|New and Improved! EvidenceAlerts has been re-designed to optimize function on all media devices. Content, alerting and search functions remain the same, but appearance on tablets and smart phones has been enhanced. Feedback most welcome!|
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.).
|General Internal Medicine-Primary Care(US)|
|Family Medicine (FM)/General Practice (GP)|
|Pediatric Hospital Medicine|
|Pediatric Emergency Medicine|
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.
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.
This is essential reading and information. It doesn't need our comments!
Need all the data we can get to continue to support vaccinations!
Report showing >90% efficacy of an mRNA vaccine, with declining immunity over a period of 6 months. Good protection against the Delta variant.
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%.
This study provides evidence of the follow up efficacy of the Covid-19 vaccine. This is something that almost all practitioner already know.