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Families eager for results as drug companies test vaccines for use on children, teens

On an unusually warm spring morning, a class of seventh and eighth graders exits the doors of Charles Gordon Senior Public School in Scarborough, Ont. They walk single file through the yard, masked and distanced from each other by a strict two metres — a sign of the times in Toronto, where kids only recently returned to in-person schooling after another lockdown.

The day’s lesson is about COVID-19 vaccines, and appropriately, it was being held at an outdoor classroom. Students had been asked to read up on the vaccines and present questions they would like to ask Canadian officials about the inoculations and their distribution.

As vaccines roll out among older adults, many of the questions from this group of students focused on the fact that children aren’t on the current inoculation schedule. Of the vaccines approved in Canada so far, only the Pfizer vaccine has been cleared for people as young as 16 years old, and the other three are currently meant for ages 18 and up.

Their teacher, Tracey Toyama, said the lesson was a natural extension of current events. “They see it every day on social media; they come in, they ask questions,” she said.

“Why are children not more prioritized in terms of receiving the COVID-19 vaccine?” asked one girl.

“Why wouldn’t we vaccinate children so that they don’t put those who are vulnerable at risk?” asked another.

Indeed, since most children tend to experience milder cases of COVID-19, they weren’t prioritized in international vaccine trials. Still, kids do get sick and they can pass on the virus.

In fact, more than 157,000 Canadians aged 19 or younger have caught COVID-19. So until both adults and children are inoculated against the virus, it’s unlikely society will be able to go back to normal.


Students at Charles Gordon Senior Public School in Scarborough, Ont., hold some of their classes outdoors during the pandemic. During this lesson, students discuss the questions they would like to ask Canadian officials about the vaccines and their distribution. (Sarah Bridge/CBC)

In recognition of this, a number of vaccines are now being tested on younger people.

Drug maker Sinovac submitted data to the Chinese government this week saying its vaccine is safe for children between the ages of three and 17.

Pfizer, Moderna, AstraZeneca, and Johnson & Johnson are now testing their COVID-19 vaccines on younger kids, too. Moderna’s trial includes children as young as six months old. Early data from Pfizer on its trials for children aged 12 years and older is expected soon.

Quebec-based Medicago, which is working through Phase 3 adult trials for its plant-based COVID-19 vaccine, says it has plans to move on to younger age groups as data emerges.

According to Nathalie Charland, a senior director with Medicago, the trials will be similar to those they’ve conducted with people aged 18 and up, though children will likely receive half the vaccine dosage.

Along with monitoring each of the test cases to make sure they’re safe, she said, “We will be looking at the immunogenicity of the vaccine candidate to see if what we saw in adults is the same that we see in children.”


Medicago has been conducting clinical trials of its plant-based COVID-19 vaccine on people aged 18 years and older. Nathalie Charland, a senior director with Medicago, says her company has plans to test the vaccine on younger age groups as well. (Medicago)

Dr. Noni MacDonald with Dalhousie University in Halifax said vaccinating children is “incredibly important.”

She said adults were “rightly” prioritized for COVID-19 vaccines because, “children have not been shown to be the big vector of transmitting this virus from one person to another; it’s mostly adults and young people.”

However, MacDonald added, “The problem we have is we know that we need to have the community immunity happen. So, if we have big pockets of children that are not immunized, that community is not immune.”

With variants circulating, she said, the impetus to vaccinate children as soon as possible is strong.

“This is not the end,” she said. “This is a wicked virus and we need to control it in all the ways we can.”

That urgency is especially acute in households where a family member is immunocompromised.

Torontonian Amerie Alvis, 15, has been worried about bringing the virus home to her mom this past year. Her mother, Jaeda Larkin, is a single parent with rheumatoid arthritis.

“What if she does get sick, and I’m all alone?” Alvis said.


Jaeda Larkin, left, and her daughter Amerie Alvis. Amerie has chosen to do online schooling until she is able to get vaccinated, in order to minimize the risk of contracting COVID-19. (Sarah Bridge/CBC)

At nearly 16 years old, Alvis should be eligible for the Pfizer vaccine in a few months and said she is “all for it.”

In the meantime, she has chosen to do online schooling rather than go back to class, in order to minimize the risk to herself and her mom. Alvis said she won’t go back until she gets a shot, but she’s hopeful life could look different next fall.

