The Federal Drug Administration on Wednesday announced that it plans to add an advisory to the COVID vaccines.
For parents weary of the pandemic battle, 2021 offers another vexing question: Is the vaccine safe enough for their children?
"There’s always risk in any medical procedure. But I felt the risk of not getting the vaccine was higher than the risk of getting the vaccine," said parent Jennifer Soboleski of San Jose.
In the spring she gave the green light for her 14-year-old son Justin to get the double dose. He hasn’t had any side effects.
The COVID-19 Vaccine Safety Technical Work Group, which presented during the Advisory Committee on Immunization Practices meeting Wednesday, said the "data available to date suggest likely association of myocarditis with mRNA vaccination in adolescents and young adults."
The group noted myocarditis most often appeared after the second dose, which was similar to data reported through VAERS.
Several experts sounded off during the public comment portion of the meeting.
"There have been several severe adverse events after receiving COVID injections," said one woman. "Review the risks of these vaccinations for all ages," chimed in another.
The medical issue involves myocarditis and pericarditis --inflammation of the muscles around the heart, and the heart. The Centers for Disease Control and Prevention says 323 cases of heart inflammation have been verified in people who received the Pfizer or Moderna COVID-19 vaccine. No deaths have been associated with this side effect.
"About a month ago, there was concern with an increased number of cases being seen in young adults that were receiving the mRNA vaccines at that time," said Dr. Theodore Ruel, a pediatric infectious diseases specialist at the University of California, San Francisco.
He said experts are studying cases to see if there’s a direct link between the vaccine and illness.
"One of the big questions is, are we noticing something because we’re looking more closely? Or is this actually happening at an increased rate?," asked Ruel.
The Soboleski family is comfortable with their decision, even as new questions emerge.
"There were very few kids in this age range getting the heart inflammation," said Soboleski.
Late Wednesday, the FDA announced plans to add an advisory to the label for the vaccines, so that parents know at the time of injection the nature of the risks.