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.


Medical reservists to the rescue as Manila steps up virus battle

Updated 11 August 2020

Medical reservists to the rescue as Manila steps up virus battle

  • 3,000 personnel face call-up amid warnings country is losing COVID-19 war

MANILA: The Philippines is considering calling up more than 3,000 military medical reservists to help in the battle against the coronavirus pandemic.

The move comes as a rising number of infections threatens to overwhelm the country’s struggling health care system. 

Defense Secretary Delfin Lorenzana said that a list had been drawn up of of 380 doctors and nurses, as well as 3,000 reservists with medical training who can be mobilized to help COVID-19 patients.

In a televised interview, Lorenzana said talks on calling up medical reservists took place at a meeting with President Rodrigo Duterte last week after warnings of a shortage of medical personnel in Manila.

He said the message from medical groups that staff were overwhelmed and exhausted sent a “distress signal to the nation.”

Hospital staff also warned that the country “is waging a losing battle against COVID-19.”

“We have medical reserves. All we have to do is find out where they are now,” Lorenzana said.

“As of last week we were able to get about 380 doctors and nurses, plus about 3,000 other medical personnel, including medical aides and medical technicians,” he added.

If the plan to mobilize medical reservists is pushed through, the defense department will deploy them to help in Manila and other areas with high rates of COVID-19 infection.

The defense secretary said he is confident many of the reservists will respond once they are called to duty.

Asked if the defense department has a timetable for their deployment, Lorenzana said: “We have to process them, but first we will have to get a go signal from the Department of Budget and Management because we need money to mobilize these people. We have to pay their salary and allowances.

“I have directed the Philippines armed forces to estimate how much we money we need,” he said.

Last week Duterte ordered a strict quarantine to be reimposed in capital and surrounding provinces until Aug. 18.

He said this will give the government time to refine its pandemic strategies and offer a “breather” to exhausted front-line workers.

Under the curfew people will be restricted to essential travel and mass transport will be closed.

As of Monday, the Philippines had recorded 129,913 COVID-19 cases, with 67,673 recoveries and 2,270 deaths.