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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 said 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 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.

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, randomised 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 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. 

New Delhi, Jul 29: Coronavirus infections in India continue to mount as the country's total case tally crossed the 15-lakh mark.

India added 48,513 fresh cases in 24 hours, taking the total tally to over 15.3 lakh, according to the Health Ministry’s 8 a.m. update on July 29.

Key Figures

Total number of confirmed coronavirus cases: 15,31,669
Active cases: 5,09,447
Cured/discharged/migrated: 9,88,029
Deaths: 34,193
Number of fresh cases in 24 hours: 48,513
One-day recoveries: 35,175
One-day deaths: 768
India’s coronavirus epidemic is growing at the fastest pace in the world, increasing 20% over the last week, according to Bloomberg’s Coronavirus Tracker. Maharashtra, Tamil Nadu, Andhra Pradesh and Karnataka are among the states where the maximum number of daily cares are being reported.

Fresh cases continued to come in at a heightened pace, hovering just below 50,000 for the last six days.

Moderna Inc.’s vaccine candidate against Covid-19 protected against the virus in a trial that inoculated 16 monkeys, an encouraging step on the path to a defense for humans against the pandemic. Pfizer Inc., however, is preparing for the novel coronavirus to endure, leading to long-term demand for a seasonal shot to protect against Covid-19.

“There is a likely scenario that either the vaccine’s immunity will not be lasting forever,” said Chief Executive Officer Albert Bourla in an interview Tuesday, “or that the virus will mutate, or that the virus will find ways to come back again and again.”

Even as the transmission rate of Covid-19 remains high in India, the pace of recovery has risen too. On Wednesday, India reported its third day of over 35,000 recoveries.

Global Update

Flare-ups in virus cases from Hong Kong to Europe are proving difficult for policy makers to wrangle. The U.S. neared 150,000 deaths from Covid-19, even as daily infections slowed in some hard-hit states. China reported 101 new cases, up from 68 a day earlier, with 98 of the total from local infections, mostly in Xinjiang.

Philippine health authorities warned that hospitals and infirmaries risk getting overwhelmed.

Globally, confirmed Covid-19 cases have topped 16.6 million with over 658,000 dead.