The World Health Organisation has suspended
the supply of Covaxin, an Indian COVID-19 vaccine manufactured in Hyderabad by Bharat
. The WHO was getting the supply
of the vaccine doses from the United Nations which bought it from Bharat
Biotech. The WHO on Saturday said that it had cancelled the order after finding
deficiencies in Covaxin manufacturing practices in an inspection. It also said
that it wants the manufacturer to upgrade production facilities.

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The WHO also asked countries that have
received the vaccine to take action. But it did not mention any specific action
against the Covaxin doses.

“Confirming the suspension of supply
of Covaxin produced by Bharat Biotech, through UN procurement agencies and
recommending to countries that received the vaccine to take actions as
appropriate,” a WHO statement read.

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The statement further said that the
suspension is in response to the outcomes of the WHO post-emergency use listing
(EUL) inspection conducted from March 14 to 22, and the vaccine maker has
indicated its commitment to suspend production of Covaxin for export.

“No impact on efficacy”

After WHO issued its statement,
Hyderabad-based Bharat Biotech in a statement on Sunday said there is “no
impact on efficacy and safety of the COVID-19 vaccine Covaxin”. “For
the millions who have received Covaxin, the vaccine certificates issued still
stand valid as there is no impact on efficacy and safety of the vaccine,”
Bharat Biotech said in the statement, news agency ANI reported.

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“The risk assessment to date does not
indicate a change in the risk-benefit ratio. The data available to WHO,
indicate the vaccine is effective and no safety concern exists,” WHO said
in its statement.

Bharat Biotech said it is slowing down the
production of Covaxin for facility optimisation. “For the coming period
the company will focus on pending facility maintenance, process and facility
optimization activities,” it said.

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The WHO said the company has
“committed to comply by addressing the GMP (good manufacturing practice)
deficiencies and is developing a corrective and preventive action plan, for
submission to the Drugs Controller General of India (DCGI) and WHO”.