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COVID-flu combo vaccine shows ‘positive’ results in phase 3 trials, Moderna says: A 'two-for' option

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COVID-flu combo vaccine shows ‘positive’ results in phase 3 trials, Moderna says: A 'two-for' option

A combination COVID-influenza vaccine is apparently one step closer to hitting the market.

Moderna, which is developing the experimental vaccine, announced Monday that in phase 3 clinical trials, mRNA-1083 achieved a better immune response than other vaccines.

The combination vaccine includes mRNA-1010 (Moderna’s vaccine candidate for seasonal influenza) and mRNA-1283 (the company’s “next-generation COVID-19 vaccine candidate”), according to a press release from the company.

COVID AND FLU VACCINE RATES ARE DECLINING FOR US HEALTH CARE WORKERS, CDC REPORTS: ‘DISTURBING TREND’

“This data serves as a milestone for the industry’s pursuit of a flu and COVID-19 combination vaccine, which could change the way we manage the respiratory illness season,” Francesca Ceddia, chief medical affairs officer at Moderna, said in a statement to Fox News Digital. 

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A combination COVID-influenza vaccine is one step closer to hitting the market with this new announcement from Moderna. (iStock)

“With mRNA-1083, we may be able to not only offer the convenience of dual protection in a single shot, but we also may offer enhanced immunity compared to today’s standalone vaccines against the two respiratory diseases with the largest burden on health care systems,” she continued.

“Our hope is that with improved convenience comes improved compliance — helping to advance public health and lower rates of severe outcomes related to COVID-19 and flu.”

Moderna is the only company with a positive phase 3 flu and COVID combination vaccine, according to the company’s press release.

MANY YOUNG KIDS ARE NOT GETTING ‘LIFE-SAVING’ VACCINES

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Moderna’s phase 3 trial was a randomized, double-blinded study that included two independent groups, each consisting of 4,000 adults.

One group included adults age 65 and older, who compared the experimental vaccine to Fluzone HD, an enhanced influenza vaccine, and Spikevax, Moderna’s currently licensed COVID-19 vaccine, the release stated.

Moderna sign

Moderna announced Monday that in phase 3 clinical trials, mRNA-1083 achieved a better immune response than other vaccines. (REUTERS/Brian Snyder)

The second group, which included adults 50 to 64 years old, compared mRNA-1083 to Fluarix, a standard dose influenza vaccine, and Spikevax.

In both groups, mRNA-1083 resulted in “statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2,” according to the release.

“One can never predict rare adverse events.”

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Amrie Grammer, a Virginia-based immunologist who previously worked with the National Institutes of Health, was not involved in the trial or the vaccine development but commented on the findings.

“Moderna’s results from their Ph3 NCT06097273 trial indicate that the dual SARS-CoV-2/influenza immunization is no less effective than two single shots,” Grammer told Fox News Digital.

COVID and flu viruses

In both groups, mRNA-1083 resulted in “statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.” (iStock)

“This makes it simpler for more Americans to protect themselves from these two serious infections, especially those 65 and older who are most at risk for COVID- and flu- related deaths,” she continued.

“Ninety percent of deaths from COVID and 70% to 85% of deaths from the flu in 2023 were in those 65 and older.”

“This is especially good news for people who are wary of too many vaccines, even if they believe in them.”

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Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was also not involved in the trial but shared insights. 

CDC RECOMMENDS ADDITIONAL COVID VACCINE FOR ADULTS 65 AND OVER

“Moderna has been working on combining a vaccine to fight both the latest coronavirus subvariant and the year’s flu strain,” he told Fox News Digital. 

“The phase 3 clinical trials look excellent — safe and effective, with more antibodies made against both than when either immunization is given alone.”

COVID clinical trials

Overall, the experimental vaccine showed an “acceptable tolerability and safety profile,” Moderna stated.  (iStock)

The effectiveness is likely due to the vaccine “waking up” the immune system to both viruses at the same time, causing a stronger, more varied and more durable response, according to Siegel.

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“This is especially good news for people who are wary of too many vaccines, even if they believe in them,” he said.

“The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache.”

“This shot creates a ‘two-for’ option and should be a useful tool, especially if primary care physicians have ready access to it.”

