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FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

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Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.

The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease. 

The most common symptoms of chikungunya include fever and joint pain. Other symptoms may include a rash, headache, and muscle pain. Some individuals may experience debilitating joint pain that persists for months or even years. Treatment includes rest, fluids, and over-the-counter medications for pain and fever.

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.

The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.

In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that lasted for at least 30 days. The Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.

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The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq.

Transmission of chikungunya virus to newborn babies from pregnant individuals with viremia (virus present in the blood) at delivery has been reported and can cause severe, potentially fatal chikungunya virus disease in newborns. In one study that evaluated whether the vaccine virus was present in the blood after vaccination, most individuals had vaccine virus detected in the blood within the first week following vaccination; the vaccine virus was not detected 14 days after vaccination. The Prescribing Information includes a warning to inform that it is not known if the vaccine virus can be transmitted from pregnant individuals to newborns, nor is it known if the vaccine virus can cause any adverse effects in the newborn. The warning also conveys that when considering administration to pregnant individuals, healthcare providers should take into consideration the individual’s risk of exposure to chikungunya virus, gestational age and risks to the fetus or neonate from disease caused by chikungunya virus in the pregnant individual.

The effectiveness of Ixchiq is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level. 

Ixchiq was approved using the Accelerated Approval pathway. Accelerated approval allows the FDA to approve certain products for serious or life-threatening conditions based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit. In the FDA’s evaluation of Ixchiq for accelerated approval, evidence of effectiveness is based on immune response data in clinical trial participants. As a condition for approval for Ixchiq, the FDA is requiring confirmatory clinical studies to be conducted to verify clinical benefit.

Ixchiq was granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. In addition, the FDA awarded the manufacturer of Ixchiq a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

The FDA granted approval of Ixchiq to Valneva Austria GmbH.

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Food and Beverage

Nationwide Health Alert for E. coli Contaminated Ground Beef: What You Need to Know

“Nationwide health alert issued for E. coli-contaminated ground beef. Check FSIS website for affected products and disposal instructions.”

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A recent national health alert has been issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regarding Greater Omaha ground beef products potentially contaminated with E. coli O157:H7. This particular strain of E. coli can cause severe gastrointestinal infections in humans. In this article, we will provide you with all the information you need to know about this alert and how to stay safe.

Product Details:
The affected ground beef products were produced and packaged on March 28, 2024, with a “Use/Freeze by” date of April 22, 2024. The packaging will also have “EST.960A” inside the USDA mark of inspection. While the ground beef was distributed to various restaurants and retail locations nationwide, it is important to note that the impacted products are no longer available for sale.

Affected Products:

  • 10-lb. ground beef chub: GROUND BEEF 85 FINE GRIND 10#/6 (Lot codes: 25, 28, 29, 30, 31, 32, and 33; Case code: 263085)
  • 5-lb. ground beef chub: GROUND BEEF GOHERF GB RIB BRISKET CHUCK CRAFT BURGER 5LB (Lot code: 26; Case code: 66500)
  • 5-lb. ground beef chub: Greater Omaha 100% ALL NATURAL 5 LBS. GOURMET BLEND RIB BRISKET CHUCK
  • 5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5#/12 EXACT WEIGHT (Lot code: 26; Case code: 663581)
  • 4-pack 8-oz ground beef patties: GROUND BEEF GOANG GB Patty 8OZ Homestyle Rib/Brisket/CH (Lot code: 34; Case code: 716800)
  • 4-pack 8-oz ground beef patties: LOT 34 Ground Beef GB GOANG 75 PATTY PUCK 8 OZ (Lot code: 34; Case code: 728075)
  • 4-pack 7-oz ground beef patties: LOT 34 GROUND BEEF GOANG Rib/Brisket/Chuck 7OZ HOMESTYLE (Lot code: 34; Case code: 716700)
  • 6-oz ground beef patties: LOT 34 GROUND BEEF GOANG GB PATTY 6 OZ HOMESTYLE RIB/BRISKET/CHUCK (Lot code: 34; Case code: 716600)
  • 5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5LB EXACT WEIGHT (Lot code: 26; Case code: 63581)
  • 6-pack 5.33-oz ground beef patties: Ground Beef GOHERF RIB BRISKET CHUCK 5.33oz HOMESTYLE (Lot code: 27; Case code: 616500)
  • 4-pack 8-oz ground beef patties: LOT 27 Ground Beef GOHERF Homestyle GB PATTY RIB/BRISKET/CHUCK 8 OZ (Lot code: 27; Case code: 616800)
  • 10-lb. ground beef chub: GROUND BEEF 73 FINE GRIND 10#/6 (Lot code: 37; Case code: 263073)
  • 4-pack 8-oz ground beef patties: LOT 51 Ground Beef GB GOANG 75 PATTY PUCK 8OZ (Lot code: 51; Case code: 728075)

Recommendations:
If you have any of the above-mentioned ground beef products stored in your freezer, the FSIS advises against consuming them. Instead, it is important to either throw them away or return them to the place of purchase. Doing so will help prevent potential health risks.

