FDA CDC News

COVID-19 Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The FDA amended the emergency use authorizations of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.

Published

2 years ago

October 19, 2022

Daily News Staff

SILVER SPRING, Md. /PRNewswire/ — The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.

For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.

What You Need to Know: Authorization of Moderna COVID-19 Vaccine, Bivalent

The data supporting FDA’s authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for both the 6 years through 11 years age group and 12 through 17 years age group is based on the FDA’s previous analysis of immune response and safety data from a clinical study in adults 18 years of age and older who received a booster dose of Moderna’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1.
For the 12 through 17 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 250 clinical trial participants in this age group who received a single booster dose of Moderna COVID-19 Vaccine at least five months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 12 through 17 years age group was comparable to the immune response to the two-dose primary series in the adult participants.
For the 6 years through 11 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 100 clinical trial participants 6 years through 11 years of age who received a single booster dose of Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 6 years through 11 years age group was comparable to the immune response to the two-dose primary series in the adult participants.
The safety of a single booster dose of monovalent Moderna COVID-19 Vaccine was evaluated in approximately 1,300 participants 12 through 17 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least five months after the second dose of the primary series, and approximately 1,300 participants 6 years through 11 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least six months after the second dose of the primary series. The most commonly reported side effects after a booster dose of the monovalent Moderna COVID-19 Vaccine in the clinical trial participants for both age groups were pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea/vomiting and fever.
Individuals who receive the bivalent vaccine may experience similar side effects reported by individuals who received the monovalent Moderna COVID-19 Vaccine.

The data for the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

What You Need to Know: Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent

The data supporting the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 5 through 11 years of age is based in part on the FDA’s previous analysis of immune response and safety data from a clinical study in adults greater than 55 years of age who received a booster dose of a Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1. In addition, the authorization is based on the FDA’s previous analysis of safety and effectiveness data of a booster dose of monovalent Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.
Individuals who receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent may experience similar side effects reported by individuals who received the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The fact sheets for both of the bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about potential side effects, as well as the risks of myocarditis and pericarditis.

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

Additional Resources:

Consumer Inquiries: Email or 888-INFO-FDA

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.

SOURCE U.S. Food and Drug Administration

Author

Daily News Staff

View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

Related Topics:COVID-19 FDA health and wellness

Up Next

FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers

Don't Miss

Nicotine dose in a single cigarette blocks estrogen production in women’s brains

Daily News Staff

FDA CDC News

Important Recall Alert: Milo’s Poultry Farms and Tony’s Fresh Market Eggs Potentially Contaminated with Salmonella

Milo’s Poultry Farms, LLC has recalled eggs under the “Milo’s Poultry Farms” and “Tony’s Fresh Market” labels in Wisconsin, Illinois, and Michigan due to Salmonella contamination, advising consumers to discard or return products.

Published

3 days ago

September 10, 2024

Hal Machina, Daily News Staff

selective focus photo of three eggs on tray — Photo by Monserrat Soldú on Pexels.com

As of September 6, 2024, Milo’s Poultry Farms, LLC, headquartered in Bonduel, Wisconsin, has issued a voluntary recall of all its egg products due to possible contamination with Salmonella. This recall applies to both “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs, spanning across various retail stores and foodservice distributors in Wisconsin, Illinois, and Michigan.

What You Need to Know

Salmonella is a bacteria that can cause serious and occasionally fatal infections, particularly in young children, the elderly, and individuals with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (potentially bloody), nausea, vomiting, and abdominal pain. In severe cases, the infection can result in the bacteria entering the bloodstream and causing more critical conditions such as infected aneurysms, endocarditis, and arthritis.

Scope of the Recall

The recall encompasses:

All carton sizes and types of eggs under the “Milo’s Poultry Farms” label, across all expiration dates.
All carton sizes of “Tony’s Fresh Market” branded eggs, applicable to all expiration dates.
All cases of eggs intended for retail foodservice distribution, regardless of expiration dates.

