Extended shelf-life for Covaxin helps lessen vaccine wastage
The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of Bharat Biotech‘s COVID-19 vaccine Covaxin‘s shelf life 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. With the shelf life extension, hospitals can now utilize the stock to avoid vaccine wastage, said the press release issued by the vaccine maker. Bharat Biotech sought approval to trial for an intranasal COVID-19 vaccine booster.
Covaxin is approved for use under the 28-day multi-dose vial policy from the Drug Controller General of India and the WHO Emergency Use Listing (WHO EUL). Covaxin Open Vial is stable at 2 to 8 degrees Celsius for 28 days and is not required to be discarded immediately in a day or at the end of the immunization session. Bharat Biotech Tweeted their detailed press release:
— BharatBiotech (@BharatBiotech) December 20, 2021
Bharat Biotech said it believes in doing a bit for the environment. The multi-dose vial policy saves money for procurement agencies by reducing the cold chain logistics and management thereby reducing the carbon footprint, costs related to open vial wastage, cold chain distribution, cold chain storage, and biomedical waste disposal among others.
“Most importantly, we believe in being environmentally friendly by reducing the quantum of packing materials and single-use plastics that are utilized in vaccines manufacturing, storage, distribution, and disposal,” the company said.
Meanwhile, news agency ANI reported that Bharat Biotech has submitted a Phase 3 clinical trial application to DCGI for its booster dose of their intranasal Covid vaccine that can be given to Covaxin and Covishield vaccinated people:
Bharat Biotech has submitted phase 3 clinical trial application to DCGI for its booster dose of their intranasal Covid vaccine that can be given to Covaxin and Covishield vaccinated people: Source pic.twitter.com/Sao0TMvMcj
— ANI (@ANI) December 20, 2021
According to news agency Reuters’ report, Bharat Biotech has submitted an application to the country’s drug regulator to conduct a late-stage trial for a booster dose of its intranasal COVID-19 vaccine.
“We have submitted Phase 3 clinical trial application to DCGI (Drugs Controller General of India),” a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns. India is yet to approve the use of Bharat Biotech’s intranasal vaccine, BBV154. In August, BBV154 had received regulatory approval for mid-to-late-stage trials. Local media had reported that the mid-stage trial has been completed.
 Bharat Biotech seeks trial for intranasal COVID-19 vaccine booster – Dec 20, 2021, Yahoo
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