James Meikle, health
correspondent
Thursday August 1, 2002
The Guardian
A hurdle said to have slowed down trials of GM vaccines was removed
yesterday as volunteers on the drugs' trials were told they can live at home
and use the public sewerage system.
To date such trials in Britain have been done in "closed" conditions
under tight hospital control, with volunteers' excrement being collected and
treated separately.
Government scientific advisers gave the all-clear for the drug company
Acambis, and St Bartholomew's hospital, London, to release the GM material
to the environment.
The hospital and firm intend to begin experiments to develop a GM vaccine
against diarrhoea. The advisers said they were satisfied the modified
bacteria shed through 50 volunteers' guts would not replicate in the
sewerage system.
Another government body, the medicines control agency, still has to
approve the trials but other companies are lining up similar applications.
Acambis stressed that it might be five years before a vaccine reached the
market; an effective one would need at least three strains of genetically
modified E coli, the bug causing diarrhoea. The prototypes knock genes out
of E coli bacteria to lessen their ability to cause diarrhoea, especially
those types caught abroad.
This was the first time the advisory committee on releases to the
environment, best known for monitoring trials of GM crops, has had to rule
on vaccine use. The committee thought it unlikely that altered bacteria
might "revert to a former state" in the sewerage system, causing a health
risk.
The developers of the vaccine said volunteers would "go about their
normal duties", shedding live GM bacteria in their stools for up to 38 days.
They would not be allowed to travel outside England and since most of the
volunteers lived near London, most GM material would enter the capital's
sewerage system.
Nicola Thomas, the project manager for Acambis, said that the bacteria
would be "effectively destroyed as soon as they were flushed".