* India aims to vaccinate 300 mln people in 6-8 months
* Country has 2nd highest number of COVID-19 infections
* Expert team recommends approving Bharat Biotech shot
(Adds possible approval for another vaccine, paragraphs 8-9)
By Krishna N. Das
NEW DELHI, Jan 2 (Reuters) - India has approved the COVID-19
vaccine developed by AstraZeneca and Oxford University,
paving the way for a huge immunisation campaign in the world's
second most populous country.
A team of experts at India's drugs regulator has also
recommended approving a vaccine developed locally by Bharat
Biotech and the government-run Indian Council of Medical
Research (ICMR), CNBC-TV18 and other media reported.
Citing sources, Reuters reported on Friday that the shot
could be approved, though little is known about the results of
its clinical trials.
India's drugs regulator, the Central Drugs Standard Control
Organization (CDSCO), and the ICMR did not immediately respond
to calls seeking comment. Bharat Biotech declined to comment.
Information and Broadcasting Minister Prakash Javadekar told
reporters on Saturday that the AstraZeneca/Oxford vaccine had
been given the green light on Friday, confirming what sources
close to the matter had told Reuters.
It is the first COVID-19 vaccine to be approved for
emergency use by India, which has the highest number of
infections after the United States, and comes on the day the
country is running a nationwide mock drill for vaccine delivery.
Javadekar said at least three more vaccines were waiting to
be approved - Bharat Biotch's COVAXIN, Zydus Cadila's
ZyCoV-D and Russia's Sputnik-V.
"India is perhaps the only country where four vaccines are
getting ready," he said.
"One was approved yesterday for emergency use, Serum's
COVISHIELD." he said, referring to the fact that the
AstraZeneca/Oxford shot is being made locally by the Serum
Institute of India (SII).
The CDSCO is expected to announce the dosage and other
details about the shot later. SII had applied for a two
full-dose regime about 28 days apart.
AFFORDABLE VACCINE
The AstraZeneca/Oxford vaccine, which was granted its first
approval by Britain on Tuesday, is cheaper and easier to use
than some rival shots - major advantages in tackling a pandemic
that has claimed more than 1.8 million lives worldwide.
However, it has been plagued by uncertainty about its most
effective dosage ever since data published in November showed a
half dose followed by a full dose had a 90% success rate while
two full shots were 62% effective.
India's regulator has also received an emergency-use
application for the COVID-19 vaccine made by Pfizer Inc
with Germany's BioNTech - the first shot to secure
regulatory approval in the West.
India has reported more than 10.3 million COVID-19 cases and
around 150,000 deaths, though its rate of infection has come
down significantly from a mid-September peak.
The country hopes to inoculate 300 million of its 1.35
billion people in the first six to eight months of this year.
SII, the world's biggest producer of vaccines, has already
stockpiled about 50 million doses of the AstraZeneca/Oxford
shot, which will be sold to the government at about 250 rupees
($3.42) per dose and 1,000 rupees on the private market.
($1 = 73.1200 Indian rupees)
(Reporting by Krishna N. Das; Editing by Kim Coghill and Mark
Potter)
Astrazeneca (AZN)
