FDA Approves Moderna’s New COVID Vaccine With Restricted Use

The FDA has approved Moderna’s new COVID-19 shot, an mRNA vaccine, with some limits on who can get it. 

The vaccine, called mNexspike, is for people who’ve previously received a COVID-19 shot and is mainly intended for adults ages 65 and older. People ages 12 to 64 may also get the shot if they have at least one medical condition that increases their risk for serious illness from COVID as defined by the CDC.

COVID is caused by SARS-CoV-2 virus, which spreads from person to person and infects the airways. While some people may only have mild symptoms, older adults, or those with certain underlying health conditions such as heart disease, diabetes, obesity, cancer, or COPD, among other conditions, are at a higher risk for severe illness. Overall, COVID remains a serious health risk that caused over 47,000 deaths in the United States last year alone. Getting vaccinated is still one of the best ways to lower this risk, especially for those who are more likely to get seriously sick.

Moderna said the FDA approved mNexspike based on results of a large study involving about 11,400 people ages 12 and older that showed it worked equally well and sometimes better than Spikevax, the original Moderna vaccine. The new shot showed about 9.3% better protection than Spikevax in people 12 and older and 13.5% better results in adults 65 and older. 

The mNexspike vaccine contains special genetic material (mRNA) that teaches the body to recognize parts of a key protein that helps the virus infect human cells. The new vaccine is based on the Omicron JN.1 COVID variant and helps your immune system make antibodies to protect you.

Common side effects include pain, redness, or swelling from the injection, painfully swollen lymph nodes in the same arm, tiredness, headache, muscle or joint pain, chills, nausea, vomiting, and fever.