FDA to reevaluate 'useless' over-the-counter cold meds
Cold And Flu News
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RSV Vaccine For Pregnant Women Could Change The Game For A Common Illness, UT Austin Scientist Says
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For six decades, there was no approved vaccine for one of the most common causes of severe illness in infants, young children and older adults: RSV. Until now.
2023 has been a breakthrough year, with multiple vaccine and treatment approvals. On Monday, the U.S. Food and Drug Administration endorsed a vaccine for pregnant women — the first RSV vaccine to offer protection to vulnerable infants.
Among the scientists responsible for this discovery is Jason McLellan, a professor at UT Austin's Department of Molecular Biosciences. Although most people are repeatedly infected with RSV throughout their lifetimes, McLellan said, it only poses a strong threat to certain groups.
"RSV causes significant disease in the very young and in the elderly," he said. "For healthy adults, it's sort of a bad cold."
According to the Centers for Disease Control and Prevention, RSV is the leading cause of hospitalization in infants. The agency estimates up to 80,000 kids under the age of 5 are hospitalized with RSV each year. Older adults are hospitalized in numbers ranging from 60,000 to 160,000 each year because of the virus, and between 6,000 and 10,000 die.
Despite these sobering statistics, McLellan says, RSV's magnitude has not always been understood.
"Most of the time, when people were sick with RSV, they didn't know it, and it was just sort of grouped as a 'flu-like illness,'" he said. "It's only been in the last decade or so with specific testing for RSV that it's been appreciated that many of these hospitalizations and deaths due to respiratory illness are actually due to RSV."
A surge of advancementA surge of cases during the 2022 winter RSV season also raised awareness of the common virus, McLellan said. Coincidentally, the timing coincided with a flurry of activity in the testing and development of vaccines and treatments.
By the end of last year, clinical trials for vaccines from a range of pharmaceutical companies were in their final phases. In May, GSK's vaccine for adults over 60, called Arexvy, became the first RSV vaccine to receive FDA approval. Approval for Pfizer's Abrysvo for older adults shortly followed. On Monday, Abrysvo was also approved for pregnant women between 32-36 weeks of gestation.
While these vaccines crossed the finish line around the same time, they all built on decades of work.
"RSV was first isolated from chimpanzees in 1956, and since then, there's been decades of research from many investigators trying to understand basic virology," McLellan said, "how the virus enters cells, what its proteins are, how it causes disease, how to make vaccines."
Several factors contributed to the long lead time before effective vaccines were approved. One was an ill-fated attempt to develop an RSV vaccine for infants in the 1960s, which ultimately made infants who received the drug more likely to become severely ill. Two died. That tragedy made researchers especially cautious about RSV vaccines for infants, McLellan said.
Additionally, he said, technology had to catch up. He and colleagues at the National Institutes of Health played a pivotal role in this advancement by developing a new way to engineer and stabilize proteins that certain viruses use to enter cells. This breakthrough also became foundational for the development of COVID-19 vaccines, the work McLellan is perhaps best known for.
What comes next?Pfizer's vaccine still needs to the greenlight from the CDC before it can be administered to pregnant women. Once it's approved, the FDA and CDC will continue to monitor the vaccine's efficacy.
Ahead of the fall and winter RSV season, the CDC is recommending infants under eight months of age receive a new monoclonal antibody treatment that can help prevent infection. With this treatment, infants are given injections of antibodies, which can offer them protection before they are old enough to muster their own immune response.
Meanwhile, McLellan and colleagues in his lab at UT are at work addressing more viruses, including human metapneumovirus, another RSV-like virus that causes severe disease in the very young and the elderly. He's also focused on other pathogens that might cause major outbreaks in the future.
"Vaccine development takes a long time," he said. "There have been a lot of funders who are starting to put money toward how to make vaccines against different families of viruses. In case there is a large epidemic or pandemic in the future, we'll already be ready."
Copyright 2023 KUT 90.5. To see more, visit KUT 90.5.
