FDA To Add Heart Warning To Pfizer, Moderna Vaccines

On Wednesday, the US Food and Drug Administration (FDA)  said Wednesday it plans to add a heart warning on Pfizer and Moderna vaccine fact sheets. The agency said that these coronavirus vaccines required a heart warning as they can cause rare cases of heart inflammation in adolescents and young adults. 

RELATED: FDA OKs Pfizer-BioNTech COVID-19 Vaccine for Teens

Heart Warning

Meanwhile, the US Centers for Disease Control and Prevention (CDC) advisory groups met to discuss reported cases of heart inflammations. Initial reports pointed to vaccines as the underlying cause of heart inflammation in adolescents and young adults are likely linked to the vaccines.

However, the CDC clarified that patients with heart inflammation following vaccination generally recover from the symptoms and do well. In addition, the CDC insisted that despite the setback, the benefits of COVID-19 protection outweigh the risk. As a result of the disclosures, Moderna shares closed down 4.2%, while Pfizer fell 1.4%.

Now, health regulators are investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology can present a risk. If the results confirm the risks, they want to know how serious they are. 

Currently, the US Department of Health and Human Services (HHS) issued a statement underscoring that vaccines remain safe and effective. They also clarified that the heart side effect remains extremely rare. “We strongly encourage everyone aged 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated,” it added.

Watch Out For Myocarditis Or Pericarditis

In addition, the CDC warned doctors and hospitals to watch out for incidences of myocarditis or pericarditis. They hoped that the FDA’s heart warning could further raise awareness of the side effects.

Right now, the bigger urgency is the growing number of coronavirus Delta strain cases. The Delta strain reportedly transmits faster and produces a more serious effect among younger people. 

Currently, the rate of Americans getting their first dose of the COVID-19 vaccine is around 85% since peaking in mid-April. President Joe Biden’s target of 70% by July 4th will not likely make it. 

Heart Warning Statement Warranted

Fink, deputy director of the agency's vaccines division, said the FDA expects to move quickly to add the warning after the meeting concludes. “Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted,” he said. 

Cases of heart inflammation appeared higher in males during the week after the second vaccine dose. The CDC identified 309 cases of hospitalizations from heart inflammation in persons under the age of 30.

Out of the 309, 295 already recovered and left the hospital. Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said that the occurrences appear at a rate of 12.6 cases per million.

This covers 12 to 39-year-olds in the three weeks after the second dose. “We're observing this in the younger age groups, mainly in people in the teens and early 20s, and observing it more in males, compared to females. This effect largely kind of disappears once you get into these older age groups – individuals 50 and over,” Shimabukuro said.

No Causal Relationship Yet

Meanwhile, the CDC said it was still assessing the risk from the condition. It has yet to confirm a causal relationship between the vaccines and the heart issue. However, the incidences were enough to warrant issuing a heart warning. It did admit that the heart inflammation cases are much higher than expected. 

Data from the US Vaccine Adverse Event Reporting System (VAERS) recorded 347 observed cases of heart inflammation in the week after the second vaccine dose in males aged 12 to 24. In contrast, estimates place the side effect at 12 or fewer cases for the same group. 

Pfizer And Modern Working To Assess The Issue

Pfizer, who already won authorization for use in teens as young as 12, said it didn’t find a higher rate of heart inflammation than expected.

Meanwhile, Modern admitted that they are aware of reports on the side effects following the mRNA vaccine shots. They are currently working with public health officials to assess the issue. Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.

Watch the TODAY video reporting on COVID-19 vaccines linked to heart issue in teens and young adults:

 Loading ...

Do you agree with imposing heart warning statements on the two vaccines? Does this inspire you to take a first or second dose (for those who haven’t yet), or does this reinforce your stand not to take a vaccine?

Let us know what you think. Share your comments below.