Friday, January 27, 2023


Stroke After Pfizer Booster May Be Connected to Flu Vaccine: Officials

Instances of stroke following receipt of Pfizer’s new booster in the elderly may be connected to the influenza vaccine, officials said on Jan. 26.

One-hundred thirty cases of ischemic stroke, which can be deadly, were recorded among people aged 65 or older within 21 days of a bivalent Pfizer booster, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee heard on Thursday.

That was higher than the 92 cases recorded in the 22- to 42-day window following vaccination, triggering a safety signal.

The U.S. Centers for Disease Control and Prevention (CDC) and the administration (FDA) revealed the signal on Jan. 13 but had not said how many cases were recorded from the U.S. government’s Vaccine Safety Datalink surveillance system, which contains records from 12.5 million people across 11 sites.

A preliminary review of medical records at one site, which saw 24 ischemic stroke cases in the three weeks following Pfizer vaccination, revealed that a majority of the people who suffered a stroke had an influenza vaccine administered on the same day as the COVID-19 vaccine.

None of the patients had a history of stroke or transient ischemic attack, which is similar to a stroke and could be a non-vaccine cause of ischemic stroke.

Three of the patients died, including a man who perished one month after the stroke. His death was determined to likely be related to the health event.

Overall, 40 cases of ischemic stroke following both COVID-19 and flu vaccination were identified among people who suffered stroke through Dec. 17, 2022. That post-signal analyses heightened the safety signal, which is a sign a vaccine may cause a condition. Only 34.5 cases were expected based on background rates.

There were 60 cases among elderly people who received a bivalent COVID-19 vaccine without receiving a flu vaccine on the same day. That number did not meet the definition of a signal.

Officials decided to compare the cases recorded among boosted people one to 21 days after vaccination with boosted people 22 to 42 days after vaccination for the primary analysis. The rationale given was that people who recently received a vaccine were “expected to be more similar to current vaccinees than unvaccinated individuals.”

Officials also revealed that they excluded post-vaccination ischemic stroke cases if a person had a personal history of certain conditions, including transient ischemic attack or atrial fibrillation, also known as irregular heartbeat.

The new information came from a set of slides that Dr. Tom Shimabukuro, a CDC official, and Dr. Nicola Klein, a Kaiser Permanente official who works closely with the CDC, presented to the FDA’s vaccine advisory panel.

“CDC and FDA are engaged in epidemiologic analyses regarding coadministration of COVID-19 mRNA bivalent booster and flu vaccine,” one slide stated, following the detection of a “significant cluster” of post-vaccination cases of the ischemic stroke.

The CDC and FDA said previously that an examination of other surveillance systems showed no signal of ischemic stroke for the bivalent boosters but failed to mention that an analysis of reports to the Vaccine Adverse Event Reporting System, which the agencies co-manage, for the original Pfizer and Moderna COVID-19 vaccines triggered the signal for ischemic stroke and hundreds of other adverse events. Both the original vaccines are still administered in the United States; the bivalents can only be obtained as boosters.

Pfizer and its partner BioNTech said in a recent joint statement that the companies were made aware of “limited reports of ischemic stroke” observed in the Vaccine Safety DataLink system.

“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) 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 companies stated.

Israel and the European Union have said that they have not detected a signal for ischemic stroke following bivalent vaccination. European officials said they also looked at Pfizer’s original vaccine.

Signal First Identified in 2022

The slides also showed that the safety signal from the Vaccine Safety Datalink was first identified in 2022.

The first time the condition met the signal was Nov. 27, 2022, one slide showed. It did not stop meeting the signal as of Jan. 8, 2023.

The signal has been “persistent for 7 weeks,” one slide stated.

While the rate ratio, or the result of the analyses, “has slowly attenuated from 1.92 to 1.47,” it “has continued to meet signaling criteria,” the slides acknowledged.

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Judge Blocks California’s COVID-19 Misinformation Law

A California judge on Wednesday halted the state’s so-called COVID-19 misinformation and disinformation law, which was challenged by doctors in two lawsuits, claiming it violates their constitutional rights.

In Hoeg v. Newsom, five doctors alleged that the state law, AB 2098, is unconstitutional under the First and Fourteenth Amendments of the U.S. Constitution. A separate related lawsuit, Hoang v. Bonta, makes similar allegations.

Both lawsuits sought a preliminary injunction to prevent California from enforcing the law.

The five doctors, Tracy Hoeg, Ram Duriseti, Aaron Kheriaty, Pete Mazolewski, and Azadeh Khatibi, filed their lawsuit against Gov. Gavin Newsom and other officials, including the president and members of the Medical Board of California.

They argued the law prevents them from providing information to their patients that may contradict what the law permits or prohibits. They also alleged the law was used to intimidate and punish physicians who disagreed with prevailing views on COVID-19.

Judge William Shubb, a George W. Bush appointee, wrote in his ruling (pdf) it was plausible that the medical board would determine their conduct violates AB 2098, and therefore the doctors’ fears are reasonable “given the ambiguity of the term ‘scientific consensus’ and of the definition of ‘misinformation’ as a whole.”

Shubb noted that this weighed in favor of the plaintiffs having standing.

“Because the definition of misinformation ‘fails to provide a person of ordinary intelligence fair notice of what is prohibited, [and] is so standardless that it authorizes or encourages seriously discriminatory enforcement,’ the provision is unconstitutionally vague,” Shubb wrote. “Accordingly, the court concludes that plaintiffs have demonstrated a likelihood of success on the merits of their vagueness challenges.”

The Law

Newsom signed the bill into law in September 2022, and it took effect on Jan. 1, 2023.

The law defines misinformation as “false information that is contradicted by contemporary scientific consensus,” and prohibits physicians from disseminating “misinformation or disinformation related to COVID-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines.”

Doctors who deviate from the established U.S. Centers for Disease Control and Prevention’s guidance by attempting to assess and advise their patients as individuals may run afoul of the new law.

The state medical board is required by law to act against any licensed doctor charged with unprofessional conduct.

The court’s ruling effectively halts the law while the legal challenge plays out.

The legal organization representing the doctors said their clients were put in a difficult position, fearing repercussions for acting in the best interests of their patients by giving them honest information, depriving them of their right to receive advice and hear treatment options without fear of professional discipline.

According to American Civil Liberties Alliance (ACLA), the First Amendment, which protects Americans’ rights to free speech and expression, applies to minority views and majority opinions.

The doctors alleged they have been threatened by other doctors and individuals on social media to use AB 2098 to have their licenses taken away, according to ACLA.

“They are being put between a rock and a hard place, fearing repercussions for acting in their patients’ best interests by honestly giving them the information they believe their patients need in order to make informed care decisions,” ACLA said in a summary of the case of its website.

One of the doctors in Hoeg v. Newsom welcomed the judge’s ruling.

“The ruling bodes well for our case: it indicates that our arguments that this law is unconstitutional have strong pre-trial facial plausibility,” Kheriaty wrote on Twitter. “Not to get ahead of ourselves, of course, or try to predict the final outcome of the case, but this is a very positive development.”

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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