Chhattisgarh Congress leader Ramdayal Uike joins BJP in Amit Shah's presence

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. 

Ayodhya, Jul 27: With days to go for the August 5 "bhoomi pujan" ceremony of the Ram temple in Ayodhya, the mosques adjacent to the demolished Babri Masjid premises are spreading the message of a peaceful coexistence of Hindus and Muslims.

There are eight mosques and two mausoleums located close to the 70-acre Babri Masjid premises mandated by the Supreme Court for a temple of Sri Ram.

Azaan and namaaz are offered in the mosques and the annual "Urs" is held at the mausoleums without any objection from the local Hindus.

The eight mosques located near the upcoming Ram temple premises are Masjid Dorahikuan, Masjid Mali Mandir ke Bagal, Masjid Kaziyana Achchan ke Bagal, Masjid Imambara, Masjid Riyaz ke Bagal, Masjid Badar Paanjitola, Masjid Madaar Shah and Masjid Tehribazar Jogiyon ki.

The two mausoleums are Khanqaahe Muzaffariya and Imambara.

"It is the greatness of Ayodhya that the mosques surrounding the Ram temple are giving a strong message of communal harmony to the rest of the world," Haji Asad Ahmad, the corporator of the Ram Kot ward, said. The Ram temple area is situated in Ahmad's ward.

"Muslims take out the 'juloos' of Barawafaat that goes through the periphery of Ram Janmabhoomi. All religious functions and rituals of Muslims are respected by their fellow citizens," the corporator said.

Asked for a comment on the presence of mosques near the upcoming Ram temple premises, the chief priest of the temple, Acharya Satyendra Das, said, "We had a dispute only with the structure that was connected to the name of (Mughal emperor) Babur. We have never had any issue with the other mosques and mausoleums in Ayodhya. This is a town where Hindus and Muslims live in peace."

"Muslims offer namaaz, we perform our puja. The mosques around us will strengthen Ayodhya's communal harmony and peace will prevail," he added.

Both Hindus and Muslims have accepted the Supreme Court verdict over Ram Janmabhoomi, Das said, adding, "We have no dispute with each other."

Sayyad Akhlaq Ahmad Latifi, the "sajjada nasheen" and "pir" of the 500-year-old Khanqaahe Muzaffariya mausoleum, said Muslims in Ayodhya are performing all religious practices freely.

"We offer prayers five times a day in the mosque at Khanqaah and hold the yearly 'Urs'," he added.

"What a scene would it be -- a grand Ram temple surrounded by small mosques and mausoleums and everyone offering prayers according to their beliefs. That will be representative of the true culture of India," Mahant Yugal Kishore Sharan Shastri, the chief priest of the Sarayu Kunj temple adjacent to the Ram Janmabhoomi premises, said.

Reacting to the presence of mosques and mausoleums near the Ram Janmabhoomi premises, Triloki Nath Pandey, the decree holder of the land as the "first friend of Ram Lalla" as mandated by the Supreme Court, said, "We do not have any objection to either those mosques or any other mosques. We will not trigger a dispute regarding any structure, Ayodhya must live in peace and communal harmony."

Mahant Raju Das, the priest of the Hanumangarhi temple, said, "The presence of the mosques tells the story of Ayodhya's communal harmony. A Ram mandir will be built and there will be no objection to the mosques or religious practices of Muslims."