Firm to test swine flu vaccine:

http://www.rte.ie/news/2009/0806/swineflu.html

Thursday, 6 August 2009 15:20

Pharmaceutical firm Baxter International says it has produced its first commercial batches of a human swine flu vaccine called Celvapan A/H1N1.

The development comes as the World Health Organisation warned that the current outbreak is the fastest pandemic and could eventually affect two billion people.

Health officials will give a weekly update on cases of human swine flu in Ireland at 5pm at Government Buildings.
Trials to confirm the safety and effectiveness of the Baxter pandemic vaccine in adults and children are scheduled to begin this month.

The batches were produced in late July and the company is now discussing plans for distribution with national and international health authorities, subject to regulatory approval.

The vaccine was made using a cell production technology within 12 weeks of receiving the H1N1 strain virus.

It is based on a system that allowed the company to secure European Medicines Agency approval for a 'mock-up' pandemic vaccine in the past, using a different strain.

A number of other drug companies are also working on candidate vaccines. Novartis has started human testing, while Sanofi-Aventis is also due to start similar tests within days.

The WHO has moved to reassure people that fast-tracking flu vaccines will not reduce safety and that the procedures will be rigorous.

It said that flu vaccines are needed fast and in big quantities for greatest impact. Vaccines arrived too late in the 1957 and 1968 flu pandemics to be of much use.
However, countries administering pandemic vaccines will have to conduct intensive monitoring, as the WHO says safety issues could arise when a vaccine is administered on a mass scale and some issues may not show up in smaller safety trials.

The World Health Organisation has said that clinical trials on experimental human swine flu vaccines are underway in at least five countries.
The first results will be known in September and will indicate if one or two doses are needed.

Dr Marie-Paule Kieny, WHO Director Initiative for vaccine research, said that in many cases the manufacture of vaccines involves old and proven technology and is no different to making a seasonal vaccine, but to deal with a new strain of the flu virus.

She said that the first vaccines should be available for use in September.
In Britain, the number of human swine flu cases has decreased significantly and there is no sign of the virus mutating.