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'No shortcuts' on H1N1 vaccine safety says GlaxoSmithKline

Published on 20/08/09 at 12:41pm

GlaxoSmithKline says the public need not doubt the safety of its vaccine against the H1N1 swine flu, which it is now preparing for widespread use from October.

In an exclusive interview with Pharmafocus, the company's senior medical advisor for pandemics in the UK, Dr Neil Formica, said time pressures would not compromise safety.

"A lot of companies have been making flu vaccines for a long time, and the characteristics of these viruses as they are put into vaccines are known, so there is a an awful lot of history there," he said.

Dr Formica says this wealth of data "puts us in a position where we are not expecting anything to go wrong, because we have used the processes over and over again."

The H1N1 virus emerged in Mexico in April and rapidly spread around the world, and was declared a pandemic by June.

There is pressure on GSK and its rival vaccine manufacturers such as Novartis and Sanofi-Aventis Pasteur MSD to have their first doses ready by autumn for the northern hemisphere, when the seasonal flu vaccines are usually administered to vulnerable groups.

Media reports have raised fears that the testing and approval process could be rushed in order to satisfy mass governments orders, and that the safety of the new vaccine cannot be guaranteed.

Most notably, an editorial in The Lancet earlier this month said countries needed to "assess carefully the risks and benefits of rapid approval of an H1N1 vaccine" especially in light of the disease being mild to date, with most patients making a full recovery.

It also said strong post-marketing surveillance needed to be put in place once the vaccines are launched, a measure the UK will be using.

However, overall the publication and others like it say the risk from H1N1 is far greater than any potential risks from a vaccine, particularly in the most vulnerable groups.

While it is true that the scale and the speed of the development of the vaccine is unprecedented, GSK and other companies say safety is not being compromised.

GSK began the first clinical trials of its pandemic vaccine in Germany last week, and will conduct a total of 16 clinical trials in over 9000 individuals across Europe, Canada and the US.

The trial in Germany will assess the use of the vaccine in healthy adults, with data ready for appraisal by regulators in September.

Further trials will examine its effects in infants, children, adults and the elderly will begin shortly. GSK says the trials will evaluate the immune response as well as tolerability and other safety aspects of the vaccine.

"The things we try to speed up are the reporting of the data and the analysis of the data, but the data itself is collected in the same way," says Formica.

"There are no shortcuts taken around the timing of the type of data that is collected," he added.

He said the company had similar, though smaller scale, experience in producing vaccines for avian flu (H5N1), and that it possessed mock-up licenses in Europe for a pandemic vaccine.

This means at the time of a pandemic, the EMEA only need technical information about the new strain of flu, and can then consider it with the data already seen in a mock-up for approval, to speed up the process.

However, an additional precaution of post-marketing surveillance studies are to be carried out after the vaccines have been administered in the UK. While this is unusual for flu vaccines, is a measure is considered necessary in a pandemic because of the scale of the vaccine programme.

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