Moderna requests FDA okay for 4th Covid shot for adults

Bloomberg: Moderna Inc. has filed for U.S. Food and Drug Administration clearance of a second Covid-19 booster shot for all adults, covering significantly more people than Pfizer Inc. and BioNTech SE’s earlier request for emergency authorization for those over 65.

The application comes amid heated debate over how long vaccinations protect from infection and whether repeated shots are necessary to prevent severe disease and death. Several countries including Israel have started administering a fourth dose to adults, with data showing a fivefold increase in the production of infection-fighting antibodies.

Authorization of another dose for all adults would allow the U.S. Centers for Disease Control and Prevention “flexibility” to decide what the appropriate use of a fourth shot would be, Moderna said in a statement. Widespread access would also let health-care providers determine on an individual basis who might benefit from a second booster shot.

The free-for-all in booster shot applications could set up for a messy and confusing debate over who needs another shot and why. Both Moderna and Pfizer are also testing an omicron-specific booster shot. Data for that may arrive within weeks or months, creating the possibility that the companies could seek regulatory clearance for an omicron-specific shot soon after the current fourth dose applications.

Moderna didn’t go into detail on what information was included in its application, other than to say that it was based partly on recent omicron data from the U.S. and Israel.

Pfizer filed for clearance of a second booster for seniors to protect the most vulnerable as immunity provided by the first three doses wanes. It also said it based its application on data from Israel, which found that giving a fourth dose to older adults at the height of the omicron wave helped prevent infections and severe cases.