After the Health Ministry announced Israel’s fifth swine flu death this morning, an agreement was signed this afternoon at Deputy Health Minister’s Ya’acov Litzman’s office for the purchase of options to buy swine flu vaccines worth NIS 7 million from French drugmaker Sanofi Pasteu – the largest company in the world devoted entirely to human vaccines.
Ahead of the agreement, Litzman said, “I hope the vaccinations will arrive as soon as possible for Israel’s general populace and particularly for those at risk.”
Sanofi Pasteur said today that it had begun human trials of its swine flu vaccine this week on about 2,000 people in the United States – becoming the third company conducting clinical trials on swine flu vaccines.
In a meeting last night, Prime Minister Binyamin Netanyahu, Finance Minister Yuval Steinitz and Litzman agreed that the Health Ministry would, in the coming days, purchase options to buy vaccines worth approximately NIS 20 million from a leading European pharmaceutical concern. The vaccines are due to be available at the start of 2010.
Sanofi Pasteur’s trials began yesterday, testing both the vaccine’s safety and how many doses would be needed to protect people from swine flu, the company said in a statement. Most experts think two doses will be necessary.
The World Health Organization’s vaccine chief Marie-Paule Kieny said yesterday that drugmakers were “on track,” and that the first batches of swine flu, or H1N1, vaccine should be delivered in September.
Sanofi Pasteur, which makes about 40 percent of the world’s flu vaccine, has applied to the US Food and Drug Administration for fast-track licensing for the vaccine.
Kieny said safety was not compromised in granting quick licenses before full safety tests are finished – a practice European and US drug regulators also use for seasonal flu vaccines. Clinical tests on new vaccines can take up to a year or more.
The European Medicines Agency said approving a swine flu vaccine for EU countries could take five days.
The WHO said Northern Hemisphere countries, as well as Southern Hemisphere doctors and nurses, should get a vaccine first because swine flu is expected to surge in the north when the regular flu season begins later this year.
Sanofi Pasteur has contracts with several governments, including France and the US, to provide swine flu vaccine and other products in bulk.
Meanwhile, Swiss pharmaceutical Novartis AG said this week it had started testing its swine flu vaccine in about 6,000 people in Britain, Germany and the US.
Last month, Australian company CSL also began testing its vaccine in Australia.
The vaccines being tested by Novartis and Sanofi Pasteur contain adjuvants – ingredients intended to boost the body’s immune response. Adjuvants, which also stretch a vaccine’s active ingredient further to make more doses, are used in European flu vaccines but not in the US The WHO has recommended they be used in swine flu vaccines to increase the global supply.
Health officials have said there is little or no information on how vaccines containing adjuvants affect pregnant women and children – two groups thought to be particularly vulnerable to swine flu.