Moderna starts data submission for COVID-19 vaccine booster

Moderna on Wednesday said it has begun submitting data to the Food and Drug Administration (FDA) about a booster dose of its COVID-19 vaccine.

The data submitted is for the use of a booster dose of its authorized two-shot vaccine at the 50 microgram dose, the company said.

The company said neutralizing antibodies had waned “significantly” prior to boosting approximately six months after the second dose. 

After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in adults ages 65 and above, the company said. 

Moderna said it expects to submit data to the European Medicines Agency and other regulatory authorities around the world in the coming days.

The announcement comes after the U.S. authorized third doses of both Moderna’s and Pfizer’s COVID-19 vaccines for immunocompromised people last month. 

More than 1 million people have since received a third dose, according to the Centers for Disease Control and Prevention (CDC), though the agency does not say if the people were immunocompromised.   

Booster doses for the general public have not been authorized, and the CDC and FDA are still reviewing the evidence. A representative from Pfizer said studies on the need for boosters are ongoing, and initial data might not be available until late September or early October.

President Biden said the U.S. plans to widely distribute COVID-19 booster shots the week of Sept. 20, pending clearance from FDA and CDC scientists.

But it’s not clear the agencies will follow that plan. 

COVID-19 vaccines continue to maintain high protection against severe disease, hospitalization and death. While some studies have found some waning of effectiveness against infection, scientists on CDC’s vaccine advisory panel this week said the evidence is not clear enough to justify a booster recommendation.