The World Health Organization (WHO) has requested Bharat Biotech for more data on its COVID-19 vaccine Covaxin, news agency ANI has reported.
The WHO's Emergency Use Authorisation (EUA) for the vaccine will be delayed by a few more days, the report said.
Hyderabad-based Bharat Biotech had submitted clinical trial data on Covaxin to the WHO in July in its application for EUA.
Responding to media reports, Bharat Biotech said it was not appropriate to speculate not comment on the expected timeline for the EUA.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
— BharatBiotech (@BharatBiotech) September 28, 2021
Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 percent.
The WHO's approval will likely make it easier for Indians who have taken the jab to travel abroad without restrictions.
The health ministry had on September 24 hinted that WHO will grant EUA for Covaxin soon.
"There is a procedure of submitting the documents for approval. WHO's emergency use authorization to Covaxin is expected soon," said Union Minister of State for Health Dr Bharati Pravin Pawar, as quoted by ANI.
NITI Aayog member VK Paul recently said the approval was expected by the end of September.
A WHO expert panel is scheduled to review the clinical trial data of Covaxin on October 5, according to the committee's agenda for the meeting seen by Moneycontrol. Following the review, the Strategic Advisory Group of Experts on Immunization (SAGE) will issue draft recommendations.
The WHO has so far granted EUA to vaccines developed by AstraZeneca (Covishield in India), Pfizer-BioNTech, Johnson & Johnson, Moderna, and Sinopharm.Covishield is manufactured by Pune-based Serum Institute of India (SII).