Millions of Covid vaccines set to expire in September

Owing to low shelf life and fall in demand, millions of Covid vaccines in India are set to expire over the next three-four months.

Vaccine industry sources indicated that they seek shelf life extension 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 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 — 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 2021 and are set to expire in September 2022. 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 (WEF) in Davos last month, Adar Poonawalla, chief executive officer (CEO) of SII indicated that the company would lose a minimum 200 million doses of vaccines. These may have to be destroyed as they are nearing their expiry by Augustseptember this year.

SII has not approached the Union ministry of health to take these doses for free and use them in the national immunisation programme.

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. 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.

Besides this inventory with the company, 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 it that is set to expire in August. And, around 9,895 doses of Covaxin are set to expire in June.

State immunisation officer Sachin Desai said the state will consume the stocks as the rate of vaccination has picked up. “In the last 10 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 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 the end of 2021 without immediate redistribution.

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

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

The World Health Organization (WHO) had noted last May that any vaccine past expiry date should not be administered.

The shelf life of a vaccine is a reflection of how long it 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.

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

Private hospitals in Mumbai said 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 had written to states in March asking them to take up vaccine stocks lying with private hospitals that are nearing expiry.

Desai said Maharashtra is open to taking stocks from the private sector and use them for public immunisation if these doses are nearing expiry. The government sector is witnessing a faster turnaround than paid vaccination at private centres.