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Pin to quick picksAstrazeneca Share News (AZN)

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UPDATE 6-UK rolls out Astra/Oxford COVID vaccine after world-first approval

Wed, 30th Dec 2020 07:08

* 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

* Britain to prioritise first shots over boosters
(Recasts with regulator briefing)

By Alistair Smout and Paul Sandle

LONDON, Dec 30 (Reuters) - Britain on Wednesday became the
first country in the world to approve a coronavirus vaccine
developed by Oxford University and AstraZeneca, hoping
that rapid action would help it stem a surge of infections
driven by a highly contagious variant of the virus.

Boris Johnson’s government, which has already ordered 100
million doses of the vaccine, has jumped ahead of other Western
countries with its vaccination programme.

It was the first to approve a shot developed by Pfizer of
the United States and Germany's BioNTech, with the result that
hundreds of thousands of people were vaccinated in Britain
before European Union countries and the United States even began
administering it this month.

The AstraZeneca/Oxford shot, unlikely to be approved for
some time by EU or U.S. regulators, will start being
administered on Monday, beginning with those most at risk from
COVID-19.

While the approval by the UK Medicines and Healthcare
products Regulatory Agency (MHRA) is a vindication for a shot
seen as essential for mass immunisations in the developing world
as well as in Britain, it does not eliminate questions about
trial data that make it unlikely to be approved so rapidly in
the European Union or the United States.

Uncertainty has swirled over the most effective dosing
pattern for the AstraZeneca/Oxford vaccine since it released
data last month showing a 90% success rate for a half-dose
followed by a full dose, but only 62% - still usually more than
enough for regulators - for two full doses.

The MHRA said that the results for the half-dose regimen had
not been borne out by analysis. Instead, it approved the regimen
of two full doses.

An official involved in the MHRA decision, said that the
vaccine's effectiveness had risen when the doses were given
three months apart.

"Effectiveness was high, up to 80%, when there was a three-
month interval between first and second doses, which is the
reason for our recommendation," Munir Pirmohamed, Chair of the
Commission on Human medicines expert Working Group on COVID-19
vaccines, told reporters.

Hancock said hundreds of thousands of doses would be
available to administer next week in Britain.

"The NHS (National Health Service) will be able to deliver
these shots into people's arms at the speed at which it can be
manufactured," Health Secretary Matt Hancock told Sky News.

"I am also now, with this approval this morning, highly
confident that we can get enough vulnerable people vaccinated by
the spring that we can now see our route out of this pandemic."

Crucially for countries with relatively basic health
infrastructure, the AstraZeneca/Oxford vaccine can be stored and
transported under normal refrigeration, rather than supercooled
to -70 degrees Celsius (-94 Fahrenheit).

India is keen to start administering the new shot next
month; Serum Institute of India (SII), the world's biggest
producer of vaccines, has already made about 50 million doses.
Chile is also interested.

(Reporting by Alistair Smout and Paul Sandle in London,
additional reporting by Pushkala Aripaka in Bengaluru, Kate
Kelland in London, John Miller in Zurich, Emilio Parodi in
Milan; editing by Guy Faulconbridge and Kevin Liffey)

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