According to people familiar with the situation, three significant Covid-19 vaccine-related reviews are expected in the upcoming meetings of the Central Drugs Standard Organisation’s (CDSCO) subject expert committee sometime this week.
Zydus Cadila’s emergency use authorisation application for its Covid-19 vaccine, ZyCoV-D, from Ahmedabad will be at the top of the review list.
The company submitted its application for its three-dose DNA technology-based vaccine on July 1, and the government’s expert panel has been reviewing the trials data it submitted as part of the approval process since then.
The company has presented interim phase 3 data that shows primary efficacy of 66.6 percent.
“The expert panel that is considering the application had sought some more data from the company. It will be difficult to say whether the approval will be granted for sure in the next meeting or not as these are domain experts who follow a thorough process, and need to be convinced about the robustness of the data presented before them. Nothing can influence their decision, so people must rest assured that when approval is given, it is foolproof,” said an official aware of the matter, on condition of anonymity.
If approved, it will be the world’s first plasmid DNA vaccine for human use, following Bharat Biotech’s Covaxin, and the second complete make-in-India Covid-19 vaccine to receive emergency use authorization.
The company had previously stated that there was sufficient evidence to show that the two-dose ZyCov-D regimen was as effective as the three-dose regimen that it was designed to be. The regulator was given relevant data to look over.
ZyCoV-D is a significant Covid-19 vaccine because it has been tested in approximately 1,000 children over the age of 12 who were enrolled in the trial along with 27,000 other participants at 50 sites across the country.
“If the data supports the claim, it could be the first Indian vaccine allowed for use in children,” said the official.
Sharvil Patel, the company’s managing director, said last month that the company should be able to produce 10-12 million doses per month.
Another emergency use application that the expert panel may consider is that of the Serum Institute of India (SII), which applied to the national drugs regulator earlier this month for approval of the Indian version of the American Novavax vaccine, which will be manufactured locally under the brand name Covovax.
According to SII’s chairman and managing director Dr. Cyrus Poonawalla, the expert panel may review the data, but the decision to launch could be hampered by the vaccine’s developers’ bottleneck with the US Food and Drug Administration.
Even if the decision to launch the product is postponed, the trial data could still be reviewed by the regulatory body, according to people familiar with the situation.
