Here We Go: FDA Advisers Recommend World’s First RSV Vaccine from Pfizer

 

On Tuesday, the Food and Drug Administration’s advisory committee voted in favor of approving the world’s first respiratory syncytial virus (RSV) vaccine for adults 60 and up from Pfizer.

Respiratory syncytial virus, also called human respiratory syncytial virus and human orthopneumovirus, is a common, contagious virus that causes infections of the respiratory tract. It is a negative-sense, single-stranded RNA virus.

In a close decision, the FDA’s independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 7 to 4 on safety and 7 to 4 on effectiveness with one member abstaining.

Several of the specialists who did not vote in favor on the basis of the vaccine’s efficacy were concerned that there were not enough people infected with respiratory syncytial virus (RSV) during the trial to properly evaluate the shot, NBC News reported.

Specialists who voted against the vaccine based on its safety profile were concerned that it might increase the risk of Guillain-Barré syndrome (GBS), a rare neurological disease that can kill nerve cells and lead to muscle weakness or paralysis.

“It was a 1 in 9,000 risk of GBS, which is concerning,” said Dr. Hana El Sahly, the FDA advisory committee chair, who voted against the shot based on its safety profile but in favor based on efficacy.

The VRBPAC claimed that the available data is “adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. ”

“The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older,” Pfizer said in its news release.

“In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the outcome of today’s VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market. We look forward to working with the FDA as it completes the review of our application.”

The FDA will now decide whether or not to approve the vaccine. This process could take months, even though the FDA typically accepts the recommendations of its advisory group. A general rollout of the vaccine is based upon a strong recommendation from the Centers for Disease Control and Prevention (CDC) following FDA approval.

FDA decision expected by PDUFA goal date in May 2023.

The RSV vaccine market for adults will be worth up to $10 billion by 2032, according to Fortune.

The outlet added, “Pfizer is also facing off with collaborators Sanofi and AstraZeneca Plc to develop prevention for dangerous RSV infections in newborns, a market that could reach $1.5 billion, according to projections by Bloomberg Intelligence.”

The Gateway Pundit reported that Pfizer is developing a new vaccine given specifically to pregnant women that will immunize an unborn baby while still in the womb. Pfizer claimed that their infants will be protected against the respiratory syncytial virus (RSV) after birth.

“MATISSE is an ongoing randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy,” Pfizer said.

In the Pfizer study, 7,400 pregnant women were randomly assigned to receive a single dosage of RSVpreF or a placebo during the late second to the third trimester of their pregnancy.