Having lost some relatives in the U.S. to COVID-19, Larkin is similarly keen to see the two of them vaccinated against the virus.

“The thought of risking my daughter or, you know, potentially having her get sick is terrifying to me,” Larkin said.

Without available vaccine data for kids under 16, some parents of younger children are hesitant to commit just yet.

Torontonians Barry Ayow and Gina Athanasiou aren’t sure whether they’ll want to vaccinate their two youngest kids, who are 12 and 14 years old, against COVID-19 right away.

“I’m willing to experiment on myself. I’m willing to be a guinea pig. But to volunteer my children to be guinea pigs, that’s a different thing, right?” said Ayow.

At the same time, a sense of duty to their older family members and neighbours is weighing on the couple.

“Will duty outweigh our obligation to our kids to make sure that they’re safe? I don’t know,” said Athanasiou, who has concerns about possible side effects of the vaccines on her kids.

She added, “Maybe we’ll feel more comfortable when we have the studies.”


Barry Ayow, right, and Gina Athanasiou say they’re willing to get vaccinated for COIVD-19, but they aren’t sure whether they want to vaccinate their two youngest children right away. (Ousama Farag/CBC)

Dr. MacDonald said parents can be reassured that a push to vaccinate children won’t be coming “out of nowhere.”

“This is going to be based on evidence,” she said.

In fact, according to MacDonald, information about the COVID-19 vaccines will be more robust than what was initially available for previous vaccines, such as polio.

When the time comes for children to get vaccinated, she said, “literally tens of millions of doses of these vaccines will have been used in the population. We’ve never had that kind of volume whenever we’ve used vaccines in children before when we were starting.”

In a show of hands, about half the students in the Grade 7 and 8 class at Charles Gordon Senior Public School said they themselves would take the vaccine based on what they currently know, with others mostly citing the need for more information on their own age group.

What’s clear from nearly all of them during their classroom discussion, though, is that the stress of the pandemic isn’t just affecting adults.

For seventh grader Isaiah Velez, keeping his family and friends safe is a personal priority, he said, as is putting an end to the pandemic. “I miss going out in public and meeting my friends — a lot,” he said.


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EU drug regulator backs AstraZeneca-Oxford COVID-19 vaccine after safety investigation

The EU’s drug watchdog said on Thursday it is still convinced the benefits of the AstraZeneca-Oxford COVID-19 vaccine outweigh the risks following an investigation into reports of blood clotting disorders that prompted more than a dozen nations to suspend its use.

The European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

But she said in a briefing that the “clear” conclusion of the review was that the vaccine’s benefits outweigh the possible risks.

“This is a safe and effective vaccine,” Cooke said.

‘I would be vaccinated tomorrow’

However, she said the agency will update its guidance for patients and health-care professionals to include an explanation about potential risks.

“If it were me, I would be vaccinated tomorrow,” Cooke said.

But the EMA wants “to raise awareness among people who have been vaccinated or are going to be vaccinated about things they should look out for,” she said.

The agency has been under growing pressure to clear up safety concerns after a small number of recent reports about bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering five million people included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

Cooke said the EMA is in touch with regulators around the world to keep tabs on possible side-effects of all COVID vaccines.

The EMA’s focus and primary concern has been on cases of blood clots in the brain, a rare, difficult to treat condition called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST). 

Countries suspended shots

More than 45 million doses of the AstraZeneca vaccine have been administered across the EEA.

At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review, the latest blow to the bloc’s faltering inoculation campaign.


The vaccination centre at the Erfurt, Germany exhibition centre was deserted on Tuesday. After the suspension of the AstraZeneca COVID-19 vaccine, thousands of appointments were cancelled. (Martin Schutt/dpa/The Associated Press)

Britain’s medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it reaffirmed that the benefits of the shot far outweighed any possible risks.

The World Health Organization also this week reaffirmed its support for the shot.

AstraZeneca has said a review covering more than 17 million people who had received the shots in the EU and Britain had found no evidence of an increased risk of blood clots.

Many governments have said the decision to pause inoculations was made out of an abundance of caution, but experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.

The bloc’s vaccine rollout has lagged behind campaigns by the United States and former EU member Britain.

