Navigation Links
FDA Grants Approval to First Bird Flu Vaccine

The Food and Drug Administration (FDA) of the US has granted approval to a French drug firm for manufacturing the first bird flu vaccine//. However it says it is only an interim measure and it is looking for more potent drugs.

The U.S. Foood and Drug Administration (FDA) has approved the first vaccine designed to protect humans against the H5N1 influenza virus, or the bird flu. It is a product of the Paris-based Sanofi-Aventis, the world's third largest drug-maker.

At least 291 people worldwide have been infected with the virus since 2003, and 172 have died, according to the World Health Organization.

The new vaccine will not be sold commercially. It is being stockpiled by the government for use if the H5N1 bird flu virus mutates to a form that can spread easily from person to person.

If it acquires the ability to pass person-to-person easily, it would spark a pandemic and scientists fear it could kill tens of millions of people.

The FDA said two injections given 28 days apart may provide "limited" protection if a pandemic occurs. About 45 percent of people who got the vaccine in a study developed an immune response to the virus.

The vaccine is "sort of an interim measure" until better ones are developed, said Norman Baylor, director of the FDA's Office of Vaccines Research and Review. Several companies are working on other versions.

"Ideally, yes, you would like a vaccine that would have a higher efficacy," Baylor told reporters.

A single shot and a lower dose also would be preferred, Baylor said. The dose needed for the new Sanofi vaccine is higher than used in the seasonal flu vaccine.

Still, "we feel as part of pandemic preparedness it would be best to have a licensed vaccine. Our review suggests this vaccine is safe and effective," Baylor said.

David Williams, president of Sanofi vaccine unit Sanofi Pasteur, said in a statement the approval was "a significan t milestone in pandemic preparedness." Sanofi manufactures the vaccine at a plant in Swiftwater, Pennsylvania.

Philip Hosbach, vice president for immunization policies and government affairs for Paris-based Sanofi, said the company was working to develop ways to make its vaccine more potent.

The U.S. Department of Health and Human Services said it had already purchased 13 million doses of the Sanofi vaccine, enough to inoculate 6.5 million people. The vaccine was approved for people age 18 to 64. Studies in other age groups are ongoing. The most common side effects reported were pain at the injection site, headache, "general ill feeling" and muscle pain, the FDA said.

Clearance from the FDA will save doctors, hospitals and regulators hours, if not days, that would otherwise be needed to gain permission to use Sanofi's shot in a pandemic, said William Schaffner, a Vanderbilt University infectious disease specialist who advises the U.S. government on vaccines.

The vaccine would be given in two 90-microgram shots, about a month apart. Seasonal flu shots normally require about 15 micrograms of viral protein for each strain they protect against.

The U.S. has awarded contracts for a smaller number of shots to Novartis AG, based in Basel, Switzerland, and Glaxo SmithKline Plc of London.

Glaxo is developing an H5N1 vaccine using a booster, called an adjuvant, which makes its shot effective in two doses of 3.75 micrograms, almost 25 times smaller than Sanofi's.
GPL/M
'"/>




Related medicine news :

1. AIDS Funding Grants Dependant on Tracking Patients Names Efficiently
2. Rice University wins Prestigious Grants from HHMI
3. Norway Grants $80 mn to Indias Health Mission
4. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
5. NIMH Grants Funds To Study The Impact Of Terrorism
6. US Grants Rs.190 mn to Fight TB in India
7. Gates Foundation Grants $23mn for AIDS programme in India
8. Ontario Grants Fast-Track Compensation Rights for Work-Related Illnesses
9. Approval for DNA test to detect cystic fibrosis
10. Vaccine For Cervical Cancer Awaits Approval
11. WHO Gives Its Approval For Bird Flu Test Kit
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/19/2017)... Mississippi (PRWEB) , ... January 19, 2017 , ... St. ... Siena Center. , Siena Center is a skilled nursing facility on the grounds of ... and semiprivate rooms. It recently was voted the best nursing home in Mississippi for ...
(Date:1/19/2017)... ... January 19, 2017 , ... For the ... Medicine Associates of Connecticut (RMACT) have earned “Top Doctor” awards. Dr. Mark Leondires, ... Williams have each been chosen by their peers for the 2017 list based ...
(Date:1/19/2017)... , ... January 19, 2017 , ... Connecticut Dermatology Group ... Kim, a highly experienced and compassionate dermatologist. Dr. Kim brings an extensive background ... , “It is with considerable pleasure to welcome back Dr. Kim to the CDG ...
(Date:1/19/2017)... California (PRWEB) , ... January 19, 2017 , ... ... paragraph styled text designs that will simplify the editing process for all media ... ProParagraph Basics is a package of 30 simplistically styled self-animating paragraphs designed for ...
(Date:1/19/2017)... , ... January 19, 2017 ... ... member of the American Osteopathic College of Proctology) announced today the opening ... throughout Southern California ( http://www.hemorrhoidsremovalcenterscalifornia.com ): Hemorrhoids Center of Los Angeles (Beverly ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... Fla. , Jan. 19, 2017  Sensus ... medical device company specializing in the treatment of ... as keloids, with superficial radiation therapy, today announced ... full year 2016 financial results on Thursday, February 2, ... Company will hold a conference call with the ...
(Date:1/19/2017)... , January 19, 2017 ... Therapeutic Option to Address Motor Symptoms and Motor ... ...      (Logo: http://photos.prnewswire.com/prnh/20151014/276718LOGO) ... Stocchi , European Neurological Review,2016;11(Suppl. 2): 2-15, ...
(Date:1/19/2017)... 2017 The Global Therapy Partnering Terms and ... partnering deals and agreements entered into by the world,s ... - Top deals by value - Deals listed by ... The report provides understanding and access to the ... leading healthcare companies. The report provides an analysis ...
Breaking Medicine Technology: