Last checked at 
* AstraZeneca's COVISHIELD, Bharat Biotech's COVAXIN
approved
* COVISHIELD found 70.42% effective
* COVAXIN "safe and provides a robust immune
response"-regulator
* No efficacy data provided for COVAXIN
(Adds comments from health minister, Bharat Biotech)
By Aftab Ahmed and Krishna N. Das
NEW DELHI, Jan 3 (Reuters) - India's drugs regulator on
Sunday gave final approval for the emergency-use of 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 for the
world's second-most populous country, which after the United
States, has recorded the most infections of the coronavirus
disease.
It is now expected to start a massive immunisation programme
within about a week, a government official said, 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.
The AstraZeneca/Oxford shot, already approved in Britain,
Argentina and El Salvador, will take the lead and Bharat
Biotech's COVAXIN will be administered under stricter conditions
given no efficacy data has been released for it.
"It's now time to reap the benefits of the robust supply
chain infrastructure we've put in place for quick and equitable
distribution of the vaccine," said Harsh Vardhan, the health
minister of India, which is the world's biggest vaccine producer
and exporter.
"Urge all citizens to entrust the stringent protocols
followed for ensuring safety, efficacy and immunogenicity of the
approved vaccines."
Drugs Controller General of India V.G. Somani said the
overall efficacy of the AstraZeneca/Oxford vaccine was 70.42%,
while Bharat Biotech's COVAXIN was "safe and provides a robust
immune response".
The British-developed AstraZeneca/Oxford shot is being made
locally by the Serum Institute of India (SII) and will be
branded COVISHIELD, while Bharat Biotech has teamed up with the
government-run Indian Council of Medical Research.
A lawmaker from Prime Minister Narendra Modi's nationalist
party had earlier complained about the apparent preference for
the foreign-made vaccine instead of the local one, whose
approval has also raised questions about a lack of transparency
in the process.
"Vaccines of M/s Serum and M/s Bharat Biotech are being
approved for restricted use in emergency situations," Somani,
the head of the Central Drugs Standards Control Organisation,
said at a news conference, reading from a written statement.
Somani did not take questions.
Both vaccines will be administered in two doses and stored
at 2-8° degrees Celsius (36 to 48°F), he said, without
clarifying what intervals between shots were being recommended.
Sources said on Saturday the doses would have to be given four
weeks apart.
Somani said the Bharat Biotech vaccine had been approved "in
public interest as an abundant precaution, in clinical trial
mode, to have more options for vaccinations, especially in case
of infection by mutant strains".
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.
SII, the world's biggest vaccine producer, has already
stockpiled more than 50 million doses of the AstraZeneca/Oxford
vaccine even before securing a formal supply deal with the
government.
"All the risks @SerumInstIndia took with stockpiling the
vaccine, have finally paid off," CEO Adar Poonawalla said on
Twitter. "COVISHIELD, India's first COVID-19 vaccine, is
approved, safe, effective and ready to roll-out in the coming
weeks."
CONTROVERSY
The AstraZeneca/Oxford 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 - a major
advantage in tackling a pandemic that has claimed more than 1.8
million lives worldwide.
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 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.
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.
SII plans to sell the AstraZeneca/Oxford 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 gave permission to Cadila
Healthcare Ltd to conduct Phase-III clinical trials on
26,000 Indian 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)
