Moderna seeks U.S. authorization for COVID-19 vaccine booster By Reuters

By Michael Erman and Manojna Maddipatla

(Reuters) – Moderna (NASDAQ:) Inc on Wednesday asked the U.S. Food and Drug Administration (FDA) to allow the use of a third booster dose of its COVID-19 vaccine.

The FDA is considering booster shots of the Pfizer (NYSE:) and BioNTech vaccine, but so far has only allowed people with weakened immune systems to receive third doses of either the Moderna or Pfizer shots.

The agency said on Wednesday that a group of its advisers will meet to discuss Pfizer’s booster shot application on Sept. 17, but it is not clear whether they will discuss Moderna’s.

Moderna said it submitted initial data for the use of a 50-microgram booster dose of its two-shot vaccine. The original Moderna vaccine contains 100 micrograms of mRNA in each shot.

Recipients of the 50-microgram dose had robust antibody responses against the Delta variant, Moderna Chief Executive Stéphane Bancel said in a statement.

The company also said the third dose of its vaccine generated a better immune response than observed after the second dose in its Phase III clinical trial.

The company said it expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days.

Several countries are already offering or have plans to give booster doses to older citizens or people with weak immune systems as infections and hospitalization soar due to the highly contagious Delta variant of the virus and evidence of waning antibody levels in vaccinated people after six months.