What Covaxin-Maker Bharat Biotech Said After WHO Approved India-Made Jab

The World Health organisation's approval of Covaxin will expedite global access and availability of the first India-made vaccine against coronavirus worldwide, its manufacturer Bharat Biotech said in a statement.

In a statement released this evening, the pharma firm said that the Emergency Use Listing will help countries expedite their regulatory approval processes to introduce and administer India's indigenously made COVID-19 vaccine. It will also allow procurement of the vaccine by UNICEF, Pan-American Health Organization (PAHO), and the GAVI COVAX facility for distribution globally and ensure equitable access, it added.

"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," said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.

"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 Emergency Use Listing process began on July 6, 2021, with rolling data submission, Bharat Biotech said. The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) reviewed the data on October 5 and granted EUL today, it said.

"The WHO nod 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," Suchitra Ella, Joint Managing Director of Bharat Biotech said. "We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic," she added.

The WHO granted Covaxin an emergency use listing, or EUL, which means the vaccine will finally be recognised by other countries, and Indians who have received the shot will no longer have to self-quarantine or face restrictions when travelling abroad. The vaccine has been cleared for use among those above 18 years of age. No recommendation has, however, been made on its use among children.

"The Technical Advisory Group (an independent panel that provides the WHO with vaccine recommendations) has determined Covaxin meets standards for protection against COVID-19... the benefit of the vaccine far outweighs risks (and) the vaccine can be used," the global health body said.

The WHO confirmed Covaxin had been found to be "78 percent 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".

Apart from Covishield and Covaxin - the two most widely used vaccines in India, the WHO has so far approved vaccines produced by American pharma giants Pfizer, Johnson & Johnson and Moderna, and China's Sinopharm.