Oxford COVID-19 vaccine trials to begin in India: Coronavirus vaccines in final phase of testing

Times Now

03rd August, 2020 12:33 IST

New Delhi: The outbreak of the novel coronavirus (SARS-CoV-2) has triggered an international effort to develop a safe and effective vaccine against COVID-19, perhaps at breakneck speed. Several experimental vaccines have shown promising results in early trials, rising hopes that one will exist before the end of the year. According to the World Health Organization (WHO), at least 26 vaccines are in clinical evaluation with six of them in late-stage, phase 3 trials.

As of July 31, WHO’s draft landscape of COVID-19 vaccines shows that some 139 candidate vaccines are in preclinical evaluation. Worldwide, at least 685,780 people have now lost their lives to the deadly virus, whereas as many as 17,896,220 cases have been confirmed in 196 countries and territories. As coronavirus continues to spread, researchers are working around the clock using different methods to find a safe jab against COVID-19. A number of large-scale studies are underway to assess the safety and efficacy of some of the most advanced vaccine candidates, including the Oxford/Astra Zeneca COVID-19 vaccine, Moderna mRNA vaccine, and Pfizer-BioNTech candidate, etc. Meanwhile, reports claimed that Russia is preparing a mass vaccination against CVOID-19 for October. However, the country is yet to release scientific data on its vaccine trials.

Serum Institute gets nod for Oxford COVID-19 vaccine trial

The Drugs Controller General of India (DCGI) has given a go-ahead to the Serum Institute of India (SII) to conduct phase 2/3 clinical trials of the vaccine developed by the Oxford University in India after a thorough evaluation and based on the recommendations of the Subject Expert Committee (SEC). ChAdOx1 nCoV-19, which is being manufactured by SII in India under technical collaboration with Oxford University/Astra Zeneca, is called as Covishield. Last week, news agency ANI reported that the vaccine maker had sought the drug regulator’s permission for conducting phase 2/3 trials in India.

Oxford researchers have found that there were no safety concerns, and the vaccine produced strong immune responses in early human trials. The vaccine is currently undergoing phase 2/3 trials in the UK, phase 3 trials in Brazil, and phase 1/2 trials in South Africa. Should the vaccine prove effective in phase 3 trials, AstraZeneca said it has the capacity to produce 2 billion doses of the jab.

COVID-19 vaccine candidates in phase 3 trials: What we know so far

Apart from Oxford’s ChAdOx1-S, five other candidates developed by Moderna/NIAID, BioNTech/Fosun Pharma/Pfizer, Beijing Institute of Biological Products/Sinopharm, Wuhan Institute of Biological, Products/Sinopharm, Sinovac have already moved into the phase 3 trials, which will evaluate safety and efficacy before being approved for use.

Moderna and Pfizer are aiming to launch their coronavirus vaccines by the end of 2020 as the companies launched large-scale phase 3 trials last week. Both the trials backed by the US government will recruit up to 30,000 volunteers in separate studies across multiple sites in the US.

As part of the global clinical programme to trial ChAdOx1-S, Oxford and AstraZeneca are working with clinical partners around the world. As per a release by the University of Oxford, the global programme is made up of a phase 3 trial in the enrolling 30,000 patients, a paediatric study, as well as phase 3 studies in low-to-middle income countries including Brazil and South Africa which are already underway.

In the next few months, equally large human trials are expected to begin, where researchers will test vaccines made by Johnson & Johnson and Novavax. Some vaccines made in China are in smaller late-stage studies in other countries.

In India, two indigenously developed vaccines against coronavirus are in phase 1 and 2 clinical trials.

In an unprecedented move, China’s military approved a COVID-19 vaccine on June 25 for use within its rank for a year. The vaccine based on an adenovirus called Ad5 was developed by the military’s research unit and a biotech firm. CanSino Biologics had said that data from clinical trials showed that the vaccine had a ‘good safety profile’ and potential to prevent COVID-19.