New Delhi: Zydus Cadila’s Covid-19 vaccine ZyCov-D could be a two-dose vaccine instead of three, the company announced Thursday.
Considering the burden on healthcare and the expense of buying three doses, among other inconveniences, the company said it evaluated a two-dose regimen for its DNA plasmid-based vaccine against Covid-19.
“We have evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three-dose regimen,” said Sharvil Patel, managing director, Zydus Cadila, at a virtual press briefing.
The company has now submitted both sets of data before the government’s subject expert committee (SEC) for approval. “The panel will take a final call. The data for two doses is strong enough and gives us a good point to discuss with these experts,” said Patel.
The vaccine doses will be administered 28 days apart and the company aims to start supplying 1 crore vaccines per month, most likely from August.
“Our new manufacturing facility will be operational by the end of this month. We plan to supply 5 crore doses by the end of this year,” Patel said.
Overall, the company plans to manufacture 1-1.2 crore doses per month, with a total production of 12 crore doses annually.
As for the price of the vaccine, the Ahmedabad-based pharmaceutical firm said it was “too early to talk about prices”. The pharma company has claimed to have invested upwards of Rs 500 crore on the development of the vaccine
Zydus Cadila also announced that it applied to the country’s drug regulator seeking emergency use authorisation (EUA) for the vaccine.
If approved, ZyCoV-D will be the country’s second indigenously-developed vaccine against the novel coronavirus, after Bharat Biotech’s Covaxin. It will also be the fifth vaccine authorised for use in India after Covishield, Covaxin, Sputnik V and Moderna’s mRNA-1273 vaccine.
Data submitted for vaccinating adolescents
The Zydus shot will be the first Covid-19 vaccine in India to have been tested in the 12-18 years age group.
The company tested the vaccine on adolescents in both phase 2 and phase 3 trials. While the number of test subjects was less than 10 in phase 2, it was more than 1,000 in the phase 3 trial.
“The vaccine was well tolerated, proven safe and effective for this age-group,” Patel said, adding that overall as well, no one has reported any serious side-effects of the vaccine till date.
The company, though, does not have data on the use of its vaccine on pregnant and breastfeeding women. “While our data includes people of age groups beyond 75 and the majority of comorbid conditions have been covered, we so far have no data on pregnant women.”
Zydus carried out the largest clinical trials in India — over 28,000 volunteers — for its Plasmid DNA vaccine at more than 50 centres.
(Edited by Manasa Mohan)