The Drugs Controller General of India (DCGI) has given the Serum Institute of India (SII) permission to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in the country.

The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19.

“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,” a senior official told PTI.

“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, ‘Covishield’, on healthy adults in India, the officials said.

The committee, which met on July 28 to deliberate on SII’s application, had asked Serum Institute to revise its protocol for phase 2 and 3 clinical trials, besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

The SII had then submitted a revised proposal the next day.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said.

Meanwhile, five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca COVID-19 vaccine, Secretary of Department of Biotechnology (DBT) Renu Swarup had said last Monday.

The Serum Institute of India (SII), the largest vaccine maker in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier this month.

July 20 marked an important day in the battle against Coronavirus as the first results of Oxford’s COVID-19 vaccine showed that it is safe and provokes an immune reaction in a person that lasts for almost two months.

The researchers have indicated that the vaccine may be ready by year end. The results showed that more than 91 per cent of volunteers injected produced an immune response against coronavirus which lasted for a month or more. The immune responses remained strong for at least 56 days.

Oxford University’s vaccine, called AZD1222, is being manufactured by pharmaceutical major AstraZeneca and the UK government has ordered 100 million doses ahead of time.

As per the results, the vaccine boosted T cell and antibody immunity. The vaccine produced strong responses on both accounts, the study found, with T cell immunity peaking after two weeks and then dropping slightly by day 56.

Antibody immunity, on the other hand, peaked after four weeks and remained high by day 56, indicating that it may well last for even longer.

The vaccine AZD1222 had a favourable response in the first phase of clinical trials. It did not prompt any serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal.

During the study, participants who received the vaccine had detectable neutralising antibodies, which have been suggested by researchers as important for protection.

These responses were strongest after a booster dose, with 100 per cent of the participants’ blood having neutralising activity against the coronavirus, showed the results.

The University of Oxford is working with the UK-based global biopharmaceutical company AstraZeneca for further development, large-scale manufacture and potential distribution of the COVID-19 vaccine, with plans for clinical development and production of the Oxford vaccine progressing globally.

Oxford and AstraZeneca are collaborating with clinical partners around the world as part of a global clinical programme to trial the Oxford vaccine.

Currently, the Oxford-AstraZeneca vaccine candidate (called AZD1222) is in the midst of phase 2 and 3 clinical trials in the United Kingdom, phase 3 trials in Brazil, and phase 1 and 2 clinical trials in South Africa.

(With agency inputs)