Overall, the experimental vaccine showed an “acceptable tolerability and safety profile,” Moderna stated. 

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“The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache,” per the release.

As Grammer pointed out, Moderna’s phase 3 trial included thousands of people with a “modest adverse event profile, but one can never predict rare adverse events.”

Child receives vaccines

As of May 2022, only some 23% of U.S. adults are up-to-date on COVID vaccines, according to data from the CDC. (Julian Stratenschulte/dpa)

Siegel also chimed in on the vaccine’s safety profile.

“Contrary to some public pronouncements, this has been shown to be an overall very safe technology, though it does cause short-term side effects, like sore arm and, rarely, something more pronounced or long-lasting,” he told Fox News Digital.

         

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As of May 2022, only some 23% of U.S. adults are up-to-date on COVID vaccines, according to data from the Centers for Disease Control and Prevention (CDC).

Flu vaccine coverage for adults was around 47% as of January 2024, per the CDC.

COVID vaccine

The effectiveness is likely due to the vaccine “waking up” the immune system to both viruses at the same time, a doctor noted. (iStock)

Looking ahead, Moderna plans to present the phase 3 clinical data and submit it for publication.

“Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication,” the release stated. “The company will engage with regulators on next steps.” 

For more Health articles, visit www.foxnews/health 

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Both Novavax and Pfizer-BioNTech also have ongoing clinical trials of SARS-CoV-2/influenza vaccines, Grammer pointed out.

“Our Phase 3 COVID-19-influenza combination study is on track to start in the second half of this year,” a spokesperson from Novovax told Fox News Digital. 

“A single combination vaccine visit creates a convenience that we believe can translate into improved vaccination rates, especially in older adults, who are most at risk.”

Fox News Digital reached out to Pfizer for comment.

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Experimental Alzheimer’s drug gets FDA advisory panel's thumbs-up: ‘Progress is happening’

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Experimental Alzheimer’s drug gets FDA advisory panel's thumbs-up: ‘Progress is happening’

An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration (FDA) advisory panel on Monday.

Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia.

At the FDA’s Peripheral and Central Nervous System Advisory Committee hearing, which was held in Maryland on Monday, the advisers unanimously agreed that the drug’s benefits outweigh any potential risks.

CAN WE REVERSE ALZHEIMER’S DISEASE? EXPERTS SUGGEST ‘NEW PARADIGM’ FOR COMBATING DEMENTIA

While this isn’t a guarantee the FDA will approve the drug, the agency does typically follow the panel’s recommendations, per reports.

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“The FDA held the advisory committee meeting to hear the viewpoints and assessments of the experts on both the benefits and the risks of donanemab,” the agency told Fox News Digital in an emailed statement. 

“As with all applications the FDA receives, we will thoroughly review and consider the input from the committee.”

An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration advisory panel on Monday. (iStock)

Officials at Eli Lilly, the Indiana pharmaceutical company that makes donanemab, were also in attendance, fielding questions from the committee about potential side effects.

At the Monday hearing, Eli Lilly officials presented clinical trial results that showed the drug slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s.

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The study was also published by the Journal of the American Medical Association.

ALZHEIMER’S DISEASE FOUND TO BE TRANSMITTED THROUGH MEDICAL PROCEDURES DECADES AGO, STUDY FINDS

In phase 3 trials published in May 2023, donanemab was shown to “significantly slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease,” according to a press release on Eli Lilly’s website.

If donanemab is approved, it would become only the second available medication designed to slow the progression of Alzheimer’s symptoms.

Man taking medicine

Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia. (iStock)

Leqembi, the first new Alzheimer’s treatment in 20 years, was given full FDA approval in July 2023.

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Donanemab works by clearing built-up amyloid from the brain. It was shown to cause side effects such as “brain swelling and tiny bleeds,” researchers found.

FDA FULLY APPROVES ‘NOVEL’ ALZHEIMER’S DISEASE DRUG LEQEMBI, WILL BE COVERED BY MEDICARE

The Alzheimer’s Association, based in Chicago, released a statement welcoming the FDA’s finding that donanemab is effective for the treatment of early Alzheimer’s disease.

