It’s not exactly an “oh, sheets” moment.
On June 25, the United States Food and Drug Administration (FDA) announced that its Moderna and Pfizer / BioNTech Covid-19 vaccine fact sheets now include information on “myocarditis” and “pericarditis”. Adding such words to the sheets was not much of a surprise. After all, two days earlier, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) had found a “probable association” between vaccines and rare cases of myocarditis and pericarditis in young people. , according to Jemima McEvoy writing for Forbes. So now the FDA fact sheets indicate that both mRNA vaccines may lead to “increased risk of myocarditis and pericarditis, especially after the second dose.”
It’s important to remember that myocarditis and pericarditis after Covid-19 vaccines are still like barely cooked steak: very rare. As I wrote on June 13 for ForbesSo far, there have been fewer than 300 confirmed cases of myocarditis or pericarditis among more than 150 million fully vaccinated people in the United States. photo accompanying the following tweet:
Ok maybe The sun is not the best source of cow statistics. And of course cow deaths are complicated and depend heavily on what you’ve done to the cow and whether the cow has any nunchucks. Either way, the point is that 300 out of 150 million or 0.0002% doesn’t seem like a high risk.
Also, having myocarditis or pericarditis is not necessarily as bad as being killed by a cow. Your “myocardium” is your heart muscle, because “myo” means muscle and “cardium” means heart. Your “pericardium” is the membranous sac that surrounds your heart because “pericardium” means around. Adding an “ite” at the end of everything means inflammation. So, myocarditis is an inflammation of the heart muscles. Pericarditis means you have an inflamed sac, which is the sac around your heart.
Inflammation, of course, is rarely a good thing. Usually, you don’t expect any part of your body to get inflamed, because “today would be much better if my butt was inflamed”. However, to date, most of these rare cases of heart inflammation after Covid-19 vaccination have not been severe. “Most often there is sharp chest pain for several days and then the symptoms quickly subside,” said Timothy Wong, MD, MS, assistant professor of medicine at the University of Pittsburgh Medical Center (UPMC) and director of the UPMC Heart and Cardiovascular Magnetic Resonance Center of the Vascular Institute. “Some patients were prescribed anti-inflammatory drugs, some just used over-the-counter drugs, and some didn’t use any medicine to recover. ”
Wong also pointed out that in the cases he has seen, “Even though there is inflammation, the heart function is still okay. Measurements of the heart’s ability to pump blood as well as the ejection fraction were within normal ranges.
In addition to chest pain, other possible symptoms of myocarditis or pericarditis include shortness of breath or unusual heart rhythms. “If you have such symptoms after receiving the Covid-19 vaccine, let your doctor know,” Wong advised. “It may not be the result of the vaccine and other things can happen”, so it is important to “be self-aware” and have your doctor assess your situation.
Currently, FDA warnings only cover Pfizer / BioNTech and Moderna Covid-19 mRNA vaccines. This does not necessarily mean that such concerns are unique to mRNA vaccines. Wong pointed out that in comparison, “there were relatively fewer doses of the Johnson & Johnson vaccine given.”
Keep in mind that “probable association” does not yet mean that a cause and effect relationship has been established. For example, if you were more likely to feel bloated after watching the TV show keeping up with the Kardashians, there could be a probable association between the two. That still wouldn’t mean that the TV show is causing the bloating. Maybe this is the cheese wheel you always eat while watching the show. Likewise, researchers will have to dig even deeper to determine if other factors are at play. These rare conditions seem to occur more frequently in adolescent men and in their early twenties. Wong stressed that it is “difficult to determine the mechanism” until more studies are done and any speculation on the mechanism would still be just speculation. “The common causes of myocarditis and pericarditis are viral,” Wong explained. “Could there be some type of immune reaction to the vaccine that then reacts with the tissues of the heart? “
All of this shouldn’t deter you from getting the Covid-19 vaccine, even if you’re a teenager, according to Wong. “Covid-19 myocarditis is much more common and feared than Covid-19 vaccine myocarditis. He stressed that all of his family members who are currently eligible have already been vaccinated and that his toddler will be the first in line to receive him when possible.
In fact, on Wednesday after ACIP’s announcement, the American Academy of Pediatrics (AAP) released a statement co-signed by Alphabet Soup from major health organizations. The list included organizations such as the US Department of Health and Human Services (HHS), CDC, American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American Heart Association, American Public Health Association (APHA), Infectious Diseases Society of America (IDSA) and National Association of County and City Health Officials (NACCHO). The statement included the following sentences: “The facts are clear: this is an extremely rare side effect, and only an extremely small number of people will suffer from it after vaccination. It is important to note that for young people who do, most cases are mild and individuals often recover on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you contract COVID-19, and the risks to the heart from COVID-19 infection may be more serious. The statement concluded by saying, “We recommend that you get the vaccine immediately if you haven’t already. It’s the best way to protect yourself, your loved ones, your community, and get back to a more normal way of life quickly and safely. “
In the following Hello america segment, Rochelle Walensky, MD, CDC director, highlighted how the benefits of continuing to vaccinate 12 to 17 year olds far outweigh the risks of heart inflammation:
Walensky explained that “if we have a group of children aged 12 to 17 that we are working to immunize over the next four months and we can immunize 1 million of them, that would be great progress over the course of over the next four months, we might expect 30 to 40 of these mild, self-limited cases of myocarditis. And for that, if we had to vaccinate every 1 million, we would avoid 8,000 cases of Covid, 200 hospitalizations, 50 stays in intensive care and one death. “
So basically don’t view these changes in the FDA fact sheets as a “bad luck leaf” situation. Myocarditis and pericarditis are still very rare possibilities after the Covid-19 vaccination. The chances of getting such conditions from Covid-19 are even much higher if you go unvaccinated. The FDA and CDC must show that they take all possible side effects of vaccines very seriously, no matter how rare they are. It’s always best to be proactive and keep these factsheets up to date before the “factsheets hit the fans” so to speak.