World Health Organisation (WHO) has extended giving the emergency use authorization for Hyderabad-based Bharat Biotech’s COVID-19 vaccine Covaxin to next week. “WHO and an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,” tweeted WHO.
Covaxin has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on September 27. “WHO experts are currently reviewing this info and if it addresses all questions raised, WHO assessment will be finalized next week,” tweeted WHO.
Covaxin, India’s first vaccine candidate for Covid-19 was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
The indigenous, inactivated vaccine was developed and manufactured in the company’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley, Hyderabad. Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
According to the Hyderabad-based vaccine manufacturer, Phase-3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent. All the relevant trial data has been submitted to WHO for Emergency Use Listing (EUL) and all clarifications by the UN health agency have been responded to Bharat Biotech.
The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm till date.
As of date, India is using three vaccines against COVID-19 in its immunization drive. These include two made-in-India vaccines – Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. The Russian Sputnik V is the third vaccine that got approval from the Drug Controller General of India (DCGI) for Emergency Use Authorisation.
In Phase I of the vaccination drive, started on January 16, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) prioritised Health Care Workers and Front Line Workers (both government and private sector). Phase II of the vaccination drive started from March 1 2021, focused on protecting the most vulnerable age groups. These prioritised age-groups included persons above 60 years of age and persons above 45 years with associated specified co-morbidities. This was further relaxed to all people above 45 years of age on April 1, 2021. In Phase III, ‘Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy’ was adopted on May 1, 2021. Under this strategy, everyone above 18 years of age are eligible for COVID-19 vaccination.