10-07-2025
Moderna's COVID vaccine gets full US approval for at-risk children aged 6 months and older
US regulators have granted Moderna Inc. full approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years, but only for those at increased risk from the virus.
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The move marks a shift in federal policy under Health and Human Services Secretary Robert F. Kennedy Jr., who has led a controversial effort to scale back universal access to pediatric COVID shots.
The Food and Drug Administration's decision, announced Thursday, means that healthy children in this age group will no longer have routine access to the vaccine unless it is prescribed off-label. Moderna's shares rose more than 4% in early trading in New York following the announcement.
Under emergency use authorization during the pandemic, COVID-19 vaccines from Moderna and Pfizer were made widely available to all children. But Kennedy, a longtime vaccine skeptic, has reversed course. In 2021, he petitioned the FDA to revoke temporary approval for children's vaccines, citing low risk of severe illness in healthy children. Now, the vaccine's full approval ensures it remains available for high-risk kids, but also restricts broader access.
What are the risks of SPIKEVAX?
For most people, getting the SPIKEVAX COVID-19 vaccine is safe and simple. But like any vaccine, there are some rare risks you should know about.
There's a very small chance of having a serious allergic reaction, usually within a few minutes to an hour after the shot. That's why your doctor or nurse may ask you or your child to wait for a short time after getting vaccinated—just to be safe.
As per the official website of Moderna, signs of a serious allergic reaction may include:
Difficulty breathing
Swelling of the face or throat
A fast or racing heartbeat
A rash all over the body
Dizziness or weakness
In rare cases, some people—mostly boys and young men between 12 and 24 years old—have developed myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) after getting an mRNA COVID-19 vaccine like SPIKEVAX.
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If you or your child experiences any of the following symptoms within two weeks of the vaccine, it's important to see a doctor right away:
Chest pain
Shortness of breath
A fast, fluttering, or pounding heartbeat
In children, signs to watch for can include chest pain, shortness of breath, pounding heartbeat, fainting, being unusually tired or irritable, poor feeding, stomach pain, vomiting, or cool, pale skin.
What are the possible side effects of SPIKEVAX?
Common side effects around the injection site: pain or tenderness, redness, swelling or firmness, and swollen lymph nodes in the same arm or sometimes in the groin
General side effects: feeling tired or sleepy, headache, muscle or joint pain, chills or fever, nausea or vomiting, rash, irritability or crying (especially in young children) and loss of appetite.
In some cases, people have also reported fainting or febrile seizures (seizures caused by a fever). While these are less common, it's helpful to be aware of them.
