H1N1 vaccines get U.S. approval

The U.S. Food and Drug Administration has approvednew swine flu vaccines, which clears the way for Americans to start getting the shots as early as the beginning of October.

Pregnant women and children will be among those at the front of the line when the first rationed supplies of the pandemic vaccine are distributed early next month, U.S. Health and Human Services Secretary Kathleen Sebelius told Congress onTuesday.

Vaccines made by Sanofi-Aventis SA, CSL Ltd, Medimmune and Novartis AG were approved, she added.The bulk of the vaccines will be available in the U.S. by mid-October.

Health Canada saidit's balancing the need for speed with its duty to make sure a vaccine is safe and effective. It's waiting for the results of Canadian trials which have just started recruiting volunteer test subjects.

Canadian vaccine trial recruits volunteers

The first test vaccines will be given in the next week or two, and the results will be available to Health Canada and the Public Health Agency of Canada, saidDr. Joanne Langley, a pediatric infectious disease specialist and the principal investigator with the pandemic vaccine clinical trial in Halifax.

It generally takes two to four weeks after the first dose to get results on the antibody levels produced by the vaccine, Langley said. The antibody levelsare a sign of the vaccine'seffectiveness.

The Canadian trials will test two vaccine formulations: one with an adjuvant, a substance added to boost effectiveness, and one without an adjuvant like thevaccines that will be distributed in the U.S.

"The purpose of the study is to determine whether we need adjuvant or not and what dose of antigen we need," Langley said.

Possible oversupply in Canada

On Monday, Canada's vaccine maker, GlaxoSmithKline, saidits first trial results fromGermany showed theformof the vaccinecontaining itsAS03 adjuvantis effective after a single dose in adults.

If those findings are confirmed, it couldmean Canada will have an oversupply of H1N1 vaccinewhen it does arrive.

As well, Health Canada has promised 1.2 million doses of adjuvant-free vaccine will be available for pregnant women.

Last week, Dr. David Butler-Jones, Canada's chief public health officer, saidCanada plans to roll out the first doses of H1N1 vaccine by mid-November, but could move that date up ifa second wave of H1N1 startssooner.