Loading...
 
Toggle Health Problems and D

Pfizer vaccination trial – 1 in 800 actually had a serious adverse event – Sept 2022

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

Vaccine, Volume 40, Issue 40, 22 September 2022, Pages 5798-5805 https://doi.org/10.1016/j.vaccine.2022.08.036
Joseph Fraiman a, Juan Erviti b Mark Jones c Sander Greenland d Patrick Whelane Robert M.Kaplan f Peter Doshi g

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. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). 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.
 Download the PDF from VitaminDWiki


Robert Malone comment on the study: (Not so) "Safe and Effective" :

Substack




Attached files

ID Name Comment Uploaded Size Downloads
18435 Serious adverse events.pdf PDF 2022 admin 15 Sep, 2022 17:01 288.47 Kb 18
See any problem with this page? Report it (WORKS NOV 2021)