Earlier this month, we reported on leaked data from a Canadian study which arrived at a disturbing conclusion: the risk of rare side effects like myocarditis and pericarditis - types of heart inflammation that are potentially deadly in some patients - was at least 2.5x higher in the Moderna jab than in its main competitor, produced by Pfizer-BioNTech.
The leaking of the data to the press was an embarrassment for the FDA and CDC, and so they pledged to investigate. Now, less than two weeks later, the FDA has just announced that it has updated its "fact sheet" to reflect the higher risk of heart inflammation in male patients under the age of 40.
For all patients, the "post-marketing" data examined by the FDA show that the risk of experiencing these side effects is highest within 7 days of receiving the second dose.
Only Pfizer has received full approval from the FDA; the Moderna jab is still technically under the emergency authorization. Whether this will delay or in any way impact the FDA's approval of the Moderna jab remains unclear.
Here's the full updated text:
Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis
Questions about the link between the mRNA jabs and heart inflammation have been circulating since these side effects were first uncovered in a group of American soldiers reporting acute chest pain after their vaccinations.
The news is weighing on Moderna's share price, which has fallen substantially since its Aug. 9 peak. It was down more than 3% on Monday afternoon.
After seeing the breaking news headlines on Twitter, seized the opportunity to joke about the Moderna jab.
Wow, I guess I can get a 'I'm a Moderna survivor' sticker now!!! pic.twitter.com/7LU8xuSMRj— Aronofsky1978 (@aronofsky1978) August 30, 2021
Readers can find the complete revised fact sheet below: