WHO approval will expedite Covaxin regulatory approval in other countries: Bharat Biotech
Nov 03, 2021
Hyderabad (Telangana) [India], November 3 : The approval of the World Health Organisation (WHO) for emergency use listing of Covid-19 vaccine COVAXIN, will lead to the expedition of regulatory approval of India's indigenously made vaccine all across the world, said the vaccine manufacturer Bharat Biotech.
"The WHO's Emergency Use Listing (EUL) for COVAXIN facilitates countries to expedite their regulatory approval processes to introduce and administer India's indigenously made COVID-19 vaccine developed and manufactured by Bharat Biotech," said the press note released by Bharat Biotech.
The World Health Organisation (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) for Covaxin.
"The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality," reads the release.
Further, Dr Krishna Ella, Chairman and MD of Bharat Biotech said that "The validation by WHO is a very significant step towards ensuring global access to India's widely administered, safe, and efficacious COVAXIN."
"As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of the Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency," added Dr Krishna Ella.
As per the official statement, the phase 3 trial data for COVAXIN was available during June 2021. The World Health Organisation (WHO) Emergency Use Listing (EUL) process commenced on July 6, 2021, with rolling data submission. The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) had reviewed COVAXIN data on October 5 and granted EUL for the vaccine on November 3.
"Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available. Within a short period of nine months, the capacity was scaled up to 50-55 million doses per month, as of October 2021. Bharat Biotech has established COVAXIN manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the United States, and other countries," added the official statement.
