ICMR damage-control bid on trials -Credibility blow in vaccine shove -Deadline absurd and impossible: Researchers

G.S. Mudur   |  TT   |   New Delhi   |   05.07.20   :  India’s health research agency on Saturday said that clinical trials on its candidate Covid-19 vaccine would follow “best practices and rigour”, prompting scientists to suggest it was trying to regain credibility it had lost by mandating a mid-August vaccine launch.

The Indian Council of Medical Research said its July 2 directive to doctors to fast-track the trials to make the vaccine available for public-health use by August 15 was “meant to cut unnecessary red tape without bypassing any necessary processes”.

But the clarification did not explain the provenance of the August 15 target that ICMR director-general Balram Bhargava had set in a letter to doctors in 12 hospitals across India that will host safety and efficacy trials on the vaccine.

Researchers had described the deadline as absurd and impossible.

“The letter has eroded the agency’s credibility. This (Saturday’s statement) is only backtracking and damage control. There is nothing about why a date for public launch was even mentioned in the letter,” said a senior virologist who requested not to be named.

The candidate vaccine — based on a killed strain of the coronavirus isolated by the ICMR’s National Institute of Virology, Pune, from an asymptomatic patient — is under joint development by the ICMR and the Hyderabad-based Bharat Biotech.

Bharat has received approval for safety and clinical trials of the vaccine in 1,125 healthy people.

Several researchers said the lingering question was why the head of the country’s apex health research agency would suggest that a vaccine could be prepared for public use within six weeks of the start of safety trials, given the challenges in vaccine development.

Eighteen candidate vaccines against Covid-19 are in clinical trials while more than 120 others are undergoing lab or animal studies, according to a World Health Organisation document.

“No one expects a vaccine to become available for routine public use anywhere before at least the end of 2020 or early 2021,” said another senior researcher who has played a role in assessing other vaccines also produced by Bharat.

“The (July 2) letter could turn India into a laughing stock in the vaccine community. India’s vaccines enjoy high credibility worldwide. This letter will provide an unwarranted opportunity to raise questions about the safety and quality of vaccines from India.”

In its clarification, the ICMR said the July 2 letter had been intended to insulate the vaccine development process from “slow file movement”.

The aim, the agency said on Saturday, was to complete the safety and efficacy trials at the earliest so that larger population-based efficacy trials could start without delay.

Senior ICMR officials did not answer phone calls this newspaper made to seek information about the envisioned August 15 launch.

The date has stirred speculation in research circles whether Bhargava had written the letter under political influence.

Several clinician-researchers said they found the letter surprising because, as a doctor-researcher involved in past clinical trials, Bhargava would be expected to grasp the complexity of assessing a brand-new medicine or vaccine – something that typically takes years.

Scientists also underlined that India had developed few entirely novel home-grown medicines or vaccines. One prominent and early contribution was the discovery in 1922 of a compound to treat leishmaniasis or kala-azar, a parasite infection, by Upendranath Brahmachari, a Calcutta physician.

India’s first home-grown vaccine to protect infants from life-threatening rotavirus infections emerged in 2013 after a 28-year joint research effort with the US to make a vaccine from scratch. Bharat Biotech now produces the vaccine.

The ICMR has said its process is “exactly in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel”.

But a senior virologist familiar with global efforts to develop vaccines against Covid-19 said that while vaccine efforts were being fast-tracked, nowhere in the world had any agency or research group announced a launch date ahead of even safety and efficacy studies.

“Normally, vaccine safety and efficacy studies are run in sequence. Now they are being considered in parallel,” said the virologist, who too requested anonymity.

“But even with that, there is no way that a vaccine that is not in human trials could have an assured launch date less than two months away. Vaccines entering human trials have a less than 10 per cent chance of success.”

India’s investment in Covid-19 vaccines is expected to be significantly lower than those by other countries fast-tracking vaccine development.

For instance, the US has pledged $456 million, $583 million and $1.2 billion to three companies pursuing candidate vaccines. The ICMR has not specified how much it is investing in its candidate vaccine with Bharat.

Scientists have underlined that the ICMR has not yet published preclinical research on the candidate vaccine.

“I hope the ICMR quickly publishes the preclinical data to build confidence among the scientific community in the process and the vaccine,” said Shahid Jameel, senior virologist and head of the Wellcome Trust DBT India Alliance, an India-UK research partnership.

“The people of India deserve a safe and efficacious vaccine.”