Farxiga side effects: Common, rare, and serious
What Is Myocarditis? What To Know About Heart Risk Warning Related To COVID-19 Vaccines
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RFK Jr. Influence Evident As Vaccine Chief Overrules Scientists, Limits COVID-19 Vaccine Approval
Dr. Vinay Prasad, the U.S. Food and Drug Administration's (FDA) top vaccine official, overruled agency scientists to limit approval of two COVID-19 vaccines, despite internal recommendations to clear them for broader use.
The decision reflects a growing pattern of vaccine restrictions under the leadership of the U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. NVAX and Moderna Inc. MRNA for individuals aged 12 and older, citing favorable risk-benefit analyses.
Also Read: Novavax's Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial
However, citing federal documents released Wednesday, ABC News reported that Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted the balance of risks and benefits.
In a five-page memo, Prasad wrote that "even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits," highlighting the need for more cautious vaccine policy.
The vaccines were eventually approved in May, but under the narrower eligibility criteria dictated by Prasad.
Novavax's shot, Nuvaxovid, is the only protein-based COVID vaccine available in the U.S., while Moderna's mNexspike is a lower-dose, updated version of its original mRNA-based vaccine.
Prasad also cited the risk of myocarditis, a rare heart inflammation, especially in younger people, as a key reason for restricting Moderna's shot.
He directed the company to conduct further studies as a condition for approval. The FDA also added updated warning labels for Moderna and Pfizer Inc.'s PFE vaccines regarding myocarditis, though external researchers say such cases are typically mild and resolve quickly.
Top FDA leaders rarely intervene in the product review, making Prasad's decision notable. He was appointed in May after Dr. Peter Marks resigned over policy disagreements with Kennedy.
In May, Kennedy, in a video posted to the social media platform X, announced that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the U.S. Centers for Disease Control and Prevention's immunization schedule.
Price Action: At the last check on Thursday, Moderna (MRNA) stock saw an increase of 1.34%, trading at $30.69, while Novavax (NVAX) stock rose by 0.67% to $6.81. Pfizer (PFE) stock was also up at the last check.
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COVID Vaccine And Myocarditis - WebMD
A rare side effect of the COVID-19 vaccines that has been report is a type of inflammation in the heart muscle called myocarditis.
Myocarditis is a condition in which your heart muscle, called the myocardium, becomes inflamed. It affects your heart's electrical signal and may cause a rapid or abnormal heart rhythm (arrhythmia). It can also affect your heart's ability to pump blood and circulate oxygen.
It usually results from a viral infection or a drug reaction. It can happen to anyone, including adults, children, and infants. In fact, it's more likely to affect people under 30 who are otherwise healthy. It affects men twice as often as women.
Myocarditis can range from mild to severe. It also affects children differently.
In mild cases, symptoms can include:
In severe cases, you might notice:
Other symptoms can be part of a viral infection that causes your myocarditis, such as a headache, body aches, joint pain, fever, a sore throat, or diarrhea.
Myocarditis symptoms in children include:
If you notice any of these symptoms, call 911.
Yes, but experts aren't sure what the link is. Most of these cases occurred:
Most people who got it quickly recovered after getting treatment and some rest. Experts are monitoring the side effects but need more research to know for sure what the causes and long-term effects might be.
Yes. The CDC recommends that people 12 and older get any of the available COVID-19 vaccines. The benefits of the vaccine against the SARS-CoV-2 virus that causes COVID-19 far outweighs the risks.
The vaccine can protect you from severe complications, such as long-term health problems, hospitalization, and even death. Getting vaccinated is the best available option to protect yourself and your family from the virus and its variants.
If you have concerns about getting the COVID-19 vaccine, talk to your doctor.
Research released in August 2024 reports that COVID-19 infection can cause myocarditis and that this myocarditis is more likely to cause long-term heart complications than myocarditis which was caused by the vaccine.
Early diagnosis is key for proper treatment, full recovery, and to prevent long-term heart problems. Your doctor may do a physical exam and ask about your medical history. They may also do lab and imaging tests to confirm how severe the condition is. These can include:
Usually, myocarditis improves on its own and you recover completely. In rare cases, you may need treatments like corticosteroids. Antiviral drugs are available, but research shows they aren't all that effective. If severe myocarditis causes heart problems, your doctor will treat them.
If you've had myocarditis, it's best to avoid intense physical activities like sports for at least 3-6 months. Talk to your doctor before getting back to fitness routines or sports.
After you get the COVID-19 vaccine, be on the lookout for side effects for up to a week after each dose. Tell your doctor as soon as possible if you have sharp chest pain, a pounding heartbeat, or any heart flutters.
If you notice myocarditis symptoms or signs of an allergic reaction like hives, swelling, or wheezing after getting the vaccine, get medical help right away.
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