New COVID booster authorization will sway parents to get young kids vaccinated, FDA vaccine chief hopes

New COVID booster authorization will sway parents to get young kids vaccinated, FDA vaccine chief hopes
New COVID booster authorization will sway parents to get young kids vaccinated, FDA vaccine chief hopes
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(WASHINGTON) — Dr. Peter Marks, the Food and Drug Administration’s vaccine chief, said he is well aware that COVID-19 booster uptake might be low for the latest shot, authorized by the government on Thursday morning for young children over 6 months old, but he told ABC News that he’s hopeful increased access may also lead to some kids getting greater protection against the virus ahead of the winter, when infections can be more likely.

The updated bivalent booster that targets multiple newer strains of the virus, will likely be available early next week for the youngest children, Marks said in an interview. That age group is the last to become eligible for the new booster.

So far, according to the Centers for Disease Control and Prevention, less than 10% of kids under 5 have gotten their initial COVID-19 vaccines — which means there’s a very small pool of children who are even eligible for boosters. But Marks hopes that those vaccinated children will soon get their boosters, and unvaccinated children will be encouraged to get their first series.

“The whole point of today’s action was to ensure that those parents who have decided to take advantage of the fact that we do have a vaccine that can help prevent the worst outcomes from COVID-19, such as hospitalization and death … could have the benefit of having the most up-to-date version of the vaccine, which is the bivalent vaccine,” Marks said.

“Hopefully this is also an opportunity that the 90% of parents who have not vaccinated their children in this age range will consider doing so. Because not being vaccinated at all puts one at risk for the worst outcomes from COVID-19,” he added.

Under the new authorization, children under 6 who received the Moderna vaccine can get a bivalent booster at least two months after their first series of shots.

For children under 5 who received the Pfizer vaccine, it’s slightly different: Kids can get the newly authorized bivalent booster in place of the third shot in the Pfizer series for young kids. And going forward, any young child who gets the three-shot Pfizer series will get two primary shots and then the bivalent booster.

On a larger scale, vaccine uptake for the youngest age group has traditionally been far lower than other groups throughout the pandemic.

And even for older age groups, booster uptake has been very low over the three months that bivalent shots have been on the market.

According to the CDC, just under 13% of people over 5 years old have gotten a bivalent booster. The rate is highest for people over 65, for whom around one-third have been boosted.

Everyone over age 12 became eligible for bivalent boosters in September, so long as it had been three months since their last vaccine. Then in October, the eligibility expanded to everyone over age 5.

And now, in December, babies as young as 6 months old are eligible as well.

Public health officials have long hoped that the arrival of cold weather and flu season would give people a natural push to get up-to-date on both their flu vaccines and their COVID-19 boosters.

But that bump in COVID-19 shots hasn’t quite materialized, Marks acknowledged, and he’s not sure that uptake will budge all that much over this winter season — despite his avid recommendations.

“I don’t quite fully understand why there’s significant hesitancy to get the bivalent boosters. I think I’m the first to acknowledge that these vaccines are not perfect. They’re not going to give you 100% protection against COVID-19. And perhaps because people have heard, ‘Well, I got the booster but I got COVID,’ there’s some skepticism there,” Marks said.

But inoculation will still cut down on the chances of contracting the virus and keep people out of the hospital, he said.

“Even if it’s not perfect — it’s the best you can do,” Marks said. “I will repeat something that has done me well to date, which is perfection is the enemy of good.”

Marks particularly encouraged getting vaccinated and boosted ahead of the winter season, when he predicted that cases were likely to go up and hospitals could be strained from the combination of heavy RSV and flu cases.

Already, wastewater surveillance systems across the country have begun to pick up upticks in COVID-19 cases, and Marks called the increasing slope of cases “disturbing.”

“From what I can see happening over the recent past, I think the good news is, we’re not likely to see the number of deaths that we’ve seen in previous winters. The part that is concerning is that we could see a large number of cases,” he said.

“We’re also seeing hospitalizations rise significantly and deaths, which had been declining, are starting to increase again. Once people see that, my guess is that will drive them to potentially consider this,” Marks said. “Though I wouldn’t wait for that.”

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Los Angeles County holds off on mask mandate even as it enters ‘high’ COVD transmission category

Los Angeles County holds off on mask mandate even as it enters ‘high’ COVD transmission category
Los Angeles County holds off on mask mandate even as it enters ‘high’ COVD transmission category
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(LOS ANGELES) — Los Angeles County said Thursday it is holding off on issuing an indoor mask mandate amid rising COVID-19 cases and hospitalizations.

