Bharat Biotech gets approval to test nasal COVID-19 shot as booster: Report

The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

Reuters

January 05, 2022 / 11:53 IST

Covaxin, Bharat Biotech

India’s drug regulator on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to a Mint report, which cited ANI.
The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

"DCGI's Subject Expert Committee has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval," according to the report on Wednesday.

Bharat Biotech and DCGI did not immediately respond to Reuters requests for comment.

As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of COVID-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from Jan. 10.

The country is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 received regulatory approval for mid- to late-stage trials. Local media had reported the mid-stage trial has completed.

COVID-19 Vaccine

Frequently Asked Questions

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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