A New, Life-Saving Vaccine for Older Americans
The FDA recently approved the first RSV vaccine for use in the United States
On May 3, 2023, the Food and Drug Administration (FDA) approved a vaccine to prevent respiratory syncytial virus (RSV) for those over 60 years of age.
Every year in the United States, RSV causes more than 3 million cases of common cold-like symptoms, 2 million out-patient visits, 150,000 hospitalizations, and 10,000 deaths in people over 60 years of age. Hospitalizations and deaths occur when RSV infects the lungs, causing viral pneumonia. About 95 percent of those hospitalized suffer from one or more medical problems such as diabetes, or chronic heart, lung, or kidney disease.
Researchers have been trying to make an RSV vaccine since the early 1960s, without success. Efforts have centered on inducing antibodies against the protein on the surface of RSV responsible for attaching the virus to cells. If the virus can’t attach to cells, then it can’t cause disease.
The RSV protein that attaches to cells is called the fusion protein. Once the virus attaches to cells, the fusion protein converts from a pre-fusion configuration to a post-fusion configuration. As it turned out, the key to a successful RSV vaccine came in understanding that the fusion protein had to be locked into a pre-fusion state. Then, and only then, could it induce high quantities of virus-neutralizing antibodies.
To make an RSV vaccine for older Americans, researchers at GlaxoSmithKline (GSK) took 120 micrograms of the pre-fusion protein and added an adjuvant. The adjuvant used in GSK’s RSV vaccine is the same as that used to make its shingles vaccine, Shingrix, which has been available since 2017.
To test whether the RSV vaccine worked, 25,000 adults over 60 years of age—many of whom had medical problems that put them at highest risk of severe infection—were randomly divided into two groups. One group received the RSV vaccine and the other received placebo.
Participants were studied for one year. Those who received the vaccine reduced their risk of RSV acute respiratory infection by 72 percent, of RSV pneumonia by 83 percent, and of severe RSV disease requiring supplemental oxygen or hospitalization by 94 percent.
The new RSV vaccine is a welcome addition in the fight against RSV. Now that it has been licensed by the FDA, it is likely that the CDC will recommend it for all adults over 60 at a meeting in June. Also, a similar RSV vaccine for older adults made by Pfizer will likely be considered by the FDA for licensure within a few weeks.
At last, a ray of hope in our efforts to prevent this deadly disease. And it’s only the beginning. A maternal RSV vaccine to prevent severe bronchiolitis—which is infection of the small breathing tubes—and pneumonia in young infants is right around the corner.
Thanks for this! Your reputation for prudent caution makes this endorsement even more meaningful for primary care docs like me who are reading and filtering, then educating and recommending.
I am troubled slightly by the GBS potential and I’m sure you’ll be watching this closely too. Helen Branswell wrote a good piece recently about these RSV vaccines:
“The background rate of GBS — the rate at which it occurs in the general population — is about 1 case per 100,000 people per year. Three cases in less than half that number — the people vaccinated in the adult RSV trials — gave pause to the members of ACIP’s adult RSV work group…”
https://www.statnews.com/2023/05/26/rsv-vaccines-will-older-adults-care/
I have at least 3 patients who experienced GBS within a suspicious time frame after flu shots, which seems like more than I should see based on the probability. Nonetheless I know experts and advisory committees do the tough and thankless job of weighing risks and benefits, so once again, thanks! I get a flu shot every year of course.
I'm a layperson but know enough to know this is great news and a vaccine I will get not too many years from now. I do have a question for anyone who knows and would be so kind as to answer. With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness." And that was indeed news to me. I knew that they were not 100 percent effective, but I never knew that vaccines in general were not developed and intended to prevent infection with whatever virus they were developed to prevent. And what jumps out at me with this RSV Vax is that it too prevents infection. My question is, do most vaccines actually prevent infection despite what the public was told after discovering that the COVID vaccines did not prevent infection? Pertinent quotation here: "Participants were studied for one year. Those who received the vaccine reduced their risk of RSV acute respiratory infection by 72 percent, of RSV pneumonia by 83 percent, and of severe RSV disease requiring supplemental oxygen or hospitalization by 94 percent." I don't know that Dr. Offit said this and don't mean this to be anything but a sincere question. My feeling is that the medical establishment sort of bent the truth on how vaccines work in order to avoid further public anger in general which was already prevalent with the COVID vax. Thanks.