The Centers for Disease Control and Prevention’s vaccine advisory committee plans to hold an emergency meeting this month to discuss the higher than expected reports of heart inflammation in young males following a second dose of the Pfizer and Moderna COVID-19 vaccines.
The June 18 meeting will address the conditions that are very infrequent and have not been directly linked to the vaccines, the agency announced on June 10.
The first portion of the meeting will feature an update on COVID-19 vaccine safety, including myocarditis cases seen after the administration of vaccines built on messenger RNA technology, according to the meeting agenda.
Myocarditis is a rare disorder that leads to heart inflammation. Causes include the flu and COVID-19.
Rates of myocarditis and a similar condition, pericarditis, for those between the ages of 16 and 24 after vaccination with two of the three COVID-19 vaccines authorized in the United States are higher than the expected rate, the Centers for Disease Control and Prevention (CDC) disclosed in a meeting earlier Thursday.
The CDC has so far identified 226 reports in people ages 30 and younger that might meet the agency’s “working case definition” of heart inflammation following the shots, Dr. Tom Shimabukuro, a deputy director at the agency, told the Food and Drug Administration’s vaccine advisory group during a virtual meeting. That was out of about 12.2 million who had received a vaccine as of May 31.
While the vast majority of the patients have recovered, 41 had ongoing symptoms, 15 are still hospitalized, and three are in intensive care units.
Shimabukuro told members that the CDC will continue to evaluate myocarditis following vaccination and assess the benefits and risks of the Pfizer and Moderna vaccines, which both use mRNA technology, ahead of the emergency meeting next week.
A CDC spokesperson told The Epoch Times via email that there will be more discussion about post-vaccination myocarditis at the meeting, the spokesperson added.
“Given the number of COVID-19 vaccine doses administered, these reports are rare. More than 18 million people between ages 12-24 have received at least one dose of COVID-19 vaccine in the United States. CDC continues to recommend COVID-19 vaccination for everyone 12 years and older,” the spokesperson said.
The agency has thus far declined to recommend a pause of vaccinating youth, despite advising such a pause after a smaller number of post-vaccination blood clotting cases appeared in April.
The CDC’s advisory group, formally known as the Advisory Committee on Immunization Practices, or ACIP, makes recommendations to the agency regarding vaccines. The recommendations are nonbinding but the CDC often takes the recommended action.
After the group recommended lifting the pause of the Johnson & Johnson vaccine following the blood clots appearing in seven women after vaccination, the CDC lifted the pause.
Not all of the reports, which were submitted to the Vaccine Adverse Event Reporting System, will turn out to be accurate, Shimabukuro told Thursday’s meeting. But he added that the higher-than-expected rate the statistics indicate are consistent with surveillance data from Israel and the Pentagon.
Dr. Monica Gandhi, professor of medicine and associate chief at the University of California, San Francisco, told The Epoch Times in an email that the CDC could end up recommending only vaccinating children who have not recovered from COVID-19 because there is a link between COVID infection and myocarditis.
Other possibilities include giving a single dose of the Moderna or Pfizer shots to those under the age of 20, lowering the dosage amount, and extending the duration between doses one and two in young people, she added.
Members of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, which heard from Shimabukuro, expressed concern about the myocarditis data.
“Because we’ve all discussed at fair length the concern about myocarditis and other side effects, which seem to generally be worse after the second dose, I think we need some studies on single dose and whether that might be adequate going forward,” Dr. Mark Sawyer, professor of pediatrics at the University of California, San Diego, told colleagues during the meeting.
“I think the myocarditis is something that needs to be looked at closely because we’re likely seeing the tip of the iceberg,” added Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, which is part of the National Institutes of Health.
Pfizer said it supports the CDC’s assessment of the heart inflammation cases, noting that “the number of reports is small given the number of doses administered.”
“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,” the company told The Epoch Times in an email.
Moderna did not respond to a request for comment.
From The Epoch Times