Zydus Cadila is likely to apply for emergency use authorisation (EUA) of its COVID-19 vaccine this month, after obtaining the first set of interim efficacy data.
“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,” Sharvil Patel, the Managing Director of Zydus Cadila, told Mint.
Phase 3 clinical trial for the plasmid DNA vaccine had started in February, with 28,000 participants. This trial is testing a three-dose regimen of the vaccine, taken at intervals of one-month.
The company is also testing a two-dose regimen of the COVID-19 vaccine, which is called ZyCoV-D. This two-dose regimen trial is also expected to be completed in May, Patel told the newspaper.
“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 was quoted as saying.
The Ahmedabad-based drugmaker is planning to manufacture 10 million doses per month, to begin with, and subsequently raise it to 20 million doses.
Currently, two COVID-19 jabs are available in India — Bharat Biotech’s Covaxin and Covishield, the Oxford University-AstraZeneca jab manufactured by the Serum Institute of India. The Drugs Controller General of India (DCGI) has also granted emergency use authorisation to Russia’s Sputnik V vaccine against COVID-19, but it has not been rolled out in the country yet.
News Source:- Moneycontrol