11/09/2021 | News release | Distributed by Public on 11/09/2021 04:05
Updated8 November 2021
Bharat Biotech's Covaxin is playing a frontal role against the COVID-19 pandemic in its home country. The vaccine was approved by WHO for emergency use against COVID-19 on 3 November. The life-saving drug has also been authorized in 9 countries around the world.
Keep reading to find out where the Covaxin vaccine has been approved.
In collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, Hyderabad-based Bharat Biotech has developed India's first indigenous vaccine for the coronavirus BBV152, or commonly known as the COVAXIN. It is an inactivated virus-based vaccine, having a two-dose regimen taken 28 days apart, similar to most others.
The good part of Biotech's jabs is that they don't require special cold-storage facilities. Covaxin can be easily and conveniently stored at 2-8 degrees celsius, which is a regular refrigerator temperature.
Covaxin WHO approval status
The World Health Organisation (WHO) has granted approval for Emergency Use Listing (EUL) for Hyderabad-based Bharat Biotech's COVID-19 vaccine, Covaxin.
All documents required for emergency use listing (EUL) of Covaxin were submitted to WHO on July 9. Earlier, the WHO panelon 26 October sought "additional clarifications" from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine. The technical advisory group met on 3 November for a final assessment and approved the vaccine for emergency use.
The approval was done on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech stated that the conclusion for the final analysis of Covaxin's efficacy was done from Phase 3 trials.
The WHO's Emergency Use Listing (EUL) and EMA's Conditional Marketing Authorization act as benchmarks for the other countries.
For COVID-19 vaccines, the UN's health branch has set the bar for minimum efficacy at 50% in its considerations for evaluation of COVID-19 vaccines. Other vaccines approved by WHO are:
Covaxin EMA status
Covaxin is yet to come under the rolling review process of EMA.
The EMA's authorization process involves the safety monitoring of vaccines and careful consideration of aspects like risks, side effects, design, clinical reports, etc. Till now, the organization has given a nod to:
Countries that have approved Covaxin
The following countries have given Covaxin the go-ahead so far:
The other vaccines approved by Guyana are AstraZeneca, Sputnik V, and Sinopharm, Sinovac, Johnson and Johnson, Pfizer, Moderna.
The other vaccines approved by India are Covishield, Sputnik V, Moderna, Zydus Cadila, Janssen and AstraZeneca.
The other vaccines approved by Iran are AstraZeneca, COVAX-19, Sputnik V, Sinopharm (Beijing), Janssen, Sputnik Light and Shifa Pharmed Industrial Co.
The other vaccines approved by Mauritius are Sputnik V, Sputnik Light, AstraZeneca, Sinopharm.
The other vaccines approved by Mexico are Pfizer, Cansino, Sputnik V, Janssen, AstraZeneca, Sinovac, Moderna and Sinopharm.
The other vaccines approved by Nepal are Covishield, Sputnik V, Sinopharm (Verocell), Sinovac, AstraZeneca, Janssen, and Pfizer
The other vaccines approved by Paraguay are AstraZeneca, Sputnik V, Sinopharm, Sinovac, Pfizer, and Moderna.
The other vaccines approved by the Philippines are Moderna, Pfizer, Sputnik V, Janssen, AstraZeneca, Sinopharm (Wuhan), Sinopharm (Beijing), Sinovac and Sputnik Light.
The other vaccines approved by Zimbabwe are Sputnik V, Sinopharm, Sinovac, Janssen and Covishield.
European countries that have approved Covaxin for vaccine passport
The other vaccines approved by Estonia are Moderna, Pfizer, Janssen, and AstraZeneca.
The other vaccines approved by Greece are Moderna, Pfizer, Janssen, and AstraZeneca.
The other vaccines approved by Switzerland are Moderna, Pfizer and Janssen.
Other countries that have approved Covaxin to allow the entry of vaccinated travellers
The other vaccines approved by Australia are Moderna, Pfizer, Janssen, AstraZeneca, Sinopharm (Beijing) and Sinovac.
The other vaccines approved by Oman are Pfizer, Sputnik V, AstraZeneca and Sinovac.
The other vaccines approved by Sri Lanka are Moderna, Pfizer, Sputnik V, AstraZeneca, Covishield, Sinopharm (Beijing) and Sinovac.