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:5/4/2016)... Ventura, CA (PRWEB) , ... May 04, 2016 , ... ... cutting-edge technology to help restore its patients’ health, is hosting a free seminar on ... and will be held at Advanced Spine & Sport, 4601 Telephone Road, Suite 110, ...
(Date:5/4/2016)... ... 2016 , ... AudioEducator is the country's top training providers ... has lined up some informative training session for the medical coding and billing ... and practical, easy-to-apply advice. , On Thursday, May 19, AudioEducator will host a ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... and elbows. Engineered with athletes in mind, OMNIFORCE offers high-performance, less bulk, ... circular knitting, common in the industry) produces premium flat-knit construction with “focused ...
(Date:5/4/2016)... City, Nevada (PRWEB) , ... May 04, 2016 , ... ... bladder infections. Bladder infections, also called UTIs, have plagued people since the beginning ... millions of women get bladder infections every year. It's not just a matter of ...
(Date:5/4/2016)... ... May 03, 2016 – (PRWEB) May ... and child products, today revealed the non-toxic benefits of its Tutti ... deal with teething pain is just part of the story. These ... are BPA-, PVC-, and phthalate-free. , “Many baby toys contain ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... India , May 4, 2016 ... spreads across 154 pages, profiling 09 key companies ... is a professional and in-depth study on the ... a basic overview of the industry including definitions, ... Needles market analysis is provided for the international ...
(Date:5/3/2016)... 3, 2016 BioNovus Innovations LLC and ... Advancing Medical Innovation (IAMI) today announced a new ... and medical devices. An agreement between ... to license, develop and commercialize medical innovations advanced ... "This partnership represents a significant advance in our ...
(Date:5/3/2016)... 4, 2016 Research and Markets ... Stem Cell Therapy Market Outlook 2020" report to ... ) , ,Recombinant technology has improved significantly in past ... be developed in coming years. Many cancer drugs have ... cell therapies are also expected to be developed with ...
Breaking Medicine Technology: