Myocarditis, an inflammation in the heart muscle, is typically caused by viral infections. In rare instances, myocarditis can also occur after COVID-19 vaccination. During the global COVID-19 vaccination campaign, the mRNA vaccines have been linked to rare cases of post-vaccine myocarditis that are usually mild and resolve; these have occurred primarily in young males. On the other hand, COVID-19 itself carries a much higher risk of heart complications, including myocarditis. Moreover, the COVID-19 vaccines decrease the risk of COVID-19-related myocarditis, meaning that COVID-19 vaccination continues to be recommended to young persons.
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Pfizer’s document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. Adverse events are health problems that occur after vaccination but aren’t necessarily caused by the vaccine. Therefore, these reports don’t establish a causal relationship between the events and the vaccine. These reports alone thus are insufficient to demonstrate that the Pfizer-BioNTech COVID-19 vaccine caused any new side effects or is unsafe.
The highly contagious Omicron variant has led to record numbers of COVID-19 cases worldwide. Although COVID-19 vaccines are much less effective at preventing infection by this variant compared to previous ones, they remain effective against severe illness and death. Current data indicates that a booster dose enhances this protection. Safety data shows that the benefits of COVID-19 vaccines far outweigh their known and potential risks.
Data from clinical trials as well as post-marketing surveillance, conducted in millions of people, demonstrate that the COVID-19 vaccines have an excellent safety profile and are highly effective at keeping people out of hospitals and dying from COVID-19.
While pregnant women were first excluded from clinical trials for COVID-19 vaccines, observational data from many countries now show that COVID-19 vaccines don’t affect pregnancy outcomes. Pregnancy places someone at a higher risk of getting severe COVID-19, and the infection increases the risk of pregnancy complications, including perinatal death. Therefore, COVID-19 vaccination offers benefits to pregnant women.
Although cases of myocarditis have been reported following mRNA vaccination against COVID-19, the cases are rare, usually mild and patients rapidly recover. In contrast, COVID-19 is associated with a higher rate of myocarditis with potential risks of clinical complications. Overall, based on all scientific evidence available, the benefits of vaccines largely outweigh their risks.
To date, more than 241 million people in the U.S. have received at least one dose of COVID-19 vaccine. Clinical trials as well as the safety monitoring of COVID-19 vaccination campaigns provide overwhelming evidence that the vaccines’ benefits far outweigh their risks. There’s no evidence indicating that the amount of spike protein generated by mRNA vaccination is dangerous. The use of multiple doses of COVID-19 vaccines isn’t unusual or unprecedented; some childhood vaccines that have been used for decades also require four or more doses for complete immunization.
Both SARS-CoV-2 infection and COVID-19 vaccines induce the body to produce antibodies against the spike protein carried by the virus. In addition, the body may also produce antibodies against other antibodies—a certain group of such antibodies are called anti-idiotypic antibodies. Such antibodies could potentially bind to antibodies against the spike protein. However, it is still unknown whether anti-idiotypic antibodies that bind to antibodies against the spike protein are actually produced in the body, and if so, whether they have any consequences on health.
The American Academy of Pediatricians recommends that children get vaccinated against COVID-19 if they’re eligible. While children do face a lower risk of illness, hospitalization, and death from COVID-19 compared to adults, overall these risks still exceed the risks posed by the COVID-19 vaccine. The scientific evidence indicates that it is safer for children to get vaccinated than to get COVID-19.
Although children are less likely to become ill and die from COVID-19, they are still susceptible to the virus and some die from the infection. Among children, the mortality rate of COVID-19 is estimated to range from around one per 10,000 to one per 30,000 children infected. Individuals who are vaccinated against COVID-19 aren’t more likely to die compared to unvaccinated individuals. The benefits of the COVID-19 vaccines outweigh their risks.