FDA Claims COVID Shots Linked to 10 Deaths, Moderna Faces Backlash

Recent developments have cast a shadow over the Covid-19 vaccination efforts in the United States. The Food and Drug Administration (FDA) is under scrutiny following claims linking Covid vaccines to the deaths of at least ten children from 2021 to 2024. This news has sparked a significant backlash, particularly against Moderna, a leading vaccine manufacturer.

FDA Director’s Controversial Memo

Vinay Prasad, the director of the Center for Biologics Evaluation and Research (CBER), issued a memo that highlighted concerns regarding myocarditis, a rare side effect associated with Covid vaccinations. In his correspondence, Prasad outlined findings indicating that a subset of the 96 deaths analyzed post-vaccination were connected to these vaccines.

Market Reactions

The announcement caused a notable decline in the stock prices of several vaccine manufacturers:

• Moderna (MRNA): Declined over 5% to $24.45.
• Pfizer (PFE): Decreased by 1.6%.
• BioNTech (BNTX): Fell by 4.6%.
• Dynavax Technologies (DVAX): Dropped 5.7%.
• Novavax: Slumped 3.9%.

This downturn is particularly significant as it follows a period where Moderna’s stock had gained 16% from November 20 to 28, quickly reversing the trend.

Covid Vaccine Uptake Decline

Despite the ongoing vaccination campaigns, current data shows that only 5.8% of children and 13.8% of adults have gotten the Covid shots this season. This decline follows the Centers for Disease Control and Prevention (CDC) ending its universal vaccine recommendation.

Implications for Future Vaccination Strategies

Given the current climate, Prasad advocates for a stricter review process for vaccine studies. His memo calls for any future clinical trials to assess effectiveness beyond just immunogenicity—how well vaccines provoke an immune response. This might lead to more robust safety protocols in vulnerable populations.

Moreover, CBER plans to require additional data from pneumococcal vaccine studies to ensure they do more than just produce antibodies against pathogens.

Vaccine Safety and Public Perception

The memo has been described as “inflammatory” by analysts and may contribute to growing vaccine skepticism. Prasad’s statements have raised uncertainties regarding the actual benefits of vaccination, leading to debates over vaccine mandates, especially for younger demographics.

As CBER prepares to implement changes in its regulatory pathways, the future of Covid vaccination strategies remains uncertain. Stakeholders must navigate this complex landscape while addressing public concerns about safety and efficacy.