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).
“ACIP will meet (as they did when they recommended the Pfizer vaccine after approval),” a CDC spokesman told The Epoch Times in an email shortly after the Food and Drug Administration (FDA) approved Moderna’s shot.
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.
Use of the vaccine “is recommended based on increased certainty that its benefits (prevention of asymptomatic infection, COVID-19, and associated hospitalization and death) outweigh vaccine-associated risks,” panel members concluded.
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.
The data analyzed came before Omicron, a variant of the CCP (Chinese Communist Party) virus, emerged in the United States. The CCP virus causes COVID-19. Omicron is now the dominant variant in the country.
One of the primary serious side effects of the vaccine is heart inflammation, most often manifesting as myocarditis or pericarditis.
Young people, especially young men, are at elevated risk of developing heart inflammation after getting the Moderna and Pfizer shots, with some studies pegging the risk as higher than from COVID-19 itself.
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.”
An FDA spokesperson, asked whether the totality of the benefits were weighed against the totality of the risks, not just heart inflammation, pointed to an FDA document (pdf) designed to be inserted into packages of Spikevax that does not appear to answer the question.
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.
“Inflammation of the heart is not a trivial health problem and, clearly, the benefits may not outweigh the risks for everyone who receives mRNA COVID-19 vaccines like Spikevax,” she told The Epoch Times in an email, pointing to information from the National Institutes of Health.
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.
