Florida Surgeon General Joseph Ladapo caused a furor this month when he advised men ages 18 to 39 not to get the vaccine because it was linked to deaths in young men. The eight-page analysis was not peer reviewed and lacked transparency and flawed statistics.
There is a rare but worrisome cardiac side effect. Older boys and young men who received the shots were more likely to suffer from myocarditis. Only a small number of people in those age groups are affected. Some deaths have been linked to vaccine myocarditis. Several new studies show that the heart muscle can take months to heal, and some scientists are concerned about what this means for patients. Pfizer and Moderna have been ordered by the FDA to conduct a number of studies.
Now that a new wave of boosters are hitting the scene, scientists and doctors are not sure if knowledge gaps should affect vaccine recommendations. The case for boosters is more complex than the case for the first two vaccine doses would suggest. Their benefits are unknown for the age group at highest risk of myocarditis, who are at lower risk of severe COVID-19 and other problems.
Jane Newburger is a doctor at Boston Children's Hospital who has cared for and studied postvaccine myocarditis patients. Michael Portman is a cardiovascular doctor at Seattle Children's Hospital and he wouldn't recommend boosters to healthy teens. Portman wants more clarity on the risk-benefit ratio.
The risk of myocarditis or pericarditis was reported by a team from Kaiser Permanente Northern California and the U.S. Centers for Disease Control and Prevention. It was less than one in 8000 after the second dose and less than one in 6000 after the first booster in 16 and 17 year olds. Men under the age of 30 have a higher risk.
The vaccine-driven myocarditis is thought to be caused by an immune reaction. A study from Germany published in The New England Journal of Medicine suggested it may be caused by an inflammatory response to the vaccine. Patients with vaccine-caused myocarditis and patients with severe COVID-19 were found to have certain antibodies. Children who developed a rare, dangerous condition called multi system inflammatory syndrome after a bout of COVID-19 had the same antibodies turn up. A cardiac pathologist at the University of Tbingen believes it is another mechanism. The cause of myocarditis is not clear.
Postvaccine myocarditis patients are usually hospitalized for a short period of time. 22 patients have been tracked at Newburger's hospital and she is reassured by their healing. Portman agrees that many of these kids are not sick after leaving the hospital.
Although their heart rhythm is normal and they usually feel fine, an injury to the muscle is what he sees in the youngsters during follow-up appointments. In June of this year, Portman and his colleagues reported in The Journal of Pediatrics that 11 of 16 patients with myocarditis had dilated cardiomyopathy four months after their hospitalization. More than half of the patients who had follow-up cardiac scans after 3 months had some kind of abnormality.
Is there much to worry about when it comes to scarring in vaccines? This doesn't seem to correlate to adverse clinical outcomes right now. About 200 people across Canada have been tracked in a registry study. Hunter Wilson is a doctor at Children's Healthcare of Atlanta who supports boosters for young people. A study comparing outcomes from myocarditis caused by vaccines is available as a preprint and under journal review.
Pfizer and Moderna are required by the FDA to conduct myocarditis studies. The study, which Portman is involved in, aims to start recruiting up to 500 patients later this fall and is co-leads by Newburger. There is a shadow version of myocarditis called subclinical myocarditis in which individuals are symptom-free.
Subclinical myocarditis is more common than we think. Christian Mller, director of the Cardiovascular Research Institute at University Hospital, collected blood samples from almost 800 hospital workers three days after they received a COVID-19 booster. None of them met the criteria for myocarditis and 40 had high levels of troponin. Mller believes that the vaccine caused troponin levels to rise in 22 of the 18 cases. He presented the findings at a meeting in August and they were in line with a study from Thailand.
troponin levels fell to normal in both studies. If we lose 1000, 2000 heart muscle cells, that doesn't concern Mller. He is worried about the cumulative effect of boosters. If we consider this a recurrent phenomenon, I am very worried.
The question is whether the benefits of a booster outweigh the risks. Young people are less likely to be hospitalized for COVID-19 than older people. A study of 1600 college athletes found that 2.5% had clinical or subclinical myocarditis after a bout of COVID-19. Long Covid is one of the effects of infections. Studies show that vaccinations reduce the risk of Long Covid by up to 80%. The vaccine is worth it because of that.
Mller doesn't have any plans to get his daughters a booster for the vaccine. Paul Offit, an infectious disease specialist at the Children's Hospital of Philadelphia, doesn't think adolescents need a booster dose if the goal is to stave off severe illness.
The new bivalent boosters are recommended for older adults and vulnerable younger people in some countries. In the United States, the CDC now recommends that anyone over the age of 5 get boosted.
The currents of the Pandemic are complicating the risk-benefit analysis. Omicron seems a lot milder than its predecessors, according to Newburger. According to the Centers for Disease Control and Prevention, at least 86% of children in the United States have been exposed to the disease. Newburger says that there is less vaccine myocarditis this year. The trend may alleviate concerns about the side effect. Everything is in motion.
Walid Gellad, a physician who studies drug safety at the University of Pittsburgh, says that the uncertainty is frustrating but that it leads to learning.
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