Health Canada Approves Adjuvant-Free H1N1 Vaccine

Health Canada announced Friday it has approved GlaxoSmithKline’s pandemic vaccine without adjuvant – but parents of young children who were hoping it might be available for their kids will be disappointed.

The 1.8 million doses of unadjuvanted vaccine bought from GSK will be reserved for pregnant women and for healthy people aged 10 through 64, Dr. David Butler-Jones, Canada’s chief medical officer of health said.

Earlier the agency had said children under age three might be given access to unadjuvanted vaccine after some experts raised concerns that there was a lack of data around the use of adjuvants – additives that boost the immune response to vaccine – in young children.

But Butler-Jones said that studies have since shown that the product with adjuvant induces a better immune response in little children, whose immune systems are developing and who don’t respond as well to vaccine without adjuvant.

He said the adjuvanted vaccine is “clearly superior and very safe.”

The head of Health Canada’s vaccine regulatory division, Dr. Elwyn Griffiths, said provinces were informed late Thursday that the vaccine could now be used.

The federal government has been shipping the vaccine to provinces so that it could be used starting as soon as the approval process was completed. But Dr. Perry Kendall, British Columbia’s chief medical officer of health, said it will likely be late in the weekend or Monday morning before the vaccine is in clinics and ready for use.

Canada bought 1.8 million doses of vaccine without adjuvant from GSK and 200,000 doses of adjuvant-free vaccine from Australian vaccine maker CSL.

Butler-Jones said there are about 300,000 to 350,000 pregnant women each year in Canada. The bulk of the unadjuvanted vaccine was bought with the idea that it might be needed for small children, he said. But it is now being directed towards healthy adolescents, teens and adults.