Covaxin's shelf life extended to a year

Published on Nov 04, 2021 05:34 AM IST

The extension given by the central drugs standard control organisation (CDSCO) means that the expiration date of the vaccine, has been increased from the date of manufacturing, therefore reducing the risk of vaccine wastage.

Bharat Biotech has submitted updated stability data to the drugs regulator for approval.(Reuters file photo)
Bharat Biotech has submitted updated stability data to the drugs regulator for approval.(Reuters file photo)

The national drugs regulator has approved increasing the shelf life of Bharat Biotech’s Covid-19 vaccine Covaxin to up to 12 months from the earlier approved nine months, according to people familiar with the development.

The extension given by the central drugs standard control organisation (CDSCO) means that the expiration date of the vaccine, has been increased from the date of manufacturing, therefore reducing the risk of vaccine wastage.

“The process is, when any drug or a vaccine is given emergency use authorization by the drugs controller general of India, its shelf life is determined by the stability data that is furnished by the manufacturer at that point in time when approval for an EUA is sought. As the drug or the vaccine becomes older, there is addition to the data and further extensions are given on the basis of stability and sterility data,” said a senior health ministry who asked not to be named.

Bharat Biotech has submitted updated stability data to the drugs regulator for approval.

The company confirmed the news in a statement.

“ CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders,” said Bharat Biotech in a statement.

Covaxin was co-developed by Bharat Biotech and the Indian Council of Medical Research (ICMR) and the extension of the shelf life is based on the stability response of the vaccine vial that is stored at two to eight degrees Celsius.

On January 3, this year, Covaxin was granted emergency use authorization, and at that time the shelf life of six months was approved by the drugs regulator. This was subsequently increased to nine months in July, and, on Wednesday, 12 months.

In October, Bharat Biotech supplied (6 crore) 60 million doses of Covaxin under the immunisation programme.

Gagandeep Kang, vaccine expert from Christian Medical College, Vellore, said “Basically all vaccines start with short expiration dates because the data for stability are from when batches are made for clinical testing. As time goes on, more stability data is collected based on the original batches. If the regulator is okay with the data, expiration can be extended.”

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