Zydus Cadila, the Ahmedabad-headquartered pharmaceutical company, has approached India’s top drug regulator for restricted emergency approval for ZyCov-D, its three-dose Covid-19 vaccine.
If approved for use, this would be the world’s first DNA vaccine against Covid-19.
The vaccine, which was tested in late-stage human clinical trials involving over 28,000 participants, has been found to have a primary efficacy of 66.6 per cent so far — this means it was able to bring down symptomatic cases of Covid-19 in those who received the vaccine by nearly 67 per cent compared with those who did not receive a vaccine.
Even though this efficacy is lower than that of most other Covid-19 vaccines approved in India, the strength of ZyCov-D lies in its effectiveness against the Delta variant of the virus, Zydus Cadila managing director Dr Sharvil Patel said.
“The study was performed at 50 different clinical sites spread across the country during the peak of the second wave of Covid-19, which reaffirms the vaccine’s efficacy against the new mutant strain, the Delta strain,” Patel said at a press conference on Thursday evening.
The company is testing the vaccine against other variants of concern and interest and, depending on the results and whether these other strains become more infectious or virulent, will decide whether to “upgrade” the vaccine.
Almost 27.61 crore people have been inoculated with at least one dose of vaccine in India so far, the bulk of them being Serum Institute of India’s Covishield. A little more than 28.61 lakh shots were administered on June 30, but vaccinations have averaged over 55.6 lakh doses every day over the 10 days since June 21, when the new vaccination policy kicked in.
Zydus Cadila has also tested ZyCov-D’s safety and ability to prompt an immune response in a trial involving 1,000 adolescents between the ages of 12 and 18 years. However, it is unclear at this stage whether the company is pushing for approval for this age group.
Eduindex News 