According to WHO’s vaccine update, there are 176 potential COVID-19 vaccines in work across the world. Out of these, only 35 are under clinical evaluation. Here’s all about COVID-19 vaccine Phase 3 in a dilemma around the globe.
Phase 3 Dilemma
On September 6, the clinical trials for the most advanced vaccine, AstraZeneca-Oxford’s vaccine candidate — ChAdOx1 was put on hold. However, the phase three trials have recommenced in Brazil and UK but will remain suspended in the US for several days. Besides, another potential coronavirus vaccine manufactured by American pharma giant Pfizer is in Phase III trials and has mentioned the prospects of launching the immunisation by the year-end. Moreover, the US government has already placed an order for 100 million doses for $1.95 billion.
That apart, several Chinese pharmaceuticals including Sinpharm, Sinovac Biotech, and Beijing Institute of technology have vaccine under Phase III clinical trials. Besides, Russia’s Sputnik Vin is also in Phase III trials. It is testing the vaccine on over 40,000 people in collaboration with the Gamaleya Research Institute — a part of Russia’s Health Ministry.
What Went Wrong in AstraZeneca?
The firm began recruiting 30,000 volunteers for Phase-3 trials in the United States. Also, SII had started conducting trials on 1600 volunteers for the same as it had been contracted for. However, a recipient in the UK developed inflammation of the spinal cord which had put trials on halt.
Vaccine Progress in India
Indian Council of Medical Research (ICMR) announced three vaccine candidates in India that are in the clinical stage of trials, and one of them will soon undergo the phase 3 trial. Balram Bhargava, ICMR’s director-general asserted that Cadila Healthcare and Bharat Biotech had completed the first phase of the trial. Also, Serum Institute of India (SII), Pune, is waiting for a nod to start Phase-3 trials on 1,500 volunteers across 14 locations. The institute had to pause the procedure over the safety concerns. Now, the Drugs Controller General of India gave the nod for resuming the trials. ICMR-National Institute for Research in Tuberculosis, Chennai is leading the Phase 2/3 studies initiated by ICMR.
Dr. Reddy’s Labs to Conduct Phase-III Trials for Sputnik V
India had decided to conduct Phase III trials for Russia’s Sputnik V. Hyderabad-headquartered drugmaker Dr Reddy’s Laboratories will begin distribution of 100 million doses for “mass vaccination” after obtaining clearance from authorities. DRL Co-Chairman and MD GV Prasad said that the vaccine could prove credible as Phase 1 and 2 trials have shown promising results.
In all, several vaccine developers are optimistic about positive results and are developing vaccines on accelerated timelines. However, these trials involving tests at multiples locations with thousands of volunteers and hence will take time.