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Bharat Biotech says working with WHO to obtain clearance, no word on approval delays

Bharat Biotech has said it doesn't 'find it appropriate to speculate or comment on the regulatory approval process and its timelines' after reports emerged of a possible delay in WHO approval

September 28, 2021 / 03:41 PM IST
A file image of Covaxin.

A file image of Covaxin.

Bharat Biotech on September 28 said it was working with the World Health Organisation to get the emergency use listing for Covaxin at the earliest, as reports talked of a delay with the UN body asking for more data on the Indian pharma firm's COVID jab.

"As a responsible manufacturer with past approvals for our other vaccines, we don’t find it appropriate to speculate or comment on the regulatory approval process and its timelines," Bharat Biotech said in a statement.

"At appropriate times, we will make announcements to indicate the availability of regulatory approvals."

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

The inclusion of Covaxin, one of the six jabs approved by India, in the WHO list will boost global acceptance of the vaccine, making it easier for beneficiaries to travel abroad.

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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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Also read: COVID-19 vaccine boosters could mean billions for drugmakers

The Hyderabad-based company’s statement comes amid reports of a likely delay in the approval by several weeks.

As reported by Moneycontrol, the Strategic Advisory Group of Experts on Immunization (SAGE), which advices WHO, will meet on October 5 to review Covaxin's safety and efficacy data emerging from clinical trials (phase 1-3 results and post-marketing), risk-management plans and other implementation considerations.

Covaxin’s clinical trial data had been compiled and was available in June 2021, Bharat Biotech said early this month. The information was submitted for EUL in early July.
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 28, 2021 03:33 pm

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