“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO, in a statement provided to Fox News Digital. 

Eli Lilly

Eli Lilly officials presented clinical trial results showing that the drug, donanemab, slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s. (iStock)

“Progress with treatment is happening. Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety,” she continued.

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“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”

The next step toward approval of donanemab is FDA review.

Dr. Marc Siegel

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation.  (Dr. Marc Siegel)

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, who was not involved in the drug trials, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation. 

“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”

— Joanne Pike, CEO of the Alzheimer’s Association

“The problem with … denonemab is similar — it can cause brain swelling and bleeding,” Siegel told Fox News Digital.

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“It is also expensive, as it’s once a month versus once every two weeks for Leqembi.” 

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Denonemab is “somewhat more effective,” Siegel noted, as it slows progression of Alzheimer’s by about 35% versus 27% for Leqembi.

“It may be better at removing plaques,” he said.

man with alzheimers supported by wife

“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” the Alzheimer’s Association president and CEO said in a statement. (iStock)

There may be limitations associated with these types of drugs, however, according to the doctor.

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“Many experts have told me that the obsession with amyloid formation may not be the holy grail it was once thought to be,” Siegel told Fox News Digital. 

“The study didn’t pay enough attention to tau proteins, which are also a key player here.” 

For more Health articles, visit www.foxnews/health

Tau proteins, which cause “tangles” in the brain of Alzheimer’s patients, are not the primary targets of these drugs, Siegel said. 

                             

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“There is also the issue of neuroinflammation and neuronal transmission abnormalities, which precede the buildup of the plaque proteins and are important targets for research.”              

In response, Eli Lilly provided the below statement.

“Lilly is pursuing multiple approaches to treat Alzheimer’s disease and other forms of dementia. Our pipeline of molecules in human testing includes ones aimed at amyloid (donanemab, remternetug), tau (OGA inhibitor), as well as lewy body dementia and frontotemporal dementia.”

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I Lost 233 Pounds With Protein Shakes to Jumpstart Weight Loss!

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Does sunscreen cause skin cancer? Doctors debunk claims gone wild on social media

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Does sunscreen cause skin cancer? Doctors debunk claims gone wild on social media

Some claims on social media about sun safety have grown into a major misconception that sunscreen could cause skin cancer.

Hundreds of creators, many on TikTok, have posted videos arguing that the sun isn’t the culprit in causing cancer, but rather that harmful chemicals found in sunscreens are to blame.

This stems from a 2021 recall of Neutrogena spray sunscreens and one Aveeno product (Aveeno Protect + Refresh aerosol sunscreen) due to the presence of benzene, a known carcinogen.

JOHNSON & JOHNSON RECALLS SEVERAL SUNSCREENS: HOW TO CHOOSE THE RIGHT PRODUCT

Johnson & Johnson officials confirmed that benzene is not a sunscreen ingredient, according to a Harvard Medical School advisory in Oct. 2021.

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Additional testing reportedly found such low levels of benzene in these products that it would not be expected to cause health problems.

Johnson & Johnson’s Neutrogena Beach Defense bottles are seen on display on a table. The Neutrogena Beach Defense is one of the sunscreens that was recalled due to containing benzene. (Aimee Dilger/SOPA Images/LightRocket via Getty Images)

Experts advised choosing a different sunscreen brand as a solution.

But a national survey by the Orlando Health Cancer Institute in Florida found that one in seven adults under 35 years old believe sunscreen is more harmful to the skin than direct sun exposure.

SKIN CANCER CHECKS AND SUNSCREEN: WHY THESE (STILL) MATTER VERY MUCH FOR GOOD HEALTH

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Another 23% believe that drinking water and staying hydrated can prevent sunburns.

“This phenomenon taps into the public’s growing distrust of companies due to the proliferation of harmful chemicals in consumer products.”

Many Americans (32%) also believe that a tan makes people look better and healthier, the survey found.

Rajesh Nair, M.D., an oncology surgeon at the Orlando Health Cancer Institute, commented in a press release that there is “no such thing as a healthy tan.”

woman using sunscreen on a beach

Thirty-two percent of Americans believe that a tan makes people look better and healthier, according to the Orlando Health Cancer Institute study. (iStock)

“It’s really just a visual manifestation of damage to the skin,” he said. “But we’re fighting against a perceived positive image and health benefits of something that actually has a totally opposite reality, which is that suntanned skin represents an increased risk of a deadly disease.”