WATCH | Inside the race to get COVID-19 vaccines to Canadians:

CBC’s David Cochrane goes inside the processes of vaccine delivery and distribution as well as the challenges to deliver on the promise of at least one shot for every Canadian who wants it by July 1. 4:08

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Wife of drug kingpin El Chapo arrested on U.S. drug charges

The wife of Mexican drug kingpin Joaquin “El Chapo” Guzman, whom U.S. law enforcement officials accuse of helping plot her husband’s daring escape from a Mexico prison in 2015, was arrested Monday at an airport in Virginia on international drug-trafficking charges, the U.S. Justice Department said.

Emma Coronel Aispuro, 31, who is a dual citizen of the U.S. and Mexico, was arrested at Dulles International Airport and is expected to appear in federal court in Washington on Tuesday.

She is charged in a single-count criminal complaint with conspiracy to distribute cocaine, methamphetamine, heroin and marijuana in the U.S.

The Justice Department also accuses her of helping her husband escape from a Mexican prison in 2015 and participating in the planning of a second prison escape before Guzman was extradited to the U.S. in January 2017.

Coronel Aispuro remained in custody, and it was not immediately clear if she had an attorney who could comment on the allegations.

Guzman, Mexico’s most powerful drug lord, escaped through an opening under the shower in his cell leading to a 1.6-kilometre-long lighted tunnel with a motorcycle on rails. The planning for the escape was extensive, prosecutors say, with his wife playing a key role.

Court papers charge that Coronel Aispuro worked with Guzman’s sons and a witness, who is now co-operating with the U.S. government, to organize the construction of the underground tunnel that Guzman used to escape from the Altiplano prison in Mexico to prevent him from being extradited to the U.S.

The plot included purchasing a piece of land near the prison, firearms and an armoured truck and smuggling him a GPS watch so they could “pinpoint his exact whereabouts so as to construct the tunnel with an entry point accessible to him,” the court papers say.


Coronel Aispuro is accused of helping her husband, Mexican drug kingpin Joaquin ‘El Chapo’ Guzman, escape from prison in 2015. (Henry Romero/Reuters)

Guzman was sentenced to life behind bars in 2019. His Sinaloa cartel was responsible for smuggling mountains of cocaine and other drugs into the United States under his 25-year leasdership, prosecutors said in recent court papers. They also said his “army of sicarios,” or “hit men,” was under orders to kidnap, torture and kill anyone who got in his way.

Coronel Aispuro, a former teen beauty queen, regularly attended Guzman’s trial, even when testimony cast her in a harsh light. The two, separated in age by more than 30 years, have been together since at least 2007 and have twin daughters, who were born in 2011.

Her father, Ines Coronel Barreras, was arrested in Mexico in 2013 with one of his sons and several other men in a warehouse with hundreds of pounds of marijuana across the border from Douglas, Ariz. Months earlier, the U.S. Treasury had announced financial sanctions against Coronel Barreras for his alleged drug trafficking.

After Guzman was re-arrested following his escape, Coronel Aispuro lobbied the Mexican government to improve her husband’s prison conditions. And after he was convicted in 2019, she moved to launch a clothing line in his name.

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Roche arthritis drug cuts deaths in hospitalized COVID-19 patients, study suggests

Roche’s arthritis drug tocilizumab cuts the risk of death among patients hospitalized with severe COVID-19, also shortening the time to recovery and reducing the need for mechanical ventilation, results of a large trial showed on Thursday.

The findings — from the U.K.-based RECOVERY trial, which has been testing a range of potential treatments for COVID-19 since March 2020 — should help clear up confusion about whether tocilizumab has any benefit for COVID-19 patients after a slew of recent mixed trial results.

“We now know that the benefits of tocilizumab extend to all COVID patients with low oxygen levels and significant inflammation,” said Peter Horby, a professor of emerging infectious diseases at Oxford University and the joint lead investigator on the RECOVERY trial.

In June last year, the RECOVERY trial found that the cheap and widely available steroid dexamethasone reduced death rates by around a third among the most severely ill COVID-19 patients. That drug has since rapidly became part of standard-of-care recommended for severe patients.

