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RSV vaccine for pregnant women inches closer to approval with FDA committee recommendation

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RSV vaccine for pregnant women inches closer to approval with FDA committee recommendation

The U.S. Food and Drug Administration (FDA) voted on Thursday to recommend approval of Pfizer’s RSV vaccine for pregnant women. The vaccine is now one step closer to becoming the first available maternal immunization to protect infants from the respiratory syncytial virus.

After a day-long public meeting held via online conference, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (14-0) in support of the vaccine’s effectiveness in preventing adverse effects of RSV in infants up to six months of age when given to women during the second or third trimesters of pregnancy.

The committee also voted 10-4 on the safety of the vaccine.

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“We are encouraged by the outcome of today’s VRBPAC meeting, as it is a critical step forward in the scientific community’s long-sought-after goal to help prevent RSV disease in infants during their most vulnerable first six months of life,” said Annaliesa Anderson, PhD, Pfizer’s senior vice president and chief scientific officer of vaccine research and development, in a media statement. 

The U.S. Food and Drug Administration (FDA) has recommended the approval of Pfizer’s RSV vaccine for pregnant women. (iStock)

“If approved, our RSV vaccine candidate has the potential to be the first maternal immunization vaccine to help protect infants at first breath through their first six months of life from this potentially serious infection,” she added.

“Giving it to pregnant women gives passive protection to the fetus, which then carries over to early infancy.”

Before making its decision, the committee reviewed the results of Pfizer’s Phase 3 clinical trial, which were published in The New England Journal of Medicine. 

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Although the recommendations are a step toward the vaccine’s availability, an official approval from the FDA is still pending.

The agency is expected to make its final decision by August 2023.

Vaccine seems promising, but more research is needed, says doctor

“I think this is a very promising vaccine and is likely very effective and safe, especially with tens of thousands of very young children being hospitalized with RSV every year,” Dr. Marc Siegel, a professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, told Fox News Digital.

Baby at doctor

Some 58,000 to 80,000 children 5 years of age and younger are hospitalized with an RSV infection, according to data from the CDC. (iStock)

“Giving it to pregnant women gives passive protection to the fetus, which then carries over to early infancy,” he added.

Last week, Siegel interviewed Dr. Paul Offit of Philadelphia, Pennsylvania, who is on the FDA advisory committee.

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“He was very positive about the vaccine,” Siegel said. “When he actually saw the full data, however, he ended up voting no [on the safety issue], apparently because of the possible association with pre-term birth.”

Added Siegel, “For me, this means further research needs to be done. I trust Dr Offit’s views on this.” 

RSV’s danger to babies

In some cases, the virus poses a danger to infants and toddlers.

Some 58,000 to 80,000 children 5 years of age and younger are hospitalized with an RSV infection, according to data from the Centers for Disease Control and Prevention (CDC).

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Mother with newborn

Infants younger than 6 months old may show symptoms including irritability, lethargy, decreased appetite and pauses in breathing. (iStock)

In most kids, RSV causes only mild cold-like symptoms, but in some cases it can lead to severe respiratory conditions like pneumonia or bronchiolitis, which may require hospitalization and supportive care.

The children at the highest risk include premature infants, babies six months and younger, kids younger than two years old who have chronic lung disease or heart disease, children with weakened immunity and those who have neuromuscular disorders, per the CDC.

FIRST-EVER RSV VACCINE APPROVED BY FDA FOR ADULTS 60 AND OVER

Infants younger than six months old may show symptoms including irritability, lethargy, decreased appetite and pauses in breathing.

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Earlier this month, it was reported that the FDA approved the first RSV vaccine, called Arexy, for use by people 60 years and older to prevent the lower respiratory tract disease.

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Could your car make you sick? Study highlights potentially cancerous toxins in vehicles

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Could your car make you sick? Study highlights potentially cancerous toxins in vehicles

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Americans may be breathing in cancer-causing chemicals while driving, recent research suggests.

