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Reading: FDA asks Moderna, Pfizer to expand Covid vaccine risk label
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African News Herald > Blog > Health > FDA asks Moderna, Pfizer to expand Covid vaccine risk label
Health

FDA asks Moderna, Pfizer to expand Covid vaccine risk label

ANH Team
Last updated: May 22, 2025 10:13 pm
ANH Team
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The Food and Drug Administration (FDA) has recently requested Moderna and Pfizer/BioNTech to expand the age range on their labels to include boys and young men who are at risk for a rare side effect causing heart inflammation after receiving mRNA Covid-19 vaccines. This move comes amid growing scrutiny over the safety of Covid-19 vaccines and the potential risks associated with them.

According to reports, the FDA has urged both vaccine manufacturers to update their safety information based on new studies that have shown cases of myocarditis or pericarditis, or both, occurring after vaccination. These rare reactions have been observed most frequently in young men within a week after receiving the second dose in the two-dose Covid-19 vaccine series, as per the Centers for Disease Control and Prevention (CDC). The majority of cases reported were mild and resulted in only brief chest pain.

In 2021, safety information was added to the vaccine labels after a CDC advisory panel concluded that the benefits of protection against Covid-19 outweighed the risks of potential side effects. Currently, Moderna’s label warns of the risk in young men aged 18-24, while Pfizer includes young men aged 12-17. The FDA’s letters have requested the companies to expand the age range to include individuals aged 16-25 and reference a 2024 paper funded by the agency in their product information.

Myocarditis, which is inflammation of the heart muscle, and pericarditis, inflammation of the tissue surrounding the heart, are believed to be triggered by an immune response following vaccination. Myocarditis often causes fatigue and shortness of breath, while pericarditis can lead to chest pain.

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Studies have indicated that the risk of developing myocarditis after receiving the Pfizer or Moderna vaccines is relatively low. A study conducted in 2022 reported that the Pfizer vaccine led to an additional 22 myocarditis cases per million in 18-29-year-olds in the U.S., while Moderna had 31 additional cases per million.

It is important to note that the risk of developing myocarditis from the vaccines is significantly lower than the risk of developing the condition due to a Covid-19 infection. According to the CDC, the rate of myocarditis among Covid-19 patients is much higher than the rate associated with vaccination.

Health experts emphasize that the benefits of Covid-19 vaccination far outweigh the risks, especially considering the potentially severe consequences of contracting the virus. Vaccination remains a crucial tool in controlling the spread of Covid-19 and protecting public health.

In response to the FDA’s request, vaccine manufacturers are expected to update their labels to reflect the expanded age range for at-risk individuals. The ongoing monitoring and evaluation of vaccine safety will continue to be a priority as the global vaccination effort against Covid-19 progresses. The Importance of Proper Nutrition for Overall Health and Well-being

Nutrition plays a crucial role in maintaining overall health and well-being. It is essential to provide our bodies with the necessary nutrients it needs to function optimally and prevent the risk of developing various diseases and health conditions.

Proper nutrition involves consuming a well-balanced diet that includes a variety of foods from all the food groups. This includes fruits, vegetables, whole grains, lean proteins, and healthy fats. Each of these food groups provides essential nutrients such as vitamins, minerals, antioxidants, and fiber that are vital for the body to function properly.

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One of the key benefits of proper nutrition is that it helps to maintain a healthy weight. Eating a balanced diet that is rich in nutrients and low in unhealthy fats and sugars can help prevent obesity and other weight-related health issues. Maintaining a healthy weight is important for reducing the risk of developing chronic conditions such as heart disease, diabetes, and certain types of cancer.

Proper nutrition also plays a significant role in supporting the immune system. A diet that is rich in vitamins and minerals helps to strengthen the immune system and protect the body against infections and illnesses. Nutrients such as vitamin C, vitamin D, zinc, and antioxidants are particularly important for supporting immune function and reducing the risk of getting sick.

In addition to supporting physical health, proper nutrition is also essential for mental health and cognitive function. Research has shown that certain nutrients, such as omega-3 fatty acids found in fish, can help improve brain function and reduce the risk of cognitive decline as we age. A diet that is rich in fruits, vegetables, and whole grains has also been linked to a lower risk of developing depression and anxiety disorders.

Overall, proper nutrition is essential for maintaining overall health and well-being. It is important to eat a well-balanced diet that includes a variety of nutrient-dense foods to provide the body with the necessary nutrients it needs to function optimally. By prioritizing nutrition and making healthy food choices, we can support our physical and mental health and reduce the risk of developing chronic diseases. Remember, you are what you eat, so choose wisely and nourish your body with the nutrients it deserves.

See also  Researcher uncovers how dietary fat may fuel cancer growth: Q&A
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