On Thursday, U.S. health officials and authorities raised their concern over a risk of heart inflammation after the administration of the Covid vaccine.
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The health officials keep track of the side effects of the vaccine by a surveillance system and integration of the various surveillance systems showed that the people who were vaccinated with Moderna and Pfizer-BioNTech showed higher than expected cases of myocarditis or even another condition called Pericarditis- inflammation of the tissue around the heart. It was noted that this affected the men more than the women after their second Almost 80% of cases were in men and the symptoms occurred within a week of vaccination. In general, Myocarditis is usually prevalent in men. Another sub-data obtained from the surveillance also showed that this side effect affected the young adults in borderline.
These concerns were raised last month by the reports of CDC when they obtained a signal from U.S. Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). The CDC urged the providers to ask patients of any prior heart inflammation condition before administration of the vaccine to prevent any bad outcomes,
FDA’s vaccines advisory committee also echoed these concerns. Their data showed that the mRNA vaccines had the potential to increase the risk of myocarditis. The potential connection was also raised by the Defence Department officials and Israeli health officials who announced officially “a possible link between the second vaccine dose and the onset of myocarditis among young men aged 16 to 30.”
However, the Centers for Disease Control and Prevention and the Food and Drug Administration have however been a little cautioned due to the lack of concrete evidence to link vaccines to the condition. This is because the surveillance systems that record these side effects have various limitations. One such is that since the new vaccine has been used only recently, it needs more data to collaborate the effects of the vaccine. Also, until recently only people above 18 years of age were vaccinated. Only recently, have the vaccinations been given to teens from 12 to 18 years. Hence, age-specific data are yet to emerge. The health officials believe that the risk of contracting Covid-19 still outweighs the risk of the side effects. Keeping in mind the risk-benefit ratio that is the deciding factor for the continuation of any medication, health officials agree that vaccinations are not be stopped.
The CDC has called for an emergency meeting to be held on June 18 to discuss the link.
Many independent advisors of the US FDA have also scheduled a meeting on Thursday to discuss how the regulators should approach their emergency use approval given to the companies for the use of their vaccine in children as the recent data could potentially affect the children.
Dr. Tom Shimabukuro, a CDC vaccine safety official, reported that the overall cases of myocarditis and pericarditis were 573 after their second dose and 216 after their first dose. It was reported in both the mRNA vaccine.
But these cases were reported in people from a data of around 130 million Americans. Most of them have recovered with 41 people recovering well, 15 hospitalized, and 3 in intensive care.
Shimabukuro was cautious to outright link the two. He said that the data presented might not have true cases of myocarditis or pericarditis and more research may be needed but it was consistent.