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Federal health officials are investigating the new data, according to two people familiar with the review who emphasized the side effect is still rare, the Washington Post reported.
Vaccination is still by far the healthier option, since the U.S. Centers for Disease Control and Prevention's vaccine advisers have already said that getting COVID-19 puts someone at much greater risk of heart inflammation and other serious medical problems than getting the vaccine does.
But officials from the U.S. Food and Drug Administration and the CDC are honing in on data from Canada that suggests the Moderna vaccine may carry a higher risk of this rare condition for young people compared to the Pfizer vaccine, particularly for males under 30. They are also analyzing U.S. data to determine whether the same is happening in the United States, the Post reported.
The Canadian data suggests there might be a 2.5 times higher incidence of myocarditis in those who get the Moderna shot compared with the Pfizer vaccine, the Post reported. Myocarditis is an inflammation of the heart.
One of the people familiar with the investigation emphasized that the agencies must do more research before deciding whether to issue any new or revised warning for the Moderna vaccine. In June, the FDA added a warning label for the Pfizer and Moderna shots about an increased risk of myocarditis.
"We have not come to a conclusion on this," the person told the Post. "The data are not slam bang."
Moderna did not respond to a request for comment.
In a statement, the CDC said its "Advisory Committee on Immunization Practices has and continues to review reports of myocarditis and pericarditis following COVID-19 mRNA vaccination. CDC, FDA, and our vaccine safety partners are actively monitoring these reports, including reviewing data and medical records, to learn more and understand any relationship to COVID-19 mRNA vaccination."
Officials want to be careful not to cause alarm, especially when they are trying to persuade more people to be vaccinated amid a surge of cases fueled by the fast-moving Delta variant, the newspaper added.
In late June, health officials first said there is a "likely association" between the Moderna and Pfizer vaccines and a raised risk of the rare heart condition in teens and young adults. However, heart issues are far more likely if a person develops COVID-19, so vaccination remains the healthier option.
The CDC and the U.S. Department of Health and Human Services, together with 15 of the country's leading medical and public health organizations — including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association and the American Nurses Association — issued a joint statement after that June meeting saying that they "strongly encourage everyone 12 and older" to get the shots because the benefits far outweigh potential harms.
Biden Puts Pressure on Nursing Homes to Vaccinate Staff Against COVID
"If you visit, live or work in a nursing home, you should not be at a high risk for contracting COVID from unvaccinated employees," Biden said during a speech made from the White House. "While I'm mindful that my authority at the federal government is limited, I'm going to continue to look for ways to keep people safe and increase vaccination rates."
The new mandate, which will come in the form of a regulation to be issued by the U.S. Centers for Medicare & Medicaid Services (CMS), could happen next month, the Associated Press reported.
The move comes as the highly infectious Delta variant now accounts for 99% of coronavirus cases in the United States and fresh data points to a link between low vaccination rates in some nursing homes and case spikes among residents, CNN reported.
Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living, praised the move, but asked for more.
"Vaccination mandates for healthcare personnel should be applied to all healthcare settings," he said in a statement. "Without this, nursing homes face a disastrous workforce challenge."
"Focusing only on nursing homes will cause vaccine-hesitant workers to flee to other healthcare providers and leave many centers without adequate staff to care for residents. It will make an already difficult workforce shortage even worse," Parkinson noted.
Why the tough federal stance on nursing homes?
Even though nursing homes have borne the brunt of the pandemic, particularly in its early stages, hundreds of thousands of nursing home workers are still not vaccinated, according to federal data.
About 1.3 million people are employed by the more than 15,000 nursing homes that participate in Medicare and Medicaid. Some 62% of those workers are vaccinated nationwide, CMS data shows, but the figure ranges from 44% to 88%, depending on the state, CNN reported.
After months of urging Americans to get shots, using incentives and giveaways in some instances, the Biden administration has been turning to stronger measures to get millions of Americans vaccinated.
In the past three weeks, Biden has said millions of federal workers must prove they have been vaccinated or face onerous requirements and restrictions, while a vaccine mandate for the military could come as soon as next month.
The new effort seems to be paying off, as the rate of new vaccinations has nearly doubled over the past month, the AP reported. Nearly 200 million Americans have now received at least one dose of the vaccines, according to the White House, but about 80 million Americans remain eligible but not yet vaccinated.
Last year, the CMS used similar regulatory authority to prohibit most visitors from nursing homes, to protect residents.
SOURCES: Washington Post; Associated Press; CNN
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