NEW DELHI: India may also consider continued reviews for the Covid-19 vaccine, particularly the Oxford-AstraZeneca-developed candidate that is already under accelerated review by the UK health regulator, to further accelerate the approval of vaccines in the current pandemic situation.
An ongoing review will allow the regulator to examine the data generated through clinical trials in real time rather than waiting for the trial to end and the full data to be immediately available for evaluation. While the emergency authorization option is open, ongoing review can speed this up, as the regulator may not have to wait until the end of Phase 3 testing and data collected thereafter.
“We are closely following global developments. The serum is only undergoing immunogenicity testing in India. They will need to send us the Phase 3 clinical trial data generated in the UK and Brazil for review. We are aware that the UK is undergoing an expedited review. We can also consider the same if the company submits an application for it, ”said a senior official who works with the National Group of Experts on Vaccine Administration for Covid-19 (NEGVAC).
Serum Institute is conducting immunogenicity tests in India mainly to check the presence of antibodies and their duration. These trials are also carried out in relatively small people. AstraZeneca, which has developed the candidate in conjunction with the University of Oxford, is conducting phase 3 trials in the UK and Brazil to verify the safety and efficacy of the vaccine. The data generated from these studies will also be shared with the Indian regulator for approval.
Now that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) is conducting an ongoing review of the potential vaccine, the company may seek the same process in India.
“This approach will help speed up the candidate vaccine evaluation and approval process,” said a regulatory official.
The executive director of the Serum Institute, Adar Poonawalla, had recently said that the vaccine is showing some good preliminary results in terms of immunogenicity responses. However, authorities are more interested in how the vaccine is progressing in phase 3 trials taking place outside of India.
An ongoing review will allow the regulator to examine the data generated through clinical trials in real time rather than waiting for the trial to end and the full data to be immediately available for evaluation. While the emergency authorization option is open, ongoing review can speed this up, as the regulator may not have to wait until the end of Phase 3 testing and data collected thereafter.
“We are closely following global developments. The serum is only undergoing immunogenicity testing in India. They will need to send us the Phase 3 clinical trial data generated in the UK and Brazil for review. We are aware that the UK is undergoing an expedited review. We can also consider the same if the company submits an application for it, ”said a senior official who works with the National Group of Experts on Vaccine Administration for Covid-19 (NEGVAC).
Serum Institute is conducting immunogenicity tests in India mainly to check the presence of antibodies and their duration. These trials are also carried out in relatively small people. AstraZeneca, which has developed the candidate in conjunction with the University of Oxford, is conducting phase 3 trials in the UK and Brazil to verify the safety and efficacy of the vaccine. The data generated from these studies will also be shared with the Indian regulator for approval.
Now that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) is conducting an ongoing review of the potential vaccine, the company may seek the same process in India.
“This approach will help speed up the candidate vaccine evaluation and approval process,” said a regulatory official.
The executive director of the Serum Institute, Adar Poonawalla, had recently said that the vaccine is showing some good preliminary results in terms of immunogenicity responses. However, authorities are more interested in how the vaccine is progressing in phase 3 trials taking place outside of India.
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