Paraguay cancels orders for one million Covaxin doses

South American nation Paraguay has initiated cancellation of orders for one million doses of Bharat Biotech’s Covid-19 vaccine, Covaxin, sources in the know said.

Bharat Biotech refused to comment on the matter. However, sources close to the development said the company had stopped production and exports of Covaxin from April, and thus if there are any pending orders, they stand cancelled. “This is an old development, because Bharat Biotech stopped exports of Covaxin long back, and is upgrading its manufacturing sites. Any orders, therefore, stand cancelled,” the person said.

Media reports, however, have claimed that Paraguay cancelled orders because of quality control issues.

On April 1, Bharat Biotech announced a temporary slowing down of production of

Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand. “For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities,” it had said.

A day after Hyderabadbased vaccine maker Bharat Biotech said it was halting production of Covaxin to upgrade its facilities as well as in response to low demand, the World Health Organisation (WHO) said it was suspending supplies of the vaccine through United Nations procurement agencies.

The Indian vaccine maker, however, maintained that there were no issues with the safety and efficacy of the vaccine, and that the certification remained valid. WHO also added that Bharat Biotech was developing a “corrective and preventive action plan” for submission to the Drugs Controller General of India (DCGI) and WHO.

“In the interim and as a precautionary measure, Bharat has indicated its commitment to suspend its production of Covaxin for export,” the global agency said, adding that there will be interruption of supply of Covaxin due to suspension of production for export. Countries that have received Covaxin to “take actions as appropriate”, WHO had said.

Earlier, Bharat Biotech’s deal with Brazil to supply 20 million doses of Covaxin was cancelled in mid-2021 after charges of irregularities against the Brazilian President Jair Bolsonaro’s government surfaced. Brazil’s health regulator Anvisa had refused to grant GMP certification to Covaxin prior to that, citing non-compliance and 12 major non-conformities.