First RSV Vaccine In The World, FDA Advisors Urge Two Shots

Credit: Guido Hofmann/Unsplash

Two RSV vaccinations, one from Pfizer and the other from GSK, have been recommended for elderly patients by an FDA advisory group, as reported by NBC.

Approving vaccine

Last week, advisors to the Food and Drug Administration suggested that the organisation approve two RSV vaccines for older patients, one from Pfizer and one from GSK.

Even though the FDA often adopts the recommendations of the advisory group, the next step is for the agency to approve each vaccine, which might take several months. Before the shots are made accessible to the general public following FDA approval, the Centers for Disease Control and Prevention must endorse them. If all of that occurs, the shots would be the first RSV vaccinations to be licenced in the United States.

Reducing risk 

The FDA advisors delivered their suggestions over the course of two days in different meetings. The Independent Vaccines and Related Biological Products Advisory Committee recommended Pfizer’s vaccine on Tuesday by a 7–4 majority, with one member abstaining. According to Pfizer, the single-dose shot has been demonstrated to reduce the risk of respiratory syncytial virus disease by as much as 86% in persons 60 and older.

The committee’s 12 voting members then unanimously endorsed GSK’s vaccine for the same age range on Wednesday based on its effectiveness. According to trial results recently published in the New England Journal of Medicine, the shot significantly reduced the likelihood of symptomatic illness and severe disease in adults 60 and older by 83% and 94%, respectively. RSV can induce lower respiratory disease, albeit most healthy persons only have minor symptoms. But, in severe cases, RSV can result in pneumonia or bronchiolitis, which irritates the airways and causes them to become mucus-filled.

Infants and older persons are more at risk for such results. Every year in the United States, RSV claims the lives of over 10,000 persons 65 and over and about 300 kids under the age of 5. Last winter saw a sharp increase in newborn cases that overflowed children’s hospitals and served as a reminder of the virus’s danger.

Trail participants 

Pfizer’s injection appeared to cause some advisory committee members more significant concern than GSK’s. A few of the specialists voiced concern that not enough trial participants from Pfizer contracted RSV to fully evaluate the effectiveness of the shot.

Regarding safety, some advisors were concerned about a possible link between the Pfizer vaccine and Guillain-Barré syndrome. This rare neurological condition affects nerve cells and results in muscle weakness or paralysis. Following vaccination, one of the men in Pfizer’s experiment experienced the onset of Guillain-Barré syndrome (GBS), and a woman experienced Miller-Fisher syndrome, a rare nerve condition associated with GBS.

“It was a 1 in 9,000 risk of GBS, which is concerning,” said Dr Hana El Sahly, the FDA advisory committee chair.

After the vaccine is approved, the FDA has requested that Pfizer do another research to assess the likelihood of developing Guillain-Barré syndrome.

The FDA also discovered one Guillain-Barre case in the GSK experiment that may have been caused by the vaccine, as well as a greater rate of atrial fibrillation (an abnormal heartbeat) among vaccine recipients compared to the control group.


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Source: NBC


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