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Govt expects Covaxin to get emergency use approval from WHO in next 2-3 months

Covaxin manufacturer Bharat Biotech International Limited submitted the data required for global emergency use approval to the World Health Organization on July 9.

July 20, 2021 / 06:06 PM IST
A file image of Covaxin.

A file image of Covaxin.

The government expects the World Health Organization (WHO) to provide approval for emergency use to Covaxin in the next 2-3 months, the Health Ministry has told Parliament.

In a written response to the Rajya Sabha on July 20, Minister of State for Health and Family Welfare Bharati Pravin Pawar said Covaxin manufacturer Bharat Biotech International Limited submitted the data required for approval to the WHO on July 9.

"Based on time taken for approval of other COVID-19 vaccines, it is estimated that the WHO-EUL process takes approximately 2 to 3 months from the date of submission," Pawar said, responding to a question by Shiv Sena MP Priyanka Chaturvedi.

According to the WHO, its Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

The WHO's approval of Covaxin will be significant as it will likely lead to more international acceptance of the vaccine. It will also boost prospects of international travel for the many Indians who have taken Covaxin, as it is currently excluded from the list of globally accepted vaccines.

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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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The approval will also allow Covaxin to join the WHO’s COVAX vaccine alliance which is ensuring supply for other countries. So far, only six vaccines have EUL from the apex global health body – AstraZeneca-Oxford, Moderna, Johnson & Johnson, Pfizer-BioNTech, Sinopharm and Sinovac.

India's other major vaccine, Covishield manufactured by Serum Institute of India has received WHO prequalification.

Earlier this year, the government had streamlined regulatory norms for approval of import and usage of offshore manufactured vaccines in India. It had allowed all foreign vaccines that have already been granted Emergency Use Authorisation (EUA) in other countries.

This allowed all vaccines currently approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to be sold in India soon.

On July 20, the government told Parliament that vaccine manufactured by Moderna has already been approved for import and usage in India by the national regulator i.e. Drug Controller General of India. "NEGVAC is in regular dialogue with offshore vaccine manufacturers for facilitating import of COVID-19 vaccines some of which have already received WHO Prequalification," it said.
Subhayan Chakraborty

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