Moderna's mRNA flu vaccine, named mFlusiva, by the FDA has raised significant concerns regarding its safety and effectiveness compared to traditional flu vaccines. This summary highlights the key points regarding the vaccine's performance and the ongoing scrutiny surrounding vaccine safety protocols.
1. FDA Approval and Efficacy:
Moderna's mFlusiva became the first mRNA flu vaccine approved by the FDA despite lacking testing against a placebo.
Analysis showed that 5,000 doses of mFlusiva would be required to prevent one hospitalization compared to standard vaccines.
The vaccine demonstrated a severe adverse reaction rate (Grade 3 reactions) of 6.4%, significantly higher than the 1% rate associated with traditional flu vaccines.
2. Ongoing Investigations:
The Senate Permanent Committee on Investigations has uncovered long-hidden COVID-19 vaccine injury data that reportedly were not disclosed under the Biden administration.
There is now renewed interest in investigating vaccine safety due to regulatory changes after the departure of officials supporting higher drug approval standards.
3. The Approval Process:
The FDA approved mFlusiva for people aged 50 and older and under accelerated approval for those aged 65 and up, requiring further studies for effectiveness against high-dose flu vaccines.
Concerns arose due to limited trial data that did not include immunocompromised patients or very frail older adults, groups particularly vulnerable to complications.
4. Regulatory Scrutiny and Industry Influence:
Criticism has been directed at the FDA for approving mFlusiva despite its substandard trial design, which was highlighted by former officials who departed recently.
Reports indicate that the FDA has shifted its stance on drug approvals, allegedly due to influence from the pharmaceutical industry following changes in leadership.
5. Public Health Implications:
The approval of mFlusiva suggests a possible return to old regulatory practices within public health agencies.
Erica Schwartz's confirmation as CDC director, despite her controversial past regarding vaccine mandates, indicates established public health policies may resume.
Moderna's mFlusiva has been approved by the FDA despite significant concerns about its safety and effectiveness. The high rate of adverse reactions compared to traditional vaccines and the lack of comprehensive trial conditions raise questions about the regulatory processes overseeing vaccine approval. The ongoing investigations into COVID-19 vaccine injuries and the shifts in public health agency leadership suggest a turbulent landscape for vaccine policy and safety moving forward.
https://justthenews.com/politics-policy/health/return-rubber-stamp-first-mrna-flu-vaccine-has-far-higher-injury-rate