LONDON, March 4 (Reuters) - Britain's medical regulator on
Thursday said it would fast-track vaccines for coronavirus
variants, adding that the makers of already-authorised shots
would not need new lengthy clinical trials to prove their
adapted vaccines will work.
There is concern that some variants, such as those first
found in South Africa and Brazil, may reduce the efficacy of the
first generation of COVID-19 vaccines, and manufacturers are
looking to adapt their shots.
The accelerated process is based on that used for seasonal
flu vaccines each year, the Medicines & Healthcare products
Regulatory Agency (MHRA) said, and would be based on robust
evidence that the shots create an immune response, rather than
full clinical trials.
"Our priority is to get effective vaccines to the public in
as short a time as possible, without compromising on safety,"
said Christian Schneider, chief scientific officer at the MHRA.
"Should any modifications to authorised COVID-19 vaccines be
necessary, this regulatory approach should help to do just
that."?
The MHRA said that researchers would be able to measure
protection by looking at antibodies in the blood after
vaccination.
As well as data on immune response, vaccine makers will need
evidence the vaccine is safe, and data from original clinical
trials and real-world evidence from vaccine rollout could also
be used.
The MHRA said it had developed the advice in conjunction
with regulators in Australia, Canada, Singapore and Switzerland.
AstraZeneca, Pfizer and Moderna,
the makers of the three vaccines the MHRA has approved for use
so far, have all said they are aiming to modify their shots to
cope with variants this year.
Britain, which is rolling out shots made by AstraZeneca and
Pfizer, has given a first shot of a vaccine to over 20 million
people. Despite regulatory approval, Moderna's vaccine is yet to
be rolled out in the country.
(Reporting by Alistair Smout; editing by Jonathan Oatis)
Astrazeneca (AZN)
