Bharat Biotech's Covaxin gets WHO's nod
Hyderabad, Nov 3: The Hyderabad-based Bharat Biotech announced on Wednesday that the World Health Organisation (WHO) has franted Emergency Use Listing to India's first indigenous Covid-19 vaccine Covaxin.
Developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, Covaxin is a whole virion-inactivated vaccine.
With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. Furthermore, UNICEF, Pan-American Health Organisation (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.
This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access, the vaccine maker said.
The EUL procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech described validation by WHO as a very significant step towards ensuring global access to India's widely administered, safe, and efficacious vaccine. "As an organisation, 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 authorisation 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."
The Phase 3 trial data for Covaxin was available during June. WHO's EUL process commenced on July 6 with rolling data submission. The Strategic Advisory Group of Experts on Immunization (SAGE) of WHO had reviewed Covaxin data on October 5 in a meeting and granted EUL for Covaxin on November 3.
Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8 degrees Celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.
Suchitra Ella, Joint Managing Director, Bharat Biotech, stated that the WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and its partners.
"It is also an opportunity for us to create 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.A We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic."
Covaxin has been evaluated through neutralizing antibody responses against several variants of concern, like B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peer-reviewed journals and available for review in the public domain.
Bharat Biotech stated that the manufacturing capacity expansion was started during first quarter 2021, as the first Phase 3 efficacy readouts were available. Within a short period of about 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.
The company has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the US, and other countries, it added.