Tocilizumab, sold under the brand name Actemra, is an intravenous anti-inflammatory monoclonal antibody drug used to treat rheumatoid arthritis. It was added to the trial in April 2020 for patients with COVID-19 who required oxygen and had evidence of inflammation.

The study included from 2,022 COVID-19 patients who were randomly allocated to receive tocilizumab by intravenous infusion, and who were compared with 2,094 patients randomly allocated to usual care alone. Researchers said 82 per cent of all patients were taking a systemic steroid such as dexamethasone.

Results showed that treatment with tocilizumab significantly reduced deaths — with 596 (29 per cent) of the patients in the tocilizumab group dying within 28 days, compared with 694 (33 per cent) patients in the usual care group.

This translates to an absolute difference of four per cent. It also means that for every 25 patients treated with tocilizumab, one additional life would be saved, Horby and his co-lead investigator Martin Landray said.

They added that benefits of tocilizumab were clearly seen to be in addition to those of steroids.

WATCH | Progress and setbacks in treating COVID-19:

While vaccines can prevent recipients from getting sick, finding and approving treatments for the virus has been difficult. 2:06

“Used in combination, the impact is substantial,” said Landray, who is also an Oxford professor of medicine and epidemiology.

Roche’s drug division chief Bill Anderson said last week that previous mixed results were likely due to differences in the type of patients studied, when they were treated, and the endpoint — the juncture at which success or failure is measured.

“We think we’re sort of zooming in on both the most relevant endpoints and relevant patient population,” Anderson said. “It seems like the ideal candidates are patients who are really in that acute phase of inflammatory attack.”

Drug used for some patients with COVID-19 in Canada

Actemra, along with Sanofi’s similar drug Kevzara, was authorized by Britain’s NHS in early January for COVID-19 patients in intensive care units after preliminary data from a smaller study called REMAP-CAP indicated it could reduce hospital stays by about 10 days.

The researchers said preliminary results will be made available on the medRxiv preprint server shortly and submitted to a peer-reviewed medical journal.

Dr. Niall Ferguson, head of critical care at Toronto’s University Health Network and Sinai Health System, sees potential in early data for tocilizumab, which is approved for use in Canada to treat rheumatoid arthritis.

Although evolving data has been mixed and is still emerging, Ferguson noted last week that the monoclonal antibody is already being used off-label for some severe patients in Toronto.

“It’s happening on a bit of an ad hoc basis when patients are caught at the right time and look like they may have a bit of
additional inflammation going on that could be set aside with this drug,” said Ferguson, who looks after the most severe COVID-19 cases at Toronto General Hospital.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine who was not directly involved in the U.K. trial, said its results were important.
 
“It is a large trial and the benefits were seen both on earlier discharge from hospital and mortality,” he said. “The 
magnitude of benefit is not startling but is clinically important, with a reduction in deaths from 33 per cent to 29 per cent.” 
 

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Eli Lilly’s COVID-19 antibody drug gets interim authorization in Canada

Canada has granted interim authorization to Eli Lilly’s antibody drug for treating COVID-19 in patients who are not hospitalized but are at risk of serious illness because of their age or other conditions, the drug-maker said on Friday.

The news comes weeks after the treatment, bamlanivimab, was given U.S. emergency use authorization by the Food and Drug Administration for helping newly diagnosed, high-risk patients avoid hospitalization.

Bamlanivimab was developed in partnership with Canadian biotech company AbCellera.

The Health Canada authorization was based on a clinical study in patients with mild-to-moderate COVID-19, where patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization.

The drug is a monoclonal antibody — a widely used class of biotech drugs — which in this case is a manufactured copy of an antibody the human body creates to fight infections.

“This authorization in Canada furthers our goal of making bamlanivimab available to patients who need it around the world and is evidence of the strong collaboration between industry and governments to get COVID-19 medicines to people as quickly as possible,” David A. Ricks, Lilly’s chair and CEO, said in a statement issued Friday.

WATCH | How well will COVID-19 vaccines work in the real world?

Infectious disease specialists answer questions about COVID-19 vaccines including if results from clinical trials will hold up in the real world. 6:49

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Philippines’ Duterte says he can be held responsible for drug killings

The Philippine president has said he has no problem with being held responsible for the many killings under his anti-drugs crackdown, adding that he was ready to face charges that could land him in jail, though not charges of crimes against humanity.

