Novartis, Sanofi-Aventis and GlaxoSmithKline are the chief beneficiaries of the US government’s decision to spend around $1 billion towards the development of a vaccine for the influenza A (H1N1) virus.
The country’s Health and Human Services Secretary, Kathleen Sebelius, announced that the department is directing the money from existing funds to be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the USA’s pre-pandemic influenza stockpile. She said that “preparation and planning are critical to keep Americans safe in the face of a potential pandemic” and “our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus”. The actions the HHS is taking “will help us be prepared if a vaccine is needed,” Ms Sibelius added.
The funds will be used to place new orders on existing contracts with companies that hold US licences for flu vaccines and produce a bulk supply of vaccine antigen and adjuvant. The HHS said that having both antigen and adjuvant on hand “provides maximum flexibility in a future immunisation programme, if … recommended”.
Novartis, which has received an order of around $290 million, and GSK ($180 million), will produce antigen and adjuvant, while Sanofi Pasteur has been awarded a $190 million antigen-only contract. Wayne Pisano, the latter unit’s chief executive, noted that production of a new product “is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side”.
The firms are now awaiting receipt of the seed virus to be used for vaccine production from the US Centers for Disease Control and Prevention (CDC). Once the seed is received, they will receive commence commercial scale production and the first bulk concentrate vaccines could be ready in a few months.
The HHS cash will also be used by the three companies, plus AstraZeneca’s MedImmune and CSL of Australia to develop pilot lots of vaccine for use in clinical studies to determine the required dose, “determine if adjuvants are appropriate and ensure a vaccine is safe and effective”.
The World Health Organisation said this morning that 12,954 people have been confirmed as infected with the new strain and the number of countries affected is 46. 92 people have died and 80 of those cases have been reported in Mexico.