During a press conference, LA County Public Health Director Barbara Ferrer said the county had moved into the “high” COVID-19 community transmission category, as defined by the Centers for Disease Control and Prevention, but it would be sticking with its “strong recommendation.”

Public Health Director Dr. Barbara Ferrer left the option of a mask mandate on the table, but if and only if 10% of county hospital beds are filled with COVID patients.

Right now that number is only 6.9%, and the rate of increase has slowed in the past week. Ferrer said it’s not a forgone conclusion that the county will reach that critical level during the current surge.

“Being at a high community level does not mean returning to the more restrictive and disruptive measures that we used at earlier times in the pandemic, before we had good access to vaccines, boosters, testing and therapeutics,” she said at the conference.

This is a reversal from previous policy in the county that moving into the CDC’s “high” transmission level would spur a mandate. The changing guidance comes as the health department has dangled the prospect of an impending mask mandate for weeks in a row for the second time this year.

“We do ask that while we are in surge everyone ages two and older wear a mask in indoor public spaces,” Ferrer said.

As of Wednesday, Los Angeles County is recording more than 5,000 daily cases, the highest number recorded since Aug. 1, according to an ABC News analysis of health department data.

It’s also an 80% increase from the 2,805 cases recorded just two weeks ago on Nov. 23, the analysis found.

However, officials have previously stated that the true number of cases is likely much higher due to people testing positive and not reporting their results to the department or not testing at all.

What’s more, a total of 1,293 people are hospitalized with the virus as of Wednesday, a figure not seen since July 18, according to the analysis.

Masks continue to be compulsory indoors at healthcare and congregate-care facilities, at business where required and for anyone who has been exposed to COVID in the last 10 days.

Officials have stressed the importance of being vaccinated and boosted to prevent infection and severe disease, especially as the holiday season approaches.

As of Nov. 27 — the latest date for which health department data is available — 73% of all residents are fully vaccinated but the percentages vary widely by age.

Seniors aged 65 and older have the highest rate with 92% fully vaccinated while children between ages 6 months and 4 years have the lowest rate with just 6% fully vaccinated.

ABC News’ Matthew Fuhrman contributed to this report.

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At least 63 children are sick with measles in Ohio

At least 63 children are sick with measles in Ohio
At least 63 children are sick with measles in Ohio
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(COLUMBUS, Ohio) — An ongoing measles outbreak in central Ohio has ballooned to 63 cases as of Thursday. Twenty-five children have been hospitalized.

The state’s health system is also fighting the surge in respiratory illness — flu, RSV and COVID-19. The high rates of those illnesses are making it harder for doctors to flag measles cases, Mysheika Roberts, the health commissioner in Columbus, Ohio, told ABC News.

“Measles can present an issue like a cold, like a mild RSV, or mild flu. And it’s not until that rash appears that most providers and parents say, oh, this is different,” she said. “By that point, the case has already exposed other individuals, whether it’s at day care, at home, at church.”

Three of the 63 children have received one dose of the measles, mumps and rubella (MMR) vaccine, a highly effective vaccine that protects against the three diseases. The remaining 60 children are unvaccinated. The majority of the children are under 5 years old.

The Centers for Disease Control and Prevention recommends that all children get two doses of the MMR vaccine — the first when they’re 12 to 15 months old and the second when they’re 4 to 6 years old. One dose is 93% effective against measles and two doses are 97% effective.

The vaccine’s effectiveness helped the United States officially eliminate measles in 2020, a designation that means the virus is no longer continuously circulating in the country. But there can still be periodic outbreaks if the virus is brought into a community where many people are unvaccinated. Rises in vaccine hesitancy over the past decade eroded MMR vaccination rates in some areas, which creates pockets in the U.S. particularly susceptible to measles spread.

For example, research showed that low vaccination rates were responsible for the 2015 Disneyland outbreak, which spread to over 125 people.

Roberts said that the children affected by the Ohio outbreak appear to be unvaccinated because their families rejected the vaccine, not because they had delays in their vaccinations as a result of the COVID-19 pandemic. The Columbus health department offers the vaccine at its clinic but the department hasn’t seen any uptick in the number of people seeking out the MMR vaccine in response to the outbreak, officials said.

