Federal officials plan three-pronged defense against another ‘tripledemic’

Federal officials plan three-pronged defense against another 'tripledemic'

To prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, Americans will be encouraged to roll up their sleeves not only for flu shots but also for two other vaccines, one of which is entirely new.

Federal health officials have already asked manufacturers to produce improved Covid vaccines to be distributed later this year. Recently, the Centers for Disease Control and Prevention took an additional step, endorsing two new vaccines against respiratory syncytial virus for older Americans.

Three shots – flu, COVID and RSV – could help reduce hospitalizations and deaths later this year. But there are uncertainties about how the vaccines are best dosed, who is most likely to benefit and what the risks may be.

For older and immunocompromised Americans, all three vaccines are a “gift from God,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital and advisor to the Food and Drug Administration.

“The number of elderly people who die from viral infections every winter and sometimes even summer in our intensive care units is huge – it’s in the thousands,” Dr. Levy said. “Each of these vaccines is a huge win.”

Yet it is unclear how many Americans will opt for the shots. Nearly 71 percent of adults age 65 and older got the flu shot last winter, but only 43 percent opted to get a Covid booster.

Last winter’s misery may help change minds. may be due to flu over 58,000 deathsAccording to the CDC, Covid killed nearly 50,000 people between November and March, peaking in December.

RSV kills 10,000 people each year, most of whom are elderly. This year the infection peaked in November and as a result almost twice the number of hospitalizedIncluding children, as was the case in the years before the pandemic.

Last autumn only the Covid and flu vaccines were available. RSV vaccines for adults are newer, and have been shown in clinical trials to be highly effective against lower respiratory tract infections, including the lungs.

In May, the FDA approved the first two versions made by Pfizer and GSK for older adults. The CDC advisory recommends that Americans age 60 and older should get vaccinated in consultation with their doctors. (The Pfizer vaccine is also being evaluated for use in pregnant women as a way to protect newborns.)

Dr. Levy said that including all three vaccinations in a single visit to a clinic or pharmacy is likely to encourage more people to get vaccinated. “Also, you want to get these shots before viral respiratory season in the winter,” he adds.

But other scientists have hesitated to endorse the idea, citing a lack of data on safety and effectiveness when all three are given at the same time.

Sometimes, vaccines work against each other when administered together. According to data presented to advisors to the CDC, the RSV and flu vaccines produce lower levels of antibodies when given at the same time than when given alone.

“I would say, when possible, it might be good to spread them,” said Dr. Camille Cotton, a physician at Massachusetts General Hospital and a member of the CDC scientific advisory panel.

“I remain concerned medically, especially where the influenza vaccine does not provide as much protection as we would like,” she said.

Most people at risk of illness and death after infection with these viruses are 75 years of age and older. Dr. Cotton and other experts said that in that group, the benefits from each vaccine clearly outweighed any safety concerns.

up to 85 percent flu related deaths According to the CDC, those in recent years were among people age 65 and older. The agency recommends that older adults get a high-dose flu vaccine or a vaccine with an adjuvant, an ingredient that can produce a stronger immune response.

Hospitalizations and deaths from COVID also occur primarily among the oldest Americans, and it is now believed that COVID boosters are primarily beneficial for older adults and those with weakened immune systems.

In June, the FDA advised Pfizer-BioNTech, Moderna and Novavax to manufacture Covid shots designed to target XBB.1.5, which is the Omicron variant. about 27 percent of cases. However, that version seems to be waning, and a new version, XBB.1.16, is on the way.

RSV is the leading cause infant hospitalization in the United States, and one of the top killers The number of young children in low- and middle-income countries. Until recently the virus was under-appreciated as a respiratory threat to adults.

More than 160,000 people may be hospitalized and 10,000 older adults may die each year due to this virus. According to CDC — and those numbers are likely to be underestimates. For every one million adults age 65 and older who get vaccinated, 25,000 outpatient visits, 2,500 hospitalizations and 130 deaths would be prevented, according to an analysis presented to the agency’s consultants.

For decades, designing vaccines against RSV proved challenging. In 2013 there was a breakthrough through the efforts of several companies. In a recent trial, the GSK vaccine, sold under the name ArxV, retained most of its potency. in the second yearAnd its efficacy is being studied for even longer periods.

Pfizer is still evaluating the stability of its vaccine, which will be marketed under the name Abrisvo. If the vaccines remain effective for a long time, the RSV shot may not be needed every year.

The companies’ trials did not enroll enough people to assess efficacy in groups that were immunocompromised, medically vulnerable, lived in long-term care facilities, or were 75 and older. These Are Also the Americans Most Vulnerable to RSV

Although there is a small risk of the autoimmune disease Guillain-Barré syndrome from flu and other vaccines, the numbers are typically on the order of one or two cases per million. While evaluating the new RSV vaccines, manufacturers reported three neurological cases, including Guillain-Barré syndrome, within 42 days of vaccination in a population of approximately 40,000 people.

Still, the trials weren’t large enough to determine whether those cases occurred by chance or were caused by the vaccines. “That information can’t really be obtained until after licensure and after recommendation and rollout,” said Dr. Helen Chu, a physician and immunologist at the University of Washington.

Influenza, COVID and RSV infections themselves pose a risk of Guillain-Barre syndrome and other neurological problems, Dr. Chu said, so the risk-benefit balance still favors vaccination.

Nevertheless, reports of adverse events related to RSV vaccines have made some CDC advisors reluctant to endorse them for people who do not face a high risk from infection.

That’s partly why the scientific panel said anyone age 60 or older can choose to get the vaccine in consultation with a doctor, rather than issuing a broad recommendation for all adults age 60 or 65.

Some experts said the decision risks deepening racial disparities regarding vaccination. Many people of color, who are often at disproportionate risk of severe illness or death, do not have easy access to a health care provider who can help them assess the risks and benefits of RSV vaccination.

Dr. Chu said the recommendation also puts the onus of assessing the risks and benefits on general practitioners and other health care providers.

“It’s hard to committee,He said referring to the expert panel of the CDC. “It’s definitely going to be a lot more difficult for a GP”

The CDC’s recommendations ensure that most Americans will not have to pay for vaccines out of pocket. The drop marks the first time that the distribution of Covid vaccines will not be managed by the federal government, but insurance companies will continue to cover the cost.

It is still unclear how much Pfizer and GSK will charge for the new RSV vaccines. Pfizer said the price of its vaccine is still under negotiation, but could fall between $180 and $270.

According to a CDC scientist with knowledge of the matter, GSK doubled its initial price of $148 two weeks before the CDC consultants’ meeting was scheduled, giving agency staff plenty of time to redo their cost-effectiveness analysis. Got less time GSK has now settled in the range of $200 to $295.

Company spokeswoman Alison Hunt said GSK raised the price because of new data showing effectiveness in the second season.

Ongoing research is likely to provide more information on new RSV vaccines. In preliminary data, the second dose of the GSK vaccine did not increase antibody levels, which puzzled science advisors at last week’s meeting.

Pfizer is investigating whether a second dose given one year after the first dose of its vaccine will increase immunity to the disease. These results are expected to come early next year. The companies are also studying whether people with weakened immune systems should get a single dose or two doses spaced a month apart.

“We never have all the information we want,” said Dr. Levy, an FDA consultant.

“But one thing we know for sure is that every winter people lose loved ones, grandmas, grandpas to the virus, and now we have better tools. And we want to deploy them.”

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