Zydus Cadila’s Sharvil Patel: We will manufacture one crore doses per month initially

India’s first indigenously developed DNA vaccine candidate against the COVID-19, being developed by the Ahmedabad-based pharmaceutical company Zydus Cadila, will be the fifth vaccine against coronavirus in India if approved.

The pharmaceutical giant had recently applied for emergency use authorisation (EUA) with the Indian drug regulator. India has already approved Covishield, Covaxin, Sputnik V, and  ModernA.

ZyCoV-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. It can be stored at 2-8 degree Celsius but has shown good stability at temperatures of 25 degree Celsius for at least 3 months

According to the World Health Organization, DNA vaccination consists of stimulating the immune system in a specific way to prevent or ameliorate diseases caused by infectious agents.

Two different approaches have been used to induce protective immune responses: one utilizes the administration of antigenic inert substances (a structural component of the whole inactivated microbe) and the other is based on the use of highly attenuated infectious microorganisms which, upon administration, replicate within the host without causing disease, thus priming the immune system in the same manner as natural infection.

Dr. Sharvil Patel, Managing Director of Zydus Group, spells out the plans about the DNA  vaccine, the advantages, and more.

Also Read: Seven Indian pharma players race to develop COVID-19 vaccine

Edited excerpts:

How much has the company invested in manufacturing the vaccine? What is the target and timeline for manufacturing?

Our group has invested upwards of Rs. 400-500 crore for the development of ZyCoV-D, the world’s first plasmid DNA vaccine for human use. We will start supplying the vaccine on receiving approvals from the regulators. We will manufacture one crore doses per month initially and will ramp the production in the coming months.

How is this DNA vaccine different from the others?

Being a DNA vaccine, ZyCoV-D has several advantages:

• ZyCoV-D is a three-dose, intradermal vaccine, which is applied using The PharmaJet^® needle-free system, Tropis^®, which can also lead to a significant reduction in any kind of side effects.
• ZyCoV-D is stored at 2-8 degree Celsius but has shown good stability at temperatures of 25 degree Celsisu for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.
• Also being a plasmid DNA vaccine, ZyCoV-D doesn’t have any problem associated with vector-based immunity.
• The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring.

The DNA platform can be easily and quickly adapted to the mutations in the virus, such as those already occurring. It also allows generating a new construct quickly to deal with mutations quickly that is why it is called a rapid plug-and-play technology.

The three doses of vaccine will be given in how much time interval?  In a competitive market, that has one dose and two doses, how will people be convinced to take this vaccine? 

ZyCoV-D, being a three-dose vaccine will be administered at day 0, day 28, and day 56. Our group has also evaluated a two dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results have been found to be equivalent to the current three dose regimen. This will further help in reducing the full course duration of vaccination in the future while maintaining the high safety profile of the vaccine. I think safety and efficacy is most important for a vaccine and ZyCoV-D is a very safe, immunogenic and efficacious vaccine

What are the plans of the company to expand its global footprint?

The company enjoys a wide global presence in over 55 nations spread across 4 continents. A substantial part of the company’s revenues already comes from the overseas operations

What are the other areas in which the company plans to foray?

Zydus is a global healthcare player, providing innovative healthcare solutions in the form of vaccines, therapeutics, and diagnostics, and is also present in the wellness space through Zydus Wellness Limited. The company will continue to expand its presence in these domains.