It’s still not clear how large this outbreak could become. The health department doesn’t have good visibility into the percentage of people who are vaccinated against measles in the state of Ohio, Roberts said. Her team is working with the CDC, insurance providers and medical providers to get a better estimate of that number.

“Once we get that information about the population here in central Ohio, the CDC is optimistic they’ll be able to get us an estimate of how large this outbreak could get,” she noted. “But at this point, just looking at past outbreaks in other communities, we’re just hoping that we don’t get as large as some of those.”

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FDA authorizes updated COVID-19 boosters for kids under 5

FDA authorizes updated COVID-19 boosters for kids under 5
FDA authorizes updated COVID-19 boosters for kids under 5
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(SILVER SPRING, Md.) — The U.S. Food and Drug Administration authorized bivalent COVID-19 boosters for children between the ages of 6 months and 4 years old Thursday.

The booster, available from both Pfizer and Moderna, was previously authorized for everyone 5 years and older in October.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so — especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert Califf said in a statement.

“As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

The updated booster targets BA.4 and BA.5, which are subvariants of the omicron variant.

Children are eligible to receive the booster at least two months from the completion of their primary series or after receiving a separate booster dose.

The authorization means there are now more than 267 million people eligible for the booster in the U.S., according to data from the Centers for Disease Control and Prevention.

However, as of Nov. 30, only about 13% of those eligible have received an updated booster dose.

The final step before the booster can be distributed to the under age 5 category is authorization from the CDC, which must be signed off on by the agency’s director, Dr. Rochelle Walensky.

When considering authorizing the updated booster, the FDA said it looked at immune response data from adults who had received the original booster, which targeted the original omicron variant BA.1, as well data from a study comparing children who received the original booster and children who only received the primary series.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19.”

“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing,” the statement continued.

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CDC report shows how infectious mpox is and how important vaccination was in stemming outbreak

CDC report shows how infectious mpox is and how important vaccination was in stemming outbreak
CDC report shows how infectious mpox is and how important vaccination was in stemming outbreak
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(ATLANTA) — A new report from the Centers for Disease Control and Prevention shows how infectious mpox can be and how important vaccination was in reducing the outbreak over the summer.

Last month, the World Health Organization renamed “monkeypox” as “mpox” over concerns of stigmatization of the disease.

The study, published Thursday, looked at cases by vaccination status among men ages 18-49 between July 31 and Oct. 1 in the U.S.

The outbreak, which has significantly decreased in recent weeks, has primarily been concentrated among gay, bisexual and other men who have sex with men, although the CDC has noted that anyone — regardless of sexual orientation — can contract the virus.

Currently, the only vaccine used in the U.S. is the JYNNEOS vaccine, which is a two-dose shot given four weeks apart and approved by the Food and Drug Administration to prevent smallpox and mpox.

To increase the number of doses available, the FDA announced a new strategy in August to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin.

This allows one vial of vaccine to be given out as five separate doses rather than a single dose.

Over the two-month period, 9,544 cases were reported in this age group. Of those cases, 87.2% were among unvaccinated individuals.

Cases among unvaccinated people were 9.6 times higher compared to vaccinated individuals, according to the study.

Additionally, mpox infections were 7.4 times higher among people who received only the first vaccine dose.

“Monitoring mpox incidence by vaccination status using currently available surveillance data provides an indication of the real-world impact of JYNNEOS vaccine on prevention of mpox to guide rapid public health decision-making,” the authors wrote.

The team also determined there was no difference if the vaccine was administered subcutaneously or intradermally.

“This supports previous clinical trial data that indicated similar immune responses to JYNNEOS vaccination over time after intradermal or subcutaneous administration,” the authors wrote.

The authors noted that the study had limitations, including not controlling for behaviors that affect the risk for virus exposure and whether the vaccine was administered pre-exposure or post-exposure.

But the study shows that at-risk individuals should get the JYNNEOS vaccine as soon as possible, they said.

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FDA weighs whether Lasik patients should be given extra warning about possible risks

FDA weighs whether Lasik patients should be given extra warning about possible risks
FDA weighs whether Lasik patients should be given extra warning about possible risks
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(NEW YORK) — The Food and Drug Administration is weighing whether or not surgeons should provide additional warnings about the risks of Lasik, a popular corrective eye-sight surgery.

