There are several things that set apart Zydus Cadila and its candidate ZyCov-D in the Covid vaccine race among indigenous players.
Behind Cadila Healthcare’s drive to develop a Covid vaccine, there lies an antecedent.
The firm, also known as Zydus Cadila, became the first Indian entity in May 2010 to get the regulator’s nod to market the indigenous H1N1 (swine) flu vaccine.
Marketed under the brand VaxiFlu-S by Vaxxicare, a division of the group focusing on preventives, the vaccine was an egg-based, inactivated one, based on conventional technology that paved the way for work on a wide spectrum of inoculations against bacterial, viral, and protozoal infections.
It was this pioneering work a decade ago that laid the foundation of one of the country’s slow but steady indigenous developments of the Covid-19 vaccine by the Gujarat-based group. The company is bullish on the capabilities and right infrastructure established during the creation of the H1N1 vaccine.
There are several things that set apart Zydus Cadila
and its candidate ZyCov-D in the Covid vaccine race among indigenous players.
“Developing the first indigenous vaccine for swine flu in 2010 in nine months gave us confidence in creating vaccines for this pandemic as well. We have the capabilities and the right infrastructure,” Sharvil Patel, managing director of Zydus Cadila, told Business Standard.
Developing the H1N1 vaccine imparted another important piece of learning —factoring in mutation.
“Developing a vaccine platform that can be adapted to a new strain when mutation occurs was important. The plasmid DNA platform developed for ZyCoV-D offers this possibility,” said Patel.
Unlike others, Zydus Cadila
has continued to focus on the efficacy of ZyCov-D and improving vaccine stability. What this also means is that when launched, ZyCov-D will have lower cold chain requirements and can be handled at room temperature as well.
“With ZyCoV-D, the company has established the DNA vaccine platform in the country. The platform is also known to show much improved vaccine stability, thus requiring lower cold chain requirements. This makes it ideal for access in remotest regions of the country. Administered through the intradermal route, it also allows easy administration. Further, the platform requires minimal biosafety requirements (BSL-1),” Patel added.
At a time when a new strain of the virus has led to lockdown and travel bans in the UK and other countries with cases emerging in India as well, Zydus’ plasmid DNA platform can allow the vaccine to be modified in case the virus mutates.
The company has said the stability of the vaccine is one of the biggest advantages of the platform amid dry runs of mass vaccination programmes being conducted in some states.
“The vaccine remains stable even at room temperature and will have a long shelf life if it is maintained at 2-8 degrees Celsius. The stability of the vaccine is one of the biggest advantages of this platform when we are looking at logistics and administration for a mass vaccination programme,” says Patel.
With its continual work in preventives, Zydus Cadila
has also built research and manufacturing capabilities that are expected to come in handy for ZyCov-D. Currently, a team of 300 scientists is working on the Covid vaccine. In all, the company has 1,400 researchers working on programmes in new chemical entities (NCEs), biologicals, vaccines, and new pharmaceutical technologies.
Its facilities in Gujarat are ready to manufacture 120 million doses to start with. In addition, the company is looking at partnering contract manufacturing organisations (CMOs) to produce another 50-70 million doses.
With phase I/II clinical trials conducted over 1,000 volunteers and data submitted for approval to conduct phase III trials, Zydus Cadila is ready to rope in 30,000 volunteers.
Patel hopes to launch the vaccine in the first quarter of next financial year, depending on the progress of the study and the outcomes.
It is, however, here that the timing of the launch could prove crucial for the company, analysts believe.
“They are definitely one of the better-placed among indigenous players and especially in the listed category of vaccine developers. We will most likely see more than one player bagging the vaccine approvals. The timing of ZyCov-D, however, will be crucial though one would not be surprised if Zydus launches the vaccine in April 2021,” an analyst said.
Pharma analyst Shrikant Akolkar also said the timing of the launch would matter.
“If it is late by two-three months and comes out by the time vaccines from Oxford and Sputnik are in the market, it may not have much of a chance. While Zydus has built its credibility over the years, it is still to be seen how much of a push the company can make among retailers and buyers for its vaccine,” Akolkar added.