FDA experts recommend RSV vaccines for adults 60 and over. What's next?
A Food and Drug Administration advisory panel said Wednesday an RSV vaccine under the agency's review is safe and effective for older adults, the second of two new vaccines targeted at adults age 60 and older to prevent severe disease.
The vaccines from Pfizer and GlaxoSmithKline still need final say from the FDA commissioner and recommendations by an advisory panel at the Centers for Disease Control and Prevention, which will require another sign-off from the CDC director. If that happens, the vaccines will likely become available by the next RSV season.
The FDA has also granted priority review to Pfizer's maternal vaccine to help protect against severe RSV in infants from birth through the first six months of life. The agency set an action date for August, according to a Pfizer release.
Respiratory syncytial virus infects nearly everyone by age 2 and typically causes cold symptoms. It’s the leading cause of hospitalizations among newborns and younger children, causing between 58,000 and 80,000 hospitalizations per year among those under 5, the CDC reports.
RSV also strikes at the other end of life, causing more than 177,000 hospitalizations and 14,000 deaths among older adults every year. Health experts say RSV cases among older adults are considered re-infections since about 70% of kids contract the virus before their first birthday and 90% by their second.
Data published in February found GSK's clinical trial found its vaccine was more than 82% effective at preventing lower respiratory tract illness caused by RSV and over 94% effective against severe disease and adults with at least one comorbidity after nearly seven months.
Pfizer data found its vaccine was more than 85% effective at preventing RSV-associated lower respiratory tract illness.
RSV vaccines: Are they on the way for babies and adults? Here's what the CDC is saying about them.
Safety: Cases of Guillain-Barré syndrome
Some committee members argued there is not enough data to support the vaccines' safety, mainly due to concerns over cases of neurological disorders among participants who received either Pfizer or GSK's vaccine.
One case occurred in a 66-year-old women eight days after receiving the Pfizer vaccine who was hospitalized and diagnosed with Miller Fisher Syndrome, which resolved in about three months. Another case occurred in a 66-year-old man seven days after vaccination who was also hospitalized with Guillain-Barré syndrome.
GSK researchers also reported a few cases of neurological disorders post-vaccination, including one case of Guillain-Barré in a 78-year-old woman in Japan about nine days after receiving the shot.
Guillain-Barré syndrome, or GBS, is a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis, according to the CDC.
Dr. Alejandra Gurtman, Pfizer’s vice president of vaccine clinical research and development, told committee members Tuesday the company plans to continue safety monitoring after the product arrives to market.
About 70% of people who are diagnosed with GBS make a full recovery, according to the National Institute of Neurological Disorders and Stroke. Symptoms may persist for years, but experts say most people recover within a few months.
GBS symptoms range in a spectrum of severity from a tingling sensation in the hands and feet, to paralysis, health experts say.
Other symptoms include difficulty with eye muscles and vision, swallowing, speaking or chewing, according to NINDS. Patients may also experience coordination problems and unsteadiness, abnormal heart rate or blood pressure and problems with digestion or bladder control.
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This article originally appeared on USA TODAY: RSV vaccines for older adults recommended by expert FDA panel
