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he Technical Advisory Group of World Health Organisation (WHO) on Wednesday, November 3, recommended Emergency Use Listing status for Bharat Biotech's Covaxin. "According to WHO, the benefits of the vaccine far outweigh the risks and the vaccine can be used," a source said.
The Technical Advisory Group (TAG) is an independent advisory committee of the World Health Organisation (WHO) that recommends whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure. On October 26, it sought additional inputs from Covaxin -maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The WHO is now evaluating Covaxin's clinical trial data for use of EUL.
After the approval, Union Health Minister Mansukh Mandaviya thanked the WHO.
Data available on the inoculation of pregnant women with the vaccine is insufficient to assess safety or efficacy in pregnancy. Studies among pregnant women, including a pregnancy sub-study and a pregnancy registry, have been planned.
Poonam Khetrapal SIngh, WHO regional director, Sourtheast Asia, congratulated India on the achievement.
Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and it recommended use of this vaccine in two doses, with a dosage interval of four weeks in all adults. Government sources said that the approval was only for the doses meant for people aged 18 and above and not for children. The application for kids was not made.
Covaxin has demonstrated 77.8% effectiveness against symptomatic Covid-19 and 65.2% protection against the new Delta variant. In June, the company said that it had concluded the final analysis of Covaxin efficacy from phase-3 trials.
Covaxin and AstraZeneca and Oxford University's Covishield are the two most-used vaccines in India.
Earlier on Wednesday, Bharat Biotech received an extension of 12 months on the shelf life of the Covid vaccine.
On Monday, Australia's medicines and medical devices regulator formally recognised India's Covaxin, as the country's border was reopened for the first time in nearly 20 months.
(With inputs from Milan Sharma)
www.indiatoday.in
The Technical Advisory Group (TAG) is an independent advisory committee of the World Health Organisation (WHO) that recommends whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure. On October 26, it sought additional inputs from Covaxin -maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The WHO is now evaluating Covaxin's clinical trial data for use of EUL.
After the approval, Union Health Minister Mansukh Mandaviya thanked the WHO.
Data available on the inoculation of pregnant women with the vaccine is insufficient to assess safety or efficacy in pregnancy. Studies among pregnant women, including a pregnancy sub-study and a pregnancy registry, have been planned.
Poonam Khetrapal SIngh, WHO regional director, Sourtheast Asia, congratulated India on the achievement.
Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and it recommended use of this vaccine in two doses, with a dosage interval of four weeks in all adults. Government sources said that the approval was only for the doses meant for people aged 18 and above and not for children. The application for kids was not made.
Covaxin has demonstrated 77.8% effectiveness against symptomatic Covid-19 and 65.2% protection against the new Delta variant. In June, the company said that it had concluded the final analysis of Covaxin efficacy from phase-3 trials.
Covaxin and AstraZeneca and Oxford University's Covishield are the two most-used vaccines in India.
Earlier on Wednesday, Bharat Biotech received an extension of 12 months on the shelf life of the Covid vaccine.
On Monday, Australia's medicines and medical devices regulator formally recognised India's Covaxin, as the country's border was reopened for the first time in nearly 20 months.
(With inputs from Milan Sharma)
WHO expert panel clears Bharat Biotech's Covaxin for emergency use
The World Health Organisation is now evaluating Covaxin's clinical trial data for use of EUL.
