Upcoming Webinar :Register now for 'ULIP as an investment during economic recovery' powered by Bajaj Allianz
you are here: HomeNewsIndia

DCGI Orders Serum Institute Of India To Suspend Recruitment For Oxford COVID-19 Vaccine Trials

DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.

Sep 12, 2020 / 01:01 PM IST
2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.

In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.

Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial.

Follow our LIVE blog for the latest updates of the novel coronavirus pandemic

The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events."

Close

COVID-19 Vaccine

Frequently Asked Questions

View more
How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

View more
Show

Following which the Pune-based firm,which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate,on Thursday said it is pausing the clinical trials in India.

Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.

"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” SII said in a statement on Thursday.

According to the DCGI’s order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data.

In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn’t pose any safety concerns."

"In the 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, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders,” the order read.

"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report,” the order further stated.

On August 2, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.

AstraZeneca, the biopharmaceutical giant in a tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was "an unexplained illness."

Follow our full coverage of the coronavirus pandemic here.
PTI
first published: Sep 12, 2020 01:01 pm

stay updated

Get Daily News on your Browser
Sections