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Drugmaker Zydus Cadila is expecting the first set of its interim efficacy data for its covid-19 vaccine this month, following which the company will immediately apply for an emergency use authorization with the Indian regulator, managing director Sharvil Patel said.

“Now we are in the phase where we believe we have to get an event number. We believe this can be achieved this month. Once that outcome is achieved, we can submit the information (to the regulator) in the same month and eventually seek approval if the data is good," Patel said in an email interview.

The Ahmedabad-based drugmaker had started the 28,000-participant phase 3 trial of its DNA plasmid vaccine in February. Unlike the Covishield, Covaxin and Sputnik V vaccines, which require two doses, Zydus Cadila’s vaccine requires three doses, with the subsequent shots administered one month after the previous dose.

This meant that the vaccine required an extra month before the counting of covid-19 cases across the placebo and vaccine arms was started. Zydus is waiting to get 158 cases across the two arms before the trial is unblinded to determine the interim efficacy.

Apart from the regimen of three doses, it is also testing a two-dose regimen, the trial for which is also expected to be completed in May, Patel said.

“If the data is equally good, we will look at it; but currently, we believe the three-dose regimen is more suitable for our vaccine and will give a better immune response and longer antibody response, which we have seen in our data," Patel said.

After it secures authorization, Zydus plans to manufacture the vaccine at the rate of 10 million doses per month to start with and subsequently scale it up to 20 million doses.

If the data is good and the company is able to secure an emergency authorization from Drugs Controller General of India V.G. Somani, Zydus Cadila’s vaccine is likely to be the fourth in India and the second indigenously developed jab to get clearance.

Bharat Biotech International’s Covaxin is also indigenously developed, while Serum Institute of India’s Covishield is a version of the vaccine developed by the University of Oxford and AstraZeneca Plc.

Russia’s Sputnik V on 12 April became the third vaccine to get an emergency authorization in India.

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