A healthcare worker stops during the coronavirus pandemic (COVID-19) in New York on Jan.
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Modern has found no link between its Covid-19 vaccine and rare heart inflammation cases reported in young people who received the vaccination, the company said on Friday.
The Massachusetts-based biotech said it reached the conclusion after “carefully reviewing the safety data previously available for the Moderna COVID-19 vaccine for cases of myocarditis and / or pericarditis”.
“The company will continue to monitor these reports closely and is actively working with public health and regulators to further evaluate this issue,” said a statement.
A spokesman for the Centers for Disease Control and Prevention did not immediately respond to a request for comment.
A CDC advisory panel is holding an emergency meeting on June 18 to resolve rare but unexpectedly high levels Reports of inflammation of the heart in 16 to 24 year olds after receiving the second dose of Pfizer‘s or Moderna’s Covid-19 vaccines.
A CDC official said Thursday that by May 31, the agency had received reports of 275 cases of myocarditis or pericarditis in this age group, up from the 10 to 102 expected cases. The condition includes inflammation of the heart muscle or the lining around it.
“We clearly have an imbalance,” said Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office on Thursday at a meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products. The group met to discuss safety issues related to the use of Covid-19 Vaccinations for children from 6 months.
The CDC’s vaccine safety group said last month it is studying heart infections in “relatively few” people who have received Covid vaccinations. Officials say they still don’t know if the condition is really related to the vaccines.
Some of the reported cases could be something other than myocarditis or pericarditis upon further investigation, Shimabukuro said Thursday.
Men make up the majority of reported cases and most cases appear to be mild, officials say. Of the 270 people who developed the disease and were discharged, 81% made a full recovery, according to a CDC presentation at Thursday’s meeting. By May 31, 15 people had been hospitalized, three of them in intensive care, the agency said.
Although no link has been found between the vaccines and the disease, health experts say side effects occur rarely once a vaccine or drug is administered to the general population. The US has distributed millions of Covid vaccines which have helped contain new cases and hospital stays across the country.