Bharat Biotech’s Krishna Ella faces his biggest challenge3 min read . Updated: 07 Jul 2020, 06:30 AM IST
Industry watchers say Ella and Bharat Biotech’s reputation will undergo a severe stress test owing to Covaxin
NEW DELHI : Krishna Ella, founder chairman of Bharat Biotech Ltd, faces the biggest test of his career this week, as Covaxin, the company’s vaccine candidate, enters human trials.
Though the timeline suggested by the Indian Council of Medical Research (ICMR) for launching the vaccine is considered unprecedented and ambitious in the field of vaccines, the company’s track record in indigenously developing vaccines has given hope to the medical fraternity on its ability to make a breakthrough despite the short time-frame.
In 2015, Bharat Biotech made headlines after Prime Minister Narendra Modi launched the first India-made Rotavirus vaccine developed by the Hyderabad-based company. The vaccine, branded Rotavac, priced at about $1 a dose, is among the cheapest available globally and has been inducted into the World Health Organization’s (WHO) immunization programme since.
“I think Indians are very good under pressure," Ella had joked at the launch of a variant of Rotavac 5D last December. The remark resonates remarkably, as Bharat Biotech and Ella race against time to develop India’s first vaccine against covid-19. Ella carries a stellar reputation in the vaccine industry, with his firm having developed the world’s first typhoid conjugate vaccine, as well as the world’s cheapest rotavirus vaccine, both pre-approved by WHO.
Bharat Biotech started operations in 1996 after Ella returned from the US to set up a company dedicated to creating innovative vaccines and bio-therapeutics. Over the years, it has successfully developed vaccines for Japanese encephalitis and hepatitis B.
It holds over 160 patents, and is working on chikungunya and zika vaccines.
However, industry watchers said Ella’s reputation will undergo a severe stress test as he comes under the limelight due to Covaxin, which has been developed jointly by Bharat Biotech and Indian Council of Medical Research’s National Institute of Virology. The vaccine was the first to get approval from the Drug Controller General of India for human trials, but the screws were tightened last week when ICMR director general and health research secretary Balram Bhargava wrote a letter setting a 15 August deadline for the launch. This was far shorter than the company’s filing in the clinical trials registry, where it estimated the phase 1 and 2 studies of 1,125 patients in total to be completed in 15 months. Around 375 volunteers will be needed in the phase 1 study across 12 sites, and 750 in phase 2.
The demand for a launch within 45 days of getting approval for a human trial is unprecedented, but the apex bio-medical research agency justified it by saying that these are unprecedented times. While it did not reiterate its much-criticised deadline in a statement on Saturday, it said the letter was meant “to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants".
An official at Bharat Biotech, on condition of anonymity said that the company is working with the government to get the vaccine ready at the earliest, and expediting the processes is the need of the hour. Usually, a trial requires one month only for follow-up of participants who are being tested with the vaccine, not to mention the other processes like the ethics committee approvals, filing of principal investigators’ reports with the DCGI, among others.
The official said the company would not cut corners and would conduct the tests as per protocol but will work towards cutting time in the ‘procedural issues’ like filing of the report by principal investigators and having greater coordination between study sites, the regulator, the company and various other stakeholders.
“If I know Dr Ella and Bharat Biotech they will proceed in the right manner, " said Manish Mannan, head of department of paediatrics and neonatology, at Paras Hospitals in Gurgaon, who was the principal investigator during a trial of the rotavirus vaccine.