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Heart inflammation in young men higher than expected after Pfizer, Moderna vaccines -U.S. CDC

Stock MarketsJun 10, 2021 02:36PM ET
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© Reuters. FILE PHOTO: A general view of the U.S. Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia September 30, 2014. REUTERS/Tami Chappell/File Photo

By Michael Erman and Manojna Maddipatla

(Reuters) -A higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 shots from Pfizer/BioNTech and Moderna (NASDAQ:MRNA), according to data from two vaccine safety monitoring systems, the U.S. Centers for Disease Control and Prevention (CDC) said on Thursday.

The CDC and other health regulators have been investigating heart inflammation cases after Israel’s Health Ministry reported that it had found a likely link to the condition in young men who received Pfizer’s COVID-19 vaccine.

The agency said it is still assessing the risk from the condition and has not yet concluded that there was a causal relationship between the vaccines and cases of myocarditis or pericarditis.

While some patients required hospitalization, most have fully recovered from their symptoms, the CDC said.

More than half of the cases reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) after people had received their second dose of either the Pfizer/BioNTech or Moderna vaccines were in people between the ages of 12 and 24, the CDC said. Those age groups accounted for less than 9% of doses administered.

"We clearly have an imbalance there," Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said in a presentation https://www.fda.gov/media/150054/download to an advisory committee to the U.S. Food and Drug Administration meeting on Thursday.

The overwhelming majority of the cases have occurred within a week of vaccination, Shimabukuro said.

There were 283 observed cases of heart inflammation after the second vaccine dose in those aged 16 to 24 in the VAERS data. That compares with expectations of 10-to-102 cases for that age range based on U.S. population background incidence rates, the CDC said.

Shimabukuro said there was a predominance of males in younger age groups among the reported heart inflammation cases.

The median age of patients who experienced the inflammation after a second vaccine dose was 24, according to the VAERS data. Just under 80% of the cases were in men.

Shimabukuro also said the Vaccine Safety Datalink (VSD) - another safety monitoring system - showed an increased incidence of heart inflammation in 16 to 39 year olds after their second shot when compared to the rate observed after the first dose.

Pfizer (NYSE:PFE) said it supports the CDC's assessment of the heart inflammation cases, noting that "the number of reports is small given the number of doses administered."

About 130 million people in the United States have received both doses of one of the mRNA vaccines.

"It is important to understand that a careful assessment of the reports is ongoing and it has not been concluded that the mRNA COVID-19 vaccines cause myocarditis or pericarditis," the company said in a statement.

Moderna said it also has not established a causal association with the condition and its vaccine. It said it is actively working with public health and regulatory authorities to further assess the issue.

The CDC said it will hold a meeting of its Advisory Committee on Immunization Practices next week to further evaluate the evidence and assess the risk of myocarditis following mRNA vaccination for COVID-19.

Heart inflammation in young men higher than expected after Pfizer, Moderna vaccines -U.S. CDC
 

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Comments (5)
mohamed alhajri
mohamed alhajri Jun 11, 2021 12:17PM ET
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Increase the duration between the two shots.
Kris GE
Kris GE Jun 10, 2021 3:01PM ET
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It is utterly criminal to vaccinate kids and young adults. How can you really do this with such a experimental product, that have only emergency approval label? Who is going to pay for the health problems in 5-10 years? Why is corrupted MSM, and Facebook, Twitter, Google blocking scientists and doctors with opposing expertise?
mohamed alhajri
mohamed alhajri Jun 10, 2021 3:01PM ET
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The product way surpassed its experimental phase millions have already used it
Felipe Daniel
Felipe Daniel Jun 10, 2021 2:39PM ET
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Truth about vaccines is coming out
Simon Manning
Simon Manning Jun 10, 2021 12:45PM ET
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Yes, we have known about this for a long time. Clots, heart inflammation...there have been frequent reports of this. However, the corrupt media has been intentionally gaslighting and not reporting on it and social media banning people from talking about. This has also been observed in children.
mohamed alhajri
mohamed alhajri Jun 10, 2021 12:32PM ET
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Vaccination without a pre-medical evaluation what could possible go wrong?! Biiiiiiig mistake
 
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