A study published in the journal Environmental Science & Technology has sparked discussions about the potentially harmful toxins that could be lurking in the cabins of vehicles.

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“Certainly the indoor air quality can cause health symptoms,” Dr. Ken Speath, M.D., the division chief and medical director for occupational and environmental medicine at Northwell Health on Long Island, New York, told Fox News Digital.

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It is important to be mindful of what you’re breathing in at home, at the office, at school and even in cars, according to Speath, who was not involved in the study.

“There can be situations where levels of harmful chemicals get high enough to potentially cause health harms,” he said.

Americans may be breathing in cancer-causing chemicals while they are driving, recent research suggests. A study published in the journal Environmental Science & Technology has sparked many discussions. (iStock)

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“A car is a closed small space — so whatever is in the air is certainly going to be breathed in.”

Research reveals ‘harmful chemicals’

The peer-reviewed study looked at 101 owned vehicles in the U.S., model year 2015 or newer.

The researchers concluded that harmful flame-retardant chemicals — including those suspected of potentially causing cancer and some neurological issues — may be polluting the air inside vehicles.

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“Flame retardant chemicals, which are intentionally added to vehicle interiors to meet flammability standards, are released into the cabin air from the materials to which they were applied,” lead author Rebecca Hoehn, a scientist at Duke University, told Fox News Digital.

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“People in these vehicles may be exposed to these chemicals.”

Seat foam was the only material the researchers measured, Hoehn said, but other interior materials could also contain the chemicals.

driver in car

The researchers concluded that harmful flame-retardant chemicals — including those suspected of potentially causing cancer and some neurological issues — may be polluting the air inside vehicles. (iStock)

“Considering the average driver spends about an hour in the car every day, this is a significant public health issue,” Hoehn warned.

“It’s particularly concerning for drivers with longer commutes, as well as child passengers, who breathe more air pound for pound than adults.”

The chemicals detected in the car cabins included a flame retardant called tris (1-chloro-isopropyl) phosphate (TCIPP), which is currently being investigated as a potential carcinogen by the U.S. National Toxicology Program.

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“Considering the average driver spends about an hour in the car every day, this is a significant public health issue.”

Other flame retardants — tris (1, 3-dichloro-2-propyl) phosphate (TDCIPP) and tris (2-chloroethyl) phosphate (TCEP) — were also detected. 

These are “two Californian Proposition 65 carcinogens linked to neurological and reproductive harms,” according to a press release.

Higher concentrations of the flame retardants were found during warmer weather.

“We found that the same cars, sampled in both winter and summer, had higher concentrations of flame retardants in the cabin air during the warm summer months,” Hoehn told Fox News Digital.

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Car fire

Flame retardants are added to vehicles to meet the National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standard, which mandated their use in the 1970s. (iStock)

Flame retardants are added to vehicles to meet the National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standard (FMVSS 302), which mandated their use in the 1970s, the release stated.

Flame retardants have been the “focus of concern for some time,” Speath told Fox News Digital.

More information is needed to determine the health risks these chemicals pose in humans, he said.

THESE MEDICATIONS COULD MAKE DRIVING DANGEROUS, THE FDA WARNS

“A number of these have been demonstrated in studies to have health harms in animals,” he said.

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“That doesn’t necessarily mean that would be true for humans, but it raises that possibility, so we need to study these chemicals more in relation to their effects on humans.”

woman driving a car

Higher concentrations of the flame retardants were found during warmer weather, the researchers said. (iStock)

Emanuela Taioli, M.D., PhD, the director of the Institute for Translational Epidemiology at Icahn School of Medicine at Mount Sinai in New York City, was also not part of the study, but shared her reactions.

“This is a very relevant finding, since it may prompt changes in cars’ upholstery, as well as in other parts of the car where there is foam,” she told Fox News Digital via email.

“We also want to know more about this finding and monitor whether it is replicated by other investigators.”

