Phase III clinical trials of Covaxin demonstrated a 77.8 per cent efficacy rate (File)
The Health Ministry on Friday hinted that the World Health Organization (WHO)'s Emergency Use Authorization (EUA) for Bharat Biotech's COVID-19 vaccine, Covaxin, is expected soon. However, as per the international public health agency, the approval is likely to be delayed.
In this regard, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to grant Emergency Use Authorization to Covaxin.
"There is a procedure of submitting the documents for approval. WHO's emergency use authorization to Covaxin is expected soon," said Dr Bharati Pravin Pawar, Union Minister of State in the Health Ministry.
According to Bharat Biotech, Phase III 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 asked for by the UN health agency have been responded to by Bharat Biotech.
"We have responded to clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines," the Hyderabad-based company said in a statement.
Earlier speaking to ANI, Chairperson of National Expert Group on Vaccine Administration Dr VK Paul said that the WHO's approval for Covaxin is likely to come before the end of this month.
The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm till date.
As of now, India is using three vaccines against COVID-19 in its immunization drive. These include two Indian-made vaccines - Serum Institute of India's Covishield and Bharat Biotech's Covaxin. The third vaccine that has approval from the Drug Controller General of India (DCGI) for Emergency Use Authorisation is the Russian Sputnik V.
In Phase I of the vaccination drive, started on January 16, 2021 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 became eligible for COVID-19 vaccination.