FDA Chief’s SHOCK Admission on Vaccine Injuries

In a surprising admission, the FDA chief confesses to knowing people injured by COVID shots, yet continues to defend their approval.

At a Glance

• FDA chief Marty Makary acknowledges personal knowledge of vaccine injuries.
• The FDA introduces stricter evidence requirements for COVID vaccine approvals.
• Vaccines for healthy children and adults under 65 face new scrutiny.
• Public trust in vaccine policies is declining, prompting regulatory changes.

FDA Faces Scrutiny Over Vaccine Approvals

The FDA, under Commissioner Marty Makary, is shifting its approach to COVID-19 vaccine approvals. Recent statements reveal that Makary knows individuals personally harmed by the vaccines. Despite this, he stands by the agency’s previous decisions, citing large-scale studies that affirm the overall safety and efficacy of mRNA vaccines for the majority. This revelation has fueled ongoing debates about the necessity and safety of vaccinating low-risk groups, particularly children, amidst declining public trust.

Makary’s acknowledgment comes as the FDA announces a new framework that will limit COVID-19 vaccines to those aged 65 and older, or individuals deemed high-risk. This move aligns with the agency’s commitment to base vaccine approvals on stricter scientific evidence. Manufacturers are now required to conduct additional clinical trials to justify vaccine use in healthy younger adults and children. These changes aim to restore trust and transparency in vaccine policies, though they may lead to confusion among healthcare providers and the public.

Public Trust and Policy Shifts

The FDA’s decision to tighten vaccine approval criteria reflects a broader shift in regulatory philosophy. Under the leadership of Makary and Dr. Vinay Prasad, the agency is responding to both scientific developments and public sentiment. The new framework marks a departure from the previous administration’s universal vaccination policy, which had become increasingly out of step with global norms. By requiring more robust evidence, the FDA hopes to address public distrust that arose from past decisions perceived as lacking transparency.

While some experts support these stricter evidence requirements, others caution against potential delays in vaccine access. Dr. Paul Offit, a prominent medical expert, questions the value of additional placebo-controlled trials for healthy individuals, given existing safety data. Nonetheless, proponents argue that such measures are necessary to ensure public confidence and align with evolving scientific understanding.

Impact on Vaccine Uptake and Industry

The FDA’s new approach is poised to have significant implications for both the public and the pharmaceutical industry. By restricting vaccine access for healthy children and adults under 65, the agency aims to prioritize high-risk individuals who benefit most from vaccination. However, this shift could lead to a reduction in vaccine uptake among low-risk groups, with uncertain effects on community transmission.

For vaccine manufacturers, the requirement for additional clinical trials represents a new regulatory hurdle. Companies like Moderna, Pfizer-BioNTech, and Novavax must adapt to these changes while maintaining market share. As the FDA finalizes its guidance for the upcoming fall season, healthcare providers and public health agencies must navigate evolving recommendations and address ongoing vaccine hesitancy.

Sources:

Politico

FiercePharma

CHOP

STAT News