Navigation Links
FDA Approves New Flu Vaccine
Date:9/28/2007

That should ensure adequate supply for coming influenza season, officials say

FRIDAY, Sept. 28 (HealthDay News) -- With flu season fast approaching, U.S. health officials announced Friday the approval of a new vaccine intended for people 18 and older.

The vaccine, called Afluria, is designed to protect adults from influenza viruses type A and type B.

"Today's action is important, because it brings to six the number of companies licensed to supply flu vaccine in the United States," Dr. Jesse L. Goodman, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, said during an afternoon teleconference.

Goodman noted that in 2000, there were only three manufacturers of flu vaccine for the United States. In 2004, one manufacturer had problems with the sterility of its British production facility, which caused a severe shortage of vaccine in the United States.

Since then, the FDA has been looking for other vaccine manufacturers to fill the gap and ensure that even if there were a problem with one manufacturer, there would still be an adequate supply, Goodman said.

Afluria was approved using the FDA's accelerated approval process, said Norman Baylor, director of FDA's office of vaccines research and review.

"This process allows the agency to approve products for serious or life-threatening diseases based on early evidence of the product's effectiveness," Baylor said at the teleconference. "This accelerated approval process can reduce the time for needed medical product to become available to the public."

Afluria is made by CSL Limited of Parkville, Australia. The company is expected to supply about 2 million doses of the vaccine to the United States market this year.

The approval means there will be an estimated 132 million doses of flu vaccine for the 2007-2008 influenza season. That's 10 million doses more than last year, officials said.

The Afluria vaccine is made with inactivated influenza viruses grown in chicken eggs. Those allergic to eggs or any other component of the vaccine should not receive the vaccine, officials said.

The most common side effects are tenderness, pain, redness and swelling at the injection site, and headache, fatigue and muscle aches.

Flu season in the United States can start in October and last until May. More than 200,000 people are hospitalized with influenza each year in the country, and about 36,000 people die annually from complications from the disease, according to the U.S. Centers for Disease Control and Prevention.

The CDC recommends that people should get their flu shot starting in September, but it's worthwhile to get a shot as late as January.

The CDC says anyone looking to avoid the flu should get vaccinated. But those at high risk for complications from the flu should get a shot. Those people include: children aged 6 months to 5 years old; pregnant women; people 50 years of age and older; people of any age with certain chronic medical conditions; and people who live in nursing homes and other long-term care facilities.

Also urged to get vaccinated are people who live with or care for those at high risk for complications from flu, including health-care workers.

More information

To learn more about the flu, visit the CDC.



SOURCES: Sept. 28, 2007, teleconference with Jesse L. Goodman, M.D., M.P.H., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Norman Baylor, Ph.D., director, office of vaccines research and review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA approves Phase 0 trial which tests experimental drugs on humans
2. FDA Approves Contraceptive Ring
3. FDA approves new device to treat womens bleeding disorder
4. FDA Approves New HIV Drug, Viread
5. FDA Approves Birth Control Skin Patch
6. FDA approves surgical gel
7. FDA Approves New Arthritis Drug, Bextra
8. FDA Approves Elidel Cream for Eczema
9. FDA approves drug for rare liver disease
10. FDA approves first pocket-sized EKG machine
11. FDA Approves New Anti-Clotting Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... Finding the right way to address a patient’s condition before it ... now getting on board. , “You do the right thing, at the right time, at ... down, not up,” said Leonard M. Fromer, MD, FAAFP, from Group Practice Forum. “Even if ...
(Date:5/3/2016)... ... 2016 , ... Dave Newberry, broker/owner of Newberry Realty, recently announced his office ... luncheon on Friday, May 20. “We have raised over $1,000 for the table to ... Newberry. , PICC is a local Kent, WA, clinic that cares for drug-exposed babies ...
(Date:5/2/2016)... ... 02, 2016 , ... It has just been announced Jack Uldrich, ... throughout the month of May. , Uldrich is the author of 11 books and ... frequently appears on the Science Channel’s FutureScape and Discovery Channel’s Inside Out. , Known ...
(Date:5/2/2016)... ... May 02, 2016 , ... As directed by its ... Pennsylvania (HAP) issues its full support to allow certified nurse practitioners (CNP) to practice ... they have worked under such supervision for three years and 3,600 hours. , In ...
(Date:5/2/2016)... ... May 02, 2016 , ... Eating Recovery Center’s Insight Behavioral ... and anxiety disorders, has rebranded its eating disorder program under a new name: Eating ... treatment facility on May 16. , To celebrate, ERC Chicago will host a ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... April 28, 2016 Oramed Pharmaceuticals Inc. ... pharmaceutical company focused on the development of oral drug delivery ... upcoming PIONEERS 2016 conference, presented by Joseph Gunnar ... New York . Nadav Kidron , ... conference. Presentation Details:   PIONEERS ...
(Date:4/27/2016)... April 27, 2016  Hologic, Inc. (Nasdaq: ... results for the fiscal second quarter ended March ... of $0.24 increased 41.2%, and non-GAAP diluted EPS ... increased 5.8% on a reported basis, and 6.3% ... "We posted another good quarter, highlighted by 14.6% ...
(Date:4/27/2016)... Transparency Market Research has published ... Global Industry Analysis, Size, Share, Growth, Trends, and Forecast ... skincare devices market was valued at US$ 7,255.8 Mn ... CAGR of 10.1% from 2015 to 2023 to reach ... full Skincare Devices Market (Treatment Device - LED Therapy Devices, ...
Breaking Medicine Technology: