Regulatory FDA Advisory Committee Recommends Agency Approve Two RSV Shots

FDA Advisory Committee Recommends Agency Approve Two RSV Shots


Two RSV vaccinations targeted toward elders, one from Pfizer and one from GSK, have been recommended for approval by the Food and Drug Administration this week.

Although the FDA often accepts the advice of the advisory group, the approval process for each vaccination can take months to complete. The injections won’t be made accessible to the public until they’ve been recommended by the CDC, which happens only after FDA clearance. In that case, the vaccinations would be the first to be authorized in the U.S. to protect against the respiratory syncytial virus.

The FDA advisory panel held multiple meetings on successive days, during which they issued their recommendations. The Independent Vaccines and Related Biological Products Advisory Committee decided to approve Pfizer’s vaccine based on its effectiveness. Seven members voted for the vaccine, while four voted against it. One member was absent from the proceedings. Pfizer claims that the single-dose vaccine can cut the chance of contracting RSV by over 85% in those aged 60 and higher.

The next day, all 12 committee members agreed that GSK’s vaccination was the best option for the same age range. The chance of symptomatic disease was reduced by 83% and the risk of severe illness by nearly 95% in adults aged 60 and higher, according to trial findings.

The majority of healthy individuals will only have mild symptoms from RSV, which causes lower respiratory infections. It can cause mild symptoms such as a runny nose and cough, but in more severe instances, it can cause bronchiolitis, which causes airway inflammation and mucus buildup, or pneumonia.

The elderly and infants are especially at risk from RSV. Over 300 children under the age of 5 and over 10,000 persons aged 65 and older perish annually in the United States due to the virus. Last winter saw a substantial increase in cases among newborns, which led to an overload at children’s hospitals and served as a stark reminder of the danger posed by the virus.

Several members of the advisory panel were less confident in Pfizer’s vaccine than they were in GSK’s. The experts were concerned that not enough people were infected with RSV during Pfizer’s experiment to draw any firm conclusions about the shot’s effectiveness.

Several experts were worried about the safety of the Pfizer vaccine because it might be linked to Guillain-Barré syndrome (GBS). GBS is a rare neurological illness that can destroy nerve cells and cause paralysis or weakness in the muscles. After receiving the vaccination, one man in the Pfizer study acquired GBS, and one woman got Miller-Fisher syndrome (MFS), an uncommon neurological illness associated with GBS.

As such, the Food and Drug Administration has requested that Pfizer perform more research on the risk of GBS following the approval of its vaccine.

Meanwhile, the FDA found one occurrence of Guillain-Barre syndrome that may be linked to the vaccination in the study conducted by GSK, as well as a greater rate of atrial fibrillation (abnormal heartbeat pattern) in the vaccine cohort compared to the control group.

“There are some challenges, some possible safety signals, but I think the data warrant a vote of ‘yes,’” stated Dr. James Hildreth, one of the committee members.

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