The threshold for a safety signal was met for Pfizer’s bivalent booster in the Vaccine Safety Datalink, a monitoring system run by the U.S. Centers for Disease Control and Prevention (CDC).
The signal was for ischemic stroke, a type of stroke caused by blood clotting.
The signal was triggered for people aged 65 and older, the CDC and the U.S. Food and Drug Administration (FDA) said in a joint statement.
Safety signals are triggered when an adverse event such as stroke happens at a certain rate following vaccination.
Signals suggest a connection between an adverse event and a vaccine but further study must be done to verify a connection.
“All signals require further investigation and confirmation from formal epidemiologic studies,” the CDC and FDA said. “Often these safety systems detect signals that could be due to factors other than the vaccine itself.”
Unlikely a ‘True Clinical Risk’
The agencies did not say when the signal was detected other than saying it happened after the updated shot became available, which was in early September 2022. Neither agency returned a request for comment.
Other systems monitored for vaccine safety, such as the Centers for Medicare and Medicaid Services, have not shown a signal for ischemic stroke among the elderly or other age groups, according to U.S. authorities.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the agencies said.
“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”
The FDA will meet with the panel, which advises it on vaccines, “to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward,” according to an earlier release.
Dr. Ramin Farzaneh-Far, a cardiologist, said it was hard to take the CDC’s word given how the agency repeatedly dismissed reported links between myocarditis and COVID-19 vaccines before eventually acknowledging a causal link.
The CDC and FDA should make stroke data public, he wrote on Twitter.
Ischemic stroke, also known as embolic stroke, is caused by a blood clot that “blocks or plugs a blood vessel in the brain,” according to the National Library of Medicine. The blockage typically prevents blood from flowing to the brain and quickly leads to brain cells dying. Other COVID-19 vaccines are believed to have caused ischemic stroke.
“There is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” Pfizer told news outlets in a statement. It produces the vaccine with BioNTech, a German company.
Rep. Cathy McMorris Rodgers (R-Wash.), chairwoman of the House Energy and Commerce Committee, said the CDC and FDA “must rapidly investigate, in an open and transparent manner, whether or not the vaccine may have contributed to the reported strokes.”
Recommended Without Clinical Data
Pfizer’s new booster, which targets the BA.4 and BA.5 Omicron subvariants in addition to the Wuhan strain, was authorized and recommended in late 2022 without any clinical data. Months later, no clinical data has been made available by Pfizer, the CDC, or the FDA.
A recent FDA study identified an increased risk of pulmonary embolism after Pfizer’s original vaccine in the elderly. That condition, a lack of oxygen to the heart, is also caused by blood clotting.
The CDC, meanwhile, flagged hundreds of safety signals for the original Pfizer and Moderna vaccines, according to monitoring results obtained by The Epoch Times. The monitoring was done on reports to the Vaccine Adverse Event Reporting System, which authorities describe as “the nation’s early warning system” for vaccines and which is co-run by the CDC and FDA.
Experts said there was a high probability that the vaccines caused some of the adverse events, including hepatic cirrhosis.
Ischemic stroke, labeled ischaemic stroke, was one of the signals that were identified.
Two hundred and seventy-four reports of ischemic stroke after Pfizer vaccination have been reported to the reporting system as of late 2022.
The CDC and FDA have aggressively promoted COVID-19 vaccination during the pandemic, and the stroke signal was not changing that stance.
“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine,” the agency said.
The Vaccine Safety Datalink is a CDC-managed group of 11 sites, including multiple Kaiser Permanente locations, that provide electronic health data such as date of vaccination and hospitalization details.
The stroke signal was not detected for the updated Moderna vaccine, according to the CDC and the FDA.
The Pfizer and Moderna vaccines have been confirmed to cause multiple side effects, including myocarditis, a form of heart inflammation.
Calls for Withdrawal
The revelation comes after a growing number of experts call to withdraw the messenger RNA shots made by Pfizer and Moderna.
Dr. Joseph Fraiman, based in Louisiana, became one of the latest to call for a pause in administration until new clinical trials can be run showing the vaccines are safe and effective.
Fraiman pointed to data including a reanalysis of the original trials that he and others conducted. They concluded that the vaccinated were at higher risk of severe adverse events.
The fact that the Omicron variant and its subvariants are also less virulent, leading to fewer hospitalizations and deaths, and the waning effectiveness of the vaccines also contributes to the building opposition to vaccinating all or portions of the population until better data is made available.
Correction: A previous version of this article inaccurately reported on the results from the monitoring of VAERS. Ischemic stroke, labeled ischaemic stroke, was one of the signals identified. The Epoch Times regrets the error.
From The Epoch Times