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Source: http://www.reuters.com/article/topNe...090903?sp=true
Single swine flu vaccine dose may be enough
Thu Sep 3, 2009 7:40am EDT
By Sam Cage and Lucy Hornby
ZURICH/BEIJING (Reuters) - Drug maker Novartis on Thursday trumpeted the effectiveness of a single dose of its anti-swine flu vaccine, boosting hopes that potentially tight supplies could go further when mass immunization programs start this month.
The outbreak of the H1N1 strain of flu, declared a pandemic on June 11, has spread around the world and could eventually affect 2 billion people, according to World Health Organization estimates.
Many experts expected that two doses per person would be needed by health authorities preparing for a possible second wave of infections at the start of the northern hemisphere winter.
Vaccination is expected to get under way in some countries this month with many others starting in October.
Novartis said its H1N1 vaccine had a strong immune response after just one dose in a pilot trial, and Chinese health authorities gave a green light to Sinovac, which says its vaccine also needs only one shot to be effective.
"First data is encouraging and indicates that should supply be limited due to low production yields, giving the population only one shot may be enough to provide protection from swine flu," Vontobel analyst Andrew Weiss said of the Novartis shot.
Another key variable is vaccine yield in the manufacturing process. Yields were initially low but the World Health Organization said last month they were improving and one strain seemed to be yielding the same amount as seasonal vaccine.
Cell-based vaccines like Novartis's are quicker and easier to manufacture that traditional flu vaccines, which are grown in chicken eggs, but supplies are limited for now -- they currently make up about 30 percent of the Swiss group's capacity.
Novartis said the trial with 100 volunteers run by Britain's Leicester University showed a potentially protective immune response in 80 percent of subjects after one dose and more than 90 percent after two doses. Other studies with more than 6,000 adults and children are continuing.
Sinovac, the first company to complete clinical trials, received approval from Chinese health authorities to mass produce a vaccine for the new strain of H1N1 and raised its annual sales forecast.
Novartis shares slipped 0.6 percent to 48.68 Swiss francs by 5:50 a.m. EDT, in line with the DJ Stoxx European healthcare sector.
WINDFALLS
Other pharmaceutical companies like Sanofi Aventis, GlaxoSmithKline and AstraZeneca's MedImmune unit are also racing to develop H1N1 vaccine as governments scramble to secure supplies.
Australia's CSL is already producing H1N1 vaccine and is making 1.0 million to 1.5 million doses per week until it fills all orders.
Antiviral drugs which treat flu rather than immunize -- Glaxo's Relenza and Tamiflu, made by Switzerland's Roche -- are also in high demand.
Sales to governments will provide a revenue and profit windfall for many drugmakers this year and in 2010.
"At the beginning of this year, we forecast our sales would rise by 20 percent," Sinovac Chief Executive Yin Weidong said on Thursday. "Looking at things now, H1N1 has given us an opportunity, so the rise should be more than 20 percent."
H1N1 vaccines would be given separately from regular seasonal flu shots.
Vaccines arrived too late in the 1957 and 1968 flu pandemics to be of much use, and flu vaccines had not been developed in the 1918 "Spanish flu" pandemic which killed an estimated 50 million people.
(Additional reporting by Emma Thomasson in Zurich, Ben Hirschler in London and Michael Perry in Sydney)
Single swine flu vaccine dose may be enough
Thu Sep 3, 2009 7:40am EDT
By Sam Cage and Lucy Hornby
ZURICH/BEIJING (Reuters) - Drug maker Novartis on Thursday trumpeted the effectiveness of a single dose of its anti-swine flu vaccine, boosting hopes that potentially tight supplies could go further when mass immunization programs start this month.
The outbreak of the H1N1 strain of flu, declared a pandemic on June 11, has spread around the world and could eventually affect 2 billion people, according to World Health Organization estimates.
Many experts expected that two doses per person would be needed by health authorities preparing for a possible second wave of infections at the start of the northern hemisphere winter.
Vaccination is expected to get under way in some countries this month with many others starting in October.
Novartis said its H1N1 vaccine had a strong immune response after just one dose in a pilot trial, and Chinese health authorities gave a green light to Sinovac, which says its vaccine also needs only one shot to be effective.
"First data is encouraging and indicates that should supply be limited due to low production yields, giving the population only one shot may be enough to provide protection from swine flu," Vontobel analyst Andrew Weiss said of the Novartis shot.
Another key variable is vaccine yield in the manufacturing process. Yields were initially low but the World Health Organization said last month they were improving and one strain seemed to be yielding the same amount as seasonal vaccine.
Cell-based vaccines like Novartis's are quicker and easier to manufacture that traditional flu vaccines, which are grown in chicken eggs, but supplies are limited for now -- they currently make up about 30 percent of the Swiss group's capacity.
Novartis said the trial with 100 volunteers run by Britain's Leicester University showed a potentially protective immune response in 80 percent of subjects after one dose and more than 90 percent after two doses. Other studies with more than 6,000 adults and children are continuing.
Sinovac, the first company to complete clinical trials, received approval from Chinese health authorities to mass produce a vaccine for the new strain of H1N1 and raised its annual sales forecast.
Novartis shares slipped 0.6 percent to 48.68 Swiss francs by 5:50 a.m. EDT, in line with the DJ Stoxx European healthcare sector.
WINDFALLS
Other pharmaceutical companies like Sanofi Aventis, GlaxoSmithKline and AstraZeneca's MedImmune unit are also racing to develop H1N1 vaccine as governments scramble to secure supplies.
Australia's CSL is already producing H1N1 vaccine and is making 1.0 million to 1.5 million doses per week until it fills all orders.
Antiviral drugs which treat flu rather than immunize -- Glaxo's Relenza and Tamiflu, made by Switzerland's Roche -- are also in high demand.
Sales to governments will provide a revenue and profit windfall for many drugmakers this year and in 2010.
"At the beginning of this year, we forecast our sales would rise by 20 percent," Sinovac Chief Executive Yin Weidong said on Thursday. "Looking at things now, H1N1 has given us an opportunity, so the rise should be more than 20 percent."
H1N1 vaccines would be given separately from regular seasonal flu shots.
Vaccines arrived too late in the 1957 and 1968 flu pandemics to be of much use, and flu vaccines had not been developed in the 1918 "Spanish flu" pandemic which killed an estimated 50 million people.
(Additional reporting by Emma Thomasson in Zurich, Ben Hirschler in London and Michael Perry in Sydney)