The World Health Organisation's (WHO) Technical Advisory Group (TAG) has finally given Bharat Biotech's COVID-19 vaccine, Covaxin approval for emergency use listing (EUL).
This approval by the WHO comes after the committee met on three different occasions and asked the Hyderabad based vaccine manufacturer to submit additional data. In its meeting on November 3, the committee has approved the same.
Covaxin received emergency use listing close to five months after Bharat Biotech members first met the WHO officials. The meeting was first scheduled on June 23.
Many countries such as the US and the countries that are a part of the European Union count only those people as vaccinated who have taken WHO approved vaccines. Since Covaxin was thus far not approved, people who received the two doses of the inactivated SARS-CoV-2 virus vaccine had to follow mandatory quarantine measures in these countries.
Now with the approval, along with several other countries such as Oman and Australia that recognise people who received Covaxin as vaccinated, the other countries mentioned earlier could also now accept the Indian vaccine.
Along with the manufacturer, the Indian government also has an active role to play in the development of this vaccine. The virus was isolated at the National Institute of Virology in Pune and the Indian Council of Medical Research has collaborated with the company for the vaccine production.
The approval also comes as a welcome relief to the manufacturers as Covaxin found itself in the middle of several controversies since the time it was launched.
The Indian drug regulator gave the vaccine an emergency use authorisation when the vaccine had just begun its Phase 3 trials. Furthermore the US Food and Drug Administration refused to give it approval to be manufactured and distributed in the country. The vaccine producer find itself dragged into another controversy in Brazil.
To be taken in the form of two doses, the vaccine is to be taken within an interval of four weeks. The WHO's TAG believes that the vaccine now meets their standards and its benefits outweigh the risks. Covaxin is 78 per cent effective against the SARS-CoV-2 virus and its variants.
However, they are still unsure of its effect on pregnant women as the data they have received is insufficient to reach any conclusion.
Covaxin constitutes close to 11 per cent of the vaccine doses administered in India, so far and is set to amplify its production capacities. Bharat Biotech has signed MOUs with three public sector units to ramp up the monthly manufacturing. Currently, Bharat Biotech is producing close to five crore doses monthly.
The company also shared today that the Indian drug regulator has increased the shelf life to 12 months. This means that the vaccine can be used for 12 months since the day it was produced.