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Strides Pharma announces results of SARS-CoV-2 vaccine clinical trial in India

The vaccine was well tolerated with no significant safety concerns and a seroconversion rate of 91%

June 24, 2022 / 12:06 PM IST
(Image: Reuters)

(Image: Reuters)

 
 
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Strides Pharma announced on June 24 results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.

The company said in an exchange filling that a preliminary review of this data reveals the vaccine was well tolerated with no significant safety concerns and a seroconversion rate of 91% at Day 56.

The Strides Pharma stock traded at Rs 327 on BSE - up more than 4 percent - at the time of writing this copy.

Furthermore, in the bridging trial, volunteers exhibited antibody titers that remained statistically significant high levels for six months, and serum samples taken from them demonstrated protection against variants of concern.

The findings will be submitted to India for Emergency Use Authorization (EUA) as a primary vaccination . Later clinical studies will be conducted to justify the vaccine's usage as a booster shot for other licenced vaccinations and for itself.

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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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It is to be noted that previous studies in the Netherlands have demonstrated robust antibody neutralisation of variants, including Delta and Omicron.

Arun Kumar, Founder of Strides Group, said, “We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the Vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.”

Akston Biosciences Corporation and Biolexis, a Strides Group Company, in collaboration, announced encouraging top-line results from phase II/III trial of their thermostable 2nd Gen COVID-19 vaccine.

Both the companies have already signed a licensing, manufacturing, and commercialisation agreement to launch this vaccine worldwide as AmbiVax-C(TM).

Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.”
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first published: Jun 24, 2022 11:56 am
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