A respiratory syncytial virus (RSV) vaccine for older adults could soon be available after an advisory committee at the Centers for Disease Control and Prevention voted to recommend it on Wednesday.
During a meeting, the agency’s Vaccination Practices Advisory Committee reviewed clinical trial data for two vaccines, one from Pfizer and one from GSK.
Barring a full recommendation, the committee said adults aged 60 and over could receive the vaccines based on individual needs and after consulting a doctor.
The vaccines have already received US Food and Drug Administration approval, so the final step is for CDC Director Dr. Rochelle Walensky signs the recommendations on what is expected of her.
This could mean the panel’s vote for older Americans:
Why is RSV so dangerous for older adults?
RSV can affect people of all ages, although some age groups are at higher risk, according to the CDC, including adults 65 and older — particularly those with chronic lung or heart disease and weakened immune systems.
Most people develop mild infections with symptoms such as cough, runny nose, and fever. However, in some cases, people may need to be hospitalized if they are having trouble breathing or are dehydrated.
So far in the 2022-23 season, there have been 67.5 RSV-related hospitalizations per 100,000 people among seniors, according to CDC data.
A general view of the headquarters of the Center for Disease Control is seen in Atlanta on August 6, 2022. Nathan Posner/Anadolu Agency via Getty Images, FILE
That number is much higher than usual, with CDC data from the 2016-17 season showing that the cumulative rate at this point in the season for older adults has never been higher than 31.5 per 100,000.
According to the CDC, between 60,000 and 160,000 older adults in the United States are hospitalized because of RSV each year, and 6,000 to 10,000 of them die.
“There is no really effective treatment for it [RSV] in terms of antiviral drugs,” said Dr. Paul Goepfert, a professor of medicine in the Department of Infectious Diseases at the University of Alabama’s Birmingham Hospital, told ABC News. “So the only treatment really is supportive care, so ideally what you should do is prevent it.”
How do the vaccines work and are they effective?
GSK’s vaccine, called Arexvy, and Pfizer’s vaccine, called Abrysvo, target a protein in the virus called F-protein, which RSV uses to attach to human cells and infect people.
The vaccine stimulates antibodies against the protein and protects against infection. GSK’s shot only protects against the A strain and Pfizer’s protects against the A and B strains.
Data from clinical trials showed that GSK’s vaccine was 82% effective in preventing lower respiratory tract disease and 94% effective in patients with at least one underlying condition.
Study data showed that Pfizer’s vaccine was more than 85% effective in preventing lower respiratory tract disease in older adults, with effectiveness declining to approximately 79% after 18 months.
Pfizer and GSK have not released data on the effectiveness of their vaccine against serious RSV disease that leads to hospitalization.
The side effects were mostly mild and included pain at the injection site, headache, fatigue, muscle pain and joint pain, according to the clinical studies.
“We know from the start that this vaccine has a shelf life, which is important compared to the COVID vaccine.” [which] can lose efficacy after four to six months, reducing public confidence in the vaccine,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Harvard Medical School, told ABC News. “These vaccines have high potency that lasts for at least two seasons.
What the CDC advisory panel vote means
The panel voted twice on Tuesday, first asking, after consulting their doctor, whether 60- to 64-year-olds could receive the vaccine. The panel received 13 votes in favor and one abstention.
The second vote asked the same question, but for those aged 65 and over, with nine votes in favor of the recommendation and five votes against.
“In my opinion it’s the right move given that it’s such a difficult and difficult condition to treat and a good recommendation to be at least an option for people who want to at least protect themselves from this infection,” Goepfert said.
Doctors told ABC News that committee members are concerned that the clinical trials don’t have very many participants over the age of 75.
Committee members were also concerned about the price. Pfizer told the panel it would charge between $180 and $270, while GSK said it would charge between $200 and $295. These do not reflect the prices that insured vaccine recipients would pay.
This 1981 photo provided by the Centers for Disease Control and Prevention (CDC) shows an electron micrograph of respiratory syncytial virus, also known as RSV.CDC via AP, FILE
“The recommendation we received from the CDC advisors was a more conservative recommendation than they typically do for their vaccination recommendations,” said Dr. Jason Schwartz, associate professor of health policy at the Yale School of Public Health ABC News. “They recommended that people aged 60 and older be able to receive this vaccine after discussions with their healthcare providers, in what they call ‘shared clinical decision-making’.”
“That’s a step below their broad recommendation, which often states that these people in this age group should get a vaccine, but it reflects somewhat the uncertainties about the vaccine and concerns about the cost of the vaccines,” he continued.
Why the vaccine could be game-changing
Researchers have tried to develop an RSV vaccine before, but to no avail.
In the late 1960s, a vaccine was made in which the virus was inactivated with formalin, a chemical that kills viruses. The vaccine was given to children in Washington, DC, but 80% of those vaccinated became ill and two children died from the vaccines.
“There hasn’t been an RSV vaccine for 60 years because early clinical trials have shown that the vaccine actually makes the disease worse, known as vaccine-associated disease,” said Dr. Gregory Poland, head of the Mayo Clinic’s vaccine research group, told ABC News. “It’s like covering the field of RSV vaccine development.”
Experts said the two vaccines represent a significant advance and provide an additional tool for disease prevention. However, it will be important to keep an eye on the real data once vaccinations begin on how well they protect the elderly and other immunocompromised people.
“It has the potential to change the game. We just have to see how it plays out in the real world,” said Dr. Shira Doron, chief infection control officer at Tuft Medical Center in Boston, told ABC News. “Our CDC’s external advisory board is really reviewing the data. They ask really tough questions and that gives me confidence in the vaccine approval process.”