Indian vaccine maker denies trial ‘irregularities’

An Indian pharmaceutical company whose coronavirus vaccine has been approved for restricted use has brushed off accusations of irregularities in its clinical trials. (Reuters/File Photo)
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Updated 09 January 2021

Indian vaccine maker denies trial ‘irregularities’

  • Volunteers say they were unaware jab was part of clinical study

NEW DELHI: An Indian pharmaceutical company whose coronavirus vaccine has been approved for restricted use has brushed off accusations of irregularities in its clinical trials by participants alleging lack of informed consent.

The vaccine, Covaxin, developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), was approved last week by the Drug Controller General of India for emergency use, despite concerns among health experts that its late-stage trials have not been completed.

The treatment is currently at the center of a controversy in Bhopal, in the central Indian state of Madhya Pradesh, with volunteers who took part in its trials saying they did not know they were participating in clinical research — an accusation the producer denies.

“Each and every volunteer who is part of the trial is informed about the details very clearly in a regional language, the language the person understands, and on top of that an informed person’s form is filled out and taken care of,” Dr. Rajni Kant, spokesman for the ICMR, which is India’s apex body for biomedical research, told Arab News.

However, those who received Covaxin shots at a People’s College of Medical Sciences and Research hospital in Bhopal, complain that they were unaware it was a trial.

“I was told that it’s a vaccine for coronavirus,” said Jitendra Narwariya, 37, a laborer from Bhopal’s Shankar Nagar who was vaccinated on Dec. 10.

He heard an announcement from a vehicle in his neighborhood offering participants 750 rupees ($11), substantially more than his wage, which does not exceed 600 rupees a day.

“I boarded the vehicle and went to the hospital where I came to know about Covaxin,” he told Arab News. “I was told that the vaccine is for protecting us from the deadly virus — that’s why I decided to come to the hospital.”

Narwariya is not alone. More than 600 people from the city’s poorer areas were enrolled for the trial.

“I was promised a vaccine for coronavirus. I was not aware that they were using a vaccine on me as a trial,” said Man Singh, 60, a daily wage worker, who was inoculated on Dec. 21.

Both men fell ill a few days after vaccination. In Narwariya’s case, the hospital carrying out Covaxin trials initially refused free treatment, but later accepted him after local activists intervened.

“Around 600 to 700 people from the poor neighborhoods went for testing. Not all of them are having trouble,” Bhopal-based social activist Rachana Dhingra said.

“The issue is that none of those we met received their informed consent form,” she said. “You are supposed to take audio-video consent of people who are illiterate. Lots of these people are vulnerable.”

According to the country’s 2018 New Drugs and Clinical Trials Rules, a freely given, informed, written consent must be obtained from each study subject. Hospitals are required to maintain an audio-video recording of consent being given if the person cannot write.

Rajesh Kapoor, vice-chancellor of the People’s College of Medical Sciences and Research, rejects all the accusations.

“There is no question of violations of any rule. We followed all the procedures for all the 1,702 people who took part in the trial. Everybody’s consent was taken,” he told Arab News.

Kant, the ICMR spokesman, said that it should be obvious that the vaccination was a trial.

“We all know that there is no vaccine available right now so only trials are happening. If people don’t know it, then it is their ignorance,” he said, while adding that “informed consent is a must.”

Bharat Biotech, the company producing Covaxin in collaboration with ICMR, declined to comment.

According to Dr. Anand Rai from Indore in Madhya Pradesh, the coronavirus vaccine race is encouraging companies to compromise the rules.

“Vaccine manufacturers who are in a rush to launch their product and earn money are violating all the norms of trial,” he said.

Mumbai-based health expert Dr. Amar Jesani flagged several problems related to the Covaxin trial, including the financial incentive for participants, which he said violate ICMR’s own guidelines.

