Serum Institute may apply to sell Covid-19 vaccine Covishield commercially

No Covid vaccine in the world has marketing authorisation allowing sales in private market

The Serum Institute of India (SII) may apply for ‘marketing authorisation’ for the Covid vaccine Covishield from the Indian drug regulator by the end of April, which will allow it to sell the vaccine commercially.

Covishield has been developed by the British-Swedish firm AstraZeneca and Oxford University. The SII manufactures it at its Pune plant. Its current licence for making Covishield is a ‘restricted emergency-use’ authorisation because of the urgency posed by the pandemic.

So far, no Covid vaccine in the world has a marketing authorisation allowing sales in the private market from any country’s drug regulator.

The move to apply to the Central Drugs Standard Control Organisation (CDSCO) for a licence is significant. At present, the SII is only allowed to sell to the government or foreign governments. It cannot sell the vaccine on the open market.  

“Technically, this prohibits commercial sale. Vaccine makers cannot sell their vaccine through the commercial route in any country. It can only sell to the government of any country,” said a source close to the development.

The SII has been periodically submitting data related to the safety and immunogenicity of Covishield from the Indian arm of the clinical trials. It carried out a bridge trial with over 1,500 people in India to test Covishield’s immune response and safety. It also submitted data from the global trials conducted by AstraZeneca.   

“Data from vaccine trials, and analyses, are being continuously generated and periodically submitted with regulators. A final tranche of data is expected from the SII in April,” said the same person.

The CDSCO has appointed a subject expert committee (SEC), which is reviewing the applications related to Covid drugs and vaccines.

The SEC had decided to recommend granting restricted emergency-use authorisation in January, based on the data available. Now, if the SII goes ahead with the application for a licence allowing commercial sale of the vaccine, the SEC must decide whether or not to approve it. 

 In January, Covishield was allowed a shelf life of six months. This was later extended to nine months, based on the stability data presented by the SII.

Stability data is generated from batches of vaccines produced to establish the shelf life of a product. Drug stability affects the safety and efficacy of the drug product; degradation impurities may cause loss of efficacy and generate possible adverse effects. A longer shelf life helps to reduce vaccine wastage.

Meanwhile, the SII has started making Covovax, the vaccine developed by US drug giant Novavax.  The trials of Covovax have begun in India and SII Chief Executive Officer Adar Poonawalla has said in a recent tweet that he hopes to launch the vaccine by September, subject to the CDSCO’s approval.  

Covovax has an overall efficacy of 89 per cent (higher than Covishield) and has been tested against the African and UK variants, said Poonawalla in his tweet.

The SII plans to make 50 million doses per month of Covovax at its Pune plant.