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.


East Manhattan a ghost town during UNGA

Updated 22 September 2020

East Manhattan a ghost town during UNGA

  • General Assembly has gone virtual for first time in its 75-year history due to COVID-19
  • Pandemic has dealt devastating blow to New York’s tourism sector, economy

NEW YORK: Even in a metropolis that draws over 62 million visitors each year, the UN General Assembly (UNGA) is usually one of the most publicized events in New York City. Not so much in 2020.

Outside the UN complex on First Avenue, curbside police barricades line the streets. But there is hardly anyone to see except a policeman, a photographer, and only a trickle of local residents going about their business as usual.

As the UN’s signature big meeting has moved online for the first time in its 75-year history, noticeably absent is the severe traffic congestion caused by police-escorted motorcades whizzing by as presidents, premiers, monarchs and other dignitaries swept across Midtown East for top-level, high-stakes meetings and conferences.

Extensive roadblocks had led the city to declare the second part of September “gridlock alert days.”

This year, no more than 200 New York-based diplomats will be allowed in the Midtown East headquarters, said Stephane Dujarric, spokesman for the UN secretary-general.

The UNGA is meeting by video because of coronavirus, compounding the pandemic’s blow to the city’s economy.

“Last year during the General Assembly we were at 100 percent occupancy, but since the pandemic everything has come down. We’re now at 20 percent,” Sylvia Natividad, who has been working at the Millennial Hilton across from the UN for the past 17 years, told Arab News.

This hotel is a leaders’ favorite, and Natividad has, along the years, met many heads of state. “It’s hard to be impressed by any of them. You want to impress me? Show me what you’re doing for your people,” she said.

Hotels usually reap about $20 million from UNGA attendees’ room rentals alone. But as she and I chatted, our voices echoed across the Hilton’s large, sumptuous but eerily empty lobby. Only one reporter came in, to ask for the key to the restrooms.  

During the initial coronavirus outbreak, this Hilton offered essential workers over 17,000 free nights.

As the pandemic’s early epicenter in the US, New York saw a 90 percent decline in visitors, dealing a harsh blow to its multibillion-dollar tourism industry.

Last year, according to the city’s tourism agency NYC & Co., visitor spending supported more than 400,000 jobs and generated over $70 billion in economic activity.

The loss of the September swarm of visitors is now mostly felt in the city’s bottom line. Local businesses and their workers hurt the most as they see their income evaporate.

Across on 44th Street, Mona’s Kitchen restaurant owner Oliver recalled the “hustle and bustle” of last year, when on average over 18,000 attendees came through the doors of the UN headquarters daily.

“We had people from all over the world. Security was so tight it blocked off each end of the street. You couldn’t even get down the street without proper clearance and badges,” he told Arab News.

“This year it’s a ghost town. It’s been a ghost town since July. You barely get people walking on 2nd Avenue, so we don’t really get people down here.”

New York restaurants are already straining from a months-long ban on dining out, continuing limitations on table service, and worries about the city’s overall path to recovery.

Mona’s Kitchen made $20,000 per day just from breakfast and lunch this time last year, 50 percent more than on regular days.

“We’ll be lucky to do at least $1,000 today. I’m hoping to do a bit more but I don’t think we will,” Oliver said.

“The only reason we’re able to stay afloat and pay the two, three people I have right now is through the government Paycheck Protection Program. We got the Emergency Disaster Loan also. That allows us to pay rent and utilities,” he added.

“But in the next two, three months, if we don’t see a huge increase in sales and people coming back to the city, it’s going to force us to shut down. I can’t afford to pay rent after a couple of months.”

The UNGA has always coincided with the US Open tennis tournament and New York Fashion Week. For that, September has often brought windfall profits for New Yorkers.

It is a crucial month for the restaurants and bars that cater to world dignitaries, tennis fans and fashion partygoers.

Summer tends to be slow for the food industry, and business owners rely on events such as the UNGA to jumpstart autumn activity.

Beyond the diplomats and dignitaries, the UNGA also brings aides, civil society activists and everyday citizens to New York, showcasing the city to the world.

Now, its tourism sector faces a punishing autumn and winter season. As many as one-third of the city’s 230,000 small businesses will not be able to survive, the non-profit organization Partnership for New York City predicted in a July report.

Poverty and unemployment will rise as tens of billions of dollars are lost in revenue, and tourism will dry up.

Despite the economic devastation of the city, Max Riley, who has been living on 1st Avenue for 20 years, still believes that the UNGA is an “incredible experience every fall.”

Security checkpoints and protests are “a reality we just accept as part of living near the UN,” he told Arab News.

Residents of the east side of Manhattan have long complained about privileged diplomatic parking, illegal parking, traffic congestion and street closures resulting from UN sessions.

However, now the pin-drop silence “is just sad,” said Natividad. “But we’re hopeful everything will come back to normal.”

Riley said: “The entire city is empty. It’s not just this neighborhood. Nothing will change until we have a vaccine, then things will come back. It’ll take a little while. Probably in two or three years we’ll be tired of hearing the word ‘renaissance’.”

Still, despite projections of even deeper economic pain awaiting the city in the months to come, Councilwoman Farah Louis told Arab News: “The economic impact must be weighed against New York’s health and safety.”

Opening up the city would have meant letting a million “potential carriers” of COVID-19 into New York, she said.

“The relative loss of allowing coronavirus to ravage New York once again is much more detrimental to the economy than the relative and temporary tourism industry deficit,” she added.

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