Other sources of toxins

Stephen Showalter, a home inspector and indoor environmental air consultant with Showalter Property Consultants in Maryland, said he typically interviews clients about their history of illness, then tests for potential sources of sickness in buildings, cars, RVs and boats. 

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Mold is a common culprit when it comes to health issues triggered by one’s environment, he said in an interview with Fox News Digital.

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Dr. Daniel Johns, a member of the International Society of Environmentally Acquired Illnesses and a chiropractor who practices in Annapolis, Maryland, echoed Showalter’s concerns about mold-related health issues.

Johns also cautioned that cars can be a daily source of mold exposure.

“Any water that leaks from a window, sunroof or convertible can get into the carpet and cause mold growth,” he said during an interview with Fox News Digital. 

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Mold in car

Mold is a common culprit when it comes to health issues triggered by one’s environment, according to an environmental expert. (iStock)

“Mold can start growing on a wet surface within 24 to 48 hours.”

For families with small children, spilled sippy cups could play a role when it comes to mold in cars, Johns warned.

“The water seeps into the upholstery and doesn’t get noticed or properly dried out, and the whole seat can become moldy,” he said.

“Mold can start growing on a wet surface within 24 to 48 hours.”

“Every time you sit on the seat, it releases a mold spore cloud into the car. Once that happens, you can’t clean it away. The upholstery must be removed and replaced.”

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The impact of these potentially harmful pollutants can vary from one person to the next, experts told Fox News Digital.

Child strapped into car seat

For families with small children, spilled sippy cups could play a role when it comes to mold in cars, an expert warned. (Kids and Car Safety)

People metabolize chemicals and toxins in different ways, according to Taioli. 

“Metabolism happens through enzymes that the body produces,” he said. 

“Each of us has a different genetic profile that defines our metabolic capacity. As a consequence, the same amount of toxin may be metabolized better/faster by some, and worse/slower by others.”

Tips for ensuring safe interiors

While further research on car-borne chemicals is needed, experts say people can take measures to limit exposure.

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“People may be able to reduce their exposure by ventilating their cars,” Hoehn advised. 

“For example, rolling down the windows to let out contaminated air, or pulling in fresh air with climate control systems, should reduce concentrations. 

“Ultimately, reducing the amount of flame retardants added to vehicles in the first place would provide the greatest reduction in exposure risk.”

Controlling your vehicle’s cabin temperature may also reduce exposure, she added. 

“Parking in a garage or shade instead of full sun may reduce the cabin temperature and limit the extent of flame retardant release,” Hoehn said.

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The researchers also called for action from regulatory agencies and vehicle manufacturers. 

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“Ultimately, reducing the amount of flame retardants added to vehicles in the first place would provide the greatest reduction in exposure risk,” Hoehn noted.

“If flammability standards for vehicles could be revised to meet fire safety guidelines without the use of added flame retardants, risk of flame retardant exposure from personal vehicles could be greatly reduced.”

Car window rain

To prevent mold in a vehicle, experts recommend keeping your windows up when it rains or snows to prevent water from permeating the carpet or fabric. (iStock)

Having your car’s air quality and surfaces tested is one way to reduce the risk of exposure to allergens, toxins and chemicals, experts told Fox News Digital.

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To prevent mold in a vehicle, Showalter recommends keeping your windows up when it rains or snows to prevent water from permeating the carpet or fabric.

He also cautioned about leaky air conditioners, which can foster mold growth in vehicles, and about leaving wet items in the car.

Lastly, before buying a used car, he said it is important to check the vehicle’s history to make sure it doesn’t have flood damage, which can lead to mold and other issues.

If you think you are experiencing illness due to chemical exposure in your car, home or office, it’s best to see a health care professional to discuss your symptoms.

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Fox News Digital reached out to several major car companies for comment.

For more Health articles, visit www.foxnews.com/health.

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fatty15 has the essential nutrient to ease stress and well-being

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fatty15 has the essential nutrient to ease stress and well-being



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