FDA Asks Pfizer - BioNTech To Submit For COVID-19 Vaccine Emergency Use Nod For Youngest Children

Pfizer Inc PFE and its partner BioNTech SE BNTX have started a rolling submission to amend its COVID-19 vaccine FDA Emergency Use Authorization (EUA) to include children six months to under five years of age.

• With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy.
• The application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. 
• Data on a third dose given at least 8 weeks after the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of EUA.
• Pfizer announced that its vaccine (a 3 µg dose for the youngest population) demonstrated non-inferiority for the 6- to 24-month-old population, compared to the 16- to 25-year-old population in which high efficacy was demonstrated, but not for the 2- to under 5-year-old population.
• “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement.
• Price Action: PFE shares are down 0.19% at $53.07, while BNTX stock is up 1.11% at $181.60 during the premarket session on the last check Wednesday.
• Photo by x3 from Pixabay