E-Paper
Expert panel to review requests for 3 vaccines
On top of the review list will be Ahmedabad-based Zydus Cadila’s emergency use authorisation application for its Covid-19 vaccine, ZyCoV-D.
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.
The company had earlier announced that there was enough data to show that the two-dose ZyCov-D regimen also worked equally well as the three-dose regimen that it was originally meant to be. Relevant data was submitted to the regulator for scrutiny.
What makes ZyCoV-D an important Covid-19 vaccine is that it has also been tried in about 1,000 children above the age of 12, who were enrolled along with 27,000 other participants at 50 sites across the country for the trial.
“If the data supports the claim, it could be the first Indian vaccine allowed for use in children,” said the official.
The company’s managing director, Sharvil Patel, last month announced that the company should have a production capacity of about 10-12 million doses per month.
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.
“Even if the launch of a vaccine is delayed for any technical reasons, the regulators can always look at the data from the trials — both local as well as global — to know about the safety and efficacy of the vaccine in general and review. Production process is different from regulatory processes,” said a government official on condition of anonymity.
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.
“It is what is called stockpiling which SII also did for Covishield before the vaccine received emergency use approval in January. It is called production at risk,” said the second official.
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. The data could also come up for review in the upcoming meeting.
“The next meeting, whenever it happens, will have some important discussions. The approval process has been streamlined and fast-tracked keeping in mind the pandemic scenario,” said the first official cited above.
Meanwhile, also to fast-track quality checks of Covid-19 vaccine batches, the Centre has approved another lab— Hyderabad’s National Institute of Animal Biotechnology— for batch-testing and release of vaccines. Currently, there is a central lab in Kasauli that alone conducts the quality checks.
“The move is aimed to strengthen the vaccine supply chain and boost the largest vaccine drive,” said the Union health ministry in a statement.
ABOUT THE AUTHORRhythma KaulRhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.
