50 million doses of Covaxin set to expire early 2023 due to poor off take

Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.

Due to lack of product demand, Production stoppage of Covaxin- a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker has established manufacturing to reach an annualised capacity of 1 billion doses at the end of 2021.

Bharat Biotech has more than 200 million doses of Covaxin in bulk form and approximately 50 million doses in vials ready to use. Due to lack of product demand, production stoppage of Covaxin was initiated several months ago, earlier this year, sources told PTI.

Covaxin doses in vials are set to expire during early 2023, resulting in losses for the company, sources further said. However, the quantum of loss that the Bharat Biotech would incur in the event of all the 50 million doses expiring next year is not known. India reported 1,082 fresh COVID-19 cases on Saturday, while the number of active cases declined to 15,200, according to Union health ministry data.

So far, 219.71 crore doses of COVID-19 vaccines, including Covaxin have been administered under the nationwide vaccination drive.

As the infection rate has been sturdily declining globally, exports of Covaxin were negatively impacted with poor off take by foreign countries.

COVID-19 is not considered a threat anymore globally, sources added. In April this year, the World health Organization (WHO) said it confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.

A statement issued by WHO then said the suspension is in response to the outcome of its post EUL (emergency use authorisation) inspection held between March 14- 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.

When the COVID-19 infection was at its peak during 2021, the Brazil government suspended its decision to import 20 million doses of Covaxin following a controversy that attracted investigation by authorities in that country.

Bharat Biotech on July 23, 2021 said it terminated the MoU it entered into with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.

In December 2021, Bharat Biotech said, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of its COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture.