India’s first indigenous COVID-19 vaccine, Bharat Biotech’s Covaxin, was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) on Wednesday.
Covaxin is a whole virion-inactivated vaccine against SARS-CoV-2, developed in partnership with the Indian Council of Medical Research and the National Institute of Virology, Pune. It has been granted EUL for use in persons 18 years and above, over two doses spaced four weeks apart.
However, no recommendation has been made for use in children, and available data for use on pregnant women is insufficient to assess safety or efficacy, the WHO said.
The EUL is a prerequisite for the COVAX initiative in vaccine supply, and allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The move is expected to ease international travel for Indians who have opted for the vaccine but experts say that this would be subjected to countries clearing Covaxin through their regulatory processes.
According to information released by the WHO, Covaxin was found to have 78% efficacy 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 its easy storage requirements.
Union Health Minister Mansukh Mandaviya, welcoming the announcement, said, “This is a proud moment for the entire country.”
The WHO in its tweets on Wednesday said that the Technical Advisory Group, convened by the WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets the WHO’s standards for protection against COVID-19; that the benefit of the vaccine far outweighs risks; and that the vaccine can be used.
It added that Covaxin vaccine was also reviewed by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE).
“With validation from WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide,” Bharat Biotech said in its statement.
It added that this will enable the COVAX facility to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access.
Dr. Krishna Ella, chairman and MD, Bharat Biotech, said, “Validation by the WHO is a very significant step towards ensuring global access to India’s widely administered, safe and efficacious Covaxin. The EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of the COVID-19 vaccine, and the access to our vaccine globally, thereby addressing the current public health emergency.”
The company, in its release, said that the phase 3 trial data for Covaxin was available during June 2021, and the WHO’s EUL process commenced on July 6, 2021, with rolling data submission. SAGE of WHO had reviewed the data on October 5 in a meeting, and now has granted EUL for Covaxin.
“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 2-8ºC. 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,” said the company.
Meanwhile, Covaxin has been evaluated through neutralising antibody responses against several Variants of Concern —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). The company added that it has established Covaxin manufacturing to reach an annualised capacity of one 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 said.