Millions of Covid vaccine doses are set to expire in India

Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September. The company is likely to destroy these vaccines if nothing works out, Sohini Das reports.

Owing to low shelf life and dip in demand, hundreds of millions of COVID-19 vaccines in India are looking to expire over the next three to four months.

Vaccine industry sources indicated that shelf life extension has been sought from time to time as more stability data is generated.

Players like Bharat Biotech have been working proactively with private hospitals for the past few months to liquidate stocks.

A company source said, "Bharat Biotech has been working proactively with private hospitals for the past several months to liquidate stocks and reduce the quantum of expired vaccines. We are replacing expired doses and also helping liquidate their stocks."

The company did not divulge the volume that is nearing expiry.

Covaxin has a shelf life of 12 months, while Covishield, the vaccine that accounted for nearly 80 per cent of India’s vaccinations, has a shelf life of nine months.

Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September.

The company is likely to destroy these vaccines if nothing works out.

Serum refused to comment on the matter.

However, speaking to the media at the World Economic Forum at Davos in May, CEO Adar Poonawalla has indicated that the company will lose 'minimum' 200 million doses of vaccines, which they might have to destroy as they are nearing expiry.

As such SII has not approached the Union ministry of health to take these doses for free and use them in the national immunisation programme before the company is compelled to destroy them, government sources revealed.

The Pune-based vaccine maker had stopped production at its site from December as they had already created a stockpile of 250 million finished doses and it also had around 200-250 million doses in the bulk form.

From there on, the company has liquidated some of its stocks through exports, supply commitments internationally and to the private and public sector in India.

Sources reveal that the company still has 200 million doses of finished formulation of Covishield, the AstraZeneca vaccine lying as inventory in Pune.

"Some of the stock has been liquidated, but still around 200 million finished doses are unused," the source said.

Not just this inventory with the company, but even states have significant doses lying with them that are nearing expiry.

Maharashtra is a case in point -- it has 3.4 million Covishield doses lying with them set for expiry in August, and around 9,895 doses of Covaxin set to expire in June.

State Immunisation Officer Sachin Desai said that they will consume the stocks as the rate of vaccination has picked up.

"In the last ten days we are averaging around 1 lakh daily doses, up from 60,000 a day. Therefore, we will exhaust the stock much before expiry," he claimed.

Around 241 million COVID-19 vaccines may have been wasted due to expiry of shelf life in the G7 countries last year, according to estimates by global health analytics firm Airfinity.

In September last year Airfinity had noted in its report that G7 could waste 241 million doses by end of 2021 without immediate redistribution.

This year, India alone is staring at wasting more than 200 mn doses of Covid-19 vaccines as they expire by September or so.

Low shelf life of Covid-19 vaccines is a challenge for manufacturers if there is low demand and vaccines cannot be re-distributed fast.

Industry sources among Indian vaccine makers indicate that they apply for shelf life extension from time to time as more stability data is generated.

However, it is on the drug regulator to take a call on the matter. Despite several attempts, the Drugs Controller General of India could not be reached.

The World Health Organisation (WHO) has noted in May that any vaccine past expiry date should not be administered.

The shelf-life of a vaccine is a reflection of how long the vaccine retains its potency and stability at a given storage temperature and therefore its effectiveness.

The shelf-life is used to establish the expiry date of each batch of the vaccine product.

"Expiry dates do not affect the safety of the vaccine, rather are related to the potency or amount of protection the vaccine gives," WHO said.

While destroying vaccines is regrettable, it is also difficult to find takers for a low shelf life product. Private hospitals in Mumbai said that they were flush with stocks as vaccine makers gave free doses to compensate for the price differential after they slashed prices recently.

However, the Centre has written to states in March asking them to take up vaccine stocks lying with private hospitals that are nearing expiry.

Desai said that they are open to taking up stocks from the private sector and use them in the public immunisation programme if these doses are nearing expiry.

The government sector is witnessing a faster turnaround than paid vaccination at private centres.