Pfizer must do local study to be approved by India: NITI Aayog
New Delhi, Jan 14: Any vaccine maker, including Pfizer that has sought emergency-use authorisation for its COVID-19 shot in India, must conduct a local study to be considered for the immunisation programme, NITI Aayog member Dr V K Paul said.
Pfizer
was
the
first
company
to
seek
emergency-use
approval
in
India,
but
didn't
attend
meetings
called
by
the
Central
Drugs
Standard
Control
Organisation,
Reuters
reported.
Serum
Institute
of
India,
the
local
manufacturer
of
the
vaccine
developed
by
AstraZeneca
Plc
and
Oxford
University,
did
months-long
local
study
on
more
than
1,500
people
before
seeking
and
receiving
emergency
approval
on
January
3.
India has also approved a homegrown vaccine made by Bharat Biotech ahead of its inoculation campaign which starts on Saturday.
Pfizer had sought to import and distribute its vaccine in India without doing local trials, according to reports.
"As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial," Vinod K Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.
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The government has already distributed 16.5 million doses of the two approved vaccines to states, with a plan to deliver 600 million jabs to the most vulnerable people in the next six to eight months. Serum Institute has stockpiled 50 million doses of the AstraZeneca vaccine and says it will raise its monthly output to much more than that now the approval has come.