Personal Injury Law

GSK Receives WHO Approval For Adjuvanted H1N1 Vaccine

By Jane Akre

WHO Approves Glaxo's Swine Flu With Adjuvant

GlaxoSmithKline PLC has just received approval from the World Health Organization (WHO) for one of its swine flu vaccines.

The vaccine, called Arepanrix, will be produced in Canada and contains an adjuvant, a chemical compound that makes the vaccine more powerful, theoretically allowing less of the active ingredients to be used.

The WHO will make available 156 million doses of swine flu vaccine to 95 poor countries beginning this month.

GSK in a statement said the WHO approved its Canadian vaccine after examining data on quality and safety.

Last month, the drug giant advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine because of the possibility it could trigger more allergic reactions than normal including a life-threatening side effect, anaphylactic shock, reports the Wall Street Journal.

172,000 doses of the batch had been distributed across Canada.

GSK is one of four companies providing swine flu shots, the fifth, AstraZeneca's MedImmune unit, produces the nasal spray.

None of the vaccines for the U.S. contain an adjuvant, according to the Food and Drug Administration. They have not been approved for use in the U.S. but are used in Europe.

Adjuvants

Adjuvants are mixed and added to vaccines to trigger a stronger response to the antigen that induces immunity. An adjuvant may boost the strength of the antigen by as much as 10-fold, but they are not without controversy.

One adjuvant, known as MF-59, has yet to be approved by the FDA and has been linked to the Gulf War Syndrome.

In July, Health and Human Services said it was buying the ingredients separately for $884 million in case there was not enough swine flu vaccine to go around in the U.S.

The funds were used to purchase bulk H1N1 antigen and adjuvant from Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. The U.S. retains its stockpile of adjuvants.

Glaxo spokeswoman, Lisa Behrens says its adjuvant has been proven safe in clinical trials with 39,000 people.

The World Health Organization recommended in July that adjuvants be used to boost the quantity of vaccine globally. #

Full post as published by InjuryBoard on December 01, 2009 (boomark / email).