“Not taking consent properly, being insensitive in terms of money, not providing a copy of the informed consent along with the participant information sheet to the participants — these are all violations of the Indian Council of Medical Research guidelines,” he told Arab News.

Thailand reports 1,390 new coronavirus infections, 3 new deaths

Updated 19 April 2021

Thailand reports 1,390 new coronavirus infections, 3 new deaths

  • Three deaths were reported

BANGKOK: Thailand reported 1,390 new coronavirus cases on Monday, slowing from six days of record highs, amid a third wave of infections in the Southeast Asian country.
Three deaths were reported. The new cases took the total number of infections to 43,742, with 104 deaths.

France restricting travel from 4 countries to curb variants

Updated 19 April 2021

France restricting travel from 4 countries to curb variants

  • Along with the mandatory quarantine, France is requiring more stringent testing for the coronavirus

PARIS: France is imposing entry restrictions on travelers from four countries — Argentina, Chile, South Africa and Brazil — in hopes of keeping out especially contagious coronavirus variants, the government has announced.

The restrictions include mandatory 10-day quarantines with police checks to ensure people arriving in France observe the requirement.  Travelers from all four countries will be restricted to French nationals and their families, EU citizens and others with a permanent home in France.

France previously suspended all flights from Brazil. The suspension will be lifted next Saturday, after 10 days, and the new restrictions “progressively” put in place by then, the government said. 

The flight suspension for Brazil will be lifted followed by “drastic measures” for entering France from all four countries, plus the French territory of Guiana, French Foreign Minister Jean-Yves Le Drian said.

The four countries “are the most dangerous in terms of the number of variants that exist and in the evolution of the pandemic in these countries,” Le Drian said Saturday on the France 3 television station.

The list of countries subject to tougher border checks could be extended, he said.

Under the new restrictions, travelers must provide an address for where they plan to observe the 10-day confinement period and police will make visits and fine those who are found in violation, the government said.

Along with the mandatory quarantine, France is requiring more stringent testing for the coronavirus. 

Travelers must show proof of a negative PCR test taken less than 36 hours instead of 72 hours before they boarded a flight, or a negative antigen test less than 24 hours

France has reported the deaths of 100,00 people in the COVID-19 pandemic.

A variant first identified in England spread to continental Europe and is now responsible for about 80 percent of the virus cases in France, while the variants first seen in Brazil and South Africa make up less than 4% of French infections, Health Minister Olivier Veran said last week.

Coronavirus likely to keep mutating: Scientists

Updated 18 April 2021

Coronavirus likely to keep mutating: Scientists

  • Warning comes amid fears that new, India variant could become dominant
  • Virologist: “We’re still early on in the lifetime of this virus as a human pathogen”

LONDON: Humanity is engaged in an “arms race” with the coronavirus Sars-CoV-2, and its capacity to adapt and evolve remains unknown and should not be underestimated, scientists have warned.
“I think it’d be a brave person to say that the virus is nearing the end of its evolutionary route and can’t go any further,” Prof. Deenan Pillay, a virologist at University College London, told The Independent.
“We’re still early on in the lifetime of this virus as a human pathogen. It normally takes many years for viruses, once they cross the species barrier, to really optimize themselves to be able to replicate well within humans.”
Pillay’s warning comes amid fears that a new strain of Sars-CoV-2, known as the India variant — which has caused a surge in the number of cases of COVID-19 — could become a dominant global strain in the coming weeks.
The India variant is known to carry two mutations that could reduce the efficacy of a number of COVID-19 vaccines.
Whilst that has not yet occurred, the nature and speed at which the virus has mutated thus far, including in the form of the South African and UK variants, has caused alarm among the scientific community that the positive impact of vaccine rollouts could be undone in the near future.
Specifically, scientists worry about Sars-CoV-2’s ability to alter spike proteins, used to attach onto human cells, through mutations.
The spike proteins, referred to by Pillay as “keys” to entering human receptor cells, are the mechanism through which most of the world’s successful COVID-19 vaccines look to attack the virus, by training various immune system responses to identify them. 
One such mutation, E484K, has been found in the South Africa and UK variants. The India variant carries a similar mutation, E484Q.
The fear is that by altering their proteins, these variants could render them less visible to the immune system of vaccinated people, making it harder to ward off infection.
Aris Katzourakis, professor of evolution and genomics at Oxford University, said beyond altering the spike protein, mutations such as E484K could “unlock a whole load of other mutations elsewhere in the spike” that have not yet been identified by scientists, with unknown repercussions for the severity of the virus.
“E484K took about 12 months before it became something we cared about. Presumably, 12 months from now, there’ll be another one or two that are just as important,” he told The Independent. 
Prof. Stephen Griffin, a virologist at Leeds University, said he believes that rather than continue to mutate indefinitely, there “will be a limit on how far the spike protein can evolve. But I’m not sure we can accurately determine what that limit may be at this point.”

