Navigation Links
FDA Approves New Type of Flu Vaccine
Date:1/16/2013

WEDNESDAY, Jan. 16 (HealthDay News) -- The U.S. Food and Drug Administration has approved a novel type of flu vaccine, the agency announced Wednesday.

Flublok, as the vaccine is called, does not use the traditional method of the influenza virus or eggs in its production. Instead, it is made using an "insect virus (baculovirus) expression system and recombinant DNA technology," the FDA said in a news release. This will allow vaccine maker Protein Sciences Corp., of Meriden, Conn., to produce Flublok in large quantities, the agency added.

The vaccine is approved for use in those aged 18 to 49.

"This approval represents a technological advance in the manufacturing of an influenza vaccine," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus."

While the technology is new to flu vaccine production, it has been employed in the making of vaccines that prevent other infectious diseases, the agency noted.

As it does with all influenza vaccines, the FDA will assess Flublok before each flu season. In research conducted at various sites in the United States, Flublok was about 45 percent effective against all circulating influenza strains, not just the strains that matched those in the vaccine. The most commonly reported adverse reactions included pain at the site of injection, headache, fatigue and muscle aches -- events also typical for conventional flu vaccines, the agency said.

The new flu vaccine could not have come at a better time, with the flu season well under way and sporadic shortages of both the traditional flu vaccine and the flu treatment Tamiflu.

"We have received reports that some consumers have found spot shortages of the vaccine," FDA Commissioner Dr. Margaret Hamburg said Monday on her blog on the agency's website.

So far, more than 128 million doses of flu vaccine have been distributed, Hamburg said, but not all the doses have been administered to people yet.

She said that people who already have the flu may also be experiencing local shortages of Tamiflu.

"We do anticipate intermittent, temporary shortages of the oral suspension form of Tamiflu -- the liquid version often prescribed for children -- for the remainder of the flu season. However, FDA is working with the manufacturer to increase supply," she said.

Flu season typically peaks in January or February but can extend as late as May. This flu season is turning out to be more severe than last year's.

Officials at the U.S. Centers for Disease Control and Prevention said on Friday that 47 states were reporting widespread influenza activity, although flu case numbers were beginning to subside in some regions, especially in the Southeast, where the flu showed up first.

It's still not too late to get a flu shot to help protect yourself, Hamburg stressed. She noted that it takes about two weeks after vaccination for your body to develop an immune response to provide protection against the flu.

People who want to get vaccinated can visit flu.gov, click on the "Flu Vaccine Finder," enter their zip code and find a list of clinics, supermarkets, pharmacies and other flu vaccination locations in their neighborhoods.

But before you go to one of the locations, call ahead to confirm that they have the flu vaccine, Hamburg advised.

According to recommendations from the CDC, all adults and children who are at least 6 months old should receive a flu vaccination each year. The best time to get vaccinated is in the fall.

More information

The U.S. Centers for Disease Control and Prevention has more about the flu and flu vaccine.

-- Robert Preidt

SOURCE: Jan. 16, 2013, news release, U.S. Food and Drug Administration; Jan. 15, 2013, blog, Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves New Once-a-Day HIV Pill
2. FDA Approves Flu Vaccine for Coming Season
3. FDA Approves 2nd New Weight-Loss Drug
4. FDA Approves 1st Pill to Help Prevent HIV Infection
5. FDA Approves First New Weight-Loss Drug in More Than a Decade
6. FDA Approves SonixGPS Needle Guidance Technology for Vascular Access Procedures
7. FDA Approves Combo Shot for Meningitis, Hib in Kids
8. FDA Approves Generic Versions of Plavix
9. Childhood Vaccine Schedule Is Safe, Report Says
10. Spot Shortages of Flu Vaccine, Tamiflu Reported, FDA Head Says
11. Major step toward an Alzheimers vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves New Type of Flu Vaccine  
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... Research and Markets has announced the addition ... Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, Binder, ... Forecast to 2021" report to their offering. ... excipients market is projected to reach USD 8.1 Billion ... forecast period 2016 to 2021. The ...
Breaking Medicine Technology: