FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use
Healgen
(WASHINGTON) — The U.S. Food and Drug Administration authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday evening.
This means the Healgen Rapid Check COVID-19/Flu A&B Antigen Test is available without a prescription. The FDA said the test is for those who are experiencing respiratory symptoms.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency.
The new combination test uses a nasal swab sample to deliver at-home results for COVID-19 and influenza in approximately 15 minutes.
Healgen’s test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu.
“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions,” the statement continued.
The test is for use by people 14 and older who can take their own sample, or those 2 and older, who have a sample taken by an adult, according to the federal health agency.
Data reviewed by the FDA found the test correctly identified 99% of negative and 92% of positive COVID samples. Additionally, the test correctly identified 99.9% of negative flu samples, and 92.5% and 90.5% of positive flu samples, respectively.
Like other over-the-counter COVID-19 antigen tests, the FDA says a positive test result likely means a patient is positive while a negative rest result may require a confirmation test.
However, people who test negative and continue to experience symptoms including cough, fever and shortness of breath should follow up with their health care provider, the FDA says. Similarity, the FDA says those who test positive should take appropriate precautions to avoid spreading either virus and should also follow up with their health care provider.
(NEW YORK) — With autumn in full swing, flu season is ramping up as well.
According to the Centers for Disease Control and Prevention, flu season in the U.S. typically picks up in the fall and winter months and children, especially, are the most likely to get sick from influenza, a type of respiratory virus.
Here’s how to prepare for the season ahead:
What causes influenza (flu)?
The flu is caused by various influenza viruses that impact the respiratory system. For the 2024-2025 flu season, the CDC expects the dominant influenza viruses in the U.S. to be an A(H1N1) virus, an A(H3N2) virus, and a B/Victoria virus.
What are common flu symptoms?
Symptoms of the flu can vary but per the CDC, they may include fever or chills, a cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, fatigue, vomiting or diarrhea. The latter two symptoms are more common among children with the flu.
What is the flu incubation period and when are you most contagious?
Individuals with the flu can spread the virus to others, and according to the CDC, the incubation period can last between one and four days. The first three days of an infection tend to be the most contagious period.
The CDC recommends a flu vaccine for nearly everyone six months and older in the U.S. every flu season, except for anyone younger than six months or anyone with a severe, life-threatening allergy to any ingredient in a vaccine or the flu vaccine specifically.
What months are considered flu season?
The flu is most active between the fall and winter months. During the 2023 to 2024 flu season, CDC reports showed that national flu activity started to increase in October 2023 and didn’t start to decline until mid-April 2024.
How can you prepare for flu season?
Dr. Meghan Martin, a pediatric emergency medicine physician and a mom, shared in a TikTok post what she keeps on hand at home to stay prepared for flu season.
Her top items include:
Disposable vomit bags
Acetaminophen/Ibuprofen in multiple forms, including chewable tablets, liquid form or suppositories
Digital Thermometer
Zyrtec or a similar second-generation histamine for allergic reactions or hives
A portable pulse oximeter to measure heart rate and oxygenation
Packs of electrolyte powder
Cough suppresants and oral anesthetics including those in lollipop forms
Saline nasal mist
A squeeze bottle kit for over-the-counter saline solutions
(NEW YORK) — A new study suggests that GLP-1 agonist medications like Ozempic, which are used for diabetes management and weight loss, may help reduce the risk of overdose and alcohol intoxication in people with substance use disorders.
“It helps to underline another significant benefit of this class of medication,” Dr. Angela Fitch, the co-founder, and chief medical officer of knownwell, a company that provides weight-inclusive health care, told ABC News.
The large study, published in the journal, Addiction, analyzed the health records of 1.3 million people from 136 U.S. hospitals for nearly nine years. That included the records of 500,000 people with opioid use and more than 800,000 with alcohol use disorder.
Those who took Ozempic or a similar drug had a 40% lower chance of overdosing on opioids and a 50% lower chance of getting drunk compared to those who didn’t take the medication, the study found.
“The existing medications for treating substance use disorder are underutilized and stigmatized,” said Fares Qeadan, associate professor of biostatistics at Loyola University in Chicago. “These medications intended for diabetes and weight loss can help addiction without the associated stigma, which will be a new window for how to deal with addiction.”
The protective effects were consistent and even applied to people with Type 2 diabetes, obesity, or both conditions.
Fitch expressed optimism about the study’s results.
“As clinicians, recognizing that people can get double benefits from something is always helpful and as more obesity medications enter the market, this can help personalize treatments,” she said.
GLP-1 drugs, such as Ozempic and the combination drug tirzepatide also included in the study, mimic a natural hormone known as glucagon-like peptide-1 to help regulate blood sugar and insulin levels. For managing obesity and diabetes, these medications work by slowing digestion, reducing appetite, and enhancing insulin release in response to meals.
Scientists don’t fully understand how these drugs work yet. Some studies indicate that they activate specific “reward” receptors in the brain that make high-calorie foods less gratifying, so users eat less.
This could also be the reason these drugs may reduce cravings for alcohol and opioids. For example, a previous study found that adding the GLP-1, exenatide, was effective at helping some people with obesity and alcohol use disorder drink less.
The Addiction study does not prove that GLP-1 medications directly lower the risks of opioid overdose and alcohol intoxication, only that people taking them seemed to be helped. And it only included hospitalizations so it’s not clear if they will work as well in less serious cases.
