Friday, September 24, 2021

3 New Research Articles in the NEJM Validate the Safety of Covid Vaccines

For guidance in how to read a medical research article, see the Critical Appraisal page on our Evidence-based Practice LibGuide.

In effort to show how-we-know-what-we-know about the safety of Covid vaccines, we offer 3 new research articles from the NEJM:

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

N Engl J Med
2021 Aug 25. Online ahead of print.
Noam Barda 1Noa Dagan 1Yatir Ben-Shlomo 1, et al.
PMID: 34432976
DOI: 10.1056/NEJMoa2110475

  • This study was recently cited by Dr. Rich Fogel at a national Ascension Covid Update Meeting as to the safety and efficacy of the Covid vaccines.
  • One of the studies from Israel where they have a high level of vaccination rates.
  • The full article includes a graphic charting the (Figure 4) Absolute Excess Risk of Various Adverse Events after Vaccination or SARS-CoV-2 Infection.  This should help clarify some of the risks of getting the vaccine vs. going without it.
  • Conclusions: In this study in a nationwide mass vaccination setting, the BNT162b2 [Pfizer] vaccine was NOT associated with an elevated risk of most of the adverse events examined.
    •  The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased AFTER SARS-CoV-2 infection. 

Pilishvili T, Gierke R, et al.; Vaccine Effectiveness among Healthcare Personnel Study Team.
N Engl J Med. 2021 Sep 22.    Online ahead of print.
PMID: 34551224

  • Results: For complete vaccination, vaccine effectiveness was 88.8% (Pfizer) and 96.3% (Moderna).
  • Conclusions:  The [Pfizer and Moderna] vaccines are highly effective under real-world conditions in preventing symptomatic Covid-19 in healthcare personnel.  

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.
El Sahly HM, Baden LR, et al.; COVE Study Group.
N Engl J Med. 2021 Sep 22.   Online ahead of print.
PMID: 34551225

  • Vaccine efficacy in preventing Covid-19 illness was 93.2%
  • The efficacy in preventing severe disease was 98.2%
  • Efficacy in preventing asymptomatic infection was 63% 14 days after the 2nd injection.

Brought to your attention by Your Ascension Wisconsin Librarians:

Michele Matucheski  &  Kellee Selden

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