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“Age, gender and phenotype play a role, too.” 

Krista Rubin, a nurse practitioner and member of Mass General Cancer Center’s Melanoma Team, told Fox News Digital that there is “little evidence supporting the claim that sunscreens are carcinogenic.” 

SUNBURN SOS: 7 TIPS TO SOOTHE YOUR SUN-DAMAGED SKIN, ACCORDING TO A WELLNESS EXPERT

“There is clear-cut evidence of the link between UV radiation exposure and skin cancer,” she wrote in an email. “However, the risk of developing skin cancer isn’t limited to UV radiation exposure – age, gender and phenotype play a role, too.” 

Males are at a higher risk of developing skin cancer, Rubin said, as are people with blonde or red hair, light skin or light eyes. 

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man applies sunscreen on his shoulder at the beach

Sunburns are caused by damage from the sun’s UV rays, according to experts. (iStock)

Other risk factors include having a suppressed immune system, being a solid organ transplant recipient or taking certain medications.

Rubin reiterated that sunburns are caused by the sun’s UV rays damaging the skin. So, while drinking water in hot weather will help prevent dehydration and keep the body cool, it will not prevent sunburn.

HOW TO WEAR SUNSCREEN THE RIGHT WAY: YOUR GUIDE TO SPF

“A tan is visible evidence of skin injury,” the expert said. “Whether from the sun or from a tanning bed, tanning exposes the skin to high levels of UVA radiation, which we know is not healthy and is linked to both skin cancer and accelerated aging.”

Social media expert Eric Dahan, founder of Mighty Joy, said she believes social media has become “rife with misinformation about sunscreen.”

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Peeling skin on the shoulder after sunburn

“A tan is visible evidence of skin injury,” one expert said. (iStock)

“It’s often spread by well-meaning but overall uninformed, self-appointed health and wellness experts and select dermatologists,” said Dahan, who is based in California. 

“A lot of the misinformation is due to actual science being less engaging and more nuanced than bold (false) statements.” 

The spread of false information regarding sunscreen reflects a “general public sentiment” about what the products contain, Dahan said. 

WHAT SPF SHOULD YOUR SUNSCREEN HAVE? FIND OUT HOW IT MAY HELP PREMATURE AGING AND SKIN CANCER

“This phenomenon taps into the public’s growing distrust of companies due to the proliferation of harmful chemicals in consumer products,” he said. 

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“Over the years, we have discovered that materials that were deemed as ‘safe’ are highly harmful – from lead, BPA, PFaS and now plastics.”

woman and man spraying sunscreen in a kayak

A rise in cancer rates among young people could be driving a “distrust of companies,” one expert noted. (iStock)

There has also been a rise in cancer rates among young people, Dahan mentioned, which further drives a “healthy distrust of companies and government regulators.”

“When it comes to sunscreen, it seems a lot of the misinformation was driven by an old chemical used decades ago that has since been prohibited, after a contamination event led to a recall,” he said.

Among consumers of social media, Dahan suggested that it is “very difficult to determine what is true if you’re not an expert.” 

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“There are conflicting studies, conflicting opinions from seemingly credible individuals, flat-out false information, and an overall lack of confidence in the private companies making these products and in government regulators,” he said.

Some experts — including Dr. Nicky Gazy, a board-certified dermatologist in Florida — have responded on social media with the recommendation to use sunscreen alternatives that do not contain benzene.

a little girl has sunscreen applied to her face

One dermatologist recommended using zinc-based mineral sunscreen. (iStock)

“When it comes to skin cancer and skin health, any sunscreen is better than no sunscreen,” Gazy said in a TikTok video posted in July 2023.

For more Health articles, visit www.foxnews/health

To decrease cumulative exposure to “chemical sunscreens,” Gazy recommended wearing a zinc-based mineral sunscreen. 

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“It’s actually what I recommend to my patients, especially my pregnant patients,” he said.

Fox News Digital reached out to Johnson & Johnson for comment.

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