The panel that advises the Centers for Disease Control and Prevention (CDC) on vaccines will meet to discuss how to handle the newly approved Moderna COVID-19 vaccine.
The formal name of the panel is the Advisory Committee on Immunization Practices (ACIP).
No details were immediately available as to the timing of the meeting.
After Pfizer’s COVID-19 vaccine was approved in August 2021, ACIP convened and heard from officials from Pfizer and the CDC concerning the safety and effectiveness of the jab.
The panel ultimately decided to change an interim recommendation for all Americans 16 and older to get the vaccine to a standard recommendation.
An FDA official is typically present at ACIP meetings to answer questions from panel members.
An analysis showed Moderna’s vaccine was effective against both infection and severe disease, the FDA said Jan. 31.
One of the primary serious side effects of the vaccine is heart inflammation, most often manifesting as myocarditis or pericarditis.
ACIP panel members will hear from government and Moderna scientists concerning safety data.
During past meetings, multiple members have expressed concern about post-vaccination heart inflammation.
The FDA said it conducted a safety analysis of Spikevax that included clinical trial data and surveillance data from after Moderna’s vaccine was authorized in December 2021.
That data “demonstrate increased risks particularly within seven days following the second dose, with the observed risk highest in males 18 through 24 years of age,” the agency said. While the data suggest many individuals have experienced resolution of their symptoms, some required intensive care and no information is yet available regarding potential long-term outcomes.
FDA workers also conducted an independent benefit-risk assessment using modeling and determined that the benefits from vaccination, including the prevention of hospitalizations, “outweigh the risk of myocarditis and pericarditis.”
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said that people considering getting Moderna’s vaccine should be aware of the surveillance data.
Symptoms of myocarditis and pericarditis include chest pain, shortness of breath, and feelings of having a fast-beating, fluttering, or pounding heart. People who experience the symptoms should seek medical care, especially if it’s within a week of getting a COVID-19 vaccine, according to the CDC and the FDA.