Pfizer Plans To Evaluate Third Shot For Its COVID-19 Vaccine In Kids Below 5 Years

Following routine review by the external independent Data Monitoring Committee (DMC), BioNTech SE BNTX / Pfizer Inc PFE will amend the clinical study evaluating their COVID-19 vaccine in children six months to under five years of age. 

• The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.
• While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. 
• Related: Pfizer Submits Application For Approval Of COVID-19 Shot For Adolescents Aged 12 To 15 Years.
• Compared to the 16 - 25 years old population in which high efficacy was demonstrated, non-inferiority was met for the 6 - 24 months old but not for the 2 - 5 years population. 
• No safety concerns were identified, and the 3 µg dose demonstrated a favorable safety profile.
• Pfizer previously said it might apply for a EUA for this youngest population by the end of December or early 2022.
• But now, if the three-dose study proves successful, Pfizer and BioNTech expect to submit data in 1H of 2022.
• Pfizer and BioNTech are also shifting to a three-dose regimen for all ages.
• The companies plan to evaluate a third dose of the 10 µg formulation in children five to under 12 years. 
• Additionally, the companies have initiated a low dose sub-study of a third dose of 10 µg or 30 µg in approximately 600 adolescents aged 12 - 17 years to assess safety and immunogenicity.
• Price Action: PFE shares are down 2.08% at $59.98, BNTX stock is up 0.69% at $285.58 during the market session on the last check Friday.
• Photo by x3 from Pixabay