Pfizer has reportedly developed its first RSV vaccine related to the RSV infection in over two decades. In March, the FDA reportedly designated Pfizer’s RSV vaccine a breakthrough therapy as well.

Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told CNN “The [study data monitoring committee] recommended, based on the data that we have, that we should go ahead and file, that this offers the potential for a safe and effective vaccine that could really dramatically help to prevent RSV during the winter season.”

Dr. Gruber added “That puts us in a very good position to essentially have something well in advance of next winter. Both Pfizer and the FDA are conscious of the ongoing heavy RSV season in the US. It will be up to them whether or not they can think of any other path that could allow this to come sooner.”

Responding reported risks from the vaccine, Dr. Guber told CNN “The vaccine is very tolerable, and no safety signals were identified, though the full results of the trial have not been published.”

“We know that children that have RSV end up having compromised lung status, and they become more susceptible, in many instances, to other respiratory infections that puts them back in the hospital. So we’re very interested in determining does this not only have a specific effect as the vaccine was intended to have against protection against RSV, but it may have a side benefit of allowing these children to fare better over the longer term,” he told CNN.