Monday, September 14, 2009

Swine Flu Shots to Start in Three Weeks as U.S. Cases Spread:

By Tom Randall and Jason Gale

Sept. 13 (Bloomberg) -- Swine flu vaccinations may begin in three weeks, earlier than previously anticipated, after the first U.S. tests found a single shot to be effective in eight to 10 days, U.S. health officials said.

The first shots may be available by the end of this month and administered to patients the first week of October, said Nancy Cox, director of the flu division at the U.S. Centers for Disease Control and Prevention in Atlanta. Health officials had previously planned for vaccinations to begin in mid-October, requiring two shots administered three weeks apart.

Swine flu outbreaks have rippled across U.S. schools and universities after pupils returned to classes in the past few weeks. Washington State University reported more than 2,500 cases, and the CDC last week reported a nationwide spike of influenza cases months earlier than the past three flu seasons. The test results are boosting hopes the vaccine may be available in time to curb the first pandemic in 41 years, Cox said.

“We were anticipating that it would begin mid-October,” Cox told reporters today at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco. “This was a conservative estimate but it was a necessary conservative estimate. We now feel that we will have vaccine for more people earlier and this is extremely good news.”


New Virus

Health authorities in the U.S. and U.K. anticipated that two shots would be required because people were being exposed to the new virus for the first time. Critics said a multidose regime wouldn’t come in time to slow widespread outbreaks in the U.S. already triggered by the start of schools. Shots now also may be available in time to bring relief in the Southern Hemisphere, where swine flu recently peaked.

The U.S. study was the first report from five government- sponsored trials initiated July 22 to test safety and proper dosing of a pandemic vaccine. They bolster similar results published by Melbourne-based CSL Ltd., said Anthony Fauci, director of the National Institute of Allergy and Infectious Disease in Bethesda, Maryland, in an interview. The CSL study found that more than 95 percent of 240 patients who were given a single shot had protective antibodies three weeks later.

The successful test results may double anticipated stockpiles of the vaccine and make more shots available in developing countries, Cox said today. The U.S. is in “very active discussions” about donating some of its supply to countries that need it, she said.

One Dose Effective

The results of the vaccine studies suggest one dose of the formula used by drugmakers should offer H1N1 protection similar to the seasonal flu shot. Paris-based Sanofi Aventis SA, London- based GlaxoSmithKline Plc, and Basel, Switzerland-based Novartis AG are among the other companies making the vaccine.

Vaccine supplies in early October will be limited and targeted at health-care workers and those most vulnerable to severe illness, such as pregnant women and children, Cox said.

“We’re on track to have an ample supply rolling by the middle of October,” Kathleen Sebelius, U.S. secretary of health and human services, said today on ABC’s “This Week” program. “We’ll get the vaccine out the door as fast as it rolls out the production line.”

Most shots in the studies of healthy adults ages 18 to 64 contained 15 micrograms of antigen, the same level as for seasonal flu vaccines. The vaccinations had similar side effects to regular flu shots, the most common being headache and pain at the injection site.

CSL said it plans to donate the vaccine to developing nations in Asia and the South Pacific and is discussing a pilot program with the World Health Organization to start by providing as many as 100,000 doses.

The vaccines in both studies didn’t use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported, though the trials are too small to detect rare conditions. The shots are being studied further and will be closely monitored once vaccination campaigns begin, according to U.S. officials.

To contact the reporter on this story: Tom Randall in San Francisco at; Jason Gale in San Francisco at

Last Updated: September 13, 2009 14:54 EDT

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