Novartis starts clinical trials on “swine flu” vaccines with and without adjuvants * WHO orders adjuvants in vaccines * FDA prepares to give emergency authorisation to untested adjuvants


Novartis has started tests on swine flu vaccines with and without adjuvants, sparking fears that vaccine companies are seeking to mask data pointing to the dangers of adjuvants by conducting parallel trials of vaccines without adjuvants even though such vaccines will not be used in the mass vaccinations expected in autumn.

Novartis was the company apparently involved in the clinical trials of bird flu vaccine in Poland 2008 that led to the deaths of at least 21 people.

The Novartis bird flu vaccine was licenced by the EU and had “adverse events reactions” listed as the “primary outcome measure.”

Novartis is conducting trials on swine flu vaccines without adjuvants even though WHO has said adjuvants should be used around the world in “swine flu” vaccines, and Novartis and other companies are planning to use adjuvants, raising questions about the purpose of clinical trials of vaccines without adjuvants.

Vaccine expert Dr Rebecca Carley has said that the adjuvants in the two-shot swine flu vaccine could lead to a massive inflammatory reaction and a cytokine storm if they follow an injection with a huge dose of live virus into a body with a weakened immune system.

The US Food and Drug Administration could allow the controversial adjuvants to be used under an emergency use authorization, thereby bypassing standard tests to ensure safety.

Canadian health authorities also want GSK to conduct a small study to offer “minimum data on initial immunogenicity and some safety data if we’re going for the adjuvanted vaccine,” according to The Canadian Press.

But is a “small” study with “minimum” data enough?

Here is a report from CBC from Wednesday 5 August.

“Human tests of a potential swine flu vaccine have begun, a spokesperson for Novartis said Wednesday, as other drug companies also prepared to start trials.

Novartis is testing a vaccine in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, said Novartis spokesman Eric Althoff.

“We initiated clinical trials about 10 days ago,” Althoff told The Associated Press.

A Briton received the first shot of H1N1 pandemic vaccine about 10 days ago, he said.

Novartis expects two doses will be required. The trial will also test this assumption.

Sanofi-Pasteur, which makes about 40 per cent of the world’s flu vaccines, expects to start testing its swine flu vaccine within days in the U.S. and Europe, said spokesman Benoit Rungeard.

GlaxoSmithKline PLC, which has orders for 291 million doses of vaccine from countries including Britain and Canada, has not yet started testing its vaccine in humans.

Stretching supply
Last month, the Australian drug company CSL began human testing in Australia.

Manufacturers are comparing vaccines with and without adjuvants, the ingredients that are used to boost immune response so less vaccine is needed.

The World Health Organization recommends using adjuvants to maximize the global supply of swine flu vaccine.

Flu vaccines in Europe often contain adjuvants but Canada and the U.S. have not licensed flu vaccines with adjuvants before.

Last week, Dr. David Butler-Jones, the head of the Public Health Agency of Canada, said Canada will likely use adjuvanted vaccine as requested by WHO.

Health Canada wants GSK to conduct a small study to offer “minimum data on initial immunogenicity and some safety data if we’re going for the adjuvanted vaccine,” Dr. Elwyn Griffiths, director general of Health Canada’s biologics and genetic therapies directorate, told The Canadian Press last week.

If U.S. politicians decide adjuvants are required, the Food and Drug Administration could also allow it under an emergency use authorization.

WHO and drug makers have said swine flu viruses grown in eggs to make vaccines are producing 25 to 50 per cent as much yield as seasonal flu viruses. WHO’s laboratory network is trying to generate new vaccine viruses with higher yields.

AstraZeneca’s MedImmune unit makes flu vaccine that is sprayed into the nose instead of injected. The company uses a different process to make vaccines than the traditional approach, and expects to start clinical trials in the U.S. around Aug. 17, Reuters reported.

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