Last week, the FDA approved Moderna's new mRNA flu vaccine, with media coverage primarily focusing on its effectiveness compared to traditional flu vaccines. However, serious safety concerns about the vaccine's trial data have emerged, largely overlooked in public discussions.
The pivotal trial showed the mRNA vaccine was 26.6% more effective than a conventional flu vaccine at preventing influenza-like illness but only reduced the risk of illness by 0.8%.
A troubling finding was the significant number of serious adverse events (SAEs) in participants: 449 in the mRNA group versus 389 in the control group, representing a concerning excess of 60 SAEs.
The FDA's advisory documents claimed SAEs were "balanced" between the two groups, but this was misleading due to the method of data analysis.
The FDA pooled data from various trials instead of focusing solely on the pivotal trial, leading to an obscured safety signal—a usual approach when searching for rare events, yet inappropriate here due to the differing nature of the trials involved.
Despite acknowledging potential issues with pooled analyses, the FDA proceeded with this method, leading to a lack of transparency regarding safety concerns.
The all-cause mortality rates raised additional alarms, with more deaths in the mRNA group across several trials, including trials where at least one death was assessed as vaccine-related.
The contrast in how efficacy and safety data were handled raises questions about the FDA's role in ensuring public safety. While claiming the vaccine is "safe and effective," significant safety signals have been downplayed, leading to concern about who is truly protecting the public from potential harm.
https://brownstone.org/articles/fdas-botched-review-of-modernas-flu-mrna-vaccine/
No comments:
Post a Comment