After setback, Serum allowed to resume Oxford's coronavirus vaccine trial
What's the story
Drugs Controller General of India (DCGI) Dr. VG Somani has permitted the Serum Institute of India (SII) to resume trial of the coronavirus vaccine candidate, being developed by the University of Oxford, revoking the last week's order that halted the process.
The Pune-based firm was, however, directed to take extra precautions.
Effectively, the order directing SII to stop recruitment of candidates was also withdrawn.
Series of events
SII approached DCGI seeking permission, regulator accepted request
DCGI's Tuesday permission came after SII furnished recommendations of the Data Safety Monitoring Board in the UK and India, as demanded by the regulator earlier, and sought approval for re-starting recruitment for the phase 2 and phase 3 trials.
Dr. Somani in its reply to SII said the letter was "carefully examined." While giving the requisite permission, DCGI asked SII to submit medication details.
Letter
Resume trial, but follow conditions: DCGI to SII
In the order, DCGI told SII it can recommence the trial dated August 2, 2020, according to the already approved protocol and under the provisions of New Drugs and Clinical Trials Rules, 2019.
The regulator also asked SII to scrupulously follow conditions "such as extra care during screening, additional information in the informed consent, and close monitoring for similar events during the study follow-up."
Looking back
Within a week, AstraZeneca paused and resumed late-stage vaccine trial
This order comes close to heels of a similar directive in the United Kingdom, which allowed pharma-giant AstraZeneca to resume the late-stage trial.
The UK-based company suspended tests last week after a woman developed an "adverse reaction" to the AZD1222 vaccine, which has given a coronavirus-battered globe much-needed hope.
AstraZeneca, which is developing the vaccine with Oxford, assured that it won't compromise on safety.
Vaccine
The vaccine was found to be effective in earlier stages
The potential vaccine consists of the replication-deficient chimpanzee viral vector (ChAdOx1) based on a weakened version of a common cold virus (adenovirus) containing the genetic material of the SARS-CoV-2 virus spike protein.
In the early-stage examination, it was found that the vaccine provides double-protection against the highly-contagious disease, by generating neutralizing antibodies against SARS-CoV-2 and also producing sufficient levels of virus-attacking T-cells.
Details
SII has signed a deal to mass produce the vaccine
As Oxford's vaccine candidate reflected promising results, several companies, like SII, signed deals for mass production of doses.
Adar Poonawalla, who is at the helm of SII, had earlier said the vaccine would be available in India by the 2021's first quarter.
However, recently, he said that in the absence of a system to safely transport vaccines to 1.4 billion people, India might suffer.
Quote
Don't see a plan to distribute vaccines in India: Poonawalla
"I still don't see a proper plan to do that (distribute vaccine) beyond 400 million doses. You don't want a situation with the vaccine where you have the capacity for your country but you can't consume it," he said in an interview with Financial Times.