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COVID-19 Vaccine Studies

December 2020

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

Walsh E et al. N Engl J Med 2020; 383:2439-2450 https://www.nejm.org/doi/full/10.1056/NEJMoa2027906

This study examined the safety and immunogenicity of two RNA-Based Covid-19 Vaccine candidates. The results of the study, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, supported the selection of *BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation .

*BNT162b2  is Comirnaty® (Pfizer/BioNTech)

 

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. 

Polack et al. December 10, 2020 DOI: 10.1056/NEJMoa2034577 https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

A total of 43,548 people aged 16 years of age or older took part in this trial.43,448 people received injections: 21,720 with BNT162b2* vaccine and 21,728 with placebo. In the group that received BNT162b2 vaccine, there were 8 cases of Covid-19 with onset at least 7 days after the second dose. In the group that received placebo, there were 162 cases of Covid-19.

A two-dose regimen of BNT162b2 resulted in95% protection against Covid-19. Safety over a median of 2 months was similar to that of other viral vaccines. Adverse events were short-term. Most common were mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

*BNT162b2  is Comirnaty® (Pfizer/BioNTech)

 

This page was updated 3 January 2021