In a draft guidance from July, the agency suggested that patients should be explicitly informed about the risks of dry eye, problems driving at night, visual disturbances — or other rare but more serious side effects related to the surgery.

The FDA is still finalizing the guidance. If implemented, companies would be asked to create a checklist of possible risks and surgeons would be asked to go through that checklist with patients to ensure they understand the possible risks and benefits of the procedure.

An FDA spokesperson said in a statement, “The FDA issued a draft guidance in July 2022 that recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices. As part of the guidance process, this document was published in the Federal Register, giving the public an opportunity to comment. The comment period for the draft guidance recently closed on November 25, 2022. With the comment period now closed, the FDA is now reviewing and considering comments for the final guidance. The timeline for the final guidance issuing is dependent on a number of factors and we cannot provide a firm timeline at this point.”

The American Academy of Opthalmology weighed in on the proposed guidance and raised concerns about the checklist.

“Much of the content presented is important for the informed consent process but it is presented with insufficient depth and nuance,” said Dr. Stephen McLeod, CEO of the academy. “The academy’s position is that effective informed consent is a process of shared information and decision-making that occurs between the physician and the patient. Risks and benefits do not exist in a vacuum, and for them to be meaningful rather than abstract, they must be interpreted and discussed in the context of a specific patient. We are also concerned that there are several statements that are not well supported by the latest evidence, and some that have actually been disproved.”

According to the FDA, Lasik is a procedure intended to reduce a person’s dependency on glasses or contact lenses. The agency said that the surgery is one of the most commonly performed and estimated that nearly 600,000 Lasik surgeries are performed each year.

In a video, the agency summarizes some risks to the procedure, stating that “Lasik is not for everyone.”

The newly drafted guidance succeeds two previous FDA measures on disclosing the risks of Lasik surgery.

In May 2009, the FDA issued a letter to eye care professionals providing them with important information about promoting and advertising Lasik after receiving complaints that consumers were not told of the risks associated with the procedure.

Two years later, the FDA issued a second letter “to remind eye care professionals of their legal responsibility to provide balanced information about medical products,” including disclosing risk information in eye care professionals’ promotional material.

In 2017, after the agency reportedly received complaints about side effects from the surgery, from dry eye to more serious stories of chronic eye pain, it commissioned studies to investigate whether patients were being adequately informed about risks, as well as clear benefits.

The 2022 draft guidance suggests that manufacturers and surgeons should explicitly walk patients through a “checklist” that includes clear warnings and benefits.

The drafted Lasik “checklist” includes part of the following.

Six months after surgery:

  • Up to 27% of patients experience dry eye symptoms
  • About 41% of patients may experience visual symptoms such as glare, halos, starbursts or double images
  • Around 4% of patients may have “very” or “extremely” bothersome symptoms
  • Around 2% of patients may have “a lot of difficulty” when not wearing glasses or contacts

Five years after surgery:

  • About 17% of patients still used eye drops for dry eyes
  • Fewer than 2% of patients still notice some visual disturbance
  • About 8% of patients have trouble driving at night
  • There are rare (fewer than 1%) reports of severe, constant pain

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Walgreens launches free Paxlovid delivery service with DoorDash and Uber

Walgreens launches free Paxlovid delivery service with DoorDash and Uber
Walgreens launches free Paxlovid delivery service with DoorDash and Uber
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(NEW YORK) — Walgreens has launched a new delivery service for the COVID-19 oral antiviral therapy Paxlovid in partnership with DoorDash and Uber to get the treatment “directly to the doorsteps of those who need it.”

Walgreens on Thursday said it has more than 8,000 locations offering same-day delivery services, available to anyone who lives within 15 miles of participating stores. Walgreens said that means real access to a lot of Americans — offering it to roughly 92% of the population.

That’s the whole point of this initiative, Walgreens said — increasing access to COVID treatments — with “a focus on reaching those in socially vulnerable or medically underserved areas at a time when COVID-19 cases are beginning to rise again across the United States.”

Paxlovid, from Pfizer, is one of the few treatments still expected to hold up against currently circulating subvariants and comes as coronavirus hospitalizations are trending upward in the elderly.

The drug stops the virus from replicating in the body and works best when taken within five days of getting symptoms. It has proven highly effective at reducing the risk of hospitalization and preventing higher-risk patients from getting even sicker.

