By Raju Vernekar
Mumbai, Sept. 23:
As a sequel to the approval given by the Drug Controller General of India (DCGI), the final stage of human clinical trials of COVID-19 vaccine candidate developed by UK’s Oxford University and manufactured by Serum Institute of India (SII), began in Mumbai and Pune on Tuesday.
The trials which had paused when a volunteer in Britain had developed an ‘unexplained illness’ during the trial, began at Sassoon General Hospital in Pune where 150 to 200 individuals are being administered the dose of ‘Covishield’. The phase III trials are also being conducted in Mumbai at KEM and Nair Hospital.
The Phase II clinical trials of the potential COVID-19 vaccine were conducted at Bharti Vidyapeeth Medical College and KEM Hospital in Pune. The SII has partnered with UK-based pharmaceutical company AstraZeneca for the manufacture of the COVID-19 vaccine candidate developed at the Oxford University.
At present, three vaccine candidates are undergoing human trials in India. Indigenous vaccine candidates of Bharat Biotech and Zydus Cadila are testing vaccine efficacy and safety in a phase I and II human trials. SII is undertaking a 1,600-participants’s Phase III clinical trial. The results of the Phase III trial study by SII–AstraZeneca are expected by end 2020. Besides the Russian Direct Investment Fund (RDIF), in tie-up with Indian drug maker Dr Reddy’s Labs, has also applied for DCGI nod to begin Phase III trials for “SputnikV” vaccine in India.
The Central Drugs Standard Control Organisation (CDSCO) has directed that the people with prior COVID-19 infection be included in clinical trials. However those with acute COVID-19 and/or acute infectious disease should not be included. CDSCO guidelines note that this is crucial as pre-vaccination screening for prior infection, may not be feasible in a real world scenario. The volunteers, with history or laboratory evidence of prior COVID-19 infection should not be excluded from COVID-19 vaccine trial” the CDSCO has said in a document.
Besides a COVID-19 vaccine must provide protective immunity in at least 50 percent of the volunteers vaccinated, CDSCO has said has listed various potential primary and secondary goals for vaccine developers to target in human trials, in its 40-page draft of regulatory guidelines. The draft guidelines are on similar lines as the one released by the World Health Organization (WHO) and the USFDA.
The draft read: “To ensure that a COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50 percent. The lower boundary of efficacy required when adjusted for probability of error in efficacy rate and trial size is listed at 30 percent.
Guidelines further ask vaccine developers and trial sponsors to follow-up trial participants for a minimum of one to two years to assess the duration of protection provided by the vaccine. The follow of would also allow assess to potential side effects or vaccine associated with respiratory diseases.
In another development Zydus Cadila Chairman Pankaj R Patel at an event organised in New Delhi by the All India Management Association (AIMA) said that if India has to produce and deliver 130 crore doses to Indian people at one year time, the country would need investment of Rs.3,000 to Rs.5,000 crore to create additional facilities for making a huge number of vaccines. These vaccines are coming from a very difficult platform and the cost of the vaccine is going to be significantly higher, so there is going to be a requirement to think about how are we going to fund this, he said in a panel discussion on ‘Race for COVID Vaccine: More than just a Cure’ at the AIMA event.