In our commitment to prioritising potential treatments
for coronavirus (COVID-19), the
Medicines and Healthcare products Regulatory Agency (MHRA)
approved the COVID-19 Oxford Vaccine Trial request to trial a
vaccine to prevent COVID-19 in a little over one working
week.
The application was made on 18 March, and on 26 March
the MHRA gave the COVID-19 Oxford Vaccine Trial the green light.
The procedures for tailored scientific advice and guidance, and a
speedy approval process, are part of MHRA’s pledge
to prioritise
clinical trial applications submitted for
COVID-19.
Scientists in Oxford started working on designing a
vaccine early in January 2020, and have now identified one to
start the first clinical testing phase. If the vaccine is proven
to be safe and effective in this and larger trials, it could
protect people and help save lives.
The project is supported by a joint
funding scheme between the UK Research and Innovation
(UKRI) and National Institute
for Health Research (NIHR).
The MHRA is dedicated to supporting researchers and
all those who are working on a response to COVID-19. We are
providing scientific advice and informal guidance for all aspects
of product development.
Science Minister,
, said:
“The government is doing all it can to support the
science and research community who are working tirelessly to
identify a vaccine to combat coronavirus.
“Accelerating UK vaccine development, including
clinical testing, will ensure that any successfully developed
vaccine can be made available to people as soon as
possible.
Dr June Raine, Chief Executive for the MHRA,
said:
“The dedicated scientific advice and rapid approval
of this important clinical trial demonstrate our commitment to
working together to find a vaccine for this
pandemic.
“We support the development and expedite
authorisation of clinical trials for COVID-19 treatments, whilst
maintaining our high regulatory standards to ensure the safety of
people involved in the trials.
"Protecting health and saving lives is at the
forefront of our work, and we are committed to enabling the
development of safe and effective vaccines and treatments for
this virus.‘
MHRA prioritises trial applications for
COVID-19
Clinical trials applications can be submitted
directly to the MHRA Clinical Trial Helpline by
emailing clintrialhelpline@mhra.gov.uk, in
parallel to the normal Common European Submission Portal
(CESP) route, so we can begin work as soon as possible. We
then liaise closely with any applicants to ensure it’s managed as
efficiently as possible. We are currently offering an expedited
review and approvals process for COVID19 clinical trials, aiming
to complete our review in a week.
