‘Efficacy 67%’: Zydus seeks nod for vaccine
NEW DELHI: Drugmaker Zydus Cadila said on Thursday it has applied for emergency use approval of its three-dose Covid-19 vaccine candidate, which has shown an efficacy rate of 66.6% in an interim analysis of its phase 3 trials.
The company said that this is the first coronavirus vaccine using a DNA plasmid in advanced trials, and the first in India to be tested in a large group of adolescents. If approved, it will be India’s second home-grown vaccine, and the fifth overall to be cleared for use in the country after Covishield, Covaxin, Sputnik V and Moderna.
“As the first ever plasmid DNA vaccine for human use, ZYCOV-D has proven its safety and efficacy profile in our fight against COVID-19. The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group,” said Sharvil Patel, managing director of Cadila Healthcare, in a statement by the company.
The clinical trials included 28,000 people who were split into two groups that either received the vaccine or a placebo. Among them were 1,000 volunteers in the 12-18 age group.
The company has not yet released data from its previous phases.
It also announced that the vaccine worked as well as a twodose regimen as it did in the three-dose formulation that it was tested in, and data pertaining to that has been submitted to the regulator for scrutiny.
Zydus, which aims to produce up to 120 million doses annually, said its study coincided with the peak of India’s second wave of infections and affirmed its efficacy against mutations, especially the Delta variant. It did not, however, disclose its efficacy against those variants.
According to the company, the tolerability profile among the adolescents was similar to what was seen in the adult population. Primary efficacy of 66.6% was attained for symptomatic RT-PCR positive cases in the interim analysis.
The company said there were no moderate cases of Covid-19 in the vaccine arm, though it did not disclose how many cases the interim analysis was based on.
“We are making constructs for variants for future upgrade, if needed. Interim data has been submitted, and we will submit more data as it gets analysed to the regulator in due course. We haven’t reported any major sideeffects for the vaccine. In fact, side-effects are similar to the placebo arm,” said Patel.
Patel added that the vaccine candidate has exhibited robust immunogenicity, and tolerability and safety profile in the adaptive phase 1/2 clinical trials carried out earlier.
NEW DELHI: Ahmedabad-based pharmaceutical firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its twoor three-shot Plasmid DNA Covid-19 vaccine, and plans to manufacture 100-120 million doses annually. If approved, it will be the fifth vaccine against coronavirus to be approved in India. Here’s more about the jab.
What is it called? Zycov-d How does it work?
It is a plasmid DNA vaccine. A plasmid, a small circular piece of DNA, is used to instruct cells for to make the spike protein of the Sars-cov-2. This helps teach the body to recognise a crucial part of the virus, to which it can then build defences. The shot is administered intradermally, which resembles a pinprick.
How many doses is it given as?
The vaccine was tested in a three-dose regimen, with the second and third given 21 and 56 days after the first. But the company said it has also evaluated a two-dose regimen and found similar results, hinting at plans to make it a two-dose regimen.
How has it performed?
The company said efficacy of its clinical trials in over 28,000 people came to 66.6%. However, the company has not disclosed its early phase trial data. Zydus said its study coincided with the peak of the second wave of infections and affirmed efficacy against variants such as Delta. The company added that the trial also included 1,000 volunteers in the 12-18 age group.
How does it compare to others?
The DNA plasmid vaccine works in a manner similar to the MRNA vaccine, in which the body is instructed to code for the antigen (the spike protein, in this case). The Oxford-astrazeneca vaccine (or Covishield) and Sputnik V deliver similar codes via viral vectors. Novavax’s vaccine delivers the proteins itself, while Covaxin uses an inactivated virus as an antigen.
When can we expect it?
Zydus Cadila managing director Sharvil Patel said the company hoped to be producing 10 million doses a month by midaugust.