2 min read.Updated: 23 Feb 2021, 06:06 AM ISTLeroy Leo
The company has invested ₹250-350 crore so far on trials of the vaccine and its manufacturing
Zydus Cadila expects to submit to the drug regulator its safety and efficacy data for the vaccine in either April or June
Zydus Cadila Ltd will expand capacity of its covid-19 vaccine ZyCoV-D to produce 150 million doses a year and hire contract manufacturers to make an additional 50 to 70 million doses, a company spokesperson said.
“We have been investing a large amount of our capacities in building the vaccine, so we will now be able to produce 150 million doses of the vaccine annually," the spokesperson said, adding that the vaccine will be produced at its Zydus Biotech Park plant in Ahmedabad.
The company has invested ₹250-350 crore so far on trials of the vaccine and its manufacturing, the spokesperson said.
Zydus Cadila expects to submit to the drug regulator its safety and efficacy data for the vaccine in either April or June.
The company is currently conducting a phase 3 clinical trial of 28,216 participants for the vaccine across India and will calculate the shot’s efficacy when it gets 158 cases of covid-19 among the participants after the vaccination cycle is completed, the spokesperson said.
“Once the vaccination cycle is completed, one needs to wait for getting the 158 number of cases who test positive for covid-19 as this is a double-blind, randomized, placebo-controlled trial. Once this efficacy analysis number comes in, the trial’s primary objective would be complete," Zydus Cadila said.
In a phase 3 trial, a vaccine’s efficacy is calculated when a pre-determined number of covid-19 cases is achieved across the vaccine and placebo arms of a blinded trial.
When the number of covid-19 cases are observed, the participants are unblinded—the researchers find out who has received the vaccine and who has got a placebo—and the efficacy is determined.
The Indian regulator, as well as the World Health Organization (WHO), has kept 50% as the minimum efficacy required to get emergency licensure.
Zydus Cadila’s DNA-based vaccine is crucial because a successful trial and subsequent regulatory authorization would make it the fourth covid-19 vaccine to be launched in India.
Also, with the vaccine platform being a relatively new technology, it can be quickly adapted to mutant strains, such as those from South Africa that are reducing the efficacy of some vaccines.
In December, Zydus Cadila said its DNA vaccine can be altered and the modified vaccine can be produced within three months.
So far, Serum Institute of India’s Covishield—a version of the jabs developed by the University of Oxford and AstraZeneca Plc—and Bharat Biotech International’s indigenous shot, Covaxin, are being administered in India.
Dr Reddy’s Laboratories last week submitted its application to Drugs Controller General of India V.G. Somani seeking emergency use authorization for the Russia-developed Sputnik V vaccine.
While the efficacy of the two-dose Covishield varies between 53-90%, depending on the interval between doses and the quantum of the first shot, Sputnik V has an efficacy of 91.6% for two shots given three weeks apart.
On the other hand, Covaxin received emergency licensure in “clinical trial mode" despite not having efficacy data as the regulators believed it would work more effectively against the recently-discovered UK strain. The proof of its effectiveness against the new strains was found through a laboratory-based study only after authorization was given.