Expert panel to review requests for 3 vaccines

NEW DELHI: Three significant Covid-19 vaccine-related reviews are expected in the forthcoming meetings of the subject expert committee of the Central Drugs Standard Organisation (CDSCO) sometime this week, according to people familiar with the matter.

On top of the review list will be Ahmedabad-based Zydus Cadila’s emergency use authorisation application for its Covid-19 vaccine, ZYCOV-D.

The company made the application on July 1 for its three-dose DNA technology-based vaccine, and since then the government’s expert panel has been looking at the rolling review of the trials data that the company submitted as part of the approval process. The interim phase 3 data that the company has presented shows primary efficacy of 66.6%.

“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 second complete make-in-india Covid-19 vaccine to receive emergency use authorisation after Bharat Biotech’s Covaxin, and the world’s first plasmid DNA vaccine for human use.

Another emergency use application that might be up for consideration with the expert panel is of Serum Institute of India (SII) that applied earlier this month to the national drugs regulator for approval of the Indian version of the American Novavax vaccine that will be manufactured locally under the brand name Covovax.

The expert panel may look at the data, but the decision to launch could be hampered by the bottleneck that the vaccine’s developers are facing with the US’ Food and Drug Administration, SII’S chairman and managing director Dr. Cyrus Poonawalla had said last Friday.

People familiar with the development said that the trial data could still be reviewed by the regulatory body even if the decision to launch the product is deferred.

According to SII CEO Adar Poonawalla, the company began clinical trials of Covovax in March and the production of the the first batch began in June.

The subject expert committee might also deliberate on the Russian-made single-dose vaccine, Sputnik V, which is being called Sputnik Light. In July, while responding to their application, the CDSCO expert panel had asked the authorised distributors, Dr Reddy’s laboratories, to not go ahead with separate bridging trials for the lighter version and submit the phase 3 data from Russia instead.