Pakistan police and rangers taken hostage in anti-France protests

Updated 18 April 2021

Pakistan police and rangers taken hostage in anti-France protests

  • Rioting has rocked the country since Monday, when the leader of the now-banned TLP was detained in Lahore
  • The protests have paralyzed cities and led to the deaths of six policemen

LAHORE: At least seven Pakistan police officers and special rangers were taken hostage Sunday by supporters of a radical party, officials said, after days of violent anti-France protests.
Rioting has rocked the country since Monday, when the leader of the now-banned Tehreek-e-Labbaik Pakistan (TLP) was detained in the second biggest city Lahore after calling for the expulsion of the French ambassador.
The protests have paralyzed cities and led to the deaths of six policemen, prompting the French embassy to recommend all its nationals temporarily leave the country.
“The TLP members are holding five police officers and two rangers hostage,” said Rana Arif, a police spokesman in Lahore told AFP, referring to the country’s paramilitary force.
Firdous Ashiq Awan, a spokeswoman for the Punjab provincial government, said 12 policemen had been abducted and taken to a TLP mosque in Lahore, where hundreds of supporters were gathered.
“Violent groups armed with petrol bombs and acid bottles stormed the Nawankot police station this morning,” she tweeted, adding that six police officers have now died in clashes this week.
TLP leaders say several of the party’s supporters were killed in Sunday’s clashes.
“We won’t bury them until the French ambassador is kicked out,” Allama Muhammad Shafiq Amini, a TLP leader in the city, said in a video statement.
The police would not comment on the reported TLP deaths.
An oil truck was seized and petrol bombs thrown at officers, both Arif and Awan said.
An AFP reporter at the scene said police used tear gas against stone-throwing protesters.
The TLP has been behind an anti-France campaign for months since President Emmanuel Macron defended the right of Charlie Hebdo magazine to republish cartoons depicting the Prophet Muhammad — an act deemed blasphemous by many Muslims.
Pakistan’s Interior Minister Sheikh Rashid Ahmed said party supporters had blocked 191 sites over the past week, with the mosque in Lahore now a gathering point.
“No negotiations are taking place, tried for two-three months but they are not ready to backtrack from their agenda and the government has no other choice but to establish its writ,” he said at a press conference.
Khan’s government has struggled to bring TLP to heel over the years, but this week announced an outright ban against the group — effectively labelling it a terrorist outfit.
Still, on Saturday he suggested the party hadn’t been banned for its ideology, but rather its methods.
“Let me make clear to people here & abroad: Our govt only took action against TLP under our anti-terrorist law when they challenged the writ of the state and used street violence & attacking the public & law enforcers,” he tweeted.
Khan said insulting the prophet hurt Muslims around the world.
“We cannot tolerate any such disrespect & abuse,” he added.
He also said Western governments should treat people who insult the Prophet Muhammad the same as those who deny the Holocaust.
“I... call on Western govts who have outlawed any negative comment on the holocaust to use the same standards to penalize those deliberately spreading their message of hate against Muslims by abusing our Prophet,” Khan tweeted.
Pakistan on Friday blocked social media and instant messaging platforms for several hours to head off major protests.
Blasphemy is a hugely sensitive issue in conservative Pakistan, where laws allow for the death penalty to be used on anyone deemed to have insulted Islam or Islamic figures.
The French embassy’s call for its nationals to leave Pakistan appears to have gone largely unheeded so far.

