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Orphan status for low RoI vaccine

A tuberculosis booster vaccine, which could potentially save millions of lives, has been recommended for orphan status by the European Medicines Agency

A tuberculosis (TB) booster vaccine, which could potentially save millions of lives, has been recommended for orphan status by the European Medicines Agency (EMEA) because it is targeted at the developing world. It is the first time that the Committee for Orphan Medicinal Products (COMP) has recommended a drug for orphan status on the back of the so-called `insufficient return on investment' criterion within EU orphan drug legislation.

Recombinant modified vaccinia virus Ankara expressing tuberculosis antigen 85A (MVA85A) is a booster vaccine designed to prevent TB infection in people who have already been BCG vaccinated. It is the first vaccine designed to prevent TB for over 80 years.

Dr Helen McShane and her team of researchers at the John Radcliffe Hospital at Oxford University conducted the MVA85A project, which was funded by the Wellcome Trust. However, the EMEA's COMP decided that MVA85A would not generate a sufficient return on investment once marketed, as developing countries would not be able to pay the full price.

Regulation EC 141/2000 on orphan products, which came into force in April 2000, stipulates that drugs can be designated as orphan products only if they are for the treatment of life-threatening or chronic conditions affecting not more than five in 10,000 people.

However, drugs with bigger target populations can also be accepted through the RoI clause, although few research sponsors have tried this route.

EMEA spokeswoman Monika Benstetter said COMP had looked at the data for predicted revenue forecasts and ìcome to the conclusion that the RoI for the [MVA 85A] vaccine would not offset the development costs even though there could potentially be a larger patient populationî.

It is widely expected that the European Commission, which usually follows COMP's advice, will ratify the opinion within the next month.

Despite being good protection for children, BCG is not so effective among adults and in some parts of the developing world. MVA85A contains the same antigen and would act as an extra barrier against TB infection.

According to the World Health Organisation, TB could kill 35 million people in the next 20 years if new controls are not introduced.

30th September 2008

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