As RSV Season Looms, New Vaccines Offer Hope In Fight Against Deadly Virus
New vaccines offer hope in fight against deadly RSVIt's back to school time. Despite the warmer weather, this time of year can also have you headed back to the doctor's office. In a FOX 32 special report, Sylvia Perez takes a look at new tools to fight a very common and deadly virus.
CHICAGO - It's back to school time. Despite the warmer weather, this time of year can also have you headed back to the doctor's office.
In a FOX 32 special report, Sylvia Perez takes a look at new tools to fight a very common and deadly virus.
We all know about cold and flu season. But what about RSV season?
"So RSV is a single-stranded RNA virus. And basically it's a virus that can infect persons of any age. Most people, you know healthy adults, will only have an upper respiratory tract infection. However, at certain ages and with certain health conditions, you can actually have more severe symptoms," said Dr. Mariam Aziz, a pediatric infectious disease special at Rush University Medical Center.
Those severe symptoms usually affect a person's lungs and their breathing. Most often in infants, toddlers and seniors.
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"About 20% of all kids in their first year of life will get lower respiratory infection with RSV. Between 60,000 and 80,000 kids under five are hospitalized every year with RSV," said Dr. Allison Bartlett, a pediatric infectious disease specialist at University of Chicago Medicine.
Bartlett adds approximately 2% of all infants are also hospitalized every year due to an RSV infection and around 200 children die from it, making RSV the most common reason a child is admitted to the hospital.
As for seniors, the statistics are even more alarming.
"There's around 150,000 to 180,000 hospitalizations every year and about 14,000 deaths. So that's pretty important in terms of a virus causing outcomes like that," Aziz said.
"It's actually a really exciting time in the world of potential prevention of RSV infections, or prevention of serious consequences."
— Dr. Allison Bartlett, pediatric infectious disease specialist at University of Chicago MedicineUntil now, doctors had little to no way to treat RSV.
"There really are no other medicines we can give it. It's watchful waiting, and it's a really hard thing for parents and health care workers to watch a child struggle to breathe," says Bartlett.
Now, the Food and Drug Administration has approved two vaccines for people age 60 and over.
As for the Centers for Disease Control and Prevention, Bartlett says it didn't issue a blanket recommendation for all seniors to get an RSV vaccine, but instead recommended "shared decision-making" where doctors and patients decide together if an RSV vaccine is best for them.
"So what we have coming, hopefully soon for the infants, is a monoclonal antibody. So instead of teaching the body's immune system how to fight off an infection, we actually give the injection of the antibodies themselves," Bartlett says.
The CDC is now recommending nirsevimab for babies under eight months old and for some older ones too. Bartlett says the biggest challenge now is making sure it's available to all infants.
"So there's not a lot of treatment out there for RSV. And that's why there's so much excitement about the vaccines that are coming out right now."
— Dr. Mariam Aziz, pediatric infectious disease specialist at Rush University Medical Center"It could significantly impact the rate of doctor visits, hospitalizations and deaths from RSV," says Bartlett.
As for the impact the two new vaccines would have on seniors' health, that depends on how many decide to get the vaccine and also have access to it.
"RSV is the leading cause, thought to be the leading cause, of death from an infectious disease aside from malaria. And so globally, if there is access to these important drugs, it could be a game changer," according to Aziz.
The approval of these new vaccines and therapeutic treatment come at a critical time.
After two years of cases increasing following the pandemic and then the "perfect storm" of RSV, the flu and COVID all hitting at the same time last year, Chicago doctors are now bracing themselves to see what this year's RSV season will look like.
"Usually it started in November or December and lasted through about March," Bartlett says.
Then in 2021, doctors unexpectedly saw it starting up in July or August and last year, it started around September.
"So it's a little bit in flux whether it's going to be August, September, or October this year. We are anxiously awaiting," she added.
Another new development doctors are excited about is the FDA has just approved one of the vaccines for seniors to be given to pregnant women as well. It will allow them to develop an immune response to RSV and pass it on to their babies.
Once the approvals have been finalized, doctors anticipate these vaccines and therapeutic treatment will be available this fall.
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