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Thomas SJ, Moreira ED Jr, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Sep 15. doi: 10.1056/NEJMoa2110345. (Original study)
Abstract

BACKGROUND: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.

METHODS: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-µg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.

RESULTS: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.

CONCLUSIONS: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).

Ratings
Discipline Area Score
General Internal Medicine-Primary Care(US) 6 / 7
Hospital Doctor/Hospitalists 6 / 7
Internal Medicine 6 / 7
Family Medicine (FM)/General Practice (GP) 6 / 7
Pediatric Hospital Medicine 6 / 7
Pediatrics (General) 6 / 7
Infectious Disease 6 / 7
Pediatric Emergency Medicine 6 / 7
Public Health 5 / 7
Emergency Medicine 5 / 7
Comments from MORE raters

Emergency Medicine rater

Segments of society decry the efficacy and safety research to support the amazing COVID-19 vaccines. This RCT provides high-quality evidence that vaccines safely save lives across populations worldwide. I suspect that most healthcare providers already knew this, but some in society should be made aware of this new research.

Emergency Medicine rater

The efficacy data along with the safety profile may encourage emergency physicians to discuss vaccination with patients who are not already vaccinated. Likewise, the drop off in efficacy may lead to a recommendation for a booster.

Infectious Disease rater

This is essential reading and information. It doesn't need our comments!

Internal Medicine rater

Need all the data we can get to continue to support vaccinations!

Pediatric Hospital Medicine rater

Report showing >90% efficacy of an mRNA vaccine, with declining immunity over a period of 6 months. Good protection against the Delta variant.

Pediatrics (General) rater

With up to 6 months of follow-up in the 16 and older group, somewhat shorter in the 12-15yo cohort, the Pfizer BioNTech BNT 162b2 shows good efficacy against symptomatic COVID as well as excellent protection against severe disease. However, in this study, protection against any symptomatic illness began to wane after 2 months, but remained at 84%.

Public Health rater

This study provides evidence of the follow up efficacy of the Covid-19 vaccine. This is something that almost all practitioner already know.
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