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Moderna’s Covid Shot Gets Regulatory Nod in India for Imports

Crucial details, including the granting of indemnity, are yet to be worked out.

Moderna’s Covid Shot Gets Regulatory Nod in India for Imports
A box of the Moderna Covid-19 vaccine vials at a drive-thru vaccination site at the Meigs County fairgrounds in Pomeroy, Ohio, U.S. (Photographer: Stephen Zenner/Bloomberg)

India’s drug regulator has cleared the imports of Moderna Inc.’s Covid-19 shot but other crucial details, including the granting of indemnity, were yet to be worked out, the head of the country’s vaccine panel said.

The Drugs Controller General of India cleared pharmaceutical company Cipla Ltd. to import the shots for restricted emergency use, V.K. Paul, who heads a panel advising Prime Minister Narendra Modi on inoculation efforts, said at a press briefing Tuesday.

“A regulatory step has been taken that opens the pathways for imports,” Paul said. “Let wait how this opportunity will be used.”

Paul said the Indian government was in talks with the vaccine manufacturer to iron out other issues, including the granting of indemnity to protect against legal liability in case of adverse effects.

India had in April fast-tracked approvals for vaccines approved by overseas to have a wider pool of shots as it struggled to control a soaring second wave of infections that crippled its health-care system and overwhelmed burial grounds and crematoriums.

India has been in talks with both Pfizer Inc. and Moderna to import additional inoculations needed for its immunization program.

Despite halting all exports in April and benefiting from a huge vaccine industry, India has fully vaccinated just over 4% of its vast population.

©2021 Bloomberg L.P.