The DCGI had on September 11 directed SII to suspend new recruitment in phase two and three clinical trials after AstraZeneca paused the clinical trials because of ''an unexplained illness'' in a participant in the study.
Serum Institute of India (SII) on September 15 received the Drugs Controller General of India (DCGI) nod to resume clinical trial of the Oxford AstraZeneca COVID-19 vaccine candidate in India. The earlier order suspending new recruitment for phase 2 and 3 trial was revoked.
The DCGI had on September 11 directed SII to suspend new recruitment in phase two and three clinical trials of the Oxford COVID-19 vaccine candidate after pharma giant AstraZeneca paused the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study.
AstraZeneca, in a statement on September 8, had said that the COVID-19 vaccine candidate, being developed by AstraZeneca and the University of Oxford, have been put on temporary hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
Frequently Asked Questions
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.
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.
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.
The trials were resumed on September 12 after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe.
However, as per a Reuters report, the vaccine trial remains on hold in the United States pending a US investigation into a serious side effect in Britain.
While allowing SII to resume trials, the DCGI has 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 has 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 the management of adverse events.
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on September 15 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 the order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials 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, news agency PTI reported.
"In view of the above, I Dr VG 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.Click here for Moneycontrol's full coverage of the COVID-19 outbreak