To use Walgreens’ new delivery service, eligible patients must have a Paxlovid prescription from a health care provider.

After the pharmacy has filled the prescription, and before it gets picked up, individuals can go online to select Same Day Delivery by visiting Walgreens.com/PrescriptionDelivery, using the Walgreens app or by calling their local store.

To use Same Day Rx Delivery, customers must be opted into Prescription Status Alerts, which will appear as an option if an order is before a particular store’s cutoff time on a given day. Walgreens noted that certain health plans do not cover or participate in Same Day Rx Delivery, and it advised customers to check with individual health plan providers for further details. They also noted that while most prescriptions are “expected to be delivered same day, some deliveries may not be eligible for delivery due to prescription type, delivery address, holidays, weather or other delivery constraints.”

“The COVID-19 pandemic has exacerbated health disparities and emphasized the need to address long-standing barriers, including access to treatments,” Anita Patel, PharmD, vice president of pharmacy services development at Walgreens, said in a statement. “Our pharmacy teams will continue to play a trusted and essential role in helping to keep people protected from COVID-19, including getting people vaccinated, tested and treated as safely, equitably and effectively as possible.”

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Doctors should ask heart patients if they take supplements to manage heart failure

Doctors should ask heart patients if they take supplements to manage heart failure
Doctors should ask heart patients if they take supplements to manage heart failure
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(NEW YORK) — Doctors should ask patients with heart failure if they’re using any supplements, specific diets, or other types of complementary and alternative medicines to help manage potential benefits and risks, the American Heart Association said in a scientific statement published Thursday.

Research shows that about a third of people with heart failure use complementary and alternative medicines, a category that refers to non-traditional treatments used along with or instead of prescribed medications, to manage their conditions. However, most people don’t bring them up with their doctors, experts said.

“Many patients do not routinely report the use of alternative therapies to health care providers, and health care professionals do not routinely ask about or monitor dietary supplements,” Sheryl Chow, the chair of the AHA scientific statement writing committee and an associate professor at the Western University of Health Sciences in California, told ABC News.

That’s a concern because research shows that some alternative treatments can be risky for people with heart failure and may interact with prescribed medications. If providers don’t know what patients are using, they can’t address any potential risk or safety concerns, Chow said.

The AHA reviewed the published data from studies on the efficacy and safety of commonly used complementary and alternative medicines in patients with heart failure. Its scientific statement highlighted the ones that might be beneficial, might be harmful, and have mixed evidence. Fish oil has the strongest evidence of benefit and might help the heart pump better in people with heart failure, for example. Yoga and tai chi might help blood pressure, the study showed.

Other supplements can be riskier, according to researchers. For example, high doses of vitamin D could interact with some common heart failure medications like calcium channel blockers. Some research shows vitamin E is associated with an increased risk of hospitalization for heart failure.

Patients, though, tend to think that alternative medicine can’t be harmful, said Rich Krasuski, a cardiologist at the Duke University School of Medicine who’s done research surveying heart patients on alternative medicine.

“I think patients look at natural or naturally occurring substances as somehow being safer for them than taking a pharmacologic agent,” he told ABC News.

Providers who work with heart failure patients also may not realize that those patients are likely to use complementary or alternative therapies, Krasuski said. Doctors know that people with back pain or cancer tend to seek out alternatives, he says.

“In heart failure, we don’t often think about that,” he said.

Chow hopes the AHA statement helps close the awareness gaps around complementary and alternative medicine in heart failure patients, and gives both providers and patients an easy reference to turn to around the issue.

“Patients aren’t reporting when they use the therapies, but even if they are reporting it, what do providers do with that information?” Chow said. “In general, I feel like health care professionals don’t have great resources for their patients.”

That’s why Krasuski said he’s glad to see this type of statement from the AHA. Rather than dig through research to find information about a specific supplement a patient might be taking, he’ll be able to refer back to this document.

It’d also be a good starting point for the conversations about alternative medicine with patients, he said. The conversations aren’t necessarily to discourage or discount alternative treatments. As long as a supplement or food group isn’t affecting proven medications, Krasuski said he doesn’t have a problem with patient’s using them.

“It’s important to recognize that these are all approaches that patients take,” he said. “I think to improve their health, it’s important that we not only address traditional but also non-traditional types of therapy.”

