Serum Institute of India gets DCGI nod to resume clinical trial of Oxford COVID-19 vaccine
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 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.
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AIITA welcomes Karnataka’s ban on obscene songs in school events
Bhatkal: The Karnataka unit of the All India Ideal Teachers Association (AIITA) has welcomed the Karnataka government’s decision to strictly ban school children from dancing to obscene songs during educational and cultural programmes in government, aided, and private schools across the state.
AIITA Karnataka State President M. R. Manvi congratulated the government for taking what he termed an important step to preserve the sanctity of education.
“Such decisions to safeguard the dignity of school children and uphold the values of education are the need of the hour. This rule should not be limited to government schools alone but must be strictly implemented in all private educational institutions as well,” he said.
He further urged the government to address other concerns within school programmes.
“The government should not only prohibit obscene dances in the name of school anniversaries, but also ensure that plays and dialogues that incite religious hatred are avoided. Schools should be centres of harmony, not platforms for spreading hatred,” he added.
According to a recent circular issued by the Department of School Education and Literacy, obscene dances are adversely affecting the mental health and moral values of students.
In this regard, schools have been advised to use songs that promote nationalism, positive thinking, the greatness of Kannada culture, and value-based traditions instead of inappropriate content during programmes.
The circular also emphasises that students should be dressed in decent attire.
AIITA also backed the department’s warning that disciplinary action would be taken against head teachers if such guidelines are violated. The association has further demanded that district Deputy Directors of Public Instruction strictly monitor the implementation of these rules.
