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(Adds Bharat Biotech application for COVID-19 vaccine)
By Neha Arora and Nivedita Bhattacharjee
NEW DELHI/BENGALURU, Dec 7 (Reuters) - India is accelerating
its review of COVID-19 vaccines developed by Pfizer Inc
and AstraZeneca to authorise for emergency use, a senior
official said on Monday, as the world's second-hardest hit
country seeks to contain the virus outbreak.
The government is pinning its hopes for mass supply on the
Serum Institute of India, the world's largest vaccine producer
by volume, which lodged the first formal application for
emergency-use approval of AstraZeneca's shot on Monday.
Pfizer had already applied for emergency-use approval for
its vaccine in India over the weekend, the government official
said, declining to be identified due to the confidential nature
of the information.
"We are in the process of reviewing. It is an accelerated
reviewing process, which is there for Serum too," said the
official. "It is the need of the hour. We have to review at the
earliest."
India's Bharat Biotech also filed an application on Monday
seeking emergency-use authorization for its COVID-19 vaccine,
the official said.
The private pharmaceutical company based in the southern
city of Hyderabad is developing a shot called Covaxin that it
plans to launch by the second quarter of 2021.
The company could not immediately be reached for comment.
The country of over 1.3 billion people has 9.68 million
infections, putting it second only to the United States for
COVID-19 cases, while more than 140,000 people have died.
Lockdowns imposed to contain the spread of the virus have
plunged the economy into one of its worst downturns in decades.
Serum Institute CEO Adar Poonawalla tweeted that the move to
apply for emergency use "will save countless lives", but did not
give any other details.
The company declined to reply to Reuters' follow-up
questions about the process.
GLOBAL VACCINE SPRINT
AstraZeneca, Pfizer and Moderna Inc are among the
drugmakers seeking advanced approvals for their vaccines, which
are increasingly being seen by governments as the only way to
stop the pandemic.
AstraZeneca's vaccine, called "Covishield" by Serum
Institute, has less stringent storage requirements and is
expected to be easier to distribute and faster to scale up in
low-income countries.
But it is also facing queries from scientists over the
robustness of some of its trial data, which showed a 1.5 dose
regimen delivered more than 90% efficacy and a full two-dose
regimen just 62%, both administered over two stages.
Britain and some other nations have pressed on with plans to
roll out the AstraZeneca vaccine, while the Philippines and
Thailand secured millions of doses, giving the shot a vote of
confidence.
AstraZeneca said two weeks ago that it could launch an
additional trial to evaluate the lower dose regimen, but Serum
Institute has said it would continue to test only the two full
doses as it would delay trials.
Poonawalla has said https://www.reuters.com/article/us-health-coronavirus-india-vaccine-idUKKBN28321S
the company will first focus on supplying the vaccine in India
before distributing it to other countries, pricing it at 1,000
rupees per dose ($13.50) for private markets.
Serum Institute has also said an emergency-use approval
could preface a full rollout by February or March.
(Reporting by Neha Arora in New Delhi, Aakriti Bhalla, Derek
Francis, Nivedita Bhattacharjee in Bengaluru; Editing by Arun
Koyyur/Patrick Graham/Saumyadeb Chakrabarty/Pravin Char)
