FDA approves new COVID-19 vaccine for babies… but there’s no emergency? What’s really going on? 🤔

The Approval Without an Emergency

In a move that has sparked considerable debate, the FDA approved a new COVID-19 vaccine for emergency use on August 22, 2024, targeting children as young as six months old. This decision comes at a time when there is no declared public health emergency related to COVID-19, given that President Joe Biden had officially ended the national emergency in the spring of 2023.

The New Vaccine Formula

The newly authorized vaccines, developed by Moderna and Pfizer, include an updated mRNA formula for the years 2024-2025. These vaccines are designed with a monovalent component aimed at the Omicron variant KP.2 strain. The FDA claims this formula will better target current variants and offer improved protection against severe outcomes like hospitalization and death. However, critics argue that the evidence supporting these claims is scant, pointing out that clinical trials primarily focused on reducing positive test rates rather than preventing severe disease outcomes.

Questionable Efficacy and Safety Data

Critics of the new vaccine authorization highlight that every new iteration or variant-specific vaccine still leans on the original six-month clinical trial data from the first COVID-19 vaccines. These trials have been criticized for misrepresented data, skewed demographics, and procedural flaws. Moreover, the vaccines have been linked to causing more harm than good, a point emphasized by independent analyses of hospitalization data.

The PREP Act and Investigational Status

Dr. Mary Talley Bowden, a senior fellow at the FLCCCA, notes that such approvals are facilitated by the Public Readiness and Emergency Preparedness (PREP) Act, which remains in effect until December 2024. This act allows for the emergency use of drugs that are technically still in the investigational phase, essentially making the general public participants in what some view as an ongoing clinical trial.

Misleading Vaccination Data

The categorization of “unvaccinated” versus “vaccinated” has also come under scrutiny. Individuals who experienced adverse outcomes or tested positive for COVID-19 within 14 days of vaccination were often classified as unvaccinated, thereby skewing the data to favor the vaccine’s perceived effectiveness. This classification has led to widespread criticism regarding the transparency and accuracy of vaccine efficacy reports.

Public Health Data and Its Discontents

Data from various public health jurisdictions initially showed that increased vaccination did not correlate with decreased hospitalizations or deaths, contrary to the narrative pushed by health authorities. However, these datasets were often removed or altered when they did not support the “safe and effective” mantra.

Regulatory Response and Public Inquiry

While the FDA continues to assert that the benefits of these new vaccines outweigh the risks, there has been a noticeable lack of response from the FDA, CDC, and other Health officials to similar inquiries about the benefits and risk calculations for the average person. The FDA is approving these new formulations without substantial public discourse or transparent data review.

A Pattern of Concern

The ongoing approval of these investigational vaccines under the guise of emergency use, despite lacking emergency conditions and substantial supportive evidence, points to a troubling trend. This pattern suggests a prioritization of pharmaceutical profits over rigorous scientific validation and public health safety, leaving many to wonder about the true motives behind these rapid authorizations. The situation underscores the need for greater transparency, more robust scientific inquiry, and an honest dialogue about the risks and benefits of such medical interventions.