Patients taking part in a new clinical study launching today
will soon receive different COVID-19 vaccines for their first
or second dose.
Backed by £7 million of government funding, the study will be
the first in the world to determine the effects of using
different vaccines for the first and second dose - for example,
using Oxford University/AstraZeneca’s vaccine for the first
dose, followed by Pfizer/BioNTech’s vaccine for the second.
The study, run by the National Immunisation Schedule Evaluation
Consortium (NISEC) across eight National Institute for Health
Research (NIHR) supported sites, will also gather immunological
evidence on different intervals between the first and second
dose for a mixed-vaccine regimen against control groups when
the same vaccine is used for both doses.
A same-dose regimen is currently implemented for the national
COVID-19 vaccination programme, and there are no current plans
for this to change. Anyone who has received either the Pfizer
or AstraZeneca vaccination as part of the UK-wide delivery plan
will not be affected by this study. They will receive their
second dose from the same source and over the same 12 week
interval.
The 13 month study will monitor the impact of the different
dosing regimens on patients’ immune responses, which have the
potential to be higher or lower than from the same dose
regimen. Initial findings are expected to be released in the
summer. The study has received ethics approval from the
Research Ethics Committee, as well as approval from the
Medicines and Healthcare products Regulatory Agency (MHRA).
Should the study show promising results, then the government
may consider reviewing the vaccine regimen approach if needed,
but only if proven to be safe and recommended by the Joint
Committee on Vaccination and Immunisation (JCVI).
Minister for COVID-19 Vaccine Deployment said:
“This is a hugely important clinical trial that will provide us
with more vital evidence on the safety of these vaccines when
used in different ways.
“Nothing will be approved for use more widely than the study,
or as part of our vaccine deployment programme, until
researchers and the regulator are absolutely confident the
approach is safe and effective.
“This is another great step forwards for British science,
expertise and innovation, backed by government funding - and I
look forward to seeing what it produces.”
Deputy Chief Medical Officer and Senior Responsible Officer for
the study, Professor Jonathan Van-Tam said:
“Given the inevitable challenges of immunising large numbers of
the population against COVID-19 and potential global supply
constraints, there are definite advantages to having data that
could support a more flexible immunisation programme, if needed
and if approved by the medicines regulator.
“It is also even possible that by combining vaccines, the
immune response could be enhanced giving even higher antibody
levels that last longer; unless this is evaluated in a clinical
trial we just won’t know.
“This study will give us greater insight into how we can use
vaccines to stay on top of this nasty disease.”
The study will initially have eight different arms testing
eight different combinations, but more products may be added. The
eight arms include:
