The U.S. company pulled an application last month seeking emergency
approval for its product in India after the drug regulator declined
its request to skip a small local safety trial. That has kept its
vaccine, developed with Germany's BioNTech SE, out of one of the
world's biggest drug markets.
Pfizer was the first company to apply for emergency use
authorisation in India, proposing to import doses from its U.S. and
European facilities instead of producing locally.
"U.S. companies want to produce vaccines in India under joint
ventures," said one of the sources, citing Pfizer and fellow U.S.
drugmaker Moderna Inc.
"They want faster approvals for clinical trials and emergency
authorisation use. They fear the government will introduce price
control policies."
Another source confirmed Pfizer was interested in manufacturing in
India but Reuters could not find a second confirmation on Moderna.
The companies did not immediately respond to requests for comment.
India's health ministry directed Reuters to the foreign ministry,
which did not immediately respond to emailed queries.
While withdrawing its application in early February, Pfizer said it
would again seek emergency use approval to launch its COVID-19
vaccine in India, potentially a market of 1.35 billion people, and
would provide more data as it becomes available.
On the government's demand to manufacture in India, the company
earlier told Reuters: "Once the pandemic supply phase is over and we
enter a phase of regular supplies, Pfizer will evaluate all
additional opportunities available."
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A Indian official told Reuters
in January the government had held discussions
with Pfizer and Moderna - both of which have
reported more than 90% efficacy for their
vaccines - to make the shots in India given its
large pharmaceuticals capacity.
The Serum Institute of India, the world's
largest vaccine maker, is already
bulk-manufacturing the Oxford University/AstraZeneca
product and plans to start producing the Novavax
Inc shot from next month.
India's government has not allowed it to sell on the higher-priced
private market, however, and is also controlling exports. Pfizer and
Moderna, whose shots are more expensive than the AstraZeneca one
being used in India's immunisation campaign, are not comfortable
with strict price and export restrictions, one of the sources said.
This week, Reuters reported that leaders of the Quad alliance -
Australia, Japan, India and the United States - plan to announce
financing agreements to increase India's vaccine manufacturing
capacity at their first meeting on Friday.
The initiative will mainly involve production of the Novavax and
Johnson & Johnson shots for supplying to regions including Southeast
Asia, where their common rival China is making gains.
(Reporting by Krishna N. Das; Editing by Catherine Evans)
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