Extension of Covaxin’s shelf life has been mishandled

The use of vaccines with extended shelf life to immunise adolescents is the latest controversy to erupt around COVID-19 vaccination.

In October, the Indian drugs regulator, the Drugs Controller General of India, allowed Covaxin manufacturer Bharat Biotech to extend the shelf life of the vaccine from nine months to 12 months. This allows vaccination centres to use their stock of Covaxin for an additional three months once cleared to do so by Bharat Biotech.

According to earlier news reports, Bharat Biotech had begun taking back such Covaxin vials, retesting them to ensure they retained their potency and stability, and either restoring them to centres with labels reflecting the new expiry dates, or replacing them.

Expiry dates indicate that a vaccine is potent and will provide the claimed protection.

But on January 3, day one of the childrens’ vaccination drive, a parent in Gurgaon (Delhi-NCR) tweeted that her teenager had narrowly missed being immunised from a vial past its sell-by date. This could, perhaps, mean that the vaccination centre was continuing to use the old stock based on the regulatory green signal to Bharat Biotech, but without it being retested and relabelled. Media reports also reflected concerns from parents about the intended use of vaccines with extended expiry dates. Earlier, private hospitals in Karnataka had complained that Bharat Biotech had been slow to take back stock for retesting.

Given the logistical and other challenges involved in picking up, testing, and transporting vaccines already in the market, the weak regulatory oversight of hospitals, and its own poor record of communication, it seems rather counterintuitive for the regulator to have allowed the extension of shelf life of an on-the-market stock, instead of approving this only for yet-to-be-distributed batches of Covaxin.

Against the backdrop of vaccine hesitancy, heated debates around the need to vaccinate children, and the power of social media to shape perceptions, it is clear that this attempt to salvage every dose, however well-intentioned, was ill thought-through.

Covaxin is the only vaccine approved for use in adolescents between 15 and 17 years of age. True, the extension of the shelf life of COVID-19 vaccines with the availability of more data has been much discussed in regulatory and public health circles. As the World Health Organization (WHO) has stated, “given the urgency of the Covid-19 pandemic, initial emergency use authorization on a number of Covid-19 vaccines.. was given by regulators when only six months’ worth of data for assignment of the expiration date was available.” As new data becomes available, a national regulatory authority can make changes to shelf life and expiry dates after approval, it has said.

However, such a change has to be handled and communicated efficiently. For one, the public cannot be expected to immediately grasp how expired drugs or vaccines can suddenly come to life. Two, it makes no sense to run the risk, however small, of centres using the stock without retesting for potency emboldened by the government’s nod to Bharat Biotech.

Indeed, the WHO, while considering an extended shelf life for Covishield by the Serum Institute of India mid-2021 under its Emergency Use Listing, clarified that any extension, if granted, would only be for stock that is not yet labelled, and distributed.

In a press release issued on January 3, the Union Ministry of Health and Family Welfare dismissed reports that expired vaccine was being administered, and stated that the decision to extend shelf life was backed by company’s data on stability. But the damage, at least on social media, had been done. It is doubly unfortunate that the flaws of this strategy are being laid bare just when a large new cohort in the age group of 15 to 17 years old, has begun to be vaccinated.

According to this news report, around 150 million doses will be needed to vaccinate adolescents with two doses. Bharat Biotech has claimed it can supply 70-80 million vaccines a month starting next month up from 50-60 million/month at present. On the other hand, only a couple of hundred thousand doses — on the outside — can reportedly be salvaged by this relabeling effort.

Maybe, it is prudent to ditch them so that the vaccination drive is not hindered by this avoidable controversy.

Gauri Kamath is an independent journalist. Twitter: @Apothecurry. Views are personal and do not represent the stand of this publication.