DCGI nod to Serum Institute of India for phase 2 and 3 human clinical trials of Oxford vaccine candidate


PTI, Aug 3, 2020, 8:39 AM IST

New Delhi: The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed COVID-19 vaccine candidate in the country.

Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr. V G 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 said.

“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 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.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil, and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the 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.

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, randomized controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world’s largest vaccine maker by the number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Terrorist entities shouldn’t get any support from Afghan soil or terror sanctuaries based in region: India

England first team to reach U-19 World Cup semifinals

Actor Shweta Tiwari lands in row for remark on God; MP minister orders probe

PM Modi vows to deepen Indo-French ties, jointly work for peaceful Indo-Pacific

SC protects Maha BJP MLA Nitesh Rane from arrest for 10 days, asks him to surrender & get bail

Rahul’s stand on social media platforms vindicated: Cong after Twitter says it is for healthy debate

Kerala HC adjourns Dileep’s anticipatory bail plea till February 2


Related Articles More

48,905 new COVID-19 cases in Karnataka, 39 deaths

Should handle COVID-19 third wave with ‘total seriousness’: Thaawar Chand Gehlot

WHO: Record weekly COVID cases last week but deaths stable

Each dose of Covishield, Covaxin likely to be capped at Rs 275 after getting regular market approval

Over 21 million new Covid-19 cases reported globally last week, highest number of weekly cases recorded since beginning of pandemic: WHO

MUST WATCH

Things You Should Know about Farming and Agriculture

Rajpath witnesses splendid fly-past of 75 aircrafts

Mysore student led NCC at the Republic Day 2022 Parade held in Delhi

NEWS BULLETIN 26-02-2022

Stunning motorcycle display by BSF all-women biker team at India’s 73 Republic Day parade


Latest Additions

Woman sexually assaulted and paraded through streets of Delhi locality, four held

Terrorist entities shouldn’t get any support from Afghan soil or terror sanctuaries based in region: India

England first team to reach U-19 World Cup semifinals

Actor Shweta Tiwari lands in row for remark on God; MP minister orders probe

Roach returns to West Indies squad for ODIs in India

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.