Jul. 8—In June, the U.S. Food and Drug Administration appended a warning to fact sheets for two federally-approved coronavirus vaccines: they came with an rare risk of heart inflammation.
As of the second week of June, some 1,200 recipients of the Pfizer and Moderna coronavirus vaccines had reported cases of myocarditis or pericarditis to the U.S. Vaccine Adverse Event Reporting System.
As of Tuesday, more than 182 million people in the U.S. had received at least one dose of a coronavirus vaccine.
Nevertheless, Jonathan Yaari, a pediatric cardiologist at Cobb-based Wellstar Health System, said his message to patients — the same message repeated, over and over, by American public health officials — remains the same.
Yaari said the risk posed by the coronavirus, even to children — in whom severe COVID-19 is rare —outweighs any risk posed by the vaccines.
With the caveat that he was speaking as an expert in pediatric cardiology, Yaari said the general view among his peers in the field "is that this vaccine is safe, this vaccine has minimal side effects, at least from a cardiac standpoint, and, when it does cause inflammation of the heart, it doesn't even compare to the inflammation that we saw with the actual virus itself.
"When you look at the benefits versus the risk, it is our opinion that the benefits outweigh those risks to pediatric patients," he continued. "Therefore, we agree with the recommendation, in general, that patients should get the vaccine. Again, it's something that everyone needs to talk to their pediatrician and their (healthcare) providers (about) to make sure that it's okay for them to get it."
More than 4,000 children infected by the coronavirus have been diagnosed with multisystem inflammatory syndrome in children. In an email, Yaari described the syndrome as "an inflammatory process secondary to the COVID-19 virus, which has severe cardiac involvement, including heart muscle inflammation and dysfunction, dangerous heart rhythms, and in some cases, results in death."
The coronavirus vaccine made by Pfizer-BioNTech has been approved for people 12 years and older.
About 1 million people are being vaccinated against the coronavirus per day in the U.S. as of early July, down from the 3 million per day who were being vaccinated in the spring. Yaari said he welcomed the FDA's warning despite the slowing vaccination campaign and deep skepticism of the vaccines among some Americans.
"I think it's important to be open and honest with everyone in terms of the possible side effects of the vaccine," he said. "And I think the FDA did a good job, actually, of coming out with that and saying, 'Hey, you know there is a warning that's here about possibly getting inflammation of the heart, but everything we know about it is that is very mild.'"
In April, use of the Johnson & Johnson coronavirus vaccine, which is designed differently than the Pfizer and Moderna vaccines, was paused for two weeks after reports of an extremely rare blood clotting issue. Use of the Johnson & Johnson vaccine eventually resumed with a warning added to the vaccine's fact sheet.
Yaari said the heart inflammation issue may have taken longer to identify due to the fact that the condition is far more common than blood clotting and that there are a wide range of possible culprits in any case of heart inflammation.
"In terms of what's causing it with COVID-19 and (with) the inflammatory response that we're seeing with the vaccine, as opposed to the infection itself ... We think it's similar to certain other diseases, where the body is mounting an inflammatory response to the virus, and here, to the vaccine," he said.
Wellstar doctors have seen the issue up close.
"There have been patients who've come into the Wellstar urgent care (centers) and Wellstar emergency rooms, who have had some inflammation, which may be linked to the second dose of the vaccine," he said. "In our clinics themselves, we've had patients who've come, very rare, because of chest pain, but we have not had any confirmed cases that we were able to link to the vaccine."
Symptoms of heart inflammation include consistent chest pain, palpitations and shortness of breath.
For parents who are unsure whether they want to vaccinate their children, Yaari said he's been able to ease their concerns by sharing some basic numbers with them: 33 million people have been infected and 600,000 have died in the country. Of those who've died, more than 2,700 have been 29 years or younger.
"And the fact that there's been so few cases of this inflammation of the heart, the fact that it's been so mild and the treatment has been so minimal, I think for the most part, after having that conversation with the parents, you know, they seem to think that it's worthwhile," he said. "Whether or not they are actually going to get the vaccine, I have absolutely no idea. There's no way to track that."