 "Bharat Biotech, Covaxin")
Bharat Biotech on Wednesday said the emergency use listing (EUL) granted by the World Health Organisation to its COVID-19 vaccine Covaxin is a significant step towards ensuring wider global access to the indigenously developed jab.
In a tweet, the WHO said it has granted emergency use listing (EUL) to Covaxin, adding to a growing portfolio of vaccines validated by the global health body for the prevention of COVID-19.
Covaxin is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV, Pune, Bharat Biotech said in a statement.
With validation from the World Health Organisation (WHO), countries can now expedite their regulatory approval processes to import and administer Covaxin, it added.
United Nations Children's Fund (UNICEF), Pan-American Health Organisation (PAHO) and GAVI COVAX facility will also be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.
"Validation by WHO is a very significant step towards ensuring global access to India's widely administered, safe, and efficacious Covaxin," Bharat Biotech Chairman and Managing Director Krishna Ella said.
As an organisation, Bharat Biotech has focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of its vaccines have received WHO prequalification, he added.
"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," Ella said.
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, Bharat Biotech said.
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, it added.
"The WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level," Bharat Biotech Joint Managing Director Suchitra Ella said.
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, she added.
Manufacturing capacity expansion was started during Q1 of 2021, as the first phase 3 efficacy readouts were available. Within a short period of around 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021, the statement said.
"Bharat Biotech 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 United States, and other countries," it added.
Covaxin has been evaluated through neutralising antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta) and P2- B.1.1.28 (Gamma), Bharat Biotech said.
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, it added.
Bharat Biotech's Covaxin and AstraZeneca-Oxford University's Covishield, manufactured by Serum Institute of India, are the two widely-used COVID-19 vaccines in India.
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