Results of clinical trials held in Europe show that one dose of Sanofi Pasteur’s H1N1 flu vaccine triggers a robust immune response in most participants, the vaccine unit of French drugmaker Sanofi-Aventis said.
The mid-stage datas stem from tests of the Panenza and Humenza vaccines on adults and children aged at least three years, after Sanofi began clinical trials in Europe in August.
One dose of Panenza or of the adjuvent or booster-type of vaccine Humenza is deemed protective in at least 93 percent of adults aged 18 to 59 years and in at least 83 percent of adults 60 years and older. In children, the response was 94 percent.
Sanofi Pasteur Chief Executive Wayne Pisano said in a statement on Thursday: “Humenza and Panenza vaccines are effective answers to different public health needs,”.
Because of its low dose, Humenza allows for more production capacity, raising the number of doses available and the number of people who can be immunized against what is commonly known as swine flu, he said.
Panenza, given in a standard dose, could be seen by European authorities as a vaccine to protect people who are most vulnerable.
Sanofi shares rose 1.2 percent to 51.16 euros, having gained nearly 2 percent earlier, while the DJ health index was little changed. Sanofi shares have risen 12.7 percent so far this year.
“The news is a mild positive for Sanofi-Aventis, but we expect H1N1 vaccine deliveries to be one-off events,” Kepler analyst Tero Weckroth said in a research note. “However, in light of the current data, Sanofi-Aventis is well positioned in the H1N1 season.”
Sanofi-Aventis Chief Executive Chris Viehbacher said the data could slightly speed up the filing of the Panenza, which could be used by pregnant women, for European approval.
“It may accelerate a little the submission of the non-adjuvent,” he told Reuters on the sidelines of a presentation in Paris.
Participants in the trial showed no serious adverse events from the vaccine jabs. Complaints of redness or swelling at the site of injection as well as mild fever, headache and fatigue were reported.
Sanofi has yet to submit its H1N1 vaccine for EU approval. The European Commission on Wednesday cleared Baxter International’s Celvapan vaccine against H1N1, following green lights for vaccines made by GlaxoSmithKline and Novartis.
The World Health Organisation earlier this week restated its confidence in the H1N1 flu vaccine, calling it the most important tool against the pandemic after some reports said some people were reluctant to be injected with the new vaccine.
Sanofi late last month began shipments to the United States of its H1N1 vaccine, ahead of schedule. It has a contract to provide 75.3 million doses of the vaccine to the U.S. government.
Separately, Viehbacher told Reuters that sales of its cancer treatment Eloxatin were suffering in the United States from the arrival of generic versions. “They are following the typical generic erosion pattern,” he said.
