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Sputnik Light single-dose vaccine launch in India may get delayed

An expert panel of the Central Drugs Standard Control Organisation asks company to conduct Phase-3 immune-bridging clinical trials on Indian population. Dr Reddy's spokesperson declines to say when the trial will start.

September 16, 2021 / 03:01 PM IST
Sputnik V vaccine.  HAZEM BADER / AFP

Sputnik V vaccine. HAZEM BADER / AFP

 
 
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The launch of Sputnik Light single-dose vaccine by Dr Reddy's in India may take some more time as the company will have to conduct Phase-3 immune-bridging clinical trials on the Indian population.

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has approved the company proposal to conduct the trials.

Sputnik Light is the first dose of Sputnik V vaccine, which uses the human adenovirus ad26 vector. A Dr Reddy's spokesperson declined to say when the trial will start.

The SEC asked Dr Reddy's to assess the primary endpoint at days 42, 90 and 180 and do an interim analysis at day 42 as this data was not generated during Sputnik V trial in India after the first dose, as this data was not generated during the Sputnik V trial in India after the first dose, as its duration was for 21 days.

The minutes of the 172 SEC meeting, which was held on August 8, said that Dr Reddy's presented the updated safety, immunogenicity and efficacy data of the Phase 3 clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct it in India.

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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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Dr Reddy's has conducted the Phase 3 bridging trial of Sputnik V vaccine, and has received approval for its restricted emergency use in India.

The company holds the sole distribution rights for the first 250 million doses of the vaccine in India, as per its agreement with the Russian Direct Investment Fund (RDIF).

Is it a U turn?

In June, Dr Reddy's submitted a proposal for the grant of marketing authorisation of Sputnik Light, along with the interim safety and efficacy data generated from Phase 1/2 clinical trials in Russia and presented the Phase 3 clinical trial protocol before the committee.

The committee, after deliberation, asked Dr Reddy's to present the safety, immunogenicity and efficacy data of the Phase 3 trial that is being carried out in Russia for considering the authorisation in the country.

The safety and immunogenicity data of component-1 in the Indian population has already been generated in the country in another trial. There seems to (be) inadequate data and justification in conducting a separate similar trial,” the SEC said.

After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the Phase 3 clinical trial of Sputnik Light that is being carried out in Russia for considering the proposal for the grant of MA in the country,” it said.

An official at a clinical research firm, who didn't want to be named, said that the SEC was clarifying its position as the data was not generated for up to 42 days during the Sputnik V trial in India.

But the previous SEC statement did lead to ambiguity, which should have been avoided,” he 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 16, 2021 03:01 pm

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