Indian COVID-19 Vaccine Receives WHO Approval

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Indian vaccine
Source: Freepik

Indian homegrown vaccine, Covaxin becomes the eighth COVID-19 vaccine to win a WHO approval.

In a recent press release, the World Health Organization (WHO) granted an emergency use listing to Covaxin. Made by Bharat Biotech, it is the first Indian homegrown COVID-19 vaccine to receive WHO approval. The decision was made after WHO’s technical advisory group conducted a review of data on the vaccine’s safety and efficacy. They found the benefits to significantly outweigh the risks.

This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic.

Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products

The Indian vaccine contains an inactivated SARS-CoV-2 antigen that evokes an immune response in vaccinated individuals. In January, India approved Covaxin even before the completion of its phase 3 trials. Thus, attracting criticism from experts all over the world. However, Bharat Biotech soon published data, stating a 78% vaccine efficacy.

‘200% Safe’

Although many believe the WHO approval is based on incomplete data, Bharat Biotech’s chairman, Dr. Krishna Ella has called the vaccine 200% safe. Moreover, WHO’s advisory panel gathered additional data from the drug maker while assessing their application for emergency approval.

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended the use of Covaxin in two doses, given four weeks apart. Currently, the vaccine is only approved for use in those aged 18 years and above. However, there’s insufficient data on the use of the vaccine in pregnant women.

The approval will open doors for millions of Indians stuck inside the country due to travel restrictions. Moreover, through the COVAX vaccine sharing effort, the shots will be available for other low- and middle-income countries.

It is important for Bharat Biotech to improve its production capacity to meet the improved demand for other countries following this approval.

Prashant Khadayate, a pharma analyst at GlobalData.

Bharat Biotech aims to manufacture an annualized capacity of 1 billion doses by the end of 2021.

Source: World Health Organization

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