Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

RCT (n=43,548) found 2-dose regimen conferred 95% protection against Covid-19 in persons ≥aged 16 years; safety over median of 2 months was similar to tha of other viral vaccines. Efficacy (90-100%) was similar across age, sex, race, ethnicity, baseline BMI, and comorbidities.

SPS commentary:

Editorial notes the sequence of the virus that led to the development of the specific antiviral RNA sequence required to design the vaccine didn’t become known until it had been determined and widely disseminated by the Chinese Center for Disease Control and Prevention in January 2020. It outlines important questions, in light of only about 20,000 people have received this vaccine:

  • Will unexpected safety issues arise when the number grows to millions and possibly billions of people?
  • Will side effects emerge with longer follow-up?
  • Implementing a vaccine that requires two doses is challenging. What happens to the inevitable large number of recipients who miss their second dose?
  • How long will the vaccine remain effective?
  • Does the vaccine prevent asymptomatic disease and limit transmission?
  • What about the groups of people who were not represented in this trial, such as children, pregnant women, and immunocompromised patients of various sorts?

New England Journal of Medicine

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Editorial