Drugs Controller General of India (DCGI) V.G. Somani on Tuesday gave a nod to Serum Institute of India (SII) to resume the phase II and III clinical trials of the Oxford Covid-19 vaccine. SII announced the suspension of its ongoing phase II or III clinical trial on September 10, after it had received a notice from DCGI.
However, in the informed consent, the DCGI asked SII to closely monitor the adverse events during the trials, to provide additional details of the events and to take extra care during screening of the volunteers.
The DGCI directed SII to suspend the clinical trials after pharma giant Astra Zeneca had paused its trials in all the countries as a volunteer had developed a “potentially unexplained illness.” The volunteer was enrolled in UK arm and had developed a serious spinal inflammatory syndrome.
The safety data of the clinical trial was sent to an independent committee to ensure that the vaccine did not cause the illness. This is the single incident out of the 10,000 volunteers enrolled in the trials for the Oxford Covid-19 vaccine candidate trial.
AstraZeneca had started its global trials in the end of May. In India, the clinical trial began on August 26. The phase II human trial began with 1,600 volunteers to check the effectiveness of the vaccine in helping develop immune response against the virus. The safety data of the phase II has been reviewed by an independent peer group and confirmed that the vaccine is safe to be tested with large population.
Race for developing vaccines
The Oxford Covid-19 vaccine candidate has been one of the most promising vaccines in the race. There are more than 170 vaccine candidates in the race around the globe. The vaccine candidate by Moderna, a US pharma firm, is also among the frontrunners.
US President Donald Trump has demanded a vaccine for Covid-19 before the US presidential election date to be held in November. Russia’s President Vladimir Putin has announced vaccine Sputnik V and claimed to have been produced no serious problems in the 76 volunteers participated in the trial, including his own daughter. India is also reportedly engaged with Russia in the Sputnik V vaccine.
The vaccine developed by Indian Council of Medical Research (ICMR) and Bharat Biotech jointly, Covaxin, is being tested in 12 institutes across India. ICMR has been pushing Bharat Biotech to launch the Covid-19 vaccine as soon as possible. Earlier, it has put a deadline of August 15. Bharat Biotech will soon start its phase II human trial for its vaccine candidate.
Indian is one of the biggest drug manufacturers and its pharma industry is worth 40 billion dollars.