U.S. health officials are investigating whether or not Moderna’s COVID-19 vaccine is tied to a higher risk of rare heart inflammation in younger adults than the Pfizer-BioNTech shot is.
Sources told The Washington Post that the probe from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention comes due to emerging reports out of Canada.
The Canadian data seem to suggest that males under age 30 have higher odds of the heart condition, known as myocarditis or pericarditis, after being dosed with the Moderna vaccine.
What’s more, the risk could 2.5 times higher for those get the Moderna jab compared to the Pfizer shot.
The source said this investigation is behind the delay in the FDA approving Moderna’s vaccine for emergency use authorization in 12-to-17-year-olds.
The FDA and CDC have launched an investigation into whether or not there is a greater risk of myocarditis/pericarditis with the Moderna vaccine than with the Pfizer vaccine. Pictured: University of Tennessee senior Gwendolyn Keiser is given her second dose of the Moderna COVID-19 vaccine at UTC’s vaccination center, April 2021
Canadian data indicate those under age 30 have a 2.5 times risk of heart inflammation with the Moderna jab. In the U.S, officials have found a risk after the second dose in adults under age 30 (above) – but not tied to any particular vaccine
One anonymous source told The Post that the investigation is still in its early stages and more evidence is needed before the federal health agencies add any new or revised warnings.
‘We have not come to a conclusion on this,’ a source told The Post.
‘The data are not slam bang.’
FDA spokeswoman Stephanie Caccomo told The Post that officials cannot comment on whether an investigation is occurring.
‘We can say that FDA is absolutely committed to reviewing data as it becomes available to us,’ she said.
‘We have previously communicated about myocarditis and COVID-19 vaccines and if new information changes the risk/benefit profile, we will update the public accordingly.’
Meanwhile, the CDC told the newspaper in a statement that its ‘Advisory Committee on Immunization Practices has and continues to review reports of myocarditis and pericarditis following COVID-19 mRNA vaccination.
‘CDC, FDA, and our vaccine safety partners are actively monitoring these reports, including reviewing data and medical records, to learn more and understand any relationship to COVID-19 mRNA vaccination.’
Young males were up to seven times more likely to report heart inflammation, known as myocarditis, than young women
Neither the CDC nor the FDA immediately responded to DailyMail.com’s request for comment.
It’s unclear which Canadian data the agencies are reviewing that indicate a higher risk of myocarditis and pericarditis from the Moderna vaccine.
The Public Health Agency of Canada states on it website that, as of August 6, there have been 423 cases reported – of which 223 have been after the Pfizer vaccine and 184 after the Moderna vaccine.
Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the lining around the heart.
These types of heart inflammation can be caused by a variety of infections, including a bout of COVID-19, as well as certain medications.
According to the CDC website, there have been more than 1,000 preliminary reports of myocarditis or pericarditis in young people under age 30 since April 2021.
It’s unclear how many of those patients were hospitalized, including in intensive care units, and how many have since recovered.
Data from a CDC June presentation suggest men are seven time more likely to report heart inflammation after receiving a second dose than women.
As of June 11, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.
What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.
At a meeting on June 23, an advisory group for the CDC said there is a ‘likely link’ between cases of heart inflammation in adolescents and young adults and COVID-19 vaccines.
However, the committee said that the risk of myocarditis is greater from the virus itself and strongly urged young Americans to get vaccinated.
Public Health Canada issued a similar warning on June 30 and updated the labels pf the Pfizer and Moderna vaccines to describe the rare reports.
Source link : https://www.dailymail.co.uk/health/article-9912485/Modernas-Covid-vaccine-maybe-linked-higher-risk-heart-inflammation-Pfizer-shot.html
