Centre terms reports of using expired Covaxin ‘misleading’
The Union health ministry on Monday dismissed reports that India was using expired vaccines to inoculate people under its Covid-19 immunisation programme, calling them “false and misleading”, and based on incomplete information.
As India began vaccinating children aged 15-18 on Monday, some people took to social media to say that the vaccine doses being administered were past their expiration date, and that when they voiced concern, they were shown a document stating that the national drugs regulator had extended the vaccine’s shelf life.
“The Central Drugs Standard Control Organization (CDSCO) on 25th October 2021... approved the extension of shelf life of Covaxin from 9 months to 12 months. Similarly, the shelf life of Covishield has been extended by the National Regulator from 6 months to 9 months on 22nd February 2021,” the Union health ministry said after the reports emerged.
“There have been some media reports alleging that expired vaccines are being administered in India under its national COVID-19 vaccination programme. This is false and misleading and based on incomplete information.” the ministry said.
The statement came after some social media posts raised concerns over the vaccines.
“So my son went to get his first vaccine, the drive for kids begin today and realized that the vaccine had already expired in November. Then a letter was shown wherein it seems the shelf life has been extended!!How, why, on what basis? To clear stock you experiment on kids?” tweeted Navanita Varadpande.
The document that was shown to her was from KR Krishna Murthy, assistant general manager, distribution, Bharat Biotech International Ltd. “This is to inform you that we have received emergency use approval for Covaxin from Drugs Controller General (India) with shelf life of 6 months when stored at 2 degree C- 8 degree C. Further, Drugs Controller General (India), CDSCO approved for extension of shelf-life 12 months from the date of manufacture. The revised expiry date dates are detailed in the table below,” the letter said.
The shelf life of vaccines was extended by the drugs regulator based on comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers, the ministry said.
“Stay Informed, Stay Safe! Media reports claiming that expired vaccines are being administered are false & misleading. CDSCO had earlier approved the extension of shelf life of Covaxin & Covishield vaccines to 12 months and 9 months, respectively,” health minister Mansukh Mandaviya tweeted.
As Covaxin’s shelf life was increased first to nine months and later to 12 months recently, there could be vials with old expiration date pasted on them, according to people familiar with the matter. However, it does not mean the vaccine being administered is expired, an official said, asking not to be named.
Bharat Biotech said it had begun lifting unused stock from hospitals. “The company, after receiving the approval from the regulator on the extension of shelf life to 12 months, have immediately begun lifting the unused stock from hospitals for relabelling,” the company said in a statement.
It will conduct testing and inspection before relabelling, the company said. “All hospitals that have placed new orders have started receiving fresh stocks,” it said.