|
Title: Glaxos Swine Flu Shot Wins U S Approval After Delay View count: 78 Rating: 5.0 (2 ratings) Description: http://www.bloomberg.com/apps/news?pid=20601202&sid=azlpOAHm5wrk Nov. 10 (Bloomberg) -- GlaxoSmithKline Plc won U.S. approval to sell its vaccine to fight H1N1 influenza, also known as swine flu, after an eight-week delay. The Food and Drug Administration cleared the shot as a strain change to Glaxos FluLaval seasonal flu vaccine, the London-based drugmaker said today in an e-mailed statement. The U.S. Health and Human Services Department has ordered 7.6 million doses of the swine flu shot as part of about 250 million doses secured from all manufacturers, the company said. While swine flu vaccines made by AstraZeneca Plc, CSL Ltd., Novartis AG and Sanofi-Aventis SA were cleared for sale by the FDA on Sept. 15, Glaxo was left out because of challenges making a vaccine without an adjuvant, an ingredient added to boost potency so more people can be treated. U.S. officials decided not to use adjuvants in their immunization program. Glaxo expects to begin shipping the vaccine in December and to provide all 7.6 million doses by the end of the year, according to the statement. The vaccine will be produced at the companys plant in Quebec, Glaxo said in the statement. U.S. vaccine supplies have been held up by production delays at two drugmakers and Glaxos trouble winning regulatory approval, Nicole Lurie, the health and human services departments assistant secretary for preparedness and response, last month. About 38 million doses of H1N1 vaccine were available as of Nov. 6 to be shipped to the states for use by local hospitals, health clinics and doctors, according to the U.S. Centers for Disease Control and Prevention. Tags: swine, flu, shot, h1n1, vaccine, side, effects, reactions, injection, mass, vaccinations, cdc, virus, who, tamiflu, doctors, nurses, adjuvant, jab, baby, children, mistake, hospital, pandemic, ingredients, cases, hpv, pandemrix, Author: VaccinationAwareness |
