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WHO panel to review Covaxin data for emergency-use listing on October 5

Inclusion of indigenously developed Covaxin in the WHO list will boost global acceptance of the Covid-19 vaccine.

September 22, 2021 / 03:41 PM IST
Vial of Covaxin (File image)

Vial of Covaxin (File image)

A World Health Organization expert panel is scheduled to review the clinical trial data of Bharat Biotech’s Covid-19 vaccine Covaxin on October 5, according to the committee’s agenda for the meeting.

Following the review, the Strategic Advisory Group of Experts on Immunization (SAGE) will issue draft recommendations, which will be critical in the process of approving Covaxin for WHO’s Emergency-Use Listing (EUL).

EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the aim of expediting their availability to people affected by a public health emergency.

Inclusion of Covaxin in the WHO list will boost global acceptance of the vaccine, which was developed indigenously.

SAGE will evaluate the vaccine’s safety and efficacy data emerging from Bharat Biotech’s clinical trials (phase 1-3 results and post-marketing), risk-management plans and other implementation considerations. In addition, it will review safety monitoring and assessment of evidence.


COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

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.

How many types of vaccines are there?

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.

What does it take to develop a vaccine of this kind?

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.

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SAGE member Hanna Nohynek will present the draft recommendations. According to the SAGE agenda, it has one and half hours for the Covaxin review, including a presentation by the company.

Bharat Biotech was yet to respond to Moneycontrol queries at the time of publishing this story.

Bharat Biotech said last week that Covaxin’s clinical trial data had been fully compiled and became available in June 2021. The information was submitted for EUL application in early July.

“We have responded to clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” the company said.

Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Sep 22, 2021 03:41 pm

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