Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Authors: Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D.
1) Ongoing
"In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose)."
"Collection of phase 2/3 data on vaccine immunogenicity and the durability of the immune response to immunization is ongoing, and those data are not reported here."
"The current cold storage requirement may be alleviated by ongoing stability studies and formulation optimization, which may also be described in subsequent reports."
2) Efficacy
BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6).
3) Warranty period
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.
4) Sponsor
Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.
5) More papers, more credits
This report does not address the prevention of Covid-19 in other populations, such as younger adolescents, children, and pregnant women. Safety and immune response data from this trial after immunization of adolescents 12 to 15 years of age will be reported subsequently, and additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as immunocompromised persons.
See: "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine", The New England Journal of Medicine, 2020;383(No. 27):2603-2615. Published December 10, 2020. DOI: 10.1056/NEJMoa2034577; https://www.nejm.org/doi/full/10.1056/NEJMoa2034577; https://pubmed.ncbi.nlm.nih.gov/33301246/
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