July 11, 2025 — The FDA has given full approval to Moderna's COVID-19 shot, Spikevax, allowing it to be used in children 6 months to 11 years old, with some limits on who can get it.
First approved in 2022, Spikevax was allowed for this age group under Emergency Use Authorization, meaning children could get it only if a doctor thought it was needed. The vaccine is mainly for adults 65 and older, but people 6 months to 64 years old can also get it if they have certain health conditions that make them more likely to get seriously sick from COVID.
COVID is caused by the SARS-CoV-2 virus, which spreads quickly and infects the airways, causing cold and flu-like symptoms. Most children usually have mild illness, but those with conditions like obesity, diabetes, nerve issues, or heart or lung problems can get very sick, sometimes requiring hospital care or intensive treatment. Getting a vaccine is still one of the best ways to lower this risk.
The Spikevax vaccine contains special genetic material (mRNA) that teaches your body’s immune system to recognize a key virus protein, helping it to make antibodies to protect you. The shot is given by a health care provider into a muscle, usually in the upper arm for kids and adults and in the upper thigh for infants. Those who’ve never had the Moderna COVID-19 shot need two doses, one now and one a month later. Those who’ve taken one previous dose need one more after a month. Those who’ve taken two or more doses need just one more, at least two months after their last shot. Moderna plans to have its updated Spikevax vaccine ready in the U.S. for people who need it during the 2025-2026 cold and flu season, according to their news release.
The most common side effects of the Spikevax shot are pain where the needle went in the skin, tiredness, headache, muscle or joint pain, chills, fever, rash, swelling or tenderness in the armpit or groin, nausea, and vomiting. Babies and toddlers may be fussy, cry, feel sleepy, have stomach pain, or not want to eat. In rare cases, they may faint or have seizures from a high fever.
Some people, mostly males 12 to 24 years old, develop inflammation of the heart muscles (myocarditis) or the lining outside the heart (pericarditis) after taking mRNA COVID-19 vaccines, usually within a week of the shot. Seek medical help right away if you or your child has chest pain, trouble breathing, or a fast or pounding heartbeat within two weeks of getting the shot. Other symptoms in children can include fainting, fussiness, not eating well, tiredness, throwing up, stomach pain, or cold and pale skin.
Before getting the vaccine, tell your health care provider about any medical conditions that you or your child may have, including allergies, a history of a serious allergic reaction to any COVID vaccine, heart-related issues, fever, bleeding problems, or a weak immune system. Also tell your health care provider if you are taking blood thinners, have received another COVID vaccine, or are taking medications that affect your immune system. If you are pregnant or planning to get pregnant or are breastfeeding, discuss what’s best with your doctor.