Moderna Receives FDA Fast-Track Approval for RSV Vaccine

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Moderna Receives FDA Fast-Track Approval for RSV Vaccine


Moderna Receives FDA Fast-Track Approval for RSV Vaccine

Flying under the radar in the shadow of COVID, the respiratory syncytial virus (RSV) has been staging a pandemic of its own, of sorts, in 2021, and now Moderna has announced that the FDA is approving a fast track for its RSV vaccine.

RSV can be spread through the air when someone coughs or sneezes. It also can contaminate solid surfaces. It causes bronchial conditions and pneumonia, particularly in infants and older adults.

The virus normally circulates in fall and winter, but the CDC issued a health advisory in June, saying that it appeared to be circulating out of season, and that health care providers should test for RSV in sick patients if they tested negative for SARS-CoV-2.

With the fast-track designation, Moderna said in a press release that its RSV vaccine is an mRNA (messenger RNA) technology that is still in Phase 1 trials. Moderna previously had received the fast-track designation for its COVID vaccine. They are targeting young children and older adults for the RSV vaccine, they said. This vaccine’s name is mRNA-3927.

“The Company also intends to evaluate the potential of combinations of mRNA-3927 with its vaccines against other respiratory pathogens in children and separately in older adults,” the company said.

“With our investments in science and manufacturing, we have taken eleven infectious disease vaccines into human clinical trials. We have accelerated research and development of our infectious disease therapeutic area and we will continue to advance our mRNA vaccines into new areas of high unmet need.”

 

SOURCES:

Moderna August 3, 2021

CDC Health Advisory June 10, 2021

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