Novartis and Baxter leading swine flu vaccine race
This article was originally published in Scrip
Novartis and Baxter seem to be leading the race to develop an influenza A (H1N1) pandemic vaccine, while GlaxoSmithKline and Sanofi Pasteur are coming behind. It seems the use of cell-based technology over traditional egg-based manufacturing is putting certain firms ahead.
Companies issued updates on their pandemic vaccine programmes following the decision by the World Health Organization to declare a pandemic of "moderate severity" last Thursday (scripnews.com, June 12th, 2009). As of June 12th, 74 countries had reported 29,669 cases of H1N1 infection, including 145 deaths.
The European regulator EMEA has also initiated its pandemic plan following the WHO decision, meaning it will quickly assess approval dossiers for influenza vaccines and antivirals, as well as undertake intensive safety monitoring when the products are used during a pandemic.
Novartis
Novartis claims that its cell-based manufacturing pandemic vaccine programme is the most advanced, it told Scrip. It has completed the production of the first batch of H1N1 vaccine, "weeks ahead of schedule". Cell-based technology gave the company significant time-savings over traditional egg-based manufacturing, as it allows the production of pandemic vaccine without the need to adapt the virus strain to grow in eggs.
The vaccine will be made at its facility in Marburg, Germany, the only licensed cell-based manufacturing site to date, it says. The site has the capacity to produce millions of doses of vaccine each week.
The cell-based manufacturing process and facility gained EU approval in 2007, but it is pending approval in the US. The company has another cell-culture facility, in collaboration with the US department of health and human services, under development in Holly Springs, North Carolina, which is to be completed in 2011.
Novartis is planning clinical trials "in the hundreds" for its H1N1 vaccine in July and expects a licence in the autumn. It will still need to work out the exact dose of H1N1 antigen per vaccine dose, it added.
More than 30 governments have requested Novartis' H1N1 antigens or its well-established MF59 adjuvant or both, but the firm will not identify the countries, except for the US order of $289 million for vaccine ingredients announced in May. Novartis told Scrip that it does not intend to donate its vaccine to developing countries, believing in tiered pricing instead.
Baxter
Baxter, another firm developing a pandemic vaccine via a cell-based route (Vero), said it has completed testing and evaluation of the H1N1 virus and is now in full-scale production of a commercial vaccine, hoping to deliver a vaccine for use as early as July. It has received EU approval for its mock-up pandemic vaccine, Celvapan, which supports fast track approval of a pandemic vaccine containing H1N1.
A number of national authorities have existing pandemic agreements with the firm that allow them to place orders for a vaccine now that a pandemic has been declared. Baxter does not say whether it will donate any of its vaccine to developing countries, stating that it is "committed to working with the WHO to allocate a portion of the company's commercial production to address global public health issues deemed most urgent".
GSK and S-Pasteur
GlaxoSmithKline says that the first doses of H1N1 vaccine antigen, developed through egg-based technology, are expected to be available in four to six months' time, subject to regulatory approval. The firm plans to manufacture the vaccine at its Canadian and German sites.
Unlike Novartis, GSK will be donating some of its vaccine. It says it has offered to convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new H1N1 vaccine. It will also supply the vaccine to developing countries under tiered pricing.
GSK has received interest from several governments to purchase the new vaccine, including the UK (60 million doses), France (50 million dose) and Belgium (12.6 million doses); Finland wants 5.3 million doses of H1N1 antigen, which is expected to be used with the government's existing stockpile of GSK's adjuvant system (AS03).
Sanofi Pasteur, the vaccine arm of Sanofi-Aventis, estimates it will have the first bulk of concentrate vaccine, also derived from egg-based technology, within four to six months. The firm's influenza vaccine sites are in Swiftwater, Pennsylvania, and Val de Reuil, France.