Reason for the Recall

The recall was triggered after environmental samples collected by the FDA tested positive for Salmonella. Further investigations through whole genome sequencing linked these samples to an ongoing outbreak of Salmonella, prompting immediate action by Milo’s Poultry Farms.

Consumer Safety Measures

Milo’s Poultry Farms, LLC has temporarily halted production and distribution of the affected products to conduct necessary testing and sanitization processes at their facilities.

What Should Consumers Do?

Customers who have purchased any of the recalled eggs are strongly advised not to consume them. These products should be discarded immediately or returned to the place of purchase for a full refund.

Consumers with additional questions or concerns can reach out directly to Milo’s Poultry Farms, LLC at (715) 758-6709 for further guidance and support.

Stay Informed

Salmonella is an ongoing risk in uncooked poultry and eggs. Consumers are reminded to cook eggs thoroughly before consumption to kill bacteria and prevent illness. Stay updated with food recall alerts and safety guidelines to ensure the health and safety of you and your family.

Remember, food safety is paramount. Keep abreast of the latest FDA warnings and manufacturer recalls to safely navigate any potential health risks associated with contaminated products.

About the FDA

The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also regulates the nation’s food supply to safeguard against contamination and prevent foodborne illnesses. One of its key functions is monitoring and managing food recalls when potential risks are identified, ensuring that hazardous foods are quickly and effectively removed from the market. The FDA issues alerts to inform the public about foodborne illness outbreaks, working collaboratively with manufacturers to recall affected products and maintain the safety and integrity of the food supply chain.

Follow FDA

Read the FDA release here: https://www.fda.gov/safety /recalls-market-withdrawals-safety-alerts/milos-poultry-farms-llc-recalls-eggs-because-possible-health-risk

Source: FDA

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

https://stmdailynews.com/category/stories-this-moment

Authors

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

News

FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment

Published

2 weeks ago

August 30, 2024

Hal Machina

In a landmark decision on August 9, 2024, the U.S. Food and Drug Administration (FDA) approved the first-ever nasal spray, neffy, for the emergency treatment of severe allergic reactions, including anaphylaxis, in individuals weighing at least 30 kilograms (approximately 66 pounds). This approval marks a significant breakthrough in the management of life-threatening allergic reactions, offering a non-injectable form of epinephrine that could transform how patients handle emergency situations.

Breaking Away from Injections: The Significance of Neffy

Traditionally, the treatment of anaphylaxis—a rapid and severe allergic reaction—has relied solely on injectable forms of epinephrine. This method, while effective, poses a challenge for many, particularly children who might fear needles, potentially delaying life-saving intervention. Neffy emerges as an innovative solution, providing epinephrine in a nasal spray form. As highlighted by Dr. Kelly Stone, MD, PhD, of the FDA’s Center for Drug Evaluation and Research, the development of neffy addresses an urgent need by removing the barrier of injection-associated anxiety and facilitating quicker, more accessible treatment.

The Science Behind Neffy

The approval of neffy was based on extensive clinical research involving 175 healthy adults. These studies explored the absorption and effect of neffy compared to traditional injectable epinephrine forms, focusing on indicators such as epinephrine concentration in the blood and the consequent physiological responses like changes in blood pressure and heart rate. The results confirmed that neffy delivers comparable epinephrine levels and physiological effects necessary for treating anaphylaxis effectively. Further research in children over 66 pounds mirrored these findings, showcasing neffy’s efficacy across different age groups.

How Neffy Works

Neffy is administered as a single dose via a nasal spray into one nostril. In cases where symptoms do not improve or worsen, a second dose may be applied using a new unit. It’s imperative for users to seek immediate medical attention after administering neffy to ensure comprehensive care and monitoring.

Considerations and Side Effects

While neffy stands as a revolutionary step forward, it comes with necessary precautions. Individuals with certain nasal conditions, such as nasal polyps or a history of nasal surgeries, may experience altered absorption rates. In such cases, traditional injectable products might be recommended. Users must also be cautious about potential side effects, which can include throat irritation, headache, nasal discomfort, and dizziness among others.

