Results8 Dec 2020 16:43
By Kate Kelland
LONDON, Dec 8 (Reuters) - AstraZeneca and Oxford University
have more work to do to confirm whether their COVID-19 vaccine
can be 90% effective, peer-reviewed data published in The Lancet
showed on Tuesday, potentially slowing its eventual rollout in
the fight against the pandemic.
Once seen as the frontrunner in the development of a vaccine
against the coronavirus crisis, the British team were overtaken
by U.S. drugmaker Pfizer, whose shots - with a success rate of
around 95% - were administered to UK pensioners on Tuesday in a
world-first hailed as V-Day.
Detailed results from the AstraZeneca/Oxford trials have
been eagerly awaited after some scientists criticised a lack of
information in their initial announcement last month.
However, the Lancet study gave few extra clues about why
efficacy was 62% for trial participants given two full doses,
but 90% for a smaller sub-group given a half, then a full dose.
"(This) will require further research as more data becomes
available from the trial," the study said.
Less than 6% of UK trial participants were given the lower
dose regimen and none of them was aged over 55, meaning more
research will be needed to investigate the vaccine's efficacy in
older people who are particularly susceptible to COVID-19.
Pooling the results, overall efficacy was 70.4%, the data on
Tuesday showed. That is above the 50% minimum set by the U.S.
Food and Drug Administration.
COVID-19 vaccines from Pfizer/BioNTech and Moderna have
reported efficacy levels of more than 90% in late stage trials.
But the AstraZeneca/Oxford vaccine is seen as particularly
important to tackling the pandemic in the developing world, as
it would be cheaper and easier to distribute.
"The basic message that the overall efficacy across the
trials that are reported here is about 70% but with a clear
description of its uncertainty," said Stephen Evans, a professor
of pharmacoepidemiology at the London School of Hygiene &
Tropical Medicine.
"The statistical uncertainty is that the efficacy could be
as low as 55% or as high as 80%. The Pfizer/BioNTech and Moderna
vaccines both have efficacies above 90% and are clearly more
efficacious under trial conditions."
Asked whether the half, then full dose regimen had been a
mistake, Andrew Pollard, director of the Oxford Vaccine Group
and chief investigator into the trials, told a news conference
it had been "unplanned."
Head of AstraZeneca's non-oncology research and
development, Mene Pangalos, said he hoped requests for approval
from regulators around the globe could still be submitted this
year.
"We hope that once the regulatory authorities review the
data, we can get approval any time from the completion of the
submission, which could be any time from the end of this year to
early next year," he said.
However, Pollard conceded the different results from the two
dosage regimens complicated matters.
"The regula