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* AstraZeneca's COVISHIELD, Bharat Biotech's COVAXIN
approved
* COVISHIELD found 70.42% effective in studies overseas
* COVAXIN "safe and provides a robust immune response"-
regulator
* No efficacy data provided for COVAXIN
(Adds comments from local maker of Astra vaccine)
By Krishna N. Das and Aftab Ahmed
NEW DELHI, Jan 3 (Reuters) - India's drugs regulator on
Sunday approved for emergency use two coronavirus vaccines, one
developed by AstraZeneca and Oxford University and the
other by local company Bharat Biotech and a state-run institute.
The decisions mark the first vaccine approvals in India,
which after the United States has recorded the most infections
of the novel coronavirus, and could enable the country to source
vaccines locally.
India is expected to start a massive immunisation programme
within about a week, and hopes to inoculate 300 million of its
1.35 billion people free of charge in the first six to eight
months of this year.
Prime Minister Narendra Modi welcomed the approvals.
"It would make every Indian proud that the two vaccines that
have been given emergency use approval are made in India!" he
said on Twitter, calling it a sign of a "self-reliant" country.
India has reported more than 10.3 million COVID-19 cases and
around 150,000 deaths, though its infection rate has come down
significantly from a mid-September peak.
The AstraZeneca shot, already approved in Britain, Argentina
and El Salvador, will take the lead in India and Bharat
Biotech's COVAXIN will be administered under stricter conditions
given no efficacy data has been released for it.
The Indian government has yet to sign a formal deal for the
AstraZeneca vaccine with its local maker, Serum Institute of
India (SII), although this is expected within days. SII has
stockpiled 50 million doses.
Health Minister Harsh Vardhan said on Twitter India was
ready for a "quick and equitable" distribution of vaccines.
SII expects the government to buy 100 million doses from it
in the next two months and restrict exports until then, Chief
Executive Adar Poonawalla told Reuters.
By August, it aims to provide 300 million doses and has also
seen interest from African and Asian countries including
Bangladesh.
LACK OF DATA
Drugs Controller General of India V.G. Somani said the
overall efficacy of the AstraZeneca vaccine, locally branded
COVISHIELD, was 70.42% based on trials done overseas. No
efficacy study has been done in India.
Bharat Biotech's COVAXIN, developed with the government-run
Indian Council of Medical Research, was found "safe and provides
a robust immune response", Somani said.
Both vaccines will be administered in two doses and stored
at 2-8° degrees Celsius (36 to 48°F), he said.
Poonawalla said they recommended that the AstraZeneca
vaccine be administered eight to 10 weeks apart.
The AstraZeneca vaccine, granted its first approval by
Britain last week, is cheaper and easier to use than some rival
shots, such as one from Pfizer Inc.
The British shot, however, 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 COVAXIN could "go up much
more" than 60% after two doses are given, a source with
knowledge of the matter told Reuters. Bharat Biotech earlier
said they could produce up to 300 million doses a year.
"While this vaccine addresses an unmet medical need during
this pandemic, our goal is to provide global access to
populations that need it the most," the company's chairman,
Krishna Ella, said. "COVAXIN has generated excellent safety data
with robust immune responses."
An opposition lawmaker and former minister, however,
questioned the approval process for COVAXIN.
"Bharat Biotech is a first-rate enterprise, but it is
puzzling that internationally accepted protocols relating to
phase 3 trials are being modified for Covaxin," Jairam Ramesh
wrote on Twitter.
India's regulator has also received an emergency-use
application for the COVID-19 vaccine made by Pfizer and
Germany's BioNTech - the first shot to secure
regulatory approval in the West.
SII plans to sell the AstraZeneca vaccine to the Indian
government at about 250 rupees ($3.42) per dose and 1,000 rupees
on the private market.
The regulator on Sunday also allowed Cadila Healthcare Ltd
to conduct Phase-III trials on 26,000 participants for
its DNA-platform vaccine candidate, saying the interim trial
data had shown it was "safe" and prompted an immune response
under a three-dose regimen.
(Additionbal reporting by Nigam Prusty and Shilpa Jamkhandikar;
Editing by Neil Fullick and Alexandra Hudson)
