Covaxin booster dose trial shows 'long-term safety', claims Bharat Biotech
India | January 08, 2022 22:41 ISTThe Covaxin booster dose trial was performed on subjects 6 months after they received the second dose of the vaccine.
The Covaxin booster dose trial was performed on subjects 6 months after they received the second dose of the vaccine.
Bharat Biotech in a Twitter post said that no paracetamol or painkillers are recommended after being vaccinated with Covaxin.
Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin).
According to reports, Bharat Biotech has proposed that its nasal vaccine can be used as booster dose for those who have already been inoculated with Covaxin or Covishield vaccines against coronavirus.
Earlier last week, vaccine major Serum Institute of India had said that it has resumed exports of its vaccine Covishield to the international vaccine sharing program COVAX.
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.
Bharat Biotech was successful in releasing Covaxin in a record time and helped to save lives of crores of fellow Indians, says Director V Krishna Mohan.
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.
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.
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.
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