India’s medical body accused of ‘fixing’ vaccine trial date

Indians wearing masks as a precaution against the coronavirus disease (COVID-19) enjoy a day out at a market in Jammu on Sunday. (AP)
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Updated 06 July 2020

India’s medical body accused of ‘fixing’ vaccine trial date

  • Experts say move is part of efforts to showcase progress in handling outbreak

NEW DELHI: A day after India’s apex medical body issued a clarification for setting Aug. 15 as the deadline to fast-track the trials of a vaccine for the coronavirus disease (COVID-19), doctors and health experts said on Sunday that the Indian Council of Medical Research (ICMR) was “fixing the date” for the use of the coveted drug.

“It is no coincidence that this vaccine fixing trial by the ICMR comes soon after the flabbergasting claim made by Baba Ramdev (a yoga guru) of discovering the Ayurvedic cure for COVID-19,” Harjit Singh Bhatti of New Delhi-based Progressive Medicos and Scientific Forum told Arab News.

He added that the fact the order was issued to launch the vaccine for public use by Aug. 15 implied that the results had already been given. 

“The so-called trial is only an attempt to put a veneer of validity on them,” he said.

This follows the ICMR’s directive on Tuesday asking select medical institutions to expedite the clinical trial approvals for Covaxin, a potential anti-virus candidate developed in collaboration with Bharat Biotech International, a leading vaccine and bio-therapeutics manufacturer based in Hyderabad.

“In light of the public health emergency ... and urgency to launch the vaccine, you are strictly advised to fast-track all approvals related to the initiation of the clinical trial ... no later than July 7. It is envisaged to launch the vaccine for public health use latest by Aug. 15 after completion of all clinical trials,” Dr. Balram Bhargava, ICMR director-general, wrote in the order.

The ICMR chief warned hospitals not to delay the trials, adding that “non-compliance” would be taken “very seriously.”

Faced with growing outrage over the message, the ICMR issued a statement on Saturday that claimed the six-week deadline was “to cut red tape.”

“The letter by the ICMR director-general to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants,” the statement said.

Health experts, however, said it was a “disturbing” development.

“It is very disturbing that the ICMR would fix a date for releasing a vaccine even before the Phase-1 trial has started. Everybody knows India mismanaged the epidemic. You cannot save face with this kind of approach to the vaccine,” Dr T. Jacob John, a biologist at the Vellore-based Christian Medical College in Tamil Nadu, told Arab News.

The missive has prompted a huge outcry among medical and political circles.

“Any doctor or scientist who has been trained to practice medicine with a scientific temperament in the service of our people would be outraged by the criminal audacity of the government,” Bhatti said.

He added that if “science were to have its way,” the trials would have been done in phases to ensure the vaccine was safe. 

Dr. Amar Jesani, Mumbai-based independent researcher and editor of the Indian Journal of Medical Ethics, said the idea was “laughable” and that it violated the ICMR’s guidelines on ethical medical practices.

“It’s a pipe dream, and you cannot have a vaccine by commanding that the vaccine should work,” Jesani told Arab News.

Meanwhile, Soumya Swaminathan, chief scientist of the World Health Organization (WHO), warned that the vaccine should not come at “the cost of scientific and ethical standards.”

“The WHO recommends that Phase-3 trials, often considered the most important, should involve up to 20-30,000 people,” she said in an interview with Indian newspapers on Sunday.

As the chief medical body of the Indian government, the ICMR is tasked with formulating guidelines to deal with COVID-19 cases in the country. 

To this end, it sets the parameters for ethical standards in medical trials, while its head reports directly to the Prime Minister’s Office.

Following the developments on Saturday, questions are now being raised as to whether the ICMR was under political pressure.

Sitaram Yechury, leader of the Communist Party of India (Marxist), said scientists were being “forced” to show results so that Prime Minister Narendra Modi could announce them during his Independence Day speech on August 15. 

“Forcing the development of an indigenous vaccine as a cure for COVID-19 by bypassing all health and safety norms... is fraught with horrendous human costs,” he tweeted on Saturday.

Jesani reasons this is owing to a “direct relationship of power with the ICMR.”

“There is no doubt that the director-general of the ICMR was assigned to get going by August 15 so that there would be something positive for the PM to say in his address to the nation. He thinks that the vaccine is the best thing to talk about,” Jesani said, adding that it could also be a means for the ICMR to redeem itself.

“No doubt the ICMR has been under great pressure for the last three months and wants to redeem its credibility…[but] it is science that ultimately controls the outcome,” he said.

As of Sunday, India had over 700,000 active COVID-19 cases with more than 20,000 deaths reported.


US to pay over $1 bn for 100 mln doses of J&J’s potential COVID-19 vaccine

Updated 05 August 2020

US to pay over $1 bn for 100 mln doses of J&J’s potential COVID-19 vaccine

  • The latest contract equates to roughly $10 per vaccine dose produced by J&J
  • This is J&J’s first deal to supply its investigational vaccine to a country

WASHINGTON: The United States government will pay Johnson & Johnson over $1 billion for 100 million doses of its potential coronavirus vaccine, its latest such arrangement as the race to tame the pandemic intensifies, the drugmaker said on Wednesday.
It said it would deliver the vaccine to the Biomedical Advanced Research and Development Authority (BARDA) on a not-for-profit basis to be used after approval or emergency use authorization by the US Food and Drug Administration (FDA).
J&J has already received $1 billion in funding from the US government — BARDA agreed in March to provide that money for the company to build manufacturing capacity for more than 1 billion doses of the experimental vaccine.
The latest contract equates to roughly $10 per vaccine dose produced by J&J. Including the first $1 billion deal with the USgovernment, the price would be slightly higher than the $19.50 per dose that the United States is paying for the vaccine being developed by Pfizer Inc. and German biotech BioNTech SE.
The US government may also purchase an additional 200 million doses under a subsequent agreement. J&J did not disclose that deal’s value.
J&J plans to study a one- or two-dose regimen of the vaccine in parallel later this year. A single-shot regimen could allow more people to be vaccinated with the same number of doses and would sidestep issues around getting people to come back for their second dose.
This is J&J’s first deal to supply its investigational vaccine to a country. Talks are underway with the European Union, but no deal has yet been reached.
J&J’s investigational vaccine is currently being tested on healthy volunteers in the United States and Belgium in an early-stage study.
There are currently no approved vaccines for COVID-19. More than 20 are in clinical trials.