Home Add to Favorite Contact Submit  
           19 October, 2021


    
Category:  Press » Health & Fitness

 

FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Popularity:
         Views: 1437
2009-12-24 05:22:00     
U.S. Food and Drug Administration

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA's accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

"As people grow older, their immune systems typically become weaker," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

For more information:

FDA Web Page on Vaccines, Blood & Biologics

Media Inquiries: Shelly Burgess, 301-796-4651
Consumer Inquiries: 888-INFO-FDA

Specialized in: Fda Approves - High Dose - Seasonal - Influenza Vaccine - Specifically Intended - People Ages 65 - Older
URL: http://www.fda.gov
Print press release      Bookmark this page
Related Press releases 
Dental Marketer is Happy to Announce the Hiring of an Additional Copywriter (Popularity: ): A proficient and highly known oral healthcare, Dental Marketer is happy to announce a copywriter's hiring. Dentists face difficult challenges, and it is highly imperative to balance the training and services with the running business.Stoney Creek, ON - Canada - June 17th, 2021 -- Dental Marketer hires an additional copywriter to promote their services across a large number of patients, try various advertising models and strategies, and utilize effective marketing ...
Clarity Surgical Proudly Announces Their New Weight Loss Surgeon: Dr. Owen Pyke, MD (Popularity: ): Clarity Surgical is proud to announce their newest hire: Dr. Owen Pyke, MD!Long Island, NY - USA, October 20, 2020 -- Clarity Surgical is proud to announce their newest hire: Dr. Owen Pyke, MD! He joined the Clarity Surgical team on September 8th and will be taking on the role of general and weight loss surgeon.Dr. Owen Pyke originally hails from the island nation of Jamaica. His family immigrated to ...
eData Services Launch Virtual Medical Staffing Service (Popularity: ): Beverly Hills, California, USA, March 1, 2016 -  eData Services announces the launch of a new virtual back-office staffing services for medical practitioners.eData will provide highly trained medical professionals are ready to do anything needed to help a medical practice’s office staff – except be there in person.  These are live, real technicians, doctors, and nurses, ready to assist with telephone calls, scheduling, prescription routing, EHR entries, mail – anything ...
Caring Hands Matter Launches New Blog on Website (Popularity: ): Fairfax City, Virginia ( press.abc-directory.com ) February 12, 2016 - Fairfax home care agency, Caring Hands Matter is pleased to announce the launch of the new blog section on its organizational website. Blogs are a great way to help caregivers of elderly loved ones, individuals suffering from illness and individuals who require special needs to become more informed about their circumstances while feeling connected to the caregiving community at large. ...
Cosmetic Surgery Clinic Offers Deal on Injectable Fillers in Oakville (Popularity: ): Oakville, ON - January 29, 2014 -- Briarwood Cosmetic Surgical Centre announces a discount on the injectable filler, Radiesse®, for a limited time only at the Oakville cosmetic surgery clinic. Qualified patients receive a free syringe of the product with every two syringes purchased. The discount is designed to not just promote Radiesse®, but also the technical and artistic skill of long time cosmetic nurse injector, Jenny De Ruiter, who ...

Press release home snapshot 


Related Business 
Bharat Vaccine Centre (Popularity: ): MMR is a vaccine given to children for protection against the viruses of Measles, Mumps as well as Rubella. Now-a-days, people are mostly opting for an advanced combination vaccine, MMRV, which gives the child an additional protection against the Varicella Virus that causes chicken pox. A child is not supposed to take MMR Immunization vaccine if he ever had an allergic reaction to gelatin, the antibiotic neomycin, or have already ...
Influenza.com (Popularity: ): Influenza can cause hospitalizations and death and there is a vaccine available to prevent it. Find who is at risk, learn the history, and discover the impact on our health and our children.
Stomach Flu (Popularity: ): The influenza virus, popularly known as “the flu” has plagued people of all ages and demographics since the beginning of time. With advances in modern science, treatments such as the flu shot have risen to prominence.
Menactra® Vaccine (Popularity: ): Menactra vaccine is given to people 9 months through 55 years of age to help prevent meningococcal disease (including meningitis) caused by certain strains of meningococcal bacteria. Menactra vaccine is not indicated for the prevention of meningitis caused by meningococcal strains not contained in the vaccine.
Kilbourne, NY Medical College Influenza Archive (Popularity: ): An archive of influenza virus reassortants, mutants, and antisera, including a database of flu viruses and vaccines, with information about phenotype, genotype, special properties, and relevant published references.
Beyond Academe (Popularity: ): Intended to help PhDs make the transition out of academia. Beyond Academe is intended specifically for historians but can be used by PhDs in the humanities as well as the sciences.
Vads Corner (Popularity: ): Emerging viruses, Outbreaks, Haze, Nipah virus, enterovirus 71, Influenza, H5N1 Influenza A, Chikungunya virus, West Nile virus, Dioxin, Arsenic, Medline, Medical Journals.
Vaccine Information (Popularity: ): Vaccine requirements and information for Canada and USA regarding thimerosal information, autism connection, and vaccine stories.
Vaccine Information (Popularity: ): Vaccine requirements and information for Canada and USA regarding thimerosal information, autism connection, and vaccine stories.
Sabin Vaccine Institute (Popularity: ): The Albert B.Sabin Vaccine Institute promotes rapid scientific advances in vaccine development, delivery and distribution worldwide.