(Adds detail, reaction, international context)
* UK ahead of others once more with emergency approval
* Britain has ordered 100 million doses of the vaccine
* Health minister eyes route out of pandemic by spring
* Regulator advocates new timing of first and second doses
* Britain to prioritise first shots over boosters
By Alistair Smout and Paul Sandle
LONDON, Dec 30 (Reuters) - Britain on Wednesday became the
first country to approve the coronavirus vaccine developed by
Oxford University and AstraZeneca, hoping that rapid
action will help it stem a record surge of infections driven by
a highly contagious form of the virus.
Prime Minister Boris Johnson’s government, which has ordered
100 million doses, had already fast-tracked approval of a
vaccine developed by Pfizer and Germany's BioNTech, and
administered hundreds of thousands of shots weeks ahead of
European Union countries and the United States.
Though cheaper and easier to distribute than rival vaccines,
the AstraZeneca/Oxford shot has been plagued with questions
about its most effective dosage ever since data published last
month showed some surprising results.
While other regulators have taken a more cautious approach,
Britain's MHRA was at pains to say it had resolved early doubts
and - unexpectedly - that it had found an 80% success rate for
the administration of two full doses, three months apart, higher
than the average that the developers themselves had found.
The government plans to take advantage by giving the first
dose to a larger number of people most at risk from COVID-19
before starting to administer the boosters.
An advisory body recommended doing the same with the Pfizer
shot, though Pfizer said its vaccine had not been tested on
different dosing schedules.
Jeremy Farrar, one of Britain's leading public health
experts, said the approval of the AstraZeneca/Oxford shot was to
be celebrated, but urged continuing scrutiny, recommending the
developers conduct a randomised trial to test the timing of the
second dose.
Jonathan Stoye, a virologist at the Francis Crick Institute,
agreed that questions remain about the real efficacy of the
vaccine, how well it works in older people, and what data exists
to support the change in dosage interval.
"In light of the sharply increasing number of cases, the
approval... is tremendous news," he said. "However, the reported
news does leave unanswered a number of important questions,
particularly regarding the longer term."
The government said it would not recommend one vaccine over
another for different cohorts of the population, even though
data on the AstraZeneca/Oxford shot's efficacy in older people
is currently limited.
INFECTIONS SOAR
Britain has already registered over 70,000 deaths from
COVID-19. On Tuesday it reported a record one-day jump of 53,135
new coronavirus infections, and it fears hospitals will soon
become overstretched in their peak winter months.
The AstraZeneca/Oxford vaccine could also be a game-changer
for global immunisation. Countries with relatively basic health
infrastructure have high hopes for a shot that, unlike Pfizer's,
can be stored and transported under normal refrigeration, rather
than supercooled to -70 degrees Celsius (-94 Fahrenheit).
India's Serum Institute of India (SII), the world's biggest
producer of vaccines, has made about 50 million doses of the
Oxford vaccine.
Experts at India's drug regulator met on Wednesday to
consider an emergency approval, and will discuss the issue again
on Friday. Chile is also interested.
World Health Organization spokesman Tarik Jasarevic said the
latest vaccine was important for its "delivery attributes, the
potential scale and affordability".
Helen Fletcher, Professor of Immunology at the London School
of Hygiene and Tropical Medicine, hailed a "turning point" for
the pandemic, which has already killed 1.7 million people around
the world, sown chaos through the global economy and upended
normal life for billions.
"With more than 30 supply agreements and partner networks
established globally, the Oxford/AstraZeneca vaccine could slow
the pandemic and should save many lives within the next year,"
she said.
EU DECISION SOON?
The EU regulator says it has not yet received full data on
the AstraZeneca shot and is unlikely to be able to approve it
next month, although Germany's top vaccine official said that a
rolling review of data meant a quick decision should be
possible.
Canada said it needs more information from the British
drugmaker as part of its ongoing review.
The UK's COVID-19 vaccine chair Wei Shen Lim said a single
dose of AstraZeneca/Oxford's vaccine was around 70% effective
from 21 days until a second dose was given at 12 weeks.
The UK Medicines and Healthcare products Regulatory Agency
(MHRA) cleared up one doubt raised by the Oxford data, saying
that a 90% success rate for a half-dose followed by a full dose
had not stood up to analysis.
A Reuters investigation detailed how the apparently more
effective dosing regime was the result of a miscalculation.
However, Munir Pirmohamed, chair of a government working
group on COVID-19 vaccines and involved in the approval, said
that when two full doses were given three months apart,
"effectiveness was high, up to 80% ... which is the reason for
our recommendation".
AstraZeneca Chief Executive Pascal Soriot told BBC radio
that Britain should be able to vaccinate tens of millions of
people by the end of the first quarter. The firm said it
expected the vaccine to work against the new variant.
Health Secretary Matt Hancock told Sky News that he was
"highly confident that we can get enough vulnerable people
vaccinated by the spring that we can now see our route out of
this pandemic".
(Reporting by Alistair Smout and Paul Sandle in London;
Additional reporting by Pushkala Aripaka in Bengaluru, Josephine
Mason and Kate Kelland in London, John Miller in Zurich, Emilio
Parodi in Milan and Rebecca Spalding; Editing by Guy
Faulconbridge, Kevin Liffey and Jan Harvey)
Astrazeneca (AZN)
