Oxford vaccine: DCGI orders Serum Institute of India to suspend recruitment for trials – India’s Comptroller General of Drugs (DCGI) ordered that there be no new recruitment for phase 2 trials and phase 3 of the Covishield Candidate vaccine from the University of Oxford which is manufactured in India by the Serum Institute of India (SII), in collaboration with the leading pharmaceutical company AstraZeneca.
- The IBS was also asked to increase the safety monitoring of subjects already vaccinated as part of the trial and to present the plan and report.
- The latest order comes after he asked IBS to stop testing the candidate vaccine after a UK volunteer showed potentially unwanted symptoms.
- In its order, DCGI V.G. Somani also ordered the SII on Friday to submit clearance to the UK Security and Data Monitoring Board and obtain clearance from its office before resuming recruitment during the trial.
- Prior to stopping IBS’s trials in India, DCGI issued a demonstrable notice to the company on September 9 for failing to notify it that AstraZeneca was suspending clinical trials of the vaccine candidate in other countries.
Meanwhile, University of Oxford and AstraZeneca resume trial
University of Oxford, in a statement, today said it is resuming trials of its coronavirus vaccine at all sites in UK clinical trials. However, he did not specify when the trials would resume.
“Around the world, approximately 18,000 people received study vaccines as part of the trial. In large trials like this, some participants are expected to feel unwell and each case should be carefully assessed to ensure a careful safety assessment, ”the statement said.
- The statement added that its “standard review process has caused a study break” in all global trials to allow review of safety data by an independent safety review board.
- “The independent review process has ended and, following recommendations from the independent safety review board and UK regulator, the Medicines and Healthcare Products Regulatory Agency, MHRA, trials will resume in the UK”.
- Pharmaceutical giant AstraZeneca also said in a separate statement on Saturday that it had resumed vaccine trials after getting the green light from UK regulators.
- It may be recalled that he announced on Wednesday that he had “voluntarily stopped” his trial of the vaccine, developed in collaboration with the University of Oxford, after a volunteer developed an unexplained illness.
- “Clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK after confirmation by the Medicines Health Regulatory Authority (MHRA) that it is safe to do so,” the company said in a release.
Sitaram Yechury, Yogendra Yadav, Jayati Ghosh, Apoorvanand and Rahul Roy appointed co-conspirators in Delhi riots case: Delhi police appointed CPI (M) Secretary General Sitaram Yechury, Swaraj Abhiyan leader, Yogendra Yadav, economist Jayati Ghosh, professor and activist Apoorvanand at the University of Delhi and documentary filmmaker Rahul Roy as co-conspirators of the February riots in Delhi, PTI reported.
- The names were on an additional charge sheet filed by the police. They were charged on the basis of confessions obtained from two members of the Pinjra Tod women’s collective, Devangana Kalita and Natasha Narwal, and Gulfisha Fathima, a student of Jamia Milia Islamia.
- The indictment says that apart from Yechury and Yogendra Yadav, Fathima’s statement mentions Bhim’s army chief Chandrasekhar, United Against Hate activist Umar Khalid, and some leaders of the Muslim community , including former- MLA Mateen Ahmed and MLA Amannatullah Khan.
PLA delivers five young people from Arunachal to India
- The Chinese People’s Liberation Army (PLA) on Saturday handed over to the Indian army the five young people from Arunachal Pradesh who had been lost in Chinese territory.
- They were handed over to the Indian Army more than 800 km east of where they had deviated beyond the McMahon Line that separates the two countries.
- The five will be handed over to their families in the Nacho area of Upper Subansiri district after spending 14 days in quarantine under the Covid-19 protocol, military officials said.
- “Our staff welcomed the five young people to Kibithu after completing all the formalities. They will be quarantined for the specified period, ”said Lt. Col. P. Khongsai, defense spokesman.
- The five teenagers had gone hunting in Tungdara or on Sera-7 Mountain near the McMahon Line. They were lost on the Chinese side on September 2 and were reportedly captured by the PLA.
- The Indian army contacted the PLA on the hotline to locate and return them. Army officials said the PLA responded on September 8 to confirm the missing people had been found. Relatives of the youths, mostly teenagers, said some of the children worked as porters for the military throughout BAC.
- “Now that they’re back home, it doesn’t matter how they got to the other side. We are grateful to the Indian military for helping to bring them back, but the government should focus on the development of our backward region so that people do not have to risk their lives for their livelihoods, ”said Prakash Ringling, the brother of Prasad Ringking, one of the missing boys.
Delhi Assembly panel summons Facebook India chief Ajit Mohan – The Delhi Assembly Commission on Peace and Harmony under President Raghav Chadha summoned Facebook India’s vice president and general manager on Tuesday Ajit Mohan to record your statement to the commission.
On August 31, the committee said that at first glance it appeared that Facebook had played a role in the riots in Delhi earlier this year and that Facebook officials in India would receive appearance notices at the next committee meeting. The committee is examining Facebook’s alleged “deliberate and intentional” inaction to include “hateful content.”
“The committee, chaired by the Honorable Sh. Raghav Chadha calls on you, the recipient, as a witness to testify under oath and help provide the relevant information and explanations to speed up the smooth running of the process. determination of the veracity of the allegations made against Facebook in the complaints and statements made before the committee, ”the statement dated September 10.
- It will be recalled that the opposition, in particular the Congress, demanded an investigation by the Joint Parliamentary Commission (JPC) into the alleged collusion between Facebook India and the BJP.
- The number of coronavirus cases reported in India stood at 47,43,472 at the time of this report, with a death toll of 78,571. Civil rights lawyer Prashant Bhushan has asked the Supreme Court for a declaration confirming the right of appeal of a person found guilty of contempt. Bhushan was recently punished for contempt of court with a nominal fine of 1 rupee. He was found guilty of scandalizing the Supreme Court with his tweets.