President Rodrigo Duterte’s televised remarks Monday night were among his clearest acknowledgement of the prospects that he could face a deluge of criminal charges for the bloody campaign he launched after taking office in mid-2016. Nearly 6,000 killings of drug suspects have been reported by police but rights watchdogs suspect the death toll is far larger.

“If there’s killing there, I’m saying I’m the one … you can hold me responsible for anything, any death that has occurred in the execution of the drug war,” Duterte said.

‘I have no problem’

“If you get killed it’s because I’m enraged by drugs,” the tough-talking president said. “If that’s what I’m saying, bring me to court to be imprisoned. Fine, I have no problem. If I serve my country by going to jail, gladly.”

At least two complaints for crimes against humanity and mass murder in connection with Duterte’s campaign are being examined by an International Criminal Court prosecutor, who will determine whether there is enough evidence to open a full-scale investigation.

Duterte responded to the complaints by withdrawing the Philippines from the world tribunal two years ago in a move that human rights groups said was a major setback in the country’s battle against impunity. The ICC prosecutor has said the examination into the drug killings would continue despite the Philippine withdrawal.

Duterte asked Monday when did “drugs become humanity?”

Says drugs a security threat

He framed his remarks by portraying the drug menace as a national security and public threat like the decades-long communist insurgency that the government is obligated to quell.

“If this is allowed to go on and on and if no decisive action is taken against them, it will endanger the security of the state,” said Duterte, a former government prosecutor.

“When you save your country from the perdition of the people like the NPAs and drugs, you are doing a sacred duty,” he said, referring to communist New People’s Army insurgents.

There are 1.6 million drug addicts in the Philippines, Duterte said, citing statistics from an anti-narcotics agency. The figure is much smaller than the 4 million addicts that he cited the police as reporting early in his presidency to justify his crackdown.

Police have reported at least 5,856 drug suspects have been killed in raids and more than 256,000 others arrested since the start of the crackdown. Human rights groups have accused authorities of considerably under reporting the deaths.

Duterte said drug killings that did not happen during police operations should not be blamed on him, adding those deaths may have been set off by gang rivalries or settling of scores.

There have been widespread suspicions of extrajudicial killings in the crackdown, allegations that Duterte and the police deny. In 2018, a court convicted three police officers of murdering a 17-year-old student after witnesses and a security video disproved their claim that the suspect was shot after violently resisting, a common reason cited by police officers after drug suspects are killed.

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Health Canada authorizes drug remdesivir for severe COVID-19 cases

Health Canada has authorized with conditions the drug remdesivir for patients with severe COVID-19, though Canada’s top doctor says the supply is limited.

The drug — which will go by the brand name Veklury — is manufactured by Gilead Sciences Canada.

On Tuesday, Health Canada announced the drug is now authorized for use in adults and adolescents aged 12 years and older with a body weight of at least 40 kilograms. 

The company did not seek permission to use the drug to treat pregnant women or children under 12.

In April, a study run by the U.S. National Institutes of Health tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. It found that the drug reduced the time it takes patients to recover by 31 per cent  — 11 days on average versus 15 days for those just given usual care.

But Dr. Theresa Tam, chief public health officer of Canada, warned that “the supply with this company is very low globally.”

WATCH | U.S. buys global supply of remdesivir:

The U.S. has bought the global supply of remdesivir, an antiviral drug that has been found to help certain patients recover more quickly from COVID-19. 4:20

Remdesivir is administered intravenously and used only in health-care facilities where patients can be closely monitored.

“It’s not something people can go out and access by themselves,” Tam said Tuesday during a press conference.

Because the drug has been given an expedited review, the manufacturer will have to ensure the continued safety, efficacy and quality of the drug, a statement by Health Canada said

Some already treated with drug

Remdesivir has also been granted emergency or conditional authorization in the U.S., Europe, Australia, Singapore and Japan.

In Canada, a small number of patients have been or are being treated with the drug under the Special Access Program.

Asked about reports the drug will be expensive, Tam said that may be the case, but the price will be subject to “appropriate reviews.”

“I am aware some of these drugs are going to cost a fair amount of money,” Tam said. “We have to look at access, as well as what’s a reasonable price.”

