Zydus seeks nod for its Covid vaccine ZyCoV-D, claims 66.6% efficacy against symptomatic infection
In its submission, the company claimed that in the interim analysis, based on 90 confirmed Covid-19 cases, no moderate, severe disease or deaths were reported in those vaccinated with ZyCoV-D.
NEW DELHI: Ahmedabad-based Zydus Cadila on Thursday applied for the emergency use authorisation for its Covid vaccine, saying that it has shown 66.6% efficacy in preventing symptomatic infection in the interim analysis of phase 3 clinical trials.
In its submission to the Central Drugs Standard Control Organisation, the company has also claimed that in the interim analysis, based on 90 confirmed Covid cases, no moderate, severe disease or deaths were reported in those vaccinated with the vaccine, named ZyCoV-D.
The phase 3 clinical trial of this vaccine -- which is administered intradermally and is, therefore, called painless -- is being conducted in over 28,000 plus volunteers, aged 12 to 99 years at over 50 places. The trial started in April during the peak of the second wave of the pandemic in India.
This was also the first time that any Covid-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India, said the firm in a statement adding that around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated though no efficacy data is available for this age group specifically.
“The tolerability profile was similar to that seen in the adult population.”
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Also, while the plasmid DNA platform-based vaccine has been tested in 3 dose regimens during the trials, the company said it has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three-dose regimen.
Thus, the ball is now in the regulator’s court to approve this vaccine as either a three or two-dose regimen.
The company meanwhile maintained that the plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with Covid as it can be easily adapted to deal with mutations in the virus, such as those already occurring.
In a press briefing after reaching out to the regulator, company managing director Sharvil Patel said that the results of the interim analysis for the vaccine are particularly significant as the vaccine was pitted against the more virulent strain of Covidvirus — Delta.
He said that whole-genome sequencing in 30% of the confirmed Covid cases during the efficacy trials were carried out, the majority of whom showed the presence of the Delta variant.
Meanwhile, the company said that while it has not stockpiled any vaccine so far, it is looking to produce nearly 5 crore doses of the vaccine by year-end and will also engage with other partners to scale up the production.
While acknowledging the support of the National Biopharma Mission, BIRAC, the department of biotechnology, and National Institute of Virology- ICMR, Patel said that the firm has spent about Rs 400-500 so far in the vaccine’s development.
In response to a query by The New Indian Express, he also said that while there has been no discussion yet on whether the vaccine will be available only in private hospitals or will also be procured by the government for its free vaccination programme, he said that understanding will come ahead of the vaccine’s commercial launch which may take 45-60 days after the approval by the CDSCO.