ChAdOx1 nCoV-19 vaccine gets DCGI nod for testing in India

Serum Institute of India (SII), the Indian pharmaceutical company, has received permission to carry out Phase II and III trials of the potential COVID-19 vaccine called Covishield (ChAdOx1 nCoV-19), being co-developed by the University of Oxford and British pharmaceutical company AstraZeneca.

The Drugs Controller General of India (DCGI) on Monday gave the approval to SII to conduct the large-scale trials in the country. SII is considered to be the world’s largest vaccine manufacturer and had entered into an agreement with AstraZeneca to produce the vaccine against COVID-19 in India.

The ChAdOx1 nCoV-19 vaccine uses a vector virus as a carrier to send a tiny portion of the nucleic acid of the SARS-CoV-2 virus into the body that allows the body's immune response to kick in and prevent COVID-19 from infecting it.

The first two phases of the trials induced the hypothesised immune response in the sample selected for the trials, the findings of which were published in the scientific journal Lancet last month. After the initial success of Phase I and II clinical trials on humans, the company had announced to conduct the advanced stages of their trials in India.

However, the DCGI had initial objections to some of the technical aspects of the trial, which had held up the process for some time. However, the DCGI’s approval at this stage signals the beginning of what would be a highly anticipated research study to be conducted in the country.

In fact, an expert committee of the Central Drugs Standard Control Organization (CDSCO) under DCGI, had asked SII to resubmit the proposal related to the trial along with relevant information. Last week, the company had submitted this revised proposal to the CDSCO panel, after which it has been approved for trial.

The Pune-based SII has now become another contender in the race for the first vaccine to be developed in the country, with other Indian pharmaceutical majors such as Bharat Biotech with their Covaxin and Zydus Cadila’s ZyCoV-D already in the running. However, the other two vaccines are currently in Phase I and II of clinical trials.

According to media reports, about 18 locations across the country have been identified for the trials of Covishield, which will include about 1,600 people, making it a sizable survey. However, the dates on which the clinical trials will take place are not known, although the company’s CEO Adar Poonawala indicates that the trials would be conducted in the month of August.

The race for the first COVID-19 vaccine has been on for a major part of the year ever since the outbreak of the disease was labelled a global pandemic by the World Health Organization in March 2020.

In the eight months since COVID-19 was first discovered in Wuhan, China, more than 18 million people have been infected by the new coronavirus infection while close to 700,000 people have lost their lives to this respiratory disease.