It probably wasn't a good idea to sign off on an experimental COVID vaccine booster based on a safety study of only eight mice.  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌
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CDC Launches Investigation Into New Pfizer Booster After Surveillance System Reveals Potential Link to Ischemic Strokes

It probably wasn't a good idea to sign off on an experimental COVID vaccine booster based on a safety study of only eight mice.

Megan Redshaw
Jan 16
 
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The Centers for Disease Control and Prevention (CDC) is launching an investigation into Pfizer’s bivalent COVID booster. Apparently, a “preliminary safety signal” was detected through the agency’s Vaccine Safety Datalink (VSD) system for ischemic strokes in people ages 65 and older.

This is the same COVID booster authorized by both the U.S. Food and Drug Administration and CDC last August without a single human clinical trial. This bivalent booster targeting the original Wuhan strain no longer in circulation and the practically obsolete BA.4/BA.5 Omicron subvariants was deemed safe based on a study of eight mice and considered effective based on a study using a booster shot for an entirely different variant.

To this day, we have no idea what happened to the eight mice, but I’m not sure that even if we did, we could justify recommending an experimental booster to millions of people without human clinical trials.

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In a statement published Friday, the CDC said its VSD surveillance system met the “statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.”

VSD showed that people who received the bivalent booster were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination. This preliminary signal has not been identified with the Moderna bivalent booster shot, the agency added. (You only have to worry about the ignored cardiac arrest safety signal with that one.)

According to the agency, an ischemic stroke “occurs when blood clots or other particles block the blood vessels to the brain.”

The CDC, in its statement, said there might be other confounding factors contributing to the VSD safety signal, and other studies did not validate the signal, nor has it been identified in other countries following the rollout of updated boosters.

A large study of updated (bivalent) Pfizer and Moderna vaccines using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke, the agency said, and Pfizer’s “global safety database” did not yield a signal — although we know from Pfizer’s own clinical trials, they’re not going to admit a safety signal even if their own clinical trial participants end up in wheelchairs.

“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,” the CDC said.

In an interview with Fox News host Neil Cavuto, Dr. Anthony Fauci said the finding “most likely is not going to be a relevant signal because several of the other surveillance and monitoring mechanisms that are put in place have not come up and found this signal.”

The CDC said its Vaccine Adverse Event Reporting System (VAERS) had not seen an increase in reporting of ischemic strokes following the bivalent vaccine. Yet, the most recent VAERS data show there have been 45,093 reports of blood-clotting disorders and 2,272 reports of ischemic strokes attributed to COVID-19 vaccines, including bivalent boosters.

In a statement to Fox News Digital, a Pfizer spokesperson said, “Pfizer and BioNTech have been made aware of limited reports of ischemic stroke that have been observed in the CDC Vaccine Safety DataLink database in people 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech.”

“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration have observed similar findings across numerous other monitoring systems in the U.S. and globally, and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the spokesperson added. 

“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine. The CDC continues to recommend vaccination with the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for all authorized ages and indications.”

In other words, Pfizer denies there’s a problem with its vaccine and holds the belief that people who receive their bivalent booster have a lower incidence of ischemic strokes — a claim undoubtedly based on the unsubstantiated assertion COVID vaccines prevent severe COVID-19.

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