A scientist at work at the Serum Institute of India, which is working on COVID-19 vaccines. Two Indian companies have received the green light to start human trials of their candidate vaccines.

By Sanjay KumarJul. 6, 2020 , 4:55 PM

Science’s COVID-19 reporting is supported by the Pulitzer Center.

NEW DELHI—The apparent speed at which an Indian government agency aims to test and approve a homegrown COVID-19 vaccine has created an uproar among scientists both in India, which is increasingly overwhelmed by the new coronavirus, and abroad. A letter leaked on Twitter on Friday suggests the first vaccines could be rolled out by 15 August, which would leave far too little time for proper testing, critics say. The Indian Academy of Sciences calls the timeline “unreasonable and without precedent.”

Six Indian companies are developing vaccines against COVID-19. Last week, the Indian government gave two of them, Bharat Biotech and Zydus Cadila, permission to start phase I and II human clinical trials of their most advanced vaccines, named covaxin and ZyCov-D respectively.

For covaxin, Bharat Biotech has joined with the National Institute of Virology, which is part of the Indian Council of Medical Research (ICMR). (The company is separately developing COVID-19 vaccine candidates in collaboration with Thomas Jefferson University in Philadelphia and the University of Wisconsin, Madison.)

ICMR Director-General Balram Bhargava revealed the extremely tight deadline in a letter to hospitals designated to be involved in the Covaxin studies. “It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” Bhargava wrote. He asked the hospitals to fast-track all approvals for the vaccine and be ready to enroll participants “no later than 7 July 2020,” adding that “noncompliance will be viewed very seriously.”

But it’s absurd to think studies could show a vaccine to be safe and effective in less than 2 months, many scientists say. “In my knowledge, such an accelerated development pathway has never ever been done for any kind of vaccine,” says Anant Bhan, an independent ethics and policy researcher and past president of the International Association of Bioethics. “This seems really, really rushed.” The timeline “carries potential risks and provides inadequate attention to required safety procedures,” Bhan adds.

“Clinical trials cannot be rushed,” concurs Indian virologist and veteran vaccine researcher Thekkekara Jacob John, formerly of the Christian Medical College in Vellore. Even when expedited, phase I and phase II trials will take a minimum of 5 months, he says. The duration of a phase III trial would depend on several factors, including the number of subjects enrolled and decisions by a data safety monitoring board, but would probably add at least another 6 months, Jacob John says. “ICMR’s intentions may be good but the processes have been vitiated and the risk is it can derail the vaccine,” he says.

Critics believe the target date is political: 15 August is India’s Independence Day, when Prime Minister Narendra Modi traditionally climbs the ramparts of the Red Fort in Delhi to give a long speech touting his government’s achievements and make major announcements.

In a statement on Saturday, ICMR said Bhargava’s letter was “meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”

“Faced with the unprecedented nature of the COVID-19 pandemic, and the consequent dislocation of the normal life, all other vaccine candidates across the globe have been similarly fast-tracked,” the agency claimed. In reality, no other country has announced plans to roll out a vaccine this fast, and ICMR did not explain how it thinks it can accelerate the process. Bharat Biotech declined Science’s request for comment.

India is eagerly awaiting a COVID-19 vaccine. It just surpassed Russia as the country with the third-highest number of cases, after the United States and Brazil. There were 24,000 confirmed new cases on Sunday; the national tally stands at 697,413 cases and 19,693 deaths.

But India should keep in mind that most vaccine candidates fail, says Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Normally, the probability of success for a vaccine in the preclinical phase is around 7%, rising to 15% to 20% for vaccines that reach clinical tests,” such as Covaxin and ZyCov-D, Berkley says.

“ICMR’s actions lower the credibility of Indian science,” says T. Sundararaman, global coordinator of the People’s Health Movement, a network of grassroots health activists, civil society organizations, and academic institutions. “It’s not about getting there first but to be able to do it well and it is good that India has been able to come up with candidate vaccines, which is not a small achievement.”