Data indicates Pfizer’s new COVID-19 vaccine could cause a type of stroke in elderly people, two U.S. health agencies said on Jan. 13.

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.”

‘Totality of Data’

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.

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.”

Pfizer did not immediately respond to a request for comment.

Recommended Without Clinical Data

The company’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 both the 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 was not one of the signals that were identified.

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 stroke signal was not detected for any other vaccines, according to the CDC and the FDA.

The revelation comes after a growing number of experts call for a withdrawal of the messenger RNA vaccines, or the shots made by Pfizer and Moderna.

Call For a Pause

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.

Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news.

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