Matthias Götte, professor and chair of the medical microbiology and immunology department at the University of Alberta, said the drug’s approval is “excellent news.”

“I guess there’s no doubt this is really the the only antiviral agent with with a clear-cut advantage shown in the large clinical trial,” he said. 

Götte explained that the drug targets what he calls “the engine of the virus.”

“This is an enzyme that is absolutely required for replication of the virus, for spread and so forth. So if you target that engine, the virus cannot spread, cannot replicate.” 

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24 killed in attack on drug rehab centre in Mexico

Gunmen burst into an unregistered drug rehabilitation centre in central Mexico and opened fire Wednesday, killing 24 people and wounding seven, authorities said.

Police in the north-central state of Guanajuato said the attack occurred in the city of Irapuato. Three of the seven wounded were reported in serious condition.

Apparently the attackers shot everyone at the rehab centre. State police said nobody was abducted. Photos purporting to show the scene suggest those at the centre were lying down when they were sprayed with bullets.

Guanajuato is the scene of a bloody turf battle between the Jalisco cartel and a local gang, and the state has become the most violent in Mexico.

No motive was given in the attack, but Gov. Diego Sinhue Rodriguez Vallejo said drug gangs appeared to have been involved.

“I deeply regret and condemn the events in Irapuato this afternoon,” Sinhue wrote. “The violence generated by organized crime not only takes the lives of the young, but it takes the peace from families in Guanajuato.”

Previous attacks on rehab centres

Mexican drug gangs have killed suspected street-level dealers from rival gangs sheltering at such facilities in the past. It was one of the deadliest attacks on a rehab centre since 19 people were killed in 2010 in Chihuahua city in northern Mexico. More than a dozen attacks on such facilities have occurred since then.

Mexico has long had problems with rehab centres because most are privately run, underfunded and often commit abuses against recovering addicts. The government spends relatively little money on rehabilitation, often making the unregistered centres the only option available for poor families.

In addition, addicts and dealers who face attacks from rivals on the streets sometimes take refuge at the rehab clinics, making the clinics themselves targets for attack. Still other gangs have been accused of forcibly recruiting recovering addicts at the centres as dealers, and killing them if they refused.

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Halt drug possession charges during pandemic to stem spike in overdose deaths, advocates say

More than 50 human rights, drug and legal policy groups are pushing the federal government to halt criminal charges for simple drug possession as part of its response to COVID-19, arguing the pandemic has led to more dangerous drug use practices and a spike in overdose deaths.

In a letter to Health Minister Patty Hajdu, Public Safety Minister Bill Blair and Justice Minister David Lametti, the organizations say COVID-19 has forced supervised consumption sites and safe needle programs to either close down or reduce their hours.

Additional street-level policing to enforce pandemic public health measures has also increased fears of arrest, causing many drug users to forego safety precautions or consume alone.

“Heightened law enforcement surveillance in the context of the pandemic further hampers their access to vital health services and ability to use drugs safely, while also increasing their risk of arrest and detention,” the letter reads.

“Not surprisingly, some cities are already seeing reports of increasing overdose deaths since the onset of the COVID-19 pandemic.”

The organizations report the situation is also increasing the risk of HIV and hepatitis C infections among intravenous drug users at a time when Canada is already battling another public health emergency — the opioid crisis.

Between January 2016 and September 2019, there were about 14,700 opioid-related deaths across the country.

Cities reporting spike in overdoses

Many cities, including Toronto, are reporting a rise in suspected overdoses and deaths over March and April of this year, after a widespread shutdown of businesses and support services was imposed in response to the pandemic. 

The groups that signed the letter — which include Amnesty International, the Canadian Nurses Association, the Canadian Public Health Association and the Criminal Lawyers’ Association — say the Controlled Drugs and Substances Act gives the federal health minister the authority to issue an exemption for criminal charges “on the basis that it is necessary for a medical or scientific purpose or is otherwise in the public interest.” 

In  2015, the government granted exemptions for supervised consumption services using that same section of the act. 

The groups say the federal cabinet also could issue a directive.

Harm reduction advocates have been pushing federal officials to decriminalize simple drug possession for years, arguing that such a move would offer major public health advantages while posing few risks to public safety.

