Serum Institute gets DCGI nod to resume clinical trial of Oxford vaccine

DCGI gave permission to Serum Institute to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country

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Coronavirus | Serum Institute of India | Oxford University

Press Trust of India  |  New Delhi 

Serum institute, coronavirus, vaccine, pharma, drugs
Serum Institute of India

Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to 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 (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 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 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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Wed, September 16 2020. 06:49 IST
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Serum Institute gets DCGI nod to resume clinical trial of Oxford vaccine

U.N. Aviation Task Force Eyes Recommendation On COVID-19 Testing By Late October -sources
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U.N. Aviation Task Force Eyes Recommendation On COVID-19 Testing By Late October -sources

U.N. Aviation Task Force Eyes Recommendation On COVID-19 Testing By Late October -sources

A UNled aviation task force aims to make a recommendation by late October on the use of COVID19 testing to reduce long quarantine requirements that have decimated air travel, two sources said, following a meeting of the group on Tuesday.

  • Last Updated: September 16, 2020, 8:15 AM IST

MONTREAL: A UN-led aviation task force aims to make a recommendation by late October on the use of COVID-19 testing to reduce long quarantine requirements that have decimated air travel, two sources said, following a meeting of the group on Tuesday.

Airlines and airports have asked the task force to recommend countries accept a negative polymerase chain reaction (PCR) test from passengers within 48 hours of traveling from countries with high COVID-19 infection rates as an alternative to 14-day quarantines.

The International Civil Aviation Organization-led CART task force plans to make a non-binding recommendation for countries on the use of testing at an October 29 meeting, although such efforts could be delayed, the sources said. It’s not yet clear what recommendation would be made over testing.

Australia, which has some of the world’s strictest COVID-19 travel and quarantine restrictions, has raised concerns over the proposal from airlines, a third source said.

Governments and industry groups are looking at options such as the use of bilateral agreements that would allow travellers to move between countries with similar infection rates without quarantines, or require testing in other cases.

The European Commission, for one, recently proposed a common traffic light system for EU member states to coordinate border controls.

And a plan proposed by the World Travel and Tourism Council (WTTC), to be discussed by G20 leaders in early October, would allow travellers from “low-risk” countries to avoid quarantine altogether with a negative test result, the London Telegraph reported on Tuesday.

Airlines are forecasting a 55% decline in 2020 air traffic, according to airline trade group IATA, which reported 85% of surveyed travelers expressed concerns about quarantine.

An Australia government spokesperson said the country is working on the international aviation response to the pandemic, while “noting different states are dealing with different levels of impact of COVID-19.”

ICAO said it would be premature to comment.

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