Oxford Coronavirus vaccine trials in India: Serum Institute of India gets approvals, phase II/III trials to start next week

Even as India battles a heavy spike of COVID+ cases per day, vaccine development and trials are being overseen in an advanced way to meet the need. In some positive news, Serum Institute of India, which has signed a pact to manufacture the Oxford-AstraZeneca Coronavirus vaccine has now won approvals to start critical phase III vaccine trials in India.

The premier vaccine maker, which had been in the limelight of late received approvals by authorities from the Drug Controller General of India (DGCI) late Sunday.

The positive news will make the Pune-based Serum Institute the first such vaccine group start crucial large scale testing in the country. Currently, phase I testing for homegrown vaccines, Covaxin and Zydus backed ZyCOV-D is currently underway, with phase II expected to start in later months.

Ever since Oxford University-AstraZeneca backed vaccine announced positive and safe results from early phase studies, researchers announced plans to outsource phase III trials in countries outside the UK. As part of the plan, phase III trials are undergoing in Brazil, South Africa and expected to start soon in the United States of America. The trials will be spread out in the coming months, with plans of getting observatory data by November.

Serum Institute of India will be testing and marketing the promising vaccine, AZD1222 or ChAdOx 1 nCoV-19, considered to be one of the most "advanced" by the WHO as 'Covishield' in India.

SII had earlier submitted a proposal to start clinical trials in the country with plans to enrol around 4000 to 5000 people in selected trial centres across the country. Early proposals suggested that the trials will be held in Mumbai and Pune. However, the Department of Biotechnology (DBT) asked them to rework guidelines, with hopes of trials happening pan India. At least 12 research centres and medical facilities are being prepped for the same.

Before the trials start, SII will have to submit safety data and other pre-requisite information needed for clinical monitoring and evaluation, an official from DGCI said in a statement.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to Phase 3 clinical trials."

The private vaccine maker, which is one of the largest vaccine and drug maker globally will be conducted randomized blind controlled trials in centres to test the safety and immunogenicity response of the vaccine.

According to revised proposals, SII will recruit 1,600 people above 18 years of age will participate in early trials, which will now be spread across 17 sites, which will include centres like All India Institute of Medical Sciences, Delhi, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, and JSS Academy of Higher Education and Research in Mysore.

The trials will be done to check whether the vaccine jab delivers good and safe immune response. For the same, each participant will be administered two doses, with a four-week gap between the two jabs. Post injected, safety and immunogenicity observations will be done at defined intervals.

Serum Institute has already promised to deliver upwards of 300 million doses before the year ends and accelerate production in the coming months to deliver doses. The vaccine company has also said that not only will a large percentage of the doses be reserved to immunize the country but the vaccine will be priced economically (Rs.1000 or lower) too.

In a separate announcement, SII, which has partnered with many other vaccine developers globally such as Novavax and Codagenix also announced plans to start work on their own COVID-19 vaccine, with steady development expected to happen next year. In aninterview with MumbaiMirror, CEO Poonawallah said:

"Each of the vaccine candidates are proceeding at their own pace. We must be mindful in ensuring that all requisite trials and procedures are conducted meticulously and appropriately. We have five candidates so far, including two of our own. We hope to announce the availability of our own vaccines by the end of 2021."