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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. 

Dubai, Jul 29: Muslim pilgrims on Wednesday begin the annual Haj, downsized this year as the Saudi hosts strive to prevent a coronavirus outbreak during the five-day pilgrimage.

The Haj, one of the five pillars of Islam and a must for able-bodied Muslims at least once in their lifetime, is usually one of the world's largest religious gatherings.

But this year only up to 10,000 people already residing in the Kingdom will participate in the ritual, a tiny fraction of the 2.5 million pilgrims from around the world that attended last year.

"There are no security-related concerns in this pilgrimage, but (downsizing) is to protect pilgrims from the danger of the pandemic," said Khalid bin Qarar Al Harbi, Saudi Arabia's director of public security.

Pilgrims will be required to wear masks and observe social distancing during a series of religious rites that are completed over five days in the holy city of Makkah and its surroundings in western Saudi Arabia.

Those selected to take part in the Haj were subject to temperature checks and placed in quarantine as they began trickling into Makkah at the weekend.

State media showed health workers sanitising their luggage, and some pilgrims reported being given electronic wristbands to allow authorities to monitor their whereabouts.

Workers, clutching brooms and disinfectant, were seen cleaning the area around the Kaaba, the structure at the centre of the Grand Mosque draped in gold-embroidered cloth towards which Muslims around the world pray.

Haj authorities have cordoned off the Holy Kaaba this year, saying pilgrims will not be allowed to touch it, to limit the chances of infection.

They also reported setting up multiple health facilities, mobile clinics and ambulances to cater to the pilgrims.

Saudi authorities said only around 1,000 pilgrims residing in the Kingdom would be permitted for the Haj. Some 70 per cent of the pilgrims are foreigners residing in the Kingdom, while the rest will be Saudi citizens, authorities said.

All worshippers were required to be tested for coronavirus before arriving in the holy city of Makkah and will also have to quarantine after the pilgrimage as the number of cases in the Kingdom nears 270,000.

They were given elaborate amenity kits that include sterilised pebbles for a stoning ritual, disinfectants, masks, a prayer rug and the Ihram, a seamless white garment worn by pilgrims, according to a Haj ministry programme document.

"I did not expect, among millions of Muslims, to be blessed with approval," Emirati pilgrim Abdullah Al Kathiri said in a video released by the Saudi media ministry.

"It is an indescribable feeling... especially since it is my first pilgrimage."

The Haj ministry said non-Saudi residents of the Kingdom from around 160 countries competed in the online selection process but it did not say how many people applied.

Despite the pandemic, many pilgrims consider it safer to participate in this year's ritual without the usual colossal crowds cramming into tiny religious sites, which make it a logistical nightmare and a health hazard.