Monday, October 30, 2023

Israeli Study: 0.62% of Healthcare Workers Jabbed with Pfizer’s mRNA Vax Show Biomarker for Myocarditis

A clinical trial (NCT05308680) in Israel was conducted by researchers at Shaare Zedek Medical Center to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Led by principal investigator Dr. Tal Hasin, Director of the Heart Failure Unit in the Cardiology Department at Shaare Zedek Medical Center, and colleagues, the team sought to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

The findings of this study have been suppressed not discussed widely, although material. Why? 0.62% of adult healthcare workers evidenced biomarker signals for mild myocarditis. While this may not seem significant, it is. This represents an extraordinarily high percentage of cases, and importantly, the study did not focus on younger males, which are considered higher risk.

The principal investigators are very careful with their language but include subtle messaging to take very seriously. This includes the subtle insertion that the findings have “profound” implications for risk-benefit analyses concerning Pfizer’s mRNA vaccine.


Registered in the American clinical trials registry, this study was based on population-based retrospective studies suggesting an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis.

The study authors point out the lack of large-scale studies to evaluate the incidence of myocarditis after the administration of the third or fourth vaccine doses, but case reports of myocarditis in recipients of the third dose were described. Although considered to be low, the estimated risk of myocarditis and myocardial injury in vaccine recipients is believed to be underestimated.

The Study

The Israeli investigators estimate the overall incidence of myocarditis at 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher.

In the present study, the team involved adult healthcare workers who received the BNT162b2 (Pfizer-BioNTech) vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign; the study participants’ blood samples were taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days.

Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and >50% increase from the first measurement.

Participants with evidence of myocardial injury underwent assessment for possible myocarditis, including electrocardiogram and echocardiography.

What did they find?

With results of this study recently reported in the European Journal of Heart Failure, Dr. Hasin and team reported that out of the study’s 324 participants, 192 (59.2%) were female, and the mean age was 51.8 ± 15.0 years.

Twenty-one (6.5%) participants had prior COVID-19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days.

The study authors report, “Vaccine-related myocardial injury was demonstrated in two (0.62%) participants; one had mild symptoms, and one was asymptomatic; both had a normal electrocardiogram and echocardiography.”

In this prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy healthcare workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Importantly, this represents a high overall percentage with implications for the hundreds of millions of persons vaccinated with the Pfizer vaccine.

For example, if these figures were extrapolated out to 100 million vaccinations, that would mean 617,284 cases involving an increase in serum troponin levels.

What do the study authors think of this output?

The authors do acknowledge a disturbing signal here, declaring: “Indeed, the current study suggests a higher incidence of myocardial injury during active monitoring for cardiac biomarkers in vaccine recipients with no clinical evidence of myocarditis. Since in our study, the average age was 51 and only 40% were male, with only 8 (2.47%) of them that were 30 years old or younger, it is currently unknown if a prospective evaluation among younger males will yield a higher incidence of myocardial injury.”

The study team further explains “Besides the pathophysiological implications, the clinical significance of the mild injury found in our study may be debated and should be further evaluated in larger studies.”

What’s the mechanism of action?

The mechanism of vaccine-induced myocarditis is unknown but may be related to the active component of the vaccine, the mRNA sequence that codes for the spike protein of SARS-CoV-2, or to an unregulated immune response that follows vaccination in certain individuals with a genetic predisposition.

The authors suggest that in some cases, acute myocardial injury may occur via a similar mechanism without material clinical myocarditis. They write, “Otherwise, a non-immune-mediated initial injury may trigger more significant immune-mediated myocarditis in susceptible individuals, but not in others.”

What are the recommendations given the findings?

Dr. Hasin and colleagues point out that given the potential magnitude of the findings (yet they downplay some more severe implications), they articulate, “A reasonable recommendation may be to withhold strenuous physical activity for a few months. Regarding the recommendation for repeat vaccine doses in the future, there is no consensus. However, given the limited clinical utility reported recently with the fourth dose against Omicron, repeat vaccination of individuals with documented post-vaccine myocardial injury deserves a profound risk–benefit consideration.”

Note, the use of the language—“profound” risk-benefit consideration moving forward!


COVID Hospitalizations Continue to Drop, CDC Data Show

Hospitalizations for COVID-19 have continued to drop, coming after a relatively small increase in cases over the summer, according to data released by the U.S. Centers for Disease Control and Prevention (CDC).

Hospitalizations fell by 5 percent for the week ending Oct. 14, while emergency department visits also dropped by 11.9 percent, and reported case numbers decreased by 0.7 percent. Deaths rose by 4.2 percent, although officials say that deaths generally lag case and hospital numbers.

For the week ending on Oct. 7, hospitalizations were down by 8.2 percent, emergency visits fell 17.7 percent, and reported cases were down by 0.8 percent, while deaths fell 3.8 percent, the data show.

Amid the drop in hospitalizations over consecutive weeks, the CDC sent out a report earlier in October claiming the virus remains a "public health threat" for older Americans, arguing that it's a reason they should take the updated COVID-19 vaccine.

The Food and Drug Administration (FDA) and CDC both signed off last month on the updated shots made by Pfizer, Moderna, and Novavax.

Few Americans Taking Updated Shots

Around the same time, the CDC said officials are expecting a “moderate COVID-19 wave” for the winter months ahead and predicted this year's peak will match last winter’s hospitalization figures. The virus levels, however, could peak earlier this season because of "limited summer activity compared to past years,” the agency said in September.
“This increase could result from the emergence of a new COVID-19 variant with an increased ability to evade the body’s prior immunity, or from a severe influenza season combined with COVID-19 and RSV waves that are similar to last year, or, as we saw last year, an increase in RSV infections,” the CDC stated. “A key factor is the timing of the peak number of hospitalizations associated with each disease and whether those peaks coincide.”

About 3 percent of all Americans who are eligible have received the updated COVID-19 booster shot, nearly two months after it was rolled out, according to officials with the Department of Health and Human Services (HHS). Overall, about 10 million people have taken it, the data show, up from 7 million a week before.

“The administration remains committed to pulling every lever at its disposal during the fall respiratory vaccination campaign, encouraging the American public to stay up to date on their vaccines to keep themselves and their loved ones safe,” an HHS spokesperson told The Epoch Times earlier in October. “As a result of these efforts, around 10 million Americans have been vaccinated since the updated vaccines were authorized and recommended last month.”

The relatively lower pace of vaccinations prompted drug giant Pfizer to revise its revenue guidance for the year, warning that demand for COVID-19 products such as vaccines has plunged.

Pharma Profits Plunge

Pfizer, which has seen its stock drop by about 40 percent for 2023, slashed its outlook by about $9 billion due to the weakened demand, the company said on Oct. 13. It particularly expects sales of its mRNA vaccine to be about $2 billion lower than it previously anticipated.

As for Moderna, the company reiterated earlier this month that its COVID-19 vaccine sales will be between $6 billion and $8 billion. It’s still too early to predict the U.S. vaccination rate, Moderna said this month, coming as the company's stock plunged $7 billion in about a week and as its stock has dropped 83 percent since its peak in August 2021.

Some analysts said that the pharmaceutical companies should be worried about their vaccine sales.

“COVID-19 vaccine revenue concerns should be at an all-time high right now,” Hartaj Singh, an analyst at Oppenheimer, said in a recent Bloomberg report. “A good third-quarter print should allay some of these fears. And good guidance early next year on 2024 potential revenues could get the stock’s mojo back.”

It comes also as multiple U.S. hospitals in recent days have dropped their COVID-19 mask mandates after they reinstated the rule several weeks ago. A handful of hospitals across the United States reimplemented mandates over the summer, although some didn't make masks a requirement for patients or visitors, just staff such as nurses and doctors.

The largest hospital group in New Jersey, Hackensack Meridian Health, reinstated mask mandates last month. However, officials with the company have confirmed it has lifted its mandate for all its hospitals except for Bayshore Medical Center in Holmdel, Old Bridge Medical Center, and Southern Ocean Medical Center in Stafford, local media reported




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