Bharat Biotech’s Covaxin gets WHO approval for emergency use

Hyderabad-based pharmaceutical major Bharat Biotech has finally secured emergency use listing, or EUL, from the World Health Organisation (WHO) for Covaxin, its COVID-19 vaccine.

NEW DELHI, 26/10/2021: A health worker showing a vial of Covaxin vaccine during the vaccination drive against corona virus at Sarvodya Kanya Vidyalaya, Vaccination Center, Rajouri Garden in West Delhi on Tuesday, October 26,2021. Photo: SHIV KUMAR PUSHPAKAR / The Hindu

 

Hyderabad-based pharmaceutical major Bharat Biotech has finally secured emergency use listing, or EUL, from the World Health Organisation (WHO) for Covaxin, its COVID-19 vaccine.

The WHO’s approval for Covaxin, the “made in India”, whole virion-inactivated vaccine against SARS-CoV2 that has been developed in partnership with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune, came on November 3, after a lengthy and rigorous review period. Bharat Biotech had provided the first batch of data on Covaxin to the WHO back in July.

Issuing a statement on the decision, the WHO’s Technical Advisory Group (TAG) said in a tweet: “WHO has granted emergency use listing (EUL) to Covaxin, developed by Bharat Biotech, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19.”

In another tweet the WHO said: “The Technical Advisory Group has determined Covaxin meets standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks (and) the vaccine can be used.” Yet another tweet from the WHO said: “Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.”

Though the WHO stated that the “available data on vaccination of pregnant women with Covaxin was insufficient to assess vaccine safety or efficacy in pregnancy”, it declared that Covaxin had been found to be “78 per cent effective against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low-and middle-income countries due to easy storage requirements”. The WHO acknowledged that “studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry”.

Covaxin, which in recent days has slowly been getting recognised by a number of countries (Australia on November 2 joined 15 other countries that have already recognised the vaccine for the purpose of establishing a traveller’s vaccination status), will now finally be accorded global recognition and Indians who have received a jab of the vaccine will be able to travel overseas without having to face restrictions or be forced to self-quarantine.

Covaxin joins Covishield and several vaccines produced by United States’ pharma giants including Pfizer, Johnson & Johnson and Moderna and China’s Sinopharm as vaccines that have been approved by the WHO.

Reacting to the WHO’s emergency use listing for Covaxin, Bharat Biotech said it was “a very significant step towards ensuring global access to India’s widely administered, safe and efficacious (vaccine)”.

Emergency Use Listing by WHO will not only expedite global access and availability of Covaxin, but will also allow its procurement by the United Nations Childrens Fund (UNICEF), the Pan American Health Organisation (PAHO), and the GAVI COVAX facility for distribution to countries in need.