NEW DELHI: Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.
The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).
SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events.
The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford Covid-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ”an unexplained illness” in a participant in the study.
On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for Covid-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.
According to Tuesday’s order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions.
DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions.
According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.
The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.
“In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019.
“You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned,” the order said.
Govt will need 80,000 crore for Covid vaccine, says Serum CEO
MUMBAI: The government may need Rs 80,000 crore over the next one year for distribution of Covid-19 vaccine and immunization of the country’s population, Adar Poonawalla, CEO and promoter of the world’s largest vaccine producer, Serum Institute, said on Saturday.
Calling it the “next concerning challenge”, which needs to be tackled, Poonawalla posted a tweet tagging the Prime Minister’s Office, which read: “We need to plan and guide vaccine manufacturers both in India and overseas to service the needs of our country in terms of procurement and distribution.”
Serum has tie ups with global manufacturers AstraZeneca and Novavax for potential Covid-19 vaccines, which are currently undergoing clinical trials. The tweet, perceived by many as alarming, also raised concerns over the government’s ability to fund the massive vaccine programme.
“The government has assured that there will be plenty of funds available for vaccines. We have now been assured by the highest levels in the government that enough funds will be available for vaccine procurement, supply and logistics. This is good news,” Poonawalla told TOI, when contacted.
While addressing the United Nations General Assembly on Saturday PM Modi said that as the world’s largest vaccine producing country, India’s vaccine production and delivery capacity will be used to help people across the world.
Although further details on Poonawala’s calculations were not immediately available, sources said, it could be assuming the benchmark price of $3-5 per dose, and including two doses for the over 1.3 billion population.
Congress may rope in Prashant Kishor for 2022 Punjab election
NEW DELHI: Pollster Prashant Kishor may get to manage Congress in the Punjab elections scheduled for early 2022. Party sources said CM Amarinder Singh is in talks with the former JD(U) member and election strategist, and a decision may be announced soon.
While Kishor is likely to get the contract for advance poll planning in the state, Congress members said he could even get an official perch to manage the affairs. Kishor had widely been credited with helping Congress ride back to power in the state in 2017. A senior AICC manager said the talks are being held by the chief minister and that the party is not involved in the negotiations.
While speculations about Kishor coming on board the Congress campaign in Punjab have been on for a while, it is only now it appears to be reaching a finality. Having been expelled from JD(U) following a scrap with Bihar CM Nitish Kumar, Kishor is said to be on the lookout for a new political platform – a reason why there are also speculations that he is looking for an entry in Congress.
Well-placed sources in Congress said Kishor has a direct line with the Gandhi siblings, a reason why not many are willing to hazard a guess about the pollster. There is some confusion in Congress ranks about Kishor.
Sources said a possible reason for CM Singh to get Kishor on board in Punjab would be to ensure that he does not work for Arvind Kejriwal’s AAP, which is set to make a strong pitch in the state in the next polls.
India slams Pakistan PM at UNGA for terror export
NEW DELHI: After Pakistan PM Imran Khan again raised the Kashmir issue at UNGA, India slammed Pakistan saying terrorism was its only crowning glory. Exercising its Right of Reply, the Indian mission also accused Khan of warmongering and of using the multilateral forum to spread lies, misinformation and malice.
“This august forum witnessed a new low on its 75th anniversary. The leader of Pakistan today called for those who incite hate and violence to be outlawed. But as he went on, we were left wondering, was he referring to himself?” said Mijito Vinito, the first secretary in the permanent mission of India to the UN, Mijito Vinito, exercising India’s Right of Reply.
The only crowning glory, he said, that this country has to show to the world for the last 70 years is terrorism, ethnic cleansing, majoritarian fundamentalism and clandestine nuclear trade. “This hall heard the incessant rant of someone who had nothing to show for himself, who had no achievements to speak of and no reasonable suggestion to offer to the world. Instead, we saw lies, misinformation, war mongering and malice spread through this Assembly,” he added.
Pakistan later exercised its right of reply too, in which it claimed that Jammu & Kashmir was never a part of India. Alluding to the “stellar record” of Pakistan, Vinito said this is the country that has the “dubious distinction” of hosting the largest number of terrorists proscribed by the United Nations, a reference to terror masterminds such as Lashkar-e-Taiba (LeT) founder Hafiz Saeed and Jaish-e-Mohammed (JeM) head Masood Azhar.
“This is the same country that provides pensions for dreaded and listed terrorists out of state funds. The leader whom we heard today is the same person who referred to terrorist Osama Bin Laden as a ‘martyr’ in the Pakistani Parliament in July,” Vinito said.
He added that it is Pakistan that brought genocide to south Asia 39 years ago when it killed its own people and it is also the country that is “shameless enough” not to offer a sincere apology for the horrors it perpetratedeven after so many years. India asserted in its Right of Reply that Khan, “who spewed venom today”, admitted in 2019 in public in the US that his country still has about 30,000-40,000 terrorists, who have been trained by Pakistan and have fought in Afghanistan and in the Indian Union Territory of Jammu and Kashmir.
“This is the country that has systematically cleansed its minorities , including Hindus, Christians, Sikhs and others, through the abuse of its blasphemy laws and through forced religious conversions,” Vinito said.
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