Investigative Report: CDC Misled ACIP on Merck’s Monoclonal Antibody
Updated
An investigative report by Maryanne Demasi, PHD, on Substack has revealed that the Advisory Committee on Immunization Practices (ACIP) was not given the complete safety information by the CDC in June when the panel approved Merck’s RSV Monoclonal Antibody. ACIP members Robert Malone and Retsef Levi have spoken out against the lack of transparency in this process. Merck’s drug was approved by the ACIP by a vote of 5-2 in June.
Demasi explains that the presentation by Matthew Daley arbitrarily separated seizure reactions into two different groups to conclude that the results were not statistically significant, despite an indication that babies are four times more likely to have a seizure after receiving Merck’s Monoclonal Antibody injection. The results included two groups: babies injected from 0-37 days and babies injected from 38 days up to 8 months. When these groups were combined and analyzed with a meta-analysis, the results were statistically significant. Daley is a pediatrician with Kaiser Permanente Colorado, which has also received funding from Sanofi.
Demasi also explained another flawed methodological approach to the CDC’s analysis. Seizures were only tracked for seven days following injection, and seizures that occurred eight or more days were included in a “control” group, which implies the seizure is not related to or caused by the drug.
“If the CDC presents safety data in a way that downplays clear signals of harm, the promise of a ‘reformed’ advisory process collapses before it even begins,” Demasi wrote. She added that the new ACIP panel that was created to subvert biased interpretations of drug safety profiles cannot live up to its promise if the CDC is still able to present scientific data in a misleading way to dismiss potential safety signals.
ACIP member Dr. Robert Malone, who voted in favor of the drug approval, wrote a Substack post stating the members were presented with the data the day before the vote, with very little time to review or ask questions.
“Going forward, speaking for myself, based on these findings, I will no longer be able to trust that what is presented in CDC summaries to the ACIP is transparent, accurate, and unbiased,” Dr. Malone wrote on a Substack post in response to Demasi’s investigative report. “Whether or not this decision will be reconsidered is speculative, and I am embargoed from discussing future ACIP plans and non-public discussions or information.”
Yaffa Shir-Raz reported for the Brownstone Institute that in addition to the misrepresentation of seizure risk, ACIP members did not receive information on mortality for either Merck’s clesrovimab or Sanofi-AstraZeneca’s Nirsevimab, both of which showed higher deaths among the group who received the treatment.
Levi responded to Demassi’s report on X. “I will speak for myself and say that we need more people like Maryanne Demassi to push the CDC, FDA, ACIP, and the industry to higher levels of transparency and deeper discussions of potential safety signals.”
Levi was also named chair of a new CDC COVID-19 vaccine working group to examine long-term health data and outcomes more than four years after the vaccines were rolled out. Levi wrote on X following the announcement. “Looking forward to working with colleagues at ACIP, CDCgov, US_FDA and leading academics & clinicians, to pursue the truth through science and evidence-based approach! Commitment to hard work, transparency and integrity!”
The HighWire has reported about multiple concerning issues related to the COVID-19 vaccines, including DNA contamination, elevated levels of spike protein years after vaccination, symptomatic shedding events, menstrual irregularities, and depression.
Demasi interviewed Levi regarding the new COVID-19 working group, its primary objective, and the individuals who will be involved. Levi said the work group has not been fully formed, but will include his ACIP colleagues, Dr. Malone and Dr. James Pagano. He said the working group has a “comprehensive and ambitious agenda we’ll be working on in the coming months and years” in consultation with the CDC to understand the safety and efficacy profile of the COVID-19 vaccines.
“This is new technology, so it raises new questions,” Levi said. “For example, unlike traditional vaccines, when a COVID vaccine is administered, we don’t know the actual dose. The vaccine introduces into the body’s cells the mRNA code that is wrapped in nano lipids, and as a result, the cells are instructed to produce the spike protein. However, everyone could produce a different amount of spike protein. The initial safety paradigm was that the vaccine contents would only stay in the arm and be cleared after a short duration. Now we know that’s not true – so we need to understand the biodistribution and persistence of the mRNA, the spike protein, and the lipid nanoparticles, and what their respective risks are.”
The CDC, under the lead of HHS Secretary Robert F. Kennedy Jr., modified COVID-19 vaccine recommendations to no longer recommend COVID-19 inoculations for healthy children. This change reflects similar guidelines adopted in the U.K. Despite that, the American Academy of Pediatrics (AAP) has issued its own child and adolescent immunization schedule that differs from the CDC.
Secretary Kennedy responded to the AAP recommendation, stating the organization has free speech rights, but should disclose its pharmaceutical conflicts of interest, including Merck, Moderna, Pfizer, and Sanofi. Levi, Florida Surgeon General Dr.Joseph Ladapo, and Dr. Malone also shared the message on X detailing the AAP’s pharma connections.
