A booster dose of the Pfizer-BioNTech COVID-19 vaccine administered 6 months after the primary 2-dose series was found to elicit high neutralization titers against the wild type and the Beta variant (B.1.351), according to early data reported by Pfizer and BioNTech. Additional data from the booster study is expected to be available soon and will also be submitted to regulatory authorities in the coming weeks.

Regarding the more contagious Delta variant (B.1.617.2 lineage), data recently published in the journal Nature showed strong neutralization titers against the variant strain in immune sera obtained shortly after the 2-dose series of the Pfizer-BioNTech COVID-19 vaccine. The Companies are conducting tests to see whether a third dose can further boost antibody titers against the Delta variant. An updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant is also in the works; clinical studies for the updated version are expected to begin in August 2021.

The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, is currently authorized for use under an Emergency Use Authorization by the FDA for active immunization to prevent COVID-19 in individuals 12 years of age and older. The vaccine is administered intramuscularly as a 2-dose series (0.3mL each) spaced 21 days apart.

In response to the Pfizer-BioNTech news, the Centers for Disease Control and Prevention (CDC) and the FDA released a joint statement on Thursday stating that, “Americans who have been fully vaccinated do not need a booster shot at this time.” The agencies confirmed that new data related to boosters is being reviewed as it becomes available and that the country is prepared to administer booster doses if they are deemed necessary. 


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References

  1. Pfizer and BioNTech provide update on booster program in light of the Delta-variant . [press release]. New York, NY and Mainz, Germany: Pfizer and BioNTech; July 8, 2021. 
  2. Joint CDC and FDA Statement on Vaccine Boosters. Accessed July 9, 2021. Published July 8, 20212. Accessed July 9, 2021. https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-vaccine-boosters.