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What to know about Pfizer’s RSV vaccine for older adults as FDA prepares to review

What to know about Pfizer’s RSV vaccine for older adults as FDA prepares to review
What to know about Pfizer’s RSV vaccine for older adults as FDA prepares to review
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(NEW YORK) — A respiratory syncytial virus, or RSV, vaccine for older adults could be on the horizon after Pfizer announced Wednesday the U.S. Food and Drug Administration would fast-track review of its experimental vaccine.

The federal health agency will make a decision by May 2023 and, if it decides to approve, it will be the first vaccine available in the country to protect against the virus that has swept the country.

“This is huge,” Dr. Gregory Poland, head of the Mayo Clinic’s vaccine research group, told ABC News. “This will be a turning point because of the burden of disease. No one needs to die or be hospitalized for this disease, again, if they take the vaccine and if they have a healthy enough immune system to respond.”

Here is everything we know about the vaccine and the review process:

How does RSV affect older adults?

Although RSV is known as a children’s disease, this is not the case, and the virus can affect adults too.

According to the Centers for Disease Control and Prevention, older adults aged 65 and above are at high risk for severe infection, particularly those with chronic lung or heart conditions and weakened immune systems.

“Older adults are at greater risk than young adults for serious complications from RSV because our immune systems weaken when we are older,” the CDC website states.

Data from the agency shows senior citizens are being hospitalized with the virus at this point in the season at a rate much higher than seen in seasons past.

As of the week ending Nov. 26, the latest date for which data is available, adults aged 65 and older are being hospitalized at a weekly rate of 2.7 per 100,000.

Although the raw number might seem small, it is much higher than usually seen at this time of year. CDC data going back to the 2014-15 season shows the rate has never been higher than 1.0 per 100,000 in early November.

What’s more, an estimated 60,000 to 120,000 older adults are hospitalized every year and between 6,000 and 10,000 die.

Why has there not been a vaccine before?

This is not the first time researchers have attempted to develop an RSV vaccine.

In the late 1960s, a vaccine was produced in which the virus was inactivated with formalin, a chemical that kills viruses. The shot was given to children in Washington, D.C., but 80% of those immunized became sick and two children died.

Studies found that the vaccine did not generate enough antibodies to fight off the virus and instead triggered an overactive immune system response.

“That stymied vaccine development for 50, 60 years in this field,” Poland said.

How does the vaccine work?

In 2013, researchers at the National Institutes of Health studied a protein from the virus called the F protein, which attaches to human cells and infects people.

They found a way to freeze the protein in the form it takes before it’s ready to attach to cells, known as prefusion form.

The Pfizer vaccine contains this prefusion form of the protein. It also is bivalent, meaning it helps protect against both the A and B strains, which are the two most common strains of the virus.

How effective is the vaccine?

Pfizer ran a phase III clinical trial testing its vaccine in adults aged 60 and older against a placebo.

In late August, the company announced that its vaccine was 66.7% effective in preventing lower respiratory tract illness and 85.7% effective at preventing severe disease.

Additionally, Pfizer said there were no safety concerns and that the vaccine was “well tolerated” among participants.

“This is outstanding,” Poland said. “We have literally gone from a vaccine that harmed people inadvertently, a shutdown in RSV vaccine research to now a phase III large global trial that showed this vaccine has excellent efficacy and preventing lower respiratory tract disease.”

What is next?

Pfizer has submitted what is known as a Biologics License Application, which is tens of thousands of pages long.

The FDA will internally review and analyze the data and make a decision on whether the vaccine is potentially ready to be marketed, Poland explained.

If the FDA decides it is ready to be marketed, it will call a meeting of its independent advisory panel, the Vaccines and Related Biological Products Advisory Committee.

During this meeting, the company will present its data, the FDA will present its analysis, there will be public commentary and the committee will discuss several questions about the vaccine including whether this is the right age group and if the vaccine is safe and efficacious.

If the committee votes to recommend authorization, the FDA will either agree with the advisory panel and authorize the vaccine or not, which should occur by May 2023.

Following this, the final step will be a similar meeting among the CDC’s advisory committee and the CDC deciding to follow or go against the recommendation.

If the vaccine is approved, it will likely be available by fall 2023.

