* 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
(Add comments on dosage)
By Krishna N. Das
NEW DELHI, Jan 2 (Reuters) - Experts at India's drugs
regulator have recommended for emergency use two coronavirus
vaccines, one developed by AstraZeneca and Oxford
University and the other backed by a state-run institute, the
government said on Saturday.
A government minister said earlier the AstraZeneca/Oxford
vaccine had been given the green light on Friday, paving the way
for a huge immunisation campaign in the world's second most
populous country.
The government said the final decision on the two vaccines
would be made by the Central Drugs Standards Control
Organisation's (CDSCO) chief, who has called a news conference
on Sunday. The process for the final approval is expected to be
a formality given the urgency for a vaccine in the country with
the highest number of COVID-19 infections in the world after the
United States.
The other vaccine, known as COVAXIN, has been developed
locally by Bharat Biotech and the government-run Indian Council
of Medical Research. Citing sources, Reuters reported on Friday
that the shot could be approved, though little is known about
the results of its clinical trials.
"Grant of permission for restricted use in emergency
situation in public interest as an abundant precaution, in
clinical trial mode, specially in the context of infection by
mutant strains," the government cited the experts'
recommendation for COVAXIN, referring to the new strain of the
virus first detected in Britain.
For the AstraZeneca/Oxford vaccine, the approval was
"subject to multiple regulatory conditionalities", it said,
without giving details.
The regulator is likely to approve administering two doses
for both vaccines, each four weeks apart, two sources with
knowledge of the matter told Reuters on Saturday. Calls to CDSCO
were unanswered outside regular business hours.
Information and Broadcasting Minister Prakash Javadekar told
reporters earlier that two other vaccines were waiting to be
approved - Zydus Cadila's ZyCoV-D and Russia's Sputnik
V that are both on trial in India.
"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 news of the sign-off on COVAXIN came after lawmaker
Subramanian Swamy, a member of Prime Minister Narendra Modi's
nationalist party, complained on Twitter that a
foreign-developed shot had been approved while a local one
tested on thousands of people at home was "in the ditch".
"We thank the citizens of India for showing confidence in an
all Indian-made vaccine!" Bharat Biotech said in reply to
Swamy's tweet, after its vaccine was recommended.
A Bharat Biotech spokeswoman declined further comment when
asked by Reuters.
The AstraZeneca/Oxford vaccine, which was granted its first
approval by Britain on Tuesday, is cheaper and easier to use
than some rival shots, such as the one from Pfizer Inc -
a major advantage 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.
The efficacy of the Indian vaccine could "go up much more"
than 60% after two doses are given, a source with knowledge of
the matter told Reuters.
India's regulator has also received an emergency-use
application for the COVID-19 vaccine made by Pfizer 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; Additional reporting by Shilpa
Jamkhandikar; Editing by Kim Coghill, Mark Potter and David
Evans)
Astrazeneca (AZN)
