India's Drug Regulator Extends Shelf Life of Covaxin To 12 Months

The shelf life of indigenously-developed Covaxin has been further extended to 12 months. WHO has also approved global use of the vaccine developed by Bharat Biotech.

Covaxin

Bharat Biotech announced on Wednesday that it has received approval from the Central Drugs Standards Control Organisation (CDSCO) for the extension of shelf life of its Covid-19 vaccine Covaxin up to 12 months.

Initially, sale and distribution of the vaccine was allowed with a shelf life of six months, from the date of manufacture, when stored at two to eight degrees Celsius. Later, the CDSCO approved extension of the shelf life to nine months based on the updated accelerated and real-time stability data of the vaccine submitted by the company. Now, it has been further extended to 12 months.

The extension of Covaxin's shelf life is based on the availability of additional stability data, which was submitted to the CDSCO, the Hyderabad-based vaccine maker said, adding that the update has been communicated to their stakeholders.

Covaxin is one of the six vaccines approved for emergency use authorisation in India. The other five include Covishield, Sputnik V, Zydus Cadila's ZyCoV-D, Moderna's mRNA-1273, and Johnson & Johnson's vaccine or Janssen Ad26.COV2.S.

WHO approves Covaxin for emergency use listing

In another good news, the World Health Organisation (WHO) has finally granted approval for Emergency Use Listing (EUL) to Bharat Biotech's Covaxin. This approval would likely remove uncertainty around overseas travel by Indians inoculated with indigenous vaccine.

"Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine COVAXIN," said Dr Poonam Khetarpal Singh, Regional Director, WHO South East Asia.

Bharat Biotech had submitted all documents required for the WHO's EUL in July 9. The review process had been underway since then. Last month, the global health body had sought additional clarifications from the drug maker to conduct a final risk-benefit assessment for the global use of Covaxin.

Covid-19 vaccines listed by WHO for global use

Covid-19 vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, China's Sinopharm and Oxford-AstraZeneca are already included in WHO's Emergency Use Listing (EUL).

The WHO listed Pfizer/BioNTech vaccine for emergency use on 31 December 2020, giving the green light for this vaccine to be rolled out globally. The organisation also listed two AstraZeneca/Oxford COVID-19 vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India, followed by COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on 12 March 2021 and then the Sinopharm COVID-19 vaccine on 7 May 2021.