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The FDA Adds Warning About Pfizer Drug as Vaccine Reactions Come Under Scrutiny

Tony Gray by Tony Gray
December 4, 2021
in US
2

Recent studies have raised questions about how honest United States President Joe Biden’s Administration is about the possible side effects of COVID-19 vaccines.

The datasets used by investigators studied males between the ages of 12 and 29 years old, lending credibility to parents’ concerns about school vaccine mandates. If increased rates of heart disease are experienced by younger adult males, will there be a geometric or exponential increase in heart disease for vaccinated 5- to 12-year-old children?

“Serious adverse events associated with receipt of new vaccines targeting COVID-19 are of high interest to the public and to public health vaccine safety surveillance,” said military doctors in a recent report. Their findings were published by Jama Cardiology in October 2021.

The U.S. military administered more than 2.8 million doses of mRNA COVID-19 vaccine in the reporting period, according to the study’s authors, who also noted that observed myocarditis case numbers were small but higher than expected among male military members after a second vaccine dose.

Of the nearly 3 million vaccinated service members, 23 male patients with a median age of 25 sought medical treatment after experiencing acute chest pain within 4 days of getting jabbed with an mRNA COVID-19 vaccine. All were reported as being previously healthy, highly fit individuals.

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“All patients had significantly elevated cardiac troponin levels,” the doctors said. “Among eight patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis.”

“In a report from the Israeli Ministry of Health, one in 3,000—to one in 6,000—men aged 16 to 24 who received the mRNA COVID-19 vaccine developed myocarditis and pericarditis,” according to Becker News.

“Ninety percent of the cases in Israel appear to be men,” Becker news reported. “Although the background rate of myocarditis in this population is high, the rate following vaccination appeared to be 5–25 times higher than the background rate.”

European Medicines Agency researchers evaluated data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.

They reviewed two large European epidemiological studies: one from France and another from Nordic registry data. The EMA’s safety committee (PRAC) determined risk for both of these conditions is overall “very rare,” meaning that up to one in 10,000 vaccinated people may be affected. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males.

“Overall, the outcome of the review confirms the risk of myocarditis and pericarditis, which is already reflected in the product information for these two vaccines, and provides further details on these two conditions,” the agency said in a statement.

Based on the reviewed data, the PRAC has recommended updating the product information accordingly.

The French and Nordic studies are not exactly comparing apples to apples because the French scientists studied cases seven days after vaccination while the Nordic scientists looked at symptoms 28 days after getting jabbed.

The French Comirnaty vaccine study found about 0.26 extra cases of myocarditis in 12- to 29-year-old males per 10,000 compared to unexposed persons after seven days while the Nordic study found 0.57 extra cases of myocarditis in 16- to 24-year-old males per 10,000 compared to unexposed persons in a period of 28 days after their second jab.

Spikevax, the French study showed, detected about 1.3 extra cases of myocarditis in 12- to 29-year-old males per 10,000 compared to unexposed persons up to seven days after their shot.

“The Nordic study shows that in a period of 28 days after the second dose of Spikevax there were around 1.9 extra cases of myocarditis in 16- to 24-year-old males per 10,000 compared to unexposed persons,” PRAC officials said, adding that myocarditis and pericarditis are inflammatory conditions of the heart with symptoms that include breathlessness, a forceful, possibly irregular, heartbeat, and chest pain.

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