Moments after WHO granted Emergency Use Listing (EUL) status for India's Covid-19 vaccine Covaxin, its manufacturer Bharat Biotech on Wednesday issued a statement underlining how the decision validated the vaccine's international safety and quality standards.
The WHO's EUL process commenced on July 6, 2021, with rolling data submission. The WHO had conducted a meeting regarding the decision on granting EUL to Covaxin on October 26 and asked Bharat Biotech for some additional data for the same. The company had provided the data required, following which the health organization held its final meeting on November 3, and granted Covaxin the EUL status.
As per the statement, Emergency Use Listing by WHO will expedite global access and availability of Covaxin. It will facilitate countries to expedite their regulatory approval processes to introduce and administer India’s indigenous COVID-19 vaccine developed and manufactured by Bharat Biotech. It will also allow procurement by UNICEF, PAHO, and the GAVI COVAX facility for distribution to countries in need. This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access.
The Emergency Use Listing approval by WHO validates the international safety and quality standards of COVAXIN®. Bharat Biotech is motivated to mitigate the worldwide pandemic. #Indianinnovationglobalvalidation #indiasfirstindigenouscovidvaccine #covid19 #covaxin @WHO pic.twitter.com/zN7wefyP5U— BharatBiotech (@BharatBiotech) November 3, 2021
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorization for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “The WHO nod for Covaxin is a validation of the tremendous effort by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create a meaningful impact at a global level. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. Covaxin is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine. We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic.”
Covaxin is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). While the phase 3 trials entailed 25,800 participants between 18-98 years of age including 10% over the age of 60, the analysis was conducted 14 days after administering the second dose of the vaccine. It has shown overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results.
On the other hand, efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 disease. Most importantly, it has proven to neutralize variants such as B.1.1.7 (Alpha), B.1.617 (Kappa), B.1.351 (Beta), and B.1.617.2 (Delta). The Haffkine Biopharmaceutical Corporation Ltd, Mumbai, Indian Immunologicals Limited in Hyderabad and Ankleshwar, Bharat Immunologicals Biologicals Limited in Bulandshahr, and the Biovet facility in Bengaluru have also been permitted to produce Covaxin.