Moreover, it is essential to note that no confirmed illness cases have been reported thus far in connection with this specific health alert. However, if you have consumed the ground beef and are experiencing any symptoms of illness, it is recommended to reach out to a healthcare provider immediately.


Ensuring the safety and well-being of consumers is a priority, and that is precisely why this nationwide health alert has been issued concerning E. coli contamination in specific Greater Omaha ground beef products. By taking the necessary precautions and following the FSIS recommendations, we can collectively prevent any potential health risks associated with this incident.

Remember, staying informed and proactive during such situations is crucial for ensuring the health and safety of yourself and your loved ones. Keep up to date with any further developments by visiting the FSIS website or seeking information from reliable sources. Stay safe and healthy!

Check out the article on The Hill regarding the E. Coli warning. https://thehill.com/changing-america/well-being/prevention-cures/4610002-nationwide-health-alert-issued-for-ground-beef-over-potential-e-coli-risk/

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What is E. Coli?

-Escherichia coli is a gram-negative, facultative anaerobic, rod-shaped coliform bacterium. – It is commonly found in the lower intestine of warm-blooded organisms. – Most E. coli strains are harmless, but some can cause food poisoning and contamination incidents. – Some strains of E. coli are beneficial to humans by producing vitamin or preventing the colonization of pathogenic bacteria. – E. coli is expelled through fecal matter and grows rapidly for three days before declining.

E. coli and other bacteria make up only a small part of the gut microbiota, but can cause disease through fecal-oral transmission. They can be used as indicators to test for fecal contamination in the environment, and some strains can survive for days outside a host.

E. coli is a bacterium that has been extensively studied for over 60 years and can be easily and inexpensively grown in a lab. It is a chemoheterotroph and requires carbon and energy. E. coli is the most widely studied prokaryotic model organism and is significant in biotechnology and microbiology. It reproduces quickly, taking as little as 20 minutes under favorable conditions. (Wikipedia)

https://stmdailynews.com/category/food-and-beverage/

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FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval

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Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.

DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.

Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.

Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.

Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.

Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.

The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.

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The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.

This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.

As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.

Source: FDA

Related Information

  • Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
  • The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

https://stmdailynews.com/category/lifestyle/

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Understanding RSV: Symptoms, Treatment, and Prevention

RSV: a viral respiratory infection affecting children and adults. Learn about symptoms, treatment, and prevention for a healthier future.

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man in gray sweater sitting beside woman
Photo by Vlada Karpovich on Pexels.com

RSV, short for Respiratory Syncytial Virus, is a common viral infection that primarily affects the respiratory system, particularly young children. While RSV infections are usually mild, they can pose a greater risk to infants, older adults, and individuals with weakened immune systems. If you or a loved one are facing RSV, it can be overwhelming to know what to do next. That’s why it’s important to know the symptoms, treatment options, and preventative measures available to you. By being informed and taking action, you can give yourself and those around you hope and guidance during this difficult time. So let’s explore what you can do to fight RSV and emerge victorious.

Symptoms and Diagnosis:
RSV presents symptoms resembling a cold, including cough, runny nose, fever, and occasionally, difficulty breathing. Infants may exhibit irritability, decreased appetite, and lethargy. Diagnosing RSV usually involves a medical professional evaluating symptoms, conducting a physical examination, and, if necessary, performing laboratory tests to confirm the presence of the virus.

Treatment and Management:
In most cases, RSV infections can be managed at home with supportive care. This includes ensuring proper hydration, maintaining a comfortable environment, and using over-the-counter medications to alleviate symptoms under a doctor’s guidance. However, for high-risk individuals or severe cases, hospitalization may be required for closer monitoring and specialized treatment, such as oxygen therapy or intravenous fluids.

Prevention is Key:
Preventing the spread of RSV is crucial, especially for vulnerable populations. Practicing good hygiene, such as frequent handwashing, covering coughs and sneezes, and avoiding close contact with infected individuals, can significantly reduce the risk of transmission. Additionally, promoting a clean and sanitized environment, particularly in daycare centers and schools, can help curb the spread of the virus.

Hopeful Outlook:
While RSV can be concerning, it’s important to remember that most cases resolve on their own with time and supportive care. In fact, the majority of children infected with RSV recover fully without complications. By following preventive measures, seeking medical attention when needed, and staying informed about the latest developments in RSV research and treatment, we can approach this viral infection with hope and confidence.

Respiratory Syncytial Virus (RSV) is a common viral infection that primarily affects young children, causing cold-like symptoms and occasionally resulting in more severe respiratory distress. However, with proper care and attention, RSV can be managed effectively. By understanding the symptoms, seeking medical help when necessary, and adopting preventive measures, we can protect ourselves and our loved ones from the impact of RSV and look forward to brighter days ahead.

You can find more information about RSV, including its treatment and prevention, by visiting the CDC website. https://www.cdc.gov/rsv/index.html

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