines in children above six months of age. The CDC has issued new guidance for the use of Comirnaty and Spikevax in children aged six months through four years and aged six months to five years, respectively.

The CDC had previously provided guidance for the use of Pfizer and BioNTech’s Comirnaty in individuals aged 5 years to 16 years last year, following the authorization of the vaccine in this patient population. However, Moderna gained EUA for adolescents and children six years of age or above earlier this week. The CDC has scheduled a meeting to discuss recommendations for the use of Spikevax in individuals aged 6 to 17 years.

The authorizations for Spikevax and Comirnaty were backed by clinical data that demonstrated the safety and effectiveness of these vaccines. Pfizer and BioNTech’s vaccine elicited a strong immune response, high efficacy and a favorable safety profile when given as a three-dose vaccine to children six months to under five years of age in clinical studies. Moderna’s two-dose vaccine was 37%-51% effective in the youngest population.

Following these authorizations, Pfizer and Moderna are on a level field in the COVID-19 space. Pfizer and BioNTech’s vaccine has been enjoying a non-competitive market for the immunization of adolescents and children in the United States since its authorizations last year.

Pfizer expects to generate total sales of approximately $32 billion by delivering Comirnaty in 2022. Moderna has advance purchase agreements for the supply of Spikevax and a booster worth $21 billion in place for 2022.

Pfizer, Moderna and BioNTech carry a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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