(Adds comment from Open Orphan executive chairman)
By Kate Kelland
LONDON, Oct 16 (Reuters) - "Human challenge" trials of
potential COVID-19 vaccines, where volunteers are deliberately
infected with the disease, could become a reality after a
British biotech firm said it was in advanced talks with the
government to create and provide strains of the virus.
Preliminary work for the trials, which aim to speed up the
process of determining the efficacy of a vaccine candidate, is
being carried out by hVIVO, a unit of pharmaceutical services
group Open Orphan, the company said.
"We are in discussions with numerous parties including the
UK government around a COVID-19 challenge study, and once any of
those contracts are signed we will make an announcement," said
Open Orphan's executive chairman, Cathal Friel.
If agreed, this would involve creating a human challenge
study model that could be used should such trials gain ethical
and safety approval from regulators.
The UK government's department for business, energy and
industrial strategy (BEIS) was not immediately available for
Supporters of human challenge trials say they are a good way
to cut short the often lengthy process of testing potential
vaccines on tens of thousands of volunteers in the real world
who go about normal life and are monitored to see if they
contract the disease or are protected from it.
In these tightly-controlled trials, volunteers are given a
vaccine and then about a month later are deliberately infected
with the disease under controlled conditions. They are then
isolated in a quarantine facility and monitored to see if they
become sick or if the vaccine protects them.
Critics say deliberately infecting someone with a
potentially deadly disease for which there is currently no
effective treatment is unethical.
Any human challenge trials conducted in Britain would have
to be approved by the Medicines and Healthcare products
Regulatory Agency, the healthcare regulator that looks into
safety, ethics and protocol.
(Editing by Pravin Char and Carmel Crimmins)