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* Emergency-use approval for Bharat's COVAXIN
* Government also approved use of AstraZeneca/Oxford vaccine
* AstraZeneca/Oxford shot to lead immunisation programme
By Krishna N. Das
NEW DELHI, Jan 3 (Reuters) - India on Sunday granted
emergency approval to Bharat Biotech's COVAXIN but faced
questions after taking the step without publishing efficacy data
for the homegrown coronavirus vaccine.
The news, announced by the drugs controller general of India
(DCGI) who did not take questions, was hailed by Prime Minister
Narendra Modi and his ministers as a success in India's
self-reliance push.
The government also approved the use of a vaccine developed
by AstraZeneca and Oxford University which will be the
lead vaccine in India's immunisation programme until other shots
are approved.
COVAXIN was jointly developed with a government institute
and means India joins a small list of countries to have approved
its own coronavirus shot.
Bharat has partnered with drug developer Ocugen Inc
to co-develop it for the U.S. market, and Brazil has signed
non-binding letters of intent to buy the shot.
The company has said it is in discussions with more than 10
countries about COVAXIN.
"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," Bharat Biotech Chairman
Krishna Ella said in a statement.
"COVAXIN has generated excellent safety data with robust
immune responses to multiple viral proteins that persist."
Neither the company nor India's Central Drugs Standards
Control Organisation would reveal its efficacy results. A source
with knowledge of the matter told Reuters its effectiveness
could be more than 60% with two doses.
China also did not publish detailed efficacy data for a
vaccine it authorised on Thursday but its developer has shared
interim data.
"On what basis was this approval given when Bharat Biotech
has NOT shown enough data proving safety & efficacy?"
transparency activist Saket Gokhale asked on Twitter.
Gokhale has filed a request under India's
right-to-information law asking the government for safety and
other data for the two vaccines approved on Sunday.
CRITICISM
COVAXIN has been fast-tracked like no other vaccine in
India. The company said in November it was likely to be launched
in the second quarter of 2021, while a government scientist had
suggested it might be February or March.
Opposition lawmakers and former ministers on Sunday
questioned the lack of transparency in approving it.
"Approval was premature and could be dangerous," said
opposition lawmaker and former minister Shashi Tharoor, asking
Health Minister Harsh Vardhan for an explanation.
"Its use should be avoided till full trials are over. India
can start with the AstraZeneca vaccine in the meantime."
Vardhan urged Indians to trust that "stringent protocols"
had been followed to ensure the safety and efficacy of the two
approved vaccines.
In the largest such trial in India, Bharat Biotech said it
had recruited 23,000 volunteers out of a target of 26,000 for an
ongoing Phase III trial of COVAXIN which began in November.
(Additional reporting by Aftab Ahmed and Nigam Prusty; editing
by Jason Neely)