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Kirstie Alley’s death at 71 puts spotlight on colon cancer: What women need to know

Kirstie Alley’s death at 71 puts spotlight on colon cancer: What women need to know
Kirstie Alley’s death at 71 puts spotlight on colon cancer: What women need to know
KATERYNA KON/SCIENCE PHOTO LIBRARY/Getty Images

(NEW YORK) — Kirstie Alley’s unexpected death at age 71 has put a spotlight on colon cancer, the disease that took her life.

Alley had been recently diagnosed with colon cancer prior to her Dec. 5 death, a rep for the actress confirmed to ABC News.

“We are sad to inform you that our incredible, fierce and loving mother has passed away after a battle with cancer, only recently discovered,” Alley’s children True and Lillie Parker wrote in a statement shared to Alley’s Twitter account Monday night. “She was surrounded by her closest family and fought with great strength, leaving us with a certainty of her never-ending joy of living and whatever adventures lie ahead. As iconic as she was on screen, she was an even more amazing mother and grandmother.”

Colorectal cancer — the umbrella term for colon and rectal cancers — is the fourth most common cancer in men and women in the United States, according to the Centers for Disease Control and Prevention.

It affects men and women almost equally. The lifetime risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.

At age 71, Alley was in the age demographic — ages 45 to 75 — when colon cancer is most likely to occur, CDC data shows.

It is not known exactly when Alley was diagnosed with colon cancer, or what stage she was in or what treatment she received. Her family said only that her cancer was “recently discovered.”

While colon cancer does have signs and symptoms, they often may not show until the disease is in its later stages, according to ABC News chief medical correspondent Dr. Jennifer Ashton.

“The key thing is that in early stages of colon cancer, there can be no symptoms or someone could be asymptomatic,” Ashton said Wednesday on “Good Morning America.” “When you get to more advanced stages, there can be signs and symptoms like abdominal pain, unexplained weight loss, blood in stool or anemia that is detected, but those are the signs typically when you’re talking about metastatic or later stages.”

Risk factors for colon cancer include everything from family history and certain genetic mutations to lifestyle factors like obesity, inactivity, smoking and alcohol to excess, and a diet low in fiber, fruits and vegetables, according to Ashton.

“It’s typically not one thing,” she said of the risk factors.

Colon cancer has been more in the spotlight in recent years with the death of Chadwick Boseman at age 43 and, more recently, with ’80s pop star Taylor Dane revealing she battled the same disease.

Earlier this year, a major study found that more young people are being diagnosed with late-stage colon cancer, prompting renewed calls among doctors for early detection and screening.

Researchers from University of Colorado School of Medicine found that young patients under 40 years old have had the highest increase in rates of new late-stage colon cancer cases diagnosed, meaning the cancer has already spread at the time of diagnosis. In particular, subgroups of non-Hispanic Black and Hispanic participants had the highest increases.

The United States Preventive Services Task Force, the leading organization on preventative medicine, recently changed the guidelines to start screening for colon cancer to age 45, down from 50, in light of the trends of increasing cases of colon cancer in younger people.

There are several different ways of screening for colon cancer, including visual exams and stool tests.

The most commonly known test, a colonoscopy, requires a doctor to use a flexible tube with a camera at the end to directly look at your colon and rectum. Flexible sigmoidoscopy can also be done where only the lower third of the colon and rectum is examined. During both tests, suspicious areas can be biopsied and removed if necessary.

A “virtual colonoscopy” uses a CT scan to take images of your colon and rectum. All these tests require a bowel prep to allow for good visualization.

Stool-based tests include three blood tests that look for hidden blood, antibodies or abnormal DNA in the stool, all indicative of cancer or polyp cells. If a test other than a colonoscopy is performed and turns up abnormal results, it should be followed up with a colonoscopy.

While a colonoscopy can be a daunting test for some due to the prep work involved — including drinking a prescription laxative drink — Ashton said there are steps people can take to make it easier.

“The first thing I tell my patients is you have anesthesia. You are asleep. You will feel no discomfort, no embarrassment,” said Ashton. “But the key thing for the prep … I say start two days before with a clear liquid diet.”

Some examples of liquids to consume include ginger ale, clear chicken broth, Jell-O and coconut water, according to Ashton.

“That will make the day before [the colonoscopy] much easier,” said Ashton. “And it will make the job of a gastroenterologist easier because they’ll be able to get a better visualization.”

Amrit K. Kamboj, MD, an internal medicine resident, and Vanya Jain, a medical student from New Jersey Medical School, who previously worked with the ABC News Medical Unit, contributed to this report.

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