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Zydus Cadila begins human trials of its potential vaccine for coronavirus

The company said that Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.

July 15, 2020 / 10:22 AM IST
3 | NHS England in talks on rollout of potential COVID vaccine from December, says report: The National Health Service (NHS) is in talks with the British Medical Association (BMA) and others around mobilising the rollout of a potential COVID-19 vaccine from December, Pulse website for health professionals reported. >There is optimism around the first cohorts being given a vaccine in December but there is a 50/50 chance of the vaccine being available by that time, Pulse reported, citing a person close to the discussions.

3 | NHS England in talks on rollout of potential COVID vaccine from December, says report: The National Health Service (NHS) is in talks with the British Medical Association (BMA) and others around mobilising the rollout of a potential COVID-19 vaccine from December, Pulse website for health professionals reported. >There is optimism around the first cohorts being given a vaccine in December but there is a 50/50 chance of the vaccine being available by that time, Pulse reported, citing a person close to the discussions.

 
 
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Zydus Cadila, on July 15 said that it has begun giving its potential coronavirus (COVID-19) vaccine to healthy volunteers in the first and second phases of human clinical trials across multiple sites.

"Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects," the company said.

As per the Clinical Trial Registry of India (CTRI) data which was updated on July 4, the phase-1 where the vaccine will be tested for safety is expected to be completed in 84 days, and phase-2 where the vaccine will be tested for safety, efficacy, will compared with placebo and it is expected to take 84 days.

The CTRI data mentions one clinical trial site of Zydus Research Centre in Ahmedabad. The ethics committee related to site has approved the trial.

Zydus had earlier this month announced that its plasmid DNA vaccine candidate (ZyCoV-D) developed at its Vaccine Technology Centre in Ahmedabad, India had successfully completed the preclinical phase and had received permission from the Drug Controller General of India (DCGI) permission to initiate Adaptive Phase I/II human clinical trials 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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"In the pre-clinical phase, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration," the company said.

With ZyCoV-D, the company said it has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.

"Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1)," the company added.
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: Jul 15, 2020 10:22 am

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