During a panel on Tuesday, the Food and Drug Administration (FDA) said a respiratory syncytial virus (RSV) vaccine developed by Pfizer has been deemed “safe and effective” for older adults. The FDA made the announcement following a review of the vaccine’s impact on individuals aged 60 and older.
As previously reported in The Dallas Express, RSV has, at times, overwhelmed North Texas hospitals in recent months. In some instances, hospitals had to activate internal disaster protocols to source outside help.
The new vaccine still requires approval from the FDA commissioner. Additionally, a Centers for Disease Control and Prevention (CDC) advisory panel still needs to make its own decision on the vaccine, which, if recommended, would then need the approval of the CDC director.
Should these sign-offs occur, the vaccine could be available by the time the next RSV season begins.
A second RSV vaccine from GlaxoSmithKline is also being considered for use by older adults. Like the first, it will similarly need to obtain FDA and CDC approvals.
A third RSV vaccine developed by Pfizer for use by expectant mothers has also been granted priority review by the FDA. The vaccine, which is administered to pregnant women, is designed to help protect newborns against RSV from birth through the first half year of life.
According to Pfizer, the FDA has set an action date on the vaccine for August 2023.
For most people contracting RSV, the symptoms experienced are similar to the common cold. By age 2, most people have had the virus at least once. Still, for babies and the elderly, RSV poses a greater threat.
Every year, upwards of 80,000 children under five are hospitalized with the respiratory virus. The CDC said it remains the leading cause of hospitalization for young children and newborns.
For the elderly, RSV leads to over 177,000 hospitalization and 14,000 deaths each year.
Pfizer’s clinical trials state the vaccine was over 85% effective at stopping lower respiratory tract illness resulting from the virus. Still, four out of 12 members of the review committee deemed the data supporting the conclusions insufficient.
A third of the members also concluded that additional data is needed to verify the vaccine’s safety after two participants in the trial faced side effects.
One subject, a 66-year-old man, was hospitalized with Guillain-Barré syndrome (GBS) one week after receiving the shot. In extreme cases, GBS can lead to paralysis when the body’s immune system attacks healthy cells.
Another participant, a 66-year-old woman, was hospitalized eight days after receiving the vaccine. The woman was diagnosed with Miller Fisher syndrome, a variant of GBS. While symptoms can persist for years, roughly 7 out of 10 people diagnosed with GBS fully recover, according to the National Institute of Neurological Disorders and Stroke.
Pfizer said that if half of the people aged 60 and above obtain the RSV shot currently under approval, it would substantially reduce hospitalizations and prevent over 5,000 deaths annually, reported CNBC.
Scientists are still trying to determine what role obesity plays in making people more prone to catching infections like RSV as well as fighting them off.
According to a study in the journal Thorax, obesity may result in reduced antiviral interferon responses, meaning that one of the first lines of the body’s natural defense against invading pathogens is compromised as a result of the extra weight.
Researchers say that further studies are necessary to eliminate individuals with comorbidities.
