- An advisory panel has recommended that federal regulators approve the use of two RSV vaccines in older adults.
- The recommendation comes as officials express concerns about the increase in RSV cases in older adults.
- The panel is expected to vote on a recommendation for an RSV vaccine for children in the next few months.
Advisers to the Food and Drug Administration (FDA) have recommended the approval of two RSV vaccines for older adults.
The Independent Vaccines and Related Biological Products Advisory Committee this week voted 7-4 in favor of recommending a Pfizer RSV vaccine. They also voted unanimously to recommend approval of the GSK RSV vaccine.
“It’s a major step forward. RSV is the last of the big three respiratory viruses that annually create a great deal of illness, hospitalization, and even death. And although it is traditionally considered a ‘pediatric virus,’ it has become increasingly recognized over the last 15 years as also having a big impact on people at the other end of the age spectrum, those 65 and older and in particular, those who have underlying lung and heart disease,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Tennessee, told Healthline.
The vaccines still require approval by the FDA with a vote expected by May.
If the FDA approves the vaccines the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will then decide what recommendations need to be made about who should get the vaccine.
If approved, these two vaccines will be the first ones for RSV in the United States.
Data from Pfizer suggests its vaccine can reduce the risk of RSV illness of a person with more than three symptoms by
Data from GSK trials found their vaccine was
RSV, which stands for respiratory syncytial virus, is a highly contagious respiratory virus that usually causes cold-like symptoms.
It can be spread through coughing and sneezing as well as by touching a surface such as a doorknob that has the virus on it.
In most people, RSV will cause mild symptoms. However, in infants and older adults, RSV can be serious and even deadly.
Last winter, there was a
“We saw what happened this past winter in the U.S. with RSV where we have hospitals, pediatric hospitals primarily, which were really impacted by the large spike of RSV that occurred in November. There’s an increasing appreciation of the severity of RSV and older adults that it can result in doctor’s visits, hospitalization, and even death,” Dr. Dean Blumberg, the chief of pediatric infectious diseases at the University of California Davis, told Healthline.
“(The RSV vaccine) could potentially be a lifesaver for many older adults. So I think there is a potential beneficial impact,” he added.
Adults most at risk for severe infection include those ages 65 and older, those with chronic heart and lung disease, and those with a weakened immune system.
Older adults with RSV are more at risk of complications such as pneumonia and lung infections.
Some experts have raised safety concerns about the RSV vaccines.
Two of the participants in the Pfizer vaccine trial and one in the GSK trial developed Guillian-Barré syndrome. This is a rare condition in which the body’s own immune system attacks nerves.
“The two cases were concerning, because if they had one case, then that would have been a red flag. And then having two cases really does suggest that… there might be a true association, that it wasn’t just a random thing that occurred. So that’s the real concern,” Blumberg said.
Experts have also expressed concern that there weren’t enough people studied in vaccine trials who were over the age of 70.
“The studies don’t have too many people beyond age 70. So that was a little bit of a matter of concern. And in addition, some people voiced a concern that the studies were not large enough to actually show the prevention of hospitalization,” Schaffner said. “To several of us, that didn’t matter very much. If you prevent infection and serious lower respiratory tract disease, as has been shown, you will prevent hospitalization. So although we don’t have hard data on that, we anticipate that that benefit will be there.”
RSV can also be dangerous for young children and infants. An estimated 58,000 to 80,000 children younger than 5 are
A decision on RSV vaccines in children is also expected within a few months.
“The vaccines are being developed for children also and we hope to have vaccines for children around the same time, maybe as early as this fall, so we hope that that happens,” said Blumberg.
“The FDA is expected to review the pediatric data in a few months. And I think that’s going to be much more clear in terms of the benefits and the safety of the vaccine. Those studies are much larger,” he added.