COVID vaccine 'adverse events of special interest' more common than expected: CDC-funded study

Global Vaccine Data Network records of more than 99 million individuals in eight countries show relatively high ratios of "observed versus expected" occurrences of Guillain-Barré syndrome, brain blood clots, heart and spinal-cord inflammation.

Published: February 20, 2024 11:00pm

Updated: February 22, 2024 4:22pm

Rep. Debbie Dingell developed a severe nerve condition from a mandatory swine flu vaccine, which initially made her "scared to death" to get a COVID-19 vaccine, she told a congressional hearing last week

The Michigan Democrat might want to reconsider her now-unquestioning enthusiasm for COVID vaccines, including those made through traditional methods, in light of a massive international study of "adverse events of special interest" funded by the Centers for Disease Control and Prevention and set to be published in the peer-reviewed Elsevier journal Vaccine.

Members of the research team, which stretched from the Americas to Europe, China and Australia, said they identified "potential safety signal[s] of concern" following mRNA and adenovirus-vector vaccination when the "observed versus expected" ratio of a given AESI rose above 1 at the lower boundary of the 95% confidence interval and reached statistical significance.

Several AESIs exceeded the lower-boundary ratio of 1.5 "across neurological, haematological, and cardiac outcomes," including Dingell's Guillain-Barré syndrome and heart inflammation, in their study of Global Vaccine Data Network records of more than 99 million individuals vaccinated in eight countries. 

Team members said they prioritized the 1.5 lower boundary "due to increased statistical evidence and the higher likelihood of being a true signal, based on expert opinion from the CDC" and collaborators in GVDN's Global COVID Vaccine Safety Project, which the CDC fully funds.

The vast majority of the AESIs had narrow confidence intervals, reflecting more certainty about the effect, including a staggering mean ratio of 6.10 for Moderna's second mRNA dose with myocarditis, which is heart muscle inflammation. The high mean ratios were most common for cardiovascular conditions, including the upper 2s for Pfizer's primary series with myocarditis and 2.09 for the booster.

Wide confidence intervals for AstraZeneca's third dose with pericarditis (mean: 6.91) and Moderna's first dose with brain and spinal-cord inflammation (3.78) reflect the small absolute difference in observed versus expected events, just five each. 

These specific "results should be interpreted with caution and confirmed in future studies," the paper says, pointing to an ongoing GVDN "follow-up study" that focuses on "a demographic not included in our analysis."

Atypically for COVID research published in high-profile journals, the researchers do not appear to have extolled the safety and efficacy of COVID vaccines anywhere in the paper.

They even warned the GVDN data may underestimate "the significance of potential safety signals" and include "false negatives, especially when detecting associations with lower confidence intervals below 1.5 that maintain statistical significance." 

Bloomberg, by contrast, began its report by claiming the vaccines "protect against severe illness, death and lingering long Covid symptoms" and have "sav[ed] over 1 million lives in Europe alone," citing a 2023 press release by the European Congress of Clinical Microbiology & Infectious Diseases on an unreleased World Health Organization study.

The Vaccine study confirms prior research and government warnings on Guillain-Barré as a known if rare side effect from adenovirus-based Johnson & Johnson and AstraZeneca vaccines, as well as myocarditis and pericarditis following Pfizer and Moderna mRNA vaccines, especially in young men. 

Brianne Dressen, cofounder of the vaccine-injury group React19, was injured in an AstraZeneca trial and recognized from the dais at the House Select Subcommittee on the Coronavirus Pandemic hearing in which Dingell, 70, shared her vaccine injury. 

Moderna and Northeastern University scientists acknowledged in the Springer Nature journal Nature Reviews Drug Discovery last month that lipid nanoparticle "structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns." 

The paper beyond the abstract is behind a subscription paywall, but mRNA vaccine pioneer-turned-critic Robert Malone extensively quoted from it in a critical review posted to his newsletter

He said the "acknowledged toxicities" include hepatotoxicity from intravenous administration, "general liver and spleen toxicity," immune responses to the lipid nanoparticle polyethylene glycol and "hypersensitivity reactions."

Due to the fast development of mRNA COVID vaccines, "the once-waning nanomedicine field is reinvigorated," according to a paragraph from the paper cited by Malone.

But the Moderna scientists warned that "serious concerns about the safety of any given mRNA-based drug could affect the entire platform," just as one "lethal case of systemic inflammation after the intravenous administration of an adenovirus vector during a phase I trial [...] halted progress in the entire gene therapy field for more than a decade."

The Vaccine paper, accepted but not yet published, determined the expected rates for 13 AESIs whose "background rates were recently generated by GVDN sites," the researchers wrote. They were based on "participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex," and observed rates based on the same datasets following vaccine rollout. 

They counted AESIs up to 42 days after administration of Pfizer, Moderna and AstraZeneca vaccines.

AstraZeneca crossed the lower boundary of the 1.5 ratio with Guillain-Barré (mean: 2.49), with 190 observed versus 76 expected events, and brain blood clots (3.23), with 69 versus 21. Moderna's first (1.74) and fourth (2.64) doses crossed it as well with pericarditis, the swelling and irritation of heart membrane.

Ratios between 1 and 1.5 on the lower boundary were far more common, including AstraZeneca's primary series for heart inflammation and AstraZeneca's first dose with inflammation of the brain and spinal cord or just the spinal cord.

They also included every Pfizer dose with pericarditis, the fourth dose for both mRNA vaccines with myocarditis, first-dose mRNA with Bell's palsy, and Moderna's first and second doses with febrile seizures. 

Asked why it continues to recommend one-size-fits-all COVID vaccination, regardless of age and underlying health, in light of the findings from the study it funded, the CDC gave Just the News a statement Thursday.

"The Global Vaccine Data Network (GVDN) in collaboration with CDC studied 99 million people across eight countries who received COVID-19 vaccines. The study confirms what we know: vaccination remains the safest and most dependable strategy to build immunity and protection against COVID-19, with billions of doses safely delivered worldwide and millions of lives saved," the statement says.

"The benefits of COVID-19 vaccination continue to outweigh any potential risks and serious reactions after COVID-19 vaccination remain rare. CDC and FDA will continue to closely monitor the safety of vaccines and will further explore the data from the study," it says.

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