NEW DELHI: India may also consider rolling reviews for Covid-19 vaccine, particularly the Oxford-AstraZeneca developed candidate which is already under accelerated review of the UK health regulator, to further fast-track the approval of the shots in the current pandemic situation.
A rolling review will enable the regulator to examine the data generated through clinical trials on a real-time basis instead of waiting for the trial to be over and full data to be available for evaluation at once. While the option of emergency authorisation is open, the rolling review can speed this up as the regulator may not need to wait till the end of the Phase 3 trials and data collated thereafter.
“We are watching the global developments closely. Serum is doing only immunogenicity trials in India. They will have to submit the Phase 3 clinical trial data generated in UK and Brazil to us for review. We are aware that UK is now conducting accelerated review. We too can consider the same if the company makes an application for the same,” a senior official working with the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) said.
Serum Institute is conducting immunogenicity trials in India primarily to check the presence of antibodies and their duration. These trials are also conducted on relatively smaller size of people. AstraZeneca – which has developed the candidate along with Oxford University – is doing Phase 3 trials in UK and Brazil to check safety and efficacy of the vaccine. The data generated from these studies will also be shared with the Indian regulator to seek approval.
Now, that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is conducting a rolling review for the potential vaccine, it is possible that the company may seek the same process in India.
“This approach will help speed up evaluation of the vaccine candidate and the approval process,” a regulatory official said.
Serum Institute CEO Adar Poonawalla had recently said that the vaccine is showing some preliminary good results in terms of immunogenicity responses. However, the authorities are more keen on knowing how the vaccine is progressing in Phase 3 trials being conducted outside India.

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