Prescribing the drugs to treat substance use, at least for now, isn’t possible because they aren’t approved by the U.S. Food and Drug Administration for that purpose, Fitch pointed out.
“One of the challenges that we have as clinicians is we know that some of these benefits help patients. And not being able to get them access is very challenging,” she said.
People with substance use disorder keep using drugs or alcohol even though it causes problems in their life. According to the CDC, there are 178,000 annual deaths linked to excessive drinking. Over 75% of drug overdose deaths in 2022 involved opioids.
If you or someone you know is living with substance use disorder, free, confidential help is available 24 hours a day, seven days a week, by calling or texting the national lifeline at 988.
Dr. Faizah Shareef is an Internal Medicine Resident Physician and a member of the ABC News Medical Unit.
(NEW YORK) — With the recent pick of Robert F. Kennedy Jr. to lead the Department of Health and Human Services, the environmental attorney’s views on vaccines have been thrust back into the spotlight.
Kennedy has been a prominent vaccine skeptic, arguing that more research of vaccines is needed, although he has claimed in interviews that he has “never been anti-vaccine.”
Vaccine researchers tell ABC News that his recent comments don’t align with his past campaigns and that, if confirmed, he could convince vaccine-hesitant parents to not vaccinate their children.
“He’s really not a vaccine skeptic; I’m a vaccine skeptic,” Dr. Paul Offit, director of the Vaccine Education Center, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia and a member of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, told ABC News.
“Everybody who sits around the table at the FDA vaccine advisory committee is a vaccine skeptic, right? Show us the data, prove that this vaccine is safe, prove that it’s effective, because then and only then will we authorize it, or recommend authorization or licensure,” he said.
Offit argued that Kennedy is a “vaccine cynic,” adding, “He thinks that we’re not getting the right information, that there’s an unholy alliance between the pharmaceutical industry and the FDA with the [Centers for Disease Control and Prevention] to hide the real data, and he’s going to find the real data, which is utter nonsense.”
Claims that vaccines cause autism
Kennedy has previously claimed that the measles, mumps and rubella (MMR) vaccine — a myth that was born out of a now-debunked paper from the U.K. in 1998.
The fraudulent paper has since been discredited by health experts, retracted from the journal in which it was published, and its primary author, Andrew Wakefield, lost his medical license. More than a dozen high-quality studies have since found no evidence of a link between childhood vaccines and autism.
Dr. Peter Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, said he’s worried that COVID-19 vaccine hesitancy has spilled over into hesitancy towards childhood vaccines.
There have been more measles outbreaks this year than last year and a five-fold increase in whooping cough cases this year from the year before, according to CDC data, which Hotez says is a sign that more parents may be increasingly vaccine-hesitant.
According to the CDC, there have been a total of 277 measles cases reported in 30 states in 2024 — more than four times the amount last year — with 16 outbreaks this year compared to four outbreaks in 2023. An estimated 96% of measles cases this year were not fully vaccinated. Additionally, whooping cough cases are at the highest levels this year since 2014, according to CDC data.
This comes as vaccinations among kindergarteners dipped in the 2023-2024 school year for the fourth year in a row – failing to meet the 95% threshold goal aimed to prevent a single infection from sparking an outbreak. The last time that threshold was met was pre-pandemic, during the 2019-2020 school year.
“Now you put someone like Robert F. Kennedy Jr., the nation’s most prominent, well-known anti-vaccine activist at the top of the food chain, at the top of Health and Human Services,” Hotez said. “I don’t see how these things improve any. If anything, they could start to decline even further. …So, I worry about further erosion in the number of kids getting vaccinated in the U.S.”
Claims about the COVID-19 vaccine
Kennedy also spread vaccine misinformation during the COVID-19 pandemic including claims that Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, and the Bill & Melinda Gates Foundation were trying to profit off a COVID-19 vaccine.
During a December 2021 Louisiana House of Representatives meeting discussing a proposal to require schoolchildren to receive the COVID-19 vaccine, Kennedy falsely called the vaccine the “deadliest vaccine ever made.”
Health officials say COVID-19 vaccines are safe and effective following clinical trials that involved tens of thousands of people, and have since helped save millions of lives.
Offit says he is worried that, as the head of the HHS, Kennedy would help select directors of the CDC, FDA and the National Institutes of Health who are not qualified, and could similarly espouse vaccine-skeptic views.
“My worry is that he is not going to pick technically competent people,” he said. “My worry is he’s going to have a role in selecting ideologues who are not well-educated about infectious diseases or vaccines, and maybe who lack government experience as well.”
Both Offit and Hotez said it will be important over the next four years for doctors to have conversations with vaccine-hesitant parents to educate them on the importance of vaccinating their children in case they are swayed by vaccine-skeptic rhetoric from Kennedy.
Offit said he is already getting emails from pediatricians about parents who are hesitant to vaccinate their children because of Kennedy’s past comments.
“Over the last few days, I’ve gotten emails from pediatricians, one particularly in Connecticut that comes to mind, where they’re saying, ‘Parents are coming in, and they’re saying they don’t want to get vaccines, in part because of what [Kennedy] said. What should we do?'” Offit said. “So, I think that’s where the rubber meets the road. It’s certainly a lot more work for clinicians than it used to be.”
