FDA approves new swine flu vaccine

Sep 15, 2009 By LAURAN NEERGAARD , AP Medical Writer
Health and Human Services Secretary Kathleen Sebelius testifies on Capitol Hill in Washington, Tuesday, Sept. 15, 2009, before the House Energy and Commerce Committee hearing on Pandemic Flu Preparedness. At left is Dr. Anne Schuchat of the Centers for Disease Control and Prevention. (AP Photo/Susan Walsh)

(AP) -- The Food and Drug Administration approved the new swine flu vaccine Tuesday, a long-anticipated step as the government works to get vaccinations under way next month. Health and Human Services Secretary Kathleen Sebelius announced the vaccine's approval to Congress - and said she hopes to get the first limited supplies distributed early in October.

The bulk of will start arriving Oct. 15, and Sebelius said it should be available at 90,000 sites around the country.

"We will have enough vaccine available for everyone" eventually, Sebelius said - everyone who wants it, that is.

The government has ordered 195 million doses for now but may order more if needed, she said. Typically 100 million Americans seek flu vaccine every year.

But the vaccine, which protects against what doctors prefer to call the 2009 H1N1 flu strain, won't arrive all at once. About 45 million doses are expected by mid-October. That's why the government wants the people most likely to catch swine flu, and to suffer complications from it, to be first in line - including children and pregnant women.

FDA licensure means that the government has certified the vaccine is made properly and meets specific manufacturing and quality standards. Separately, the National Institutes of Health is studying the vaccine dosage and safety. Last week, the NIH announced that one dose appears to protect adults - and that that protection kicks in eight to 10 days after the shot.

Studies in children and are continuing.

The vaccine approved Tuesday is made by CSL Ltd. of Australia; Switzerland's ; Sanofi-Pasteur of France; and Maryland-based Medimmune, which makes the only nasal-spray .

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: FDA approves hard-to-abuse narcotic painkiller

add to favorites email to friend print save as pdf

Related Stories

Flu season: How many shots?

Aug 30, 2009

(AP) -- Doctors don't know yet if it will take one dose or two of vaccine to protect against the new swine flu. Add that to vaccine for the regular winter flu, and it could be a multishot season for a lot of people - or ...

US expects far fewer swine flu shots in October

Aug 18, 2009

(AP) -- The U.S. won't have nearly as much swine flu vaccine ready by mid-October as long predicted - 45 million doses instead of the anticipated 120 million, a federal official said Monday.

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

User comments : 0