To avoid a repeat of last winter’s “triple epidemic” of respiratory illness, Americans will be encouraged to roll up their sleeves not only for flu shots, but also for two other vaccines, one of which is brand new.
Federal health officials have already asked manufacturers to produce reformulated Covid vaccines for distribution later this year. Recently, the Centers for Disease Control and Prevention went the extra mile by approving two new respiratory syncytial virus vaccines for older Americans.
The three injections – flu, Covid and RSV – could help reduce hospitalizations and deaths later this year. But there are uncertainties about how best to administer the vaccines, who is likely to benefit most and what the risks may be.
For elderly and immunocompromised Americans, all three vaccines are a “God send,” said Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital and advisor to the Food and Drug Administration.
“The number of elderly people who die of a viral infection in our intensive care units each winter, and sometimes in the summer as well, is high – it runs into the tens of thousands,” said Dr. Levy. “Any one of these vaccines is a huge win.”
Still, it’s unclear how many Americans will opt for the shots. About 71 percent of adults age 65 and older got a flu shot last winter, but only about 43 percent chose to get the Covid booster.
The misery of last winter can help to change your mind. The flu may have resulted in as many as 58,000 deaths, peaking in December, according to the CDC, Covid claimed about 50,000 lives between November and March.
RSV kills up to 10,000 people each year, most of them older. Infections peaked in November this year and resulted in about twice as many hospitalizations, including children, as in prepandemic years.
Last fall, only the Covid and flu vaccines were available. The adult RSV vaccines are new and have been proven in clinical trials to be highly effective against infection of the lower respiratory tract, including the lungs.
In May, the FDA approved the first two versions, made by Pfizer and GSK, for older adults. The CDC’s advisors recommend that Americans age 60 and older get the shot in consultation with their doctor. (The Pfizer vaccine is also being evaluated for use in pregnant women as a way to protect newborn babies.)
Bundling all three immunizations into a single visit to a clinic or pharmacy is likely to encourage more people to get immunized, said Dr. Levy. “Plus, you want to get these shots in your arms before the winter viral breathing season,” he added.
But other scientists have been hesitant to endorse the idea, citing the lack of data on safety and effectiveness when all three are given at the same time.
Sometimes vaccines work against each other when given simultaneously. According to data presented to CDC consultants, the RSV and flu vaccines produced lower levels of antibodies when given at the same time than when given separately.
“I would say that if possible, it would be good to spread them,” said Dr. Camille Kotton, a Massachusetts General Hospital physician and member of the CDC’s scientific advisory panel.
“I remain clinically concerned, especially when the flu vaccine doesn’t provide as much protection as we’d like,” she said.
The vast majority of people at risk of illness and death from infections with these viruses are 75 and older. In that group, the benefit of any of the vaccines clearly outweighs any safety concerns, said Dr. Kotton and other experts.
Up to 85 percent of flu-related deaths in recent years have been among those age 65 and older, according to the CDC. immune response.
Hospitalizations and deaths from Covid are also prevalent among the oldest Americans, and Covid boosters are now thought to be especially beneficial for older adults and those with weakened immune systems.
In June, the FDA advised Pfizer-BioNTech, Moderna and Novavax to take Covid shots designed to target XBB.1.5, the Omicron variant that accounts for about 27 percent of cases. However, that variant seems to be withdrawing and a newer variant, XBB.1.16, is on the rise.
RSV is the leading cause of infant hospitalizations in the United States and one of the leading causes of death of young children in low- and middle-income countries. The virus was until recently underappreciated as a respiratory threat to adults.
The virus can lead to as many as 160,000 hospitalizations and 10,000 deaths among older adults each year, according to the CDC — and those numbers are likely underestimated. For every million adults age 65 and older who receive the vaccine, 25,000 outpatient visits, 2,500 hospitalizations and 130 deaths would be prevented, according to an analysis submitted to the agency’s advisers.
For decades, vaccines against RSV have proved challenging to design. A breakthrough in 2013 boosted the efforts of several companies. In a recent trial, the GSK vaccine, which will be sold as Arexvy, retained much of its potency into its second year, and its efficacy is being studied for an even longer period of time.
Pfizer is still evaluating the sustainability of its vaccine, which will be marketed as Abrysvo. If the vaccines remain effective over a long period of time, an RSV injection may not be necessary every year.
The companies’ studies didn’t enroll enough people who were immunocompromised, medically frail, living in long-term care facilities, or age 75 and older to measure efficacy in those groups. These are also the Americans most vulnerable to RSV
While flu and other vaccines carry a small risk of the autoimmune disease Guillain-Barré syndrome, those numbers are generally on the order of one or two cases per million. In evaluating the new RSV vaccines, the manufacturers each reported three neurological cases, including Guillain-Barré syndrome, within 42 days of vaccination in a population of about 40,000 people.
Still, the studies weren’t large enough to determine whether those cases happened by chance or were caused by the vaccines. “That information can really only be obtained after licensing and after recommendation and rollout,” says Dr. Helen Chu, a physician and immunologist at the University of Washington.
Influenza, Covid and RSV infections themselves pose a risk for Guillain-Barré syndrome and other neurological problems, so the risk-benefit ratio is still strongly in favor of vaccination, said Dr. Chu.
Still, the reports of side effects related to the RSV vaccines caused some CDC advisers to be reluctant to endorse them for people who are not at high risk for the infection.
That’s partly why the scientific panel said anyone 60 and older “can” choose to get the vaccine in consultation with a doctor, rather than making a blanket recommendation for all adults over 60 or even 65.
That decision threatens to deepen racial disparities related to vaccination, some experts said. Many people of color, often at a disproportionate risk of serious illness or death, do not have ready access to a healthcare provider who can help them weigh the risks and benefits of RSV vaccination.
The recommendation also places the responsibility on primary care physicians and other healthcare providers to weigh the risks and benefits, Dr. Chu up.
“It is difficult for the committee,she said, referring to the CDC’s expert panel. “It will certainly be much, much more difficult for a GP”
The CDC’s recommendations ensure that most Americans will not have to pay out of pocket for the vaccines. This fall marks the first time that the distribution of Covid vaccines is not controlled by the federal government, but insurance companies continue to cover the costs.
How much Pfizer and GSK will charge for the new RSV vaccines is still unclear. Pfizer said the price of its vaccine is still being negotiated, but could drop to between $180 and $270.
GSK doubled its initial price of $148 two weeks before CDC advisers were due to meet, leaving agency staff with little time to redo its cost-effectiveness analysis, according to a CDC scientist with expertise. GSK has now established a $200 to $295 range.
GSK raised its price because of the new data showing effectiveness in a second season, said Alison Hunt, a company spokeswoman.
Ongoing research is likely to provide more information about the new RSV vaccines. According to preliminary data, a second dose of the GSK vaccine did not raise antibody levels, puzzling scientific advisers at last week’s meeting.
Pfizer is studying whether a second dose of its vaccine, given a year after the first, will boost immunity. Those results are expected sometime early next year. The companies are also studying whether people with weakened immune systems should receive a single dose or two doses a month apart.
“We never have all the information we want,” said Dr. Levy, the FDA advisor.
“But one thing we know for sure: every winter people lose loved ones, grandmothers, grandfathers to the viruses, and now we have better tools. And we want to use that.”
