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September 2, 2009
Share ThisWe are pleased to hear that the vaccine developer Novavax (NVAX) has made a major breakthrough in a phase II clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate. While the trial carried out on 221 people (aged 18 to 49 years) showed strong immune system responses against three flu strains (H3N2, H1N1, and B), no major adverse events were reported.
Given the success of the mid-stage trial, Novavax now plans to initiate a study in elderly adults by the fourth quarter and a phase III study next year. Although the progress made by Novavax is positive news, the vaccine is not likely to hit the market in the next few years. Hence, the vaccine will not be of much use in the current pandemic.
Any development on the influenza vaccine front is welcome news as a second wave of swine flu is expected to hit with the onset of winter in the northern hemisphere. It is estimated that globally about 5% to 20% of the population are infected from seasonal flu, killing as many as 250,000-500,000 people each year. According to the World Health Organization (WHO), up to a third of the world's population may be infected with swine flu this year, with about 15% of them requiring hospital care.
In another development, Chinese vaccine makers Sinovac Biotech and Hualan Biological Engineering expect their swine flu vaccines to be approved by the Chinese authorities this week. The most interesting aspect of this vaccine is that contrary to the earlier expectation that two doses of vaccine would be necessary; both companies have proved the effectiveness of the vaccine in single doses. While Sinovac expects to produce 30 million doses of the vaccine in a year, Hualan plans to produce up to 160 million doses.
According to the Centers for Disease Control, swine flu has become the world’s fastest-moving influenza pandemic, sweeping across 177 countries in the four months since it was first identified. Currently, AstraZeneca (AZN), GlaxoSmithKline (GSK) Novartis (NVS) and Sanofi-Aventis (SNY), supply seasonal flu vaccine in the US market. Many of these have started clinical testing of their swine flu vaccines recently.
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