Row erupts over Covaxin's shelf life extension

Concerns emerged over the extension of the shelf life of Covaxin to one year as the vaccination drive for children between 15-18 years kicked off.
Covaxin vial
Covaxin vial
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India kicked off its vaccination programme that allows children aged between 15 and 18 years to be inoculated against COVID-19 on Monday, January 3, for the first time since the pandemic. For this age group, Bharat Biotech’s Covaxin is the only vaccine available, after it was approved for emergency usage for children in December 2021.

However, concerns over the safety of the vaccine arose after reports showed that the Central Drugs Standard Control Organization (CDSCO) approved the extension of the shelf life of Covaxin, from nine months to 12 months in November. With this, the vaccine manufactured in April 2021 for example, which was originally said to expire in September 2021, will now be safe to use until March 2022. In light of this, vials that were close to the expiration date were recalled by Bharat Biotech, in order to relabel them to show the new expiration date.

This move concerned sections of the public, especially parents, who were sceptical about the shelf life of the vaccines being extended. Some even took to social media and questioned how expired vaccines could be administered and accused the company of trying to clear old stock.

But according to Bharat Biotech, “This approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO. With the shelf-life extension, hospitals can now utilise the stock which was nearing the expiry and avoid vaccine wastage.”

The Union government has also refuted the allegations of private hospitals using expired vaccines as “false and misleading and based on incomplete information”.

Dr Prasanna, the head of the Private Hospitals And Nursing Association (PHANA) in Bengaluru, hinted that the COVID-19 vaccine was manufactured only as a response to the pandemic emergency, which was an extraordinary event. “The vaccine was a new product, they did not know how long it would be stable. With whatever data was there, the DCGI approved the shelf life to be nine months. But now the new data has shown it can be stable for one year,” he said.

However, Dr T Sundararaman, health systems and health policy expert, told TNM that, despite it being manufactured in an emergency situation, the first step should have been to make a public statement that the original shelf life was not accurate. “The point is to say the shelf life of the vaccine was misjudged in the first place. People are losing trust because of the lack of transparency in the way the data is rolled out,” he said.

He also added that many breakthrough infections are being seen, and it is unclear whether these are because the virus escaped the net of vaccines, or because the vaccine itself was ineffective or was expired.  “You cannot justify retrospectively extending the shelf life of products already in the market,” he said.

Meanwhile, according to a report in the Times of India, Karnataka’s Technical Advisory Committee for COVID-19 said that Bharat Biotech should take back the expired doses and provide the vaccination centres and hospitals with fresh supplies. In this way, the committee said, the company will help build the confidence of children and parents.

On the first day of the vaccine drive opening for children between 15 to 18 years, over 41 lakh children in this age group got the jab across India, till 8 pm on Monday. According to the Health Ministry, the daily vaccination tally was expected to increase with the compilation of the final reports for the day by late on Monday night. "Well done Young India! Over 40 lakh between 15-18 age group received their first dose of COVID-19 vaccine on the first day of vaccination drive for children, till 8 pm. This is another feather in the cap of India's vaccination drive (sic)," Union Health Minister Mansukh Mandaviya tweeted.

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