CDC vaccine advisers’ vote sets stage for first RSV shot for older adults this fall

By Jen Christensen, CNN

(CNN) — Adults 60 and older will be eligible to get a shot that could protect them from respiratory syncytial virus, or RSV, this fall if the US Centers for Disease Control and Prevention follows the advice of its independent vaccine advisory committee.

The US Food and Drug Administration approved GlaxoSmithKline’s RSV vaccine for older adults in May, and Pfizer’s version was approved soon after. Also in May, the FDA’s independent advisory committee voted to recommend an RSV vaccine to protect newborns, but the agency is still considering it.

On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted in favor of allowing adults 60 and older, in consultation with their doctors, to get the RSV vaccine. The CDC will make the final decision before the shots can be given.

The committee voted twice Wednesday.

One vote asked the committee whether “individual adults aged 60-64 years may receive a single dose of RSV vaccine, using shared clinical decision-making.” The question got 13 affirmative responses and a single abstention.

The other question, “adults 65 years of age and older may receive a single dose of RSV vaccine, using shared clinical decision-making,” had nine votes in favor and five against. The committee amended prior language. The question originally asked: “Adults 65 years of age and older are recommended to receive a single dose of RSV vaccine.”

Among other concerns, some of the committee members were unhappy that that Pfizer would not commit to a price for its vaccine, as the advisers take cost into consideration when recommending how the shot should be used. GSK said it would keep the price of its RSV shot, called Arexvy, within a range of $200 to $295.

“This reflects the totality of our data reviewed earlier concluding that Arexvy provides durable efficacy for at least two full seasons,” said Dr. Leonard Friedland, vice president and director of scientific affairs and public health with GSK’s Vaccines North America division.

Pfizer told the committee that it had given the CDC a range of $180 to $270, but the price is not guaranteed because it’s still “in the middle of competitive price negotiations.”

Some of the members also expressed concern that the clinical trials of the vaccines lacked people over 75, “the frail folks who are most likely to have severe outcomes,” said Dr. Sarah Long, a professor of pediatrics at the Drexel University College of Medicine.

RSV flooded children’s hospitals with patients last year, and although it does not typically cause severe illness in as many adults, it can be a serious and even deadly disease for seniors and people with underlying health conditions.

Too often, RSV flies under the radar in adults, experts say. In the United States, tracking for viruses like RSV isn’t nearly as thorough as it is for diseases like Covid-19 or the flu, so it’s difficult to know exactly how many adults catch RSV. Based on best estimates, there are between 10,000 and 15,000 adult deaths in the United States from RSV each year and about 150,000 hospitalizations.

A 2015 study of older adults in industrialized countries found that the disease burden of RSV is “substantial” and calculated that about 14.5% of the 1.5 million adults who caught RSV were admitted to hospitals. People who were 65 and older were more likely to be hospitalized than those ages 50 to 64, studies show.

Pfizer’s and GSK’s vaccines would be the first in the world to fight RSV, and data the companies presented to the CDC’s advisers on Wednesday suggests that the shots are effective.

GSK said a late-stage trial found that its single-dose vaccine was more than 67% effective in preventing lower respiratory tract illness over two full RSV seasons, which typically run between October and March in the US. After one season, the vaccine was considered nearly 83% effective against lower respiratory tract illness due to RSV.

Against severe disease, the shot was nearly 79% effective after two seasons and more than 94% effective after one season. The company released data Wednesday showing that it was effective even in people who had underlying medical problems.

GSK’s vaccine was generally well-tolerated, and the most frequent side effect was pain at the injection site. Some people reported fatigue or a headache, muscle or joint pain. The side effects were typically short-lived.

A model created by the University of Michigan that was presented to the CDC committee showed that with 1 million doses in adults 65 and older, the GSK vaccine alone could prevent 23,000 outpatient visits, 2,300 hospitalizations and 120 deaths over two RSV seasons. If given to a million adults between the ages of 60 and 64, it could prevent 18,000 trips to the doctor, 890 hospitalizations and 35 additional deaths.

When the RSV vaccine was given along with a flu vaccine, it was safe and well-tolerated, the company said, and didn’t seem to affect the immune response.

GSK also tested a second shot a year after participants’ first ones, but it didn’t seem to provide much benefit: The cumulative efficacy of two doses was a little over 67%. This probably means the vaccine would need to be given every other year, but GSK is still studying how long protection lasts.

Pfizer also presented new data to the CDC’s committee about its RSV shot. It was nearly 79% effective against more severe lower respiratory tract illness with three or more symptoms about a year and a half after administration, down from nearly 86% efficacy through the end of the first RSV season.

Pfizer’s shot showed nearly 67% efficacy against illness with two or more symptoms through one season, but after about a year and a half, efficacy had fallen to 49%. The company expects to release two-year data this year that will give a fuller understanding of how long protection lasts.

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