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(STUDY) Higher risk of adverse events for mRNA Covid-19 vaccines

Dated: September 3, 2022 by Sharyl Attkisson 3 Comments

      

A study in the journal Vaccine finds: Excess risk of serious adverse events from Pfizer and Moderna Covid-19 vaccines outweighs risks from Covid-19 itself.

Pfizer vaccine: 36% higher risk of serious adverse events than placebo. Moderna: 6% higher. Combined: 16% higher.

The following is an excerpt from the journal article published in Vaccine: "Serious Adverse Events of Special Interest following mRNA Covid-19 Vaccination in Randomized Trials in Adults."

Introduction

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA Covid-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

Pfizer and Moderna mRNA Covid-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively.

The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83).

The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). 

Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious Covid-19 outcomes.

These analyses will require public release of participant level datasets.

Read full abstract and view data sets here.


      
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About Sharyl Attkisson

Emmy-Award Winning Investigative Journalist, New York Times Best Selling Author, Host of Sinclair's Full Measure

Reader Interactions

Comments

  1. Amy Provias says

    September 4, 2022 at 1:03 pm

    What kind of adverse effects/events? Suddenly, my knees started with rheumatoid arthritis. This does not run in my family. Has this happened to anyone else?

    Reply
    • Sharyl Attkisson says

      September 4, 2022 at 3:13 pm

      Various vaccines are well established to cause inflammation and arthritis. Looking at Covid vaccine adverse event reports, there are many reports of arthritis. Causality isn't necessarily accepted.

      Reply

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