Violence, insecurity threaten Afghan economy as investors flee war-torn country

Updated 18 April 2021

Violence, insecurity threaten Afghan economy as investors flee war-torn country

  • Official says capital flight last year led to almost $1.5 billion in losses

KABUL: Growing insecurity, political instability, and a lack of confidence in Afghanistan’s future has driven hundreds of businessmen out of the country, leading to almost $1.5 billion in losses last year for the already fragile economy, the deputy head of Afghanistan’s Chamber of Commerce and Investment (ACCI) told Arab News on Sunday.
“In 2020 alone, unfortunately, based on our estimates, 1,500 small-scale traders, investors and businessmen left the country because of infighting among government leaders, rising insecurity and corruption,” Khan Jan Alokozai said.
“Our unofficial estimates indicate that there was capital flight of at least $1.5 billion that was sent or taken overseas for investment last year,” he added.
Alokozai traced the investors’ exit to late 2014, when Afghanistan saw a drastic drawdown of US-led troops, resulting in infighting between President Ashraf Ghani and the then chief executive Dr. Abdullah Abdullah following allegedly fraudulent elections where both claimed victory.
The power struggle between the two leaders was further exacerbated during the 2019 polls that allowed the Taliban to gain ground, even as regional commanders and self-proclaimed ethnic leaders “pushed for their type of future government.”
It also follows a deadlock in the intra-Afghan peace talks between Ghani’s government and Taliban representatives. The talks began in September last year and have failed to make any progress in the peace process.
Fearing a repeat of events due to internal divisions within the government — which led to the fall of the Moscow-backed communist regime in the 1990s, following the departure of the former Soviet Union’s troops — Alokozai said that a majority of investors had opted to settle in Turkey instead, with “60 percent of the private sector shutting down their activities in Afghanistan in recent years.”
He added: “These traders have bitter experiences from the fall of Dr. Najib (communist-era president), which happened as a result of an internal war, and they want to leave now.
“About 60 percent of the private sector has ended activities in recent years. Factories have closed, and only those involved in businesses such as food and fuel items operate. We had some $15 billion in our annual circulation, but it has dropped to $6 or $7 billion now,” he added.
The losses have trickled down to the tertiary level as well, since most Afghan investors and traders “spend 25 percent of their income on bodyguards and armored vehicles, apart from the losses they incur due to daily violence across the country and the payment of bribes,” Alokozai said.
He cited the example of a leaked video of Minister of Finance Khalid Payenda telling officials that “$1 million is looted from the customs division in the western city of Herat alone every day.”
Alokozai added that recent developments surrounding the deadline for the complete withdrawal of US-led troops from Afghanistan has also affected the market, “not because of the possibility of the return of the Taliban,” but due to fears that the departure could push the country “back into a civil war.”
He said: “There is a big mistrust among leaders and people about the future of the country and anarchy in government. The traders are not afraid of the return of the Taliban. There will be some social restrictions, but overall the Taliban have treated the business community well, because they do not allow corruption and mafia activities.”
Saifuddin Saihoon, a Kabul-based economic expert, agreed, and said that the loss of capital and investors would have a “long-term impact on the economy of Afghanistan,” which has relied on foreign funds since the Taliban’s ouster in the US-led invasion of 2001.
“This causes the economy to slow down, closure of factories and joblessness, and gradually an economic crisis, as well as psychological fears about the future of the country,” Saihoon told Arab News.