- A CDC panel is holding a meeting to discuss rare, but higher-than-expected, reports of heart inflammation in young people after receiving their second Covid vaccine dose.
- The public meeting is scheduled to run from 11 a.m. ET to 4 p.m. ET, according to a draft of the agenda.
A key Centers for Disease Control and Prevention advisory panel is holding a meeting Wednesday to discuss rare, but higher-than-expected, reports of heart inflammation in 16- to 24-year-olds after receiving their second dose of Pfizer's or Moderna's Covid-19 vaccines.
The CDC's Advisory Committee on Immunization Practices meeting comes about two weeks after the agency said it had seen a higher-than-projected number of cases of myocarditis or pericarditis in 16- to-24-year-olds after their second Covid shot. Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the membrane surrounding the heart.
The meeting was originally slated for June 18, but was rescheduled to account for the observance of the Juneteenth National Independence Day holiday.
There have been nearly 800 reported cases of heart problems to the vaccine safety monitor system, according to the U.S. agency.
The CDC said two-thirds of the cases were in young males, with a median age of 30. Symptoms, which include chest pain and shortness of breath, typically develop within a few days of receiving the shot, the CDC said. Some of the reported cases may not be verified or even related to the shots, though the number of cases is still concerning, Dr. Tom Shimabukuro of the CDC's Immunization Safety Office said earlier this month.
"We clearly have an imbalance there," Shimabukuro said on June 10 at a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee. The FDA advisory group met to discuss safety issues surrounding the use of Covid vaccines in children as young as 6 months old.
Here's what you need to know.
The public meeting is scheduled to run from 11 a.m. ET to 4 p.m. ET, according to a draft of the agenda.
During the meeting, U.S. officials will provide an update on the safety data on the messenger RNA vaccines, including any potential additional cases of heart inflammation. They are also expected to discuss whether the benefits outweigh the risks for use in adolescents and young adults and discuss potential recommendations for additional doses of Covid vaccines.
A vote on a recommendation was not listed on the draft agenda.
Federal officials still don't know whether the condition is being caused by the vaccines.
The CDC's vaccine safety group is looking into the heart inflammation conditions reported. It is coordinating its investigation with the Food and Drug Administration, which last month authorized the Pfizer-BioNTech vaccine for adolescents ages 12 to 15.
Moderna, whose vaccine is currently authorized for people age 18 and up, said on June 11 it had not found a link between its Covid-19 vaccine and the cases of a rare heart inflammation condition reported in young adults. The company said it is actively working with public health and regulatory authorities to further assess this issue.
In a statement, Pfizer said it is aware of the reported cases and supports the CDC's request for "careful assessment of suspected myocarditis and pericarditis cases."
"All adverse events are regularly and thoroughly reviewed by Pfizer as well as by CDC. It is important to understand that a careful assessment of the reports is ongoing and it has not been concluded that the mRNA COVID-19 vaccines cause myocarditis or pericarditis," it said.
The CDC said people should be on the lookout for chest pain, shortness of breath or a pounding heart.
Men make up the majority of the reported cases and most of the cases appear to be mild, CDC officials say. Of the 270 people who have developed the condition and have been discharged, 81% of them have fully recovered, according to a CDC presentation at a meeting earlier this month. As of May 31, 15 people were hospitalized, with three in intensive care, the agency said.
It's possible additional cases haven't been recorded, former FDA chief Dr. Scott Gottlieb told CNBC on June 11, but "we are probably capturing most of the severe cases." He added, "When you look at the number of people who are having severe cases of pericarditis, it's very small numbers right now."
The CDC and most health experts say yes.
Though no link has been found between the vaccines and the condition, health experts say finding rare side effects once a vaccine or drug is administered to the general population is common. The U.S. has distributed millions of Covid vaccines, which have been helpful in driving down new cases and hospitalizations across the country.
"CDC continues to recommend COVID-19 vaccination for everyone 12 years of age and older, given the risk of COVID-19 illness and related, possibly severe complications, such as long-term health problems, hospitalization, and even death," the agency said on its website.