A Forward Leap in Allergy Management

With the introduction of neffy, patients and caregivers now have a less invasive option at their disposal. This development not only expands the tools available for combating severe allergic reactions but also significantly lowers the threshold for timely, effective intervention. The FDA’s fast-track designation of neffy underscores its potential impact, promising a new era of empowerment for those living with severe allergies.

In conclusion, the FDA’s approval of neffy represents a major advance in allergy care, highlighting ongoing innovation in medical treatments and patient care options. As neffy becomes available, it is poised to become a crucial asset in allergy management, enhancing safety and comfort for patients across the United States.

Source: FDA

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm_medium=email&utm_source=govdelivery

https://stmdailynews.com/category/stories-this-moment

Author

Hal Machina

View all posts

Discover more from Daily News

Subscribe to get the latest posts sent to your email.

health and wellness

Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata

Published

4 weeks ago

August 20, 2024

Hal Machina, Daily News Staff

Sun Pharmaceutical Industries Limited is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. This approval is a significant milestone, particularly for the roughly 300,000 Americans living with this challenging condition.

Alopecia areata is an autoimmune disorder marked by significant hair loss, often resulting in severe emotional and psychological distress. The journey to finding effective treatment options has been fraught with challenges, as the condition could be unpredictable and resistant to previous therapies.

Groundbreaking Clinical Trial Results

The FDA’s approval of LEQSELVI™ was supported by robust evidence from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which collectively enrolled 1,220 patients. These studies demonstrated that LEQSELVI™ delivered substantial hair regrowth: at 24 weeks, approximately one-third of the patients achieved 80% or more scalp hair coverage, a significant improvement from an average baseline scalp hair coverage of just 13%.

How LEQSELVI™ Works

LEQSELVI™ is a cutting-edge, twice-daily oral medication that selectively inhibits Janus Kinases (JAK) JAK1 and JAK2. This mechanism targets the immune pathways believed to contribute to the hair loss seen in severe alopecia areata, offering a new hope to those who have had limited success with existing treatments.

Safety and Efficacy

The treatment has been carefully tested for safety across several studies. While the medication is generally well-tolerated, it does carry warnings for serious infections, malignancies, thrombosis, and gastrointestinal perforations, similar to other treatments in its class. Patients and healthcare providers are advised to monitor for symptoms and manage them accordingly.

Support and Accessibility

Understanding the challenges associated with treatment access, Sun Pharma is initiating a comprehensive access program. This initiative will help eligible patients begin and adhere to their treatment, ensuring that LEQSELVI™ reaches those who need it the most. More details about this program are available on the official LEQSELVI™ website.

A Step Forward for the Alopecia Community

The approval of LEQSELVI™ represents a significant advancement for the alopecia community. Abhay Gandhi, CEO North America Business, Sun Pharma, shared his enthusiasm about bringing this innovative treatment to the market, stating it “offers a new and effective solution that will significantly enhance the options for patients and their physicians.”

Moreover, organizations such as the National Alopecia Areata Foundation (NAAF) have welcomed this new treatment option. Nicole Friedland, President and CEO of NAAF, highlighted the importance of this development, underscoring the profound impact alopecia areata can have on individuals’ lives.

Looking Ahead

With the introduction of LEQSELVI™, Sun Pharma continues to cement its position as a leader in dermatological treatments. The company’s commitment to addressing complex medical conditions through innovative solutions is evident in their rapidly expanding dermatology portfolio.

For patients suffering from severe alopecia areata, LEQSELVI™ represents not merely a new treatment option but a new hope—a possibility of regaining not just their hair, but also their confidence and quality of life.

For further details on LEQSELVI™ and patient support initiatives, visit www.LEQSELVI.com.

View the full multimedia release.

Disclaimer:
This content may include forward-looking statements, which are based on current expectations and projections about future events. Readers should not place undue reliance on these statements, as actual results may vary.