PowerMed, a UK biotechnology company, is seeking permission from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to begin human clinical trials in London for its experimental needle-free avian flu vaccine. The vaccine should protect people from H5N1 bird flu virus strain infection.
If the trial is approved it will be carried out at the Guy’s Drug Research Unit (GDRU), London, UK.
This vaccine, unlike traditional ones, utilizes fragments of the Vietnam H5N1’s DNA to trigger a human immune response. The vaccine has copies of the virus gene, which are enclosed in tiny gold particles. The particles are blasted at supersonic speed into the immune cells of the skin. No needles are used. PowerMed says this method should produce better immunity.
Traditional vaccines are based on technology which is over 50 years old, using live chicken eggs. The traditional method is very slow.
PowerMed says that although the vaccine shows promise, it will be years before it goes on the market.
According to a study carried out by PowerMed in the USA, this vaccine produces 100% immune response from normal human flu. The makers believe it will provide the same protection against the deadly H5N1 bird flu virus strain.
(Bird Flu = Avian Flu)
Governments, agencies and most people would like to see a bird flu vaccine for humans come onto the market before the H5N1 virus mutates and brings about a serious flu pandemic. Several companies around the world are working on bird flu vaccines, such as Sanofi Aventis, Novartis, GlaxoSmithKine, and some others.
Dr Beadle, Chief Medical officer, PowerMed Ltd, said ?This is an exciting opportunity for PowderMed to conduct this first clinical trial on a vaccine which may have a very important role in the event of a future pandemic. We have selected the GDRU to conduct this study because of their expertise and experience in recruiting for and conducting such Phase I studies.?