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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 28: Chief Minister Ashok Gehlot had "unconstitutionally" merged six MLAs of the Bahujan Samaj Party (BSP) with the Congress in Rajasthan, he did the same in his earlier tenure too, for which we wanted to teach him and his party a lesson, said BSP chief Mayawati on Tuesday.

The BSP chief added that her party could have gone to courts earlier but decided to wait for the "right opportunity".

"In Rajasthan, after elections results, BSP gave unconditional support of all its 6 MLAs to Congress. Unfortunately, Chief Minister Ashok Gehlot, out of his malicious intent and to damage BSP, merged them with Congress unconstitutionally. He did the same even during his earlier tenure," Mayawati said here.

"BSP could have gone to the court earlier too but we were looking for the time to teach Congress party and CM Ashok Gehlot a lesson. Now we have decided to go to the Court. We will not let this matter alone. We will go even to the Supreme Court," she added.

The BSP chief further reiterated that the party has asked the six MLAs to vote against the Congress government led by Ashok Gehlot if a trust vote takes place on the floor of the Rajasthan Assembly, failing which "their party membership will be cancelled".
She further said that the merger of BSP MLAs with Congress was immoral and went against the mandate given by voters in Rajasthan.
"Ulta-chor kotwal ko daante (the thief accuses the cop of wrongs) they (Congress) themselves indulge in wrongdoing and then accuse us," she further said.
On Sunday, the BSP issued a whip to six MLAs, asking them to vote against Congress in case of a no-confidence motion or any proceedings to be held during the Rajasthan Assembly session.

National General Secretary of BSP Satish Chandra Mishra, while speaking to news agecncy said, "Notices have been issued to the six MLAs separately as well as collectively, pointing out that since BSP is a National Party, there cannot be any merger at the state level at the instance of six MLAs unless there is a merger of BSP at the national level. If they violate it, they will be disqualified.

Notices have been issued to all six MLAs- - R Gudha, Lakhan Singh, Deep Chand, JS Awana, Sandeep Kumar and Wajib Ali, who are elected to the Rajasthan Assembly."
However, later on Monday, Lakhan Singh, hit back saying he and the five others had already joined the Congress.

"We six MLAs have already joined the Congress. BSP remembered us after nine months. They have issued this whip, after a message from the BJP. On this basis they are going to court", said Karauli MLA Lakhan Singh.

Rajasthan government is in turmoil after simmering differences between Deputy Chief Minister Sachin Pilot and Gehlot came out in the open. Pilot was removed as the Deputy Chief Minister and the state unit chief of Congress.

The Congress has accused the BJP of indulging in horse-trading to bring down the Gehlot government. The BJP has rejected the allegations.