Pfizer and BioNTech's COVID-19 Vaccine Receives Emergency Use Authorization in the US

Strategic Insights -

The US Food and Drug Administration has granted emergency use authorization to Pfizer and BioNTech's COVID-19 vaccine, BNT162b2, for individuals 16 years of age or older, paving the way for a mass vaccination campaign in the US. This development is a significant milestone in the fight against the pandemic, with the vaccine demonstrating a 95% efficacy rate in clinical trials.

Key Takeaways:

  • The vaccine will be distributed in the US through Operation Warp Speed, a public-private partnership between the Department of Defense and the Department of Health and Human Services.
  • The distribution will be prioritized according to the Advisory Committee on Immunization Practices guidelines, focusing on high-risk populations.
  • Pfizer and BioNTech have enrolled over 44,000 participants in the Phase 3 clinical trial, with the majority receiving their second dose.
  • The trial has demonstrated 95% efficacy in preventing COVID-19, with consistent results across age, gender, race, and ethnicity demographics.
  • The participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety.
  • Pfizer and BioNTech plan to provide an option for trial participants to receive the vaccine at scheduled timepoints, and will begin delivering the first doses in the US immediately.
  • The companies have announced an agreement with the HHS and the DoD to meet the Operation Warp Speed goal, with delivery fulfillment expected to be completed in 2021.

Statistics:

  • 95% efficacy rate in preventing COVID-19 among participants without prior SARS-CoV-2 infection.
  • More than 44,000 participants enrolled in the Phase 3 clinical trial.
  • The trial has been conducted at over 150 clinical trial sites in the US, Germany, Turkey, South Africa, Brazil, and Argentina.
  • 1-to-1 vaccine candidate to placebo ratio in the clinical trial.
  • At least 2 years of long-term safety and protection monitoring for trial participants.
  • 2021: Expected completion of delivery fulfillment under Operation Warp Speed.

Sources:

  • M2 PHARMA-December 14, 2020-Pfizer, BioNTech COVID-19 Vaccine Authorized in the US (C)2020 M2 COMMUNICATIONS.