Needle of Doubt: Death of a COVID19 vaccine trial volunteer in Bhopal raises questions on the vaccine approval

Bharat Biotech has not made public the results of final trials of Covaxin, but the Drug Controller General of India has approved the vaccine. Meanwhile, several volunteers allege they were “kept in the dark”

Kushal Mishra
| Updated: January 11th, 2021

Photo: Bharat Biotech

Two vaccines, Covishield, of the Serum Institute of India, and Covaxin of Bharat Biotech have been officially approved by the Drug Controller General of India (DCGI)  for immunisation against the COVID-19 pandemic. 

However, with reports of the death of a 42-year-old man in Bhopal who had volunteered for the clinical trials of the Covaxin from Bharat Biotech, some uncomfortable questions are being raised about the efficacy and the safety of the vaccines. The volunteer had taken part in a Covaxin clinical trial on December 12, 2020.  

This is a matter of some concern as Covaxin from Bharat Biotech got the approval of the DCGI even before it completed the third phase of trials (it declared enrolling over 25,000 volunteers for phase 3 trials on January 7). Detractors demand to know how a vaccine can be approved when it is still in trial, and with the news of the unfortunate volunteer, the voices are getting louder. 

When Covaxin received the official approval, several opposition leaders such as Shashi Tharoor and Jairam Ramesh sought clarifications from the union health minister Harsh Vardhan about the vaccine trials and the approval. 

Meanwhile, there were words exchanged between the two vaccine companies as well.  

Adar Poonawala, the CEO of Serum Institute of India had said in a statement to a TV channel that at the moment, there are three vaccines in the world namely Pfizer, Moderna and Covishield which have proved their efficacy 70, 80 and 90 per cent respectively. Poonawala, in his statement, described the other vaccines enigmatically as ‘safe as water’. Thereafter, Krishna Ella, managing director of Bharat Biotech defended Covaxin at a press conference and presented a number of arguments in its support.  

However, a day later, a joint statement was released by both the companies stating that they fully understood the importance of the vaccine, and have resolved to make the COVID-19 vaccine available globally.  

How safe is the vaccine?  

The results of the third phase of trials of the Covishield vaccine is out, and the Serum Institute has claimed it to be above 70 per cent effective. The third phase of trials of Bharat Biotech’s Covaxin have just completed but the data on the vaccine’s efficacy has not been released. 

“Transparency [about the vaccine trials] is very important,” Amar Jesani, editor of the ‘Indian Journal of Medical Ethics’ told Gaon Connection. “If the approval had to be given without the completion of the vaccine trials, why did the government wait this long? They should have simply approved Bharat Biotech’s vaccine in September itself following its second phase of trials,” he said. At that time, the government had insisted on the third phase trials whereas now it had hastily approved the vaccine without awaiting the trial results, he pointed out. 

“Bharat Biotech’s vaccine may be a very good one but the common man’s trust on science is only evidence-based and so, if you give approval without any data, wouldn’t there be questions raised,” asked Jesani.  Experts from the subject-expert committee have also mentioned in their report that Bharat Biotech must complete its third phase trials or, at least, release the preliminary report of its results. But it has not done so, said Jesani.  

It usually takes two to three years to complete the process of vetting a vaccine and declaring it safe. However, the regulatory framework has been relaxed in view of the huge impact of COVID-19 virus on normal life. 

The various steps in the development of a vaccine are as follows… 

1. Preclinical 

2. Phase 1 (Safety Tests) 

3. Phase 2 (Extended Testing) 

4. Phase 3 (Efficiency Test) 

5. Regulatory Review 

6. Approval and distribution

“Every vaccine undergoes testing for safety in phase one trial, i.e., it is seen that there is no risk associated with the vaccine. In phase two trial, it is seen whether the body generates immune response against the disease for which the vaccine has been given, and in the third phase, it is seen to what extent the infection could be prevented through the vaccination,” D Raghunandan, executive member and former chairman of the All-India People’s Science Network, a national network associated with the People’s Science Movement of India, explained to Gaon Connection.  

These parameters had to be followed to determine the efficacy of the vaccine, he insisted. “Otherwise it may happen that a person may still become infected with COVID-19 despite vaccination. Such a thing would only defeat the purpose of these efforts and exercise. So, it is important that data on both the vaccines should be brought out,” he said. 

The Central Drugs Standard Control Organisation in its guidelines has stipulated at least 50 per cent efficacy for any vaccine. The World Health Organization (WHO) has also mandated the same for vaccines in its guidelines. 

While the Covidshield vaccine has claimed over 70 per cent efficacy, the supporting data on its trials must also be brought out, said Raghunandan.  “We need to wait longer for the third phase trials of Covaxin to happen so that we win the confidence of the people based on the authentic data,” he stated.

The Indian Council of Medical Research (ICMR) has collaborated with Bharat Biotech for producing the indigenous vaccine Covaxin. Bharat Biotech began the vaccine’s third phase trials in November and is conducting its trial on more than 25,000 volunteers across the country.  

Tried and tested, says DCGI

However, after the Drug Controller General of India approved the two vaccines for emergency use, the officials deemed them as completely safe. “Both the vaccines are completely safe and can be used in emergencies. We’ll never approve anything if there’s slightest of safety concern. Vaccines are a hundred and ten per cent safe,” VG Somani, director, DCGI declared. 

“Even though some may question the trials of Bharat Biotech’s Covaxin, it is certain that the vaccine is completely safe,” K Suresh Kishan Rao, a public health specialist who has been associated with the government of India’s universal immunization programme for nearly 50 years and has worked on several vaccines in India, told Gaon Connection

“Bharat Biotech has conducted vaccine trials on approximately 25,000 volunteers and so far, no question has been raised on its safety,” pointed out Rao.

“The results of Bharat Biotech may not have been revealed but the committee of experts has approved Covaxin in view of the data received so far. Hence, we must understand that when the country is suffering from the COVID-19 pandemic, we have to take steps to provide vaccination to the people at the earliest. The government has approved the emergency use of the vaccine which is the right step and for the betterment of the people,” Rao said.

Read the story in Hindi.