A health worker holds a vial of Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York City, January 29, 2021.
Mike Ségar | Reuters
Moderna has not found a link between its Covid-19 vaccine and the rare cases of heart inflammation reported in young people who have received the vaccine, the company said on Friday.
The Massachusetts-based biotech company said it came to this conclusion after “carefully reviewing the safety data available to date for the Moderna COVID-19 vaccine for cases of myocarditis and / or pericarditis.”
“The company will continue to closely monitor these reports and is actively working with public health and regulatory authorities to further assess this issue,” he said in a statement.
A spokesperson for the Centers for Disease Control and Prevention did not immediately respond to a request for comment.
A CDC advisory group is holding an emergency meeting on June 18 to discuss rare, but higher than expected, reports of heart inflammation in 16-24 year olds after receiving their second dose of Covid-19 vaccines from Pfizer or by Moderna.
A CDC official said Thursday the agency had received reports of 275 cases of myocarditis or pericarditis in that age group as of May 31, higher than the 10 to 102 expected cases. The condition involves inflammation of the heart muscle or the lining that surrounds it.
“We clearly have an imbalance there,” Dr. Tom Shimabukuro of the CDC’s Office of Immunization Safety said at a meeting of the FDA’s Vaccines and Related Biologics Advisory Committee on Thursday. The group met to discuss the safety concerns surrounding the use of Covid-19 vaccines in children as young as 6 months old.
The CDC’s vaccine safety group said last month it was examining conditions of heart inflammation in “relatively few” people who have received Covid vaccines. Officials say they still don’t know if the disease is really linked to vaccines.
Some of the reported cases could be something other than myocarditis or pericarditis after further investigation, Shimabukuro said Thursday.
Men make up the majority of reported cases and most cases appear to be mild, officials said. Of the 270 people who developed the disease and were released, 81% made a full recovery, according to a CDC presentation at the meeting Thursday. As of May 31, 15 people were hospitalized, including three in intensive care, the agency said.
Although no link has been found between vaccines and the disease, health experts say it is common to find rare side effects once a vaccine or drug is given to the general population. The United States has distributed millions of Covid vaccines, which have been helpful in reducing new cases and hospitalizations across the country.