Serum Institute of India, which is currently conducting Phase 2 and 3 trials of the Oxford COVID-19 vaccine, has sought approval to expand the scope of vaccine trials in India.
The Pune-based vaccine maker has written to the drug regulator to broaden the participant inclusion criteria to now cover older individuals, people with health conditions, those at high risk of Sars-Cov2 infection like household contacts, and those who recovered from COVID-19 infection.
Broadening the inclusion criteria will align the Indian trials of Covishield with that of the ongoing global trials and test the vaccine for high-risk individuals and real-world distribution scenarios.
The Subject Expert Committee responding to the proposal submitted on October 6th recommended approval of the amendments. It said, “After detailed deliberation, the committee recommended for approval of the proposed amendments subject to the condition that the inclusion & exclusion criteria are same as that of AstraZeneca/Oxford Trial with regard to the omission of history of COVID-19 disease in household contacts or history of COVID-19 infection or currently positive for SARS-CoV2 by RT-PCR, as it is bridging study and the same should be submitted to CDSCO.”
COVID-19 vaccines are targeted for high-risk populations, such as older individuals, those with co-morbidities, healthcare workers, or household contacts of COVID positive individuals. Hence, testing the vaccine’s effectiveness in this group of people is crucial.
“There were certain cohorts in the current trial structure which are restricted to people under 60 or 65 years, now there will be no upper age limit. Senior citizens, who are actually high risk and older people with co-morbidities will be included and it makes it a fuller trial,” said a senior medical doctor with expertise in vaccine trials. He didn’t wish to be named.
Besides, testing people for current or past exposure to viruses before administering the vaccine is not possible when the vaccine is rolled out to the general public. “Hence, the vaccine needs to be one that can be administered to any high-risk individual and we know that it will work and is safe,” explained the senior medical doctor quoted above.
According to Serum Institute’s trial protocols published on the Clinical Trials Registry of India, people with a history of laboratory-confirmed COVID-19 disease in household or workplace contact, those who show IgG seropositivity to SARS-CoV-2, those recovered or currently positive for SARS-CoV-2 by RT-PCR test are all currently excluded from the trial.
Serum Institute’s vaccine trials are part of Phase 3 global trials being conducted by the University of Oxford/AstraZeneca in more than 30,000 individuals. Oxford’s trial global trials include adults aged 18 years or over from diverse racial, ethnic, and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.
With the Subject Expert Committee’s recommendations already in, Serum Institute now has to submit the proposal to the drug regulator for the final nod.
There are 42 candidate COVID-19 vaccines in clinical evaluation and nearly 9 experimental vaccines are in late-stage clinical trials globally. Vaccine makers Bharat Biotech and Zydus Cadila are currently testing their indigenously developed vaccines in Phase 1 / 2 clinical trial. – CNBCTV18