The FDA has authorized two booster shots for approval under the manufacturing license of Moderna Therapeutics Inc.
The agency said it approved the shots, which are intended to restore production of therapeutic proteins similar to the human digestive tract and immune system.
The decision paves the way for the booster shots to be used in any adults with chronic cancer who were previously treated with a live immunotherapy drug made by an immune system checkpoint inhibitor.
Moderna is developing a kind of universal immune system booster, called an mRNA booster, that targets signaling proteins.
“By developing an effective mRNA booster system that is compatible with a broad range of immunotherapy drugs, we hope to develop the best possible response in patients,” said Dr. Steven Rubin, chief medical officer of Moderna Therapeutics, in a statement.
The booster will first be used as part of the oncology cancer regimen for the adult cancer patients. The longer-term use of the booster will be tested after a patient recovers.
To date, the company has enrolled about 4,000 patients in its clinical trials, which aim to validate the protein products produced by its technology.