Claim Review: FDA Approves Monkeypox Vaccine Despite Known Risks

Introduction

The recent approval of the ACAM2000 vaccine for monkeypox by the Food and Drug Administration (FDA) has sparked controversy due to its acknowledged risks, particularly cardiac inflammation. This article aims to review the claim that the FDA approved the vaccine despite knowing its dangers.

Background

The ACAM2000 vaccine, developed by Emergent BioSolutions, was initially approved for smallpox in 2007. On August 29, 2024, the FDA expanded its approval to include individuals at high risk for monkeypox, such as members of the LGBT community.

Claim Analysis

The claim suggests that the FDA approved the ACAM2000 vaccine despite knowing its risks. The FDA's medication guide for ACAM2000 lists numerous side effects, including the potential spread of the live vaccinia virus to close contacts and serious complications such as myopericarditis (heart lining and/or muscle inflammation).

According to Karl Jablonowski, a senior research scientist at Children's Health Defense, the risk of cardiac inflammation is significant, with estimates ranging from one in 2,000 to one in 175 vaccinations. Dr. Meryl Nass, an internist and biological warfare expert, also highlighted the CDC's acknowledgment of this risk during a June 2022 meeting.

However, it is crucial to understand the FDA's approval process. The agency evaluates the benefits and risks of a vaccine, especially in the context of public health emergencies. The approval of ACAM2000 for monkeypox was likely based on the assessment that the benefits outweigh the risks for high-risk individuals.

Scientific Evidence

The risk of myopericarditis associated with ACAM2000 is well-documented. A study published in the New England Journal of Medicine  reported cases of myopericarditis following smallpox vaccination, highlighting the need for careful monitoring and risk assessment.

The FDA's approval process involves rigorous evaluation of clinical data and consideration of public health needs. While the risks are acknowledged, the decision to approve the vaccine reflects a balance between these risks and the potential benefits in preventing monkeypox.

Conclusion

The claim that the FDA approved the ACAM2000 vaccine for monkeypox despite acknowledging its dangerous side effects is partially true. While the vaccine has known risks, the FDA's approval process considers the benefits versus the risks in the context of public health emergencies. It is essential for individuals to be informed about the potential side effects and for healthcare providers to monitor vaccinated individuals closely.