FDA Finalizes Guidance on Heart Risks Linked to COVID-19 Vaccines
When it comes to staying healthy during the COVID-19 pandemic, vaccines have been one of the most important tools we’ve had. But with any medical treatment, there can be risks.
Recently, the U.S. Food and Drug Administration (FDA) finalized new warnings about possible heart-related side effects from the COVID-19 vaccines made by Pfizer and Moderna. These warnings aren’t completely new, but they now include clearer information about the chances of developing myocarditis or pericarditis - conditions that cause inflammation in or around the heart, which could sometimes lead to long-term heart problems.
The updated warnings apply to the Comirnaty vaccine by Pfizer and the Spikevax vaccine by Moderna. Both companies have included some details about these risks since 2021, but the FDA decided that the labeling needed to be more specific, especially for younger men, who seem to be more at risk.
The new labeling states that, based on data from health insurance claims, the estimated unadjusted rate of myocarditis or pericarditis within a week after getting the 2023-2024 mRNA COVID-19 vaccines is about 8 cases per million doses for people aged 6 months to 64 years.
But for males aged 12 to 24 years, the rate jumps to roughly 27 cases per million doses. This higher rate for young men has been one of the main reasons for the FDA’s push to update the vaccine labels.
The FDA found lingering heart issues in some post-vaccine myocarditis cases and will keep monitoring.
To give a better sense of what happens to patients who develop these heart issues, the FDA referenced a study tracking people diagnosed with myocarditis after their vaccinations. Most of the patients in the study had received two vaccine doses before they developed symptoms.
The study followed these patients for around five months after their shots. During this time, many of them still showed abnormal results on cardiac MRI scans, signs of ongoing heart injury.
However, it’s not yet clear what these lingering findings mean for a person’s long-term health, and experts still don’t know if they could lead to future heart problems. Despite these concerns, the FDA emphasized that it will continue to keep an eye on vaccine safety.
In a safety communication released on June 25, the agency stated,
“Continuous monitoring and assessment of the safety of all vaccines, including the mRNA COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines.”
commons.wikimediaAs part of the approval agreements for Comirnaty and Spikevax, the FDA is requiring both Pfizer and Moderna to run studies to see if people who got myocarditis after vaccination face long-term heart effects. These studies are already underway, but it could take some time before results are available.
For people who haven’t heard of myocarditis, it’s a condition that causes inflammation of the heart muscle, which can lead to chest pain, shortness of breath, or irregular heartbeats. Pericarditis involves inflammation of the lining around the heart and can cause similar symptoms.
While these conditions can be serious, they are rare side effects when it comes to vaccines. That rarity has led most health experts to agree that the benefits of COVID-19 vaccination far outweigh the small risk of these complications.
Despite experts saying COVID-19 vaccines are safe, some argue any risk is too much for young, healthy people.
Still, these risks have fueled debates. Many major medical groups, like the American College of Cardiology and the American Heart Association, have repeatedly said that COVID-19 vaccines are safe and important for preventing severe illness.
They’ve stood by their recommendations for people to get vaccinated. But some people believe that any risk, no matter how small, is too much, especially for young, otherwise healthy people who might be less likely to get very sick from COVID-19.
commons.wikimediaThese new warnings don’t change the fact that vaccines have saved millions of lives during the pandemic. However, they do make sure that everyone has a clearer picture of possible side effects so they can make informed choices.
As the FDA continues to collect and analyze data, it promises to keep the public updated. In the end, whether someone chooses to get vaccinated or not is a personal decision.
But knowing the facts, including both the benefits and the risks, can help people talk with their doctors and decide what’s right for them. The updated warnings are another step in making sure everyone has the information they need.
