2 doses of COVID vaccine Covaxin (BBV152) are 50 pc effective against symptomatic COVID disease, according to 1st real-world assessment of COVID vaccine published in the Lancet Infectious Diseases journal.
The step will benefit more fully vaccinated Indians planning travel to the UK without the need for a pre-departure PCR test or self-isolation at the address declared on their compulsory Passenger Locator Forms.
The approval comes days after Covaxin received the emergency use listing from WHO.
Recently, WHO granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses.
Bharat Biotech Chairman and MD Krishna Ella said that the company is looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin.
On November 3, the World Health Organisation (WHO) had granted emergency use approval for Covaxin.
Bharat Biotech's Covaxin and AstraZeneca and Serum Institute's Covishield are the two widely used vaccines in India.
Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin vaccine meets WHO standards for protection against COVID, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world," the world health body said.
In a tweet, Bharat Biotech said, "The 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."
Meanwhile, Covaxin is yet to receive approval from the World Health Organisation, which last week said it expects to receive clarifications from Bharat Biotech.
Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI to WHO on April 19 for the vaccine's Emergency Use Listing.
Earlier this week, the global health organisation had said in a tweet that it is expecting one additional piece of information from Bharat Biotech regarding COVAXIN.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- participated in the meeting.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
Bharat Biotech's COVID-19 vaccine Covaxin has received the Subject Expert Committee's nod for administering the drug to children aged 2-18 years.
An expert panel of the Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children in the 2 to 18 years age group with certain conditions. With this, Covaxin becomes the first COVID-19 vaccine that can be administered to children in India.
The World Health Organisation (WHO) on Tuesday informed that the decision on Emergency Use Listing (EUL) authorisation of Bharat Biotech’s Covid-19 vaccine 'Covaxin' will be finalised next week.
Covaxin production would touch 55 million doses in October as against 35 million in September.
The WHO is currently reviewing Covaxin data submitted by Bharat Biotech. According to WHO website, the date for a decision on the jab is yet to be confirmed.
Bharat Biotech's Covaxin will get approval from the World Health Organisation (WHO) this week, sources told news agency ANI.
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