“We’ve wanted (the government) to decriminalize simple drug possession more broadly, but we think now there’s even more urgency given the increase in deaths,” said Sandra Ka Hon Chu, director of research and advocacy at the Canadian HIV/AIDS Legal Network.

“The fact that people who use drugs are more often in public spaces means they’re more vulnerable to police surveillance, potential harassment or detention. And the last place we want them to be at this point is detention.”

Limiting the spread in jails, prisons

Ka Hon Chu said it would make little sense to put drug users in jail when provincial and federal prisons are taking steps to depopulate to limit the spread of COVID-19 behind bars.

The confined environment in detention – coupled with the fact that many incarcerated people have chronic health conditions – has led many to warn that the virus could spread quickly behind bars and lead to severe symptoms.

People who use drugs, especially those who are homeless or have precarious housing arrangements, are more likely to have the kind of chronic health issues that make them prone to developing severe symptoms if they’re infected with the virus, the groups say.

An expert in the United Nations Office of the Commissioner for Human Rights issued a statement last month outlining the additional risks that people who use drugs face during the pandemic. It said the COVID-19 crisis requires countries to take “extraordinary measures” to protect their health.

“To prevent unnecessary intake of prisoners and unsafe drug consumption practices, moratoria should be considered on enforcement of laws criminalizing drug use and possession,” the April 16 statement reads.

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Antiviral drug remdesivir shortens time to recover from pandemic virus, top U.S. health official says

A top U.S. health official said Gilead Sciences Inc’s experimental antiviral drug remdesivir is likely to become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped certain patients recover more quickly from the illness caused by the coronavirus.
 
The study, run by the U.S. National Institutes of Health, tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. At the White House, NIH’s Dr. Anthony Fauci said the drug reduced the time it takes patients to recover by 31 per cent  — 11 days on average versus 15 days for those just given usual care.
 
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness. The statement sent its shares up seven per cent on the Nasdaq.
 
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.”
 
“This will be the standard of care,” Fauci predicted, adding, “The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
 
Several studies have painted a mixed picture of its effectiveness, and Fauci cautioned that the full data still needs to be analyzed.

“Although with 31 per cent improvement doesn’t seem like a knockout 100 per cent, it is a very important proof of concept, because what it is proven is that a drug can block this virus.”

 
 
U.S. President Donald Trump during a White House meeting greeted Gilead’s reports as good news.
 
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can 
shut down other organs in severe cases, until a preventive vaccine emerges.

In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. (Gilead Sciences/Associated Press)


 
“There’s now enough data to support consideration of access under an emergency use authorization by FDA,” former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter.
 
Gilead provided information on two clinical trials. The study conducted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.



 
Those preliminary results have been highly anticipated because it compares how patients who received remdesivir fared versus those given a placebo, meaning it should definitively demonstrate whether the drug provides benefit.
 
“It is the first truly high-powered randomized placebo-controlled trial,” Fauci said.
 
The trial’s lead researcher told Reuters on Friday that full results could come by mid-May.       

Mixed results

Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, said more information is needed.
 
“While a new study offers a glimmer of hope that … remdesivir has an effect against COVID-19, determination of its benefit for the general population must await release of pertinent details to evaluate the study’s findings and 
scientific analysis comparing them to other studies of the drug that have shown mixed results,” he said in a statement.

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Dr. Nadia Alam of Georgetown, Ont., describes how one elderly patient didn’t want to be on a ventilator and how her children are afraid that she, too, may get sick. 10:28
 
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centres, which does not have a placebo comparison but tested the drug given by intravenous infusion under five-day and 10-day regimens.
 
In that 397-patient trial, Gilead said 62 per cent of patients treated early with remdesivir were discharged from the hospital, compared with 49 per cent of patients who were treated later in the course of the infection.
 
Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
 
Also on Wednesday, results were published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Gilead said previously that those findings, released inadvertently by the World Health Organization last week, were inconclusive because the study was terminated early.
 
Gilead chief executive Daniel O’Day earlier this month said the company was prepared to donate 1.5 million doses of remdesivir to hospitals dealing with severely ill patients. Regulatory approval of the drug would also clear the way for commercial sales.
 
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host’s immune system.
 
The company is also studying the drug in patients with less severe COVID-19, but those results are not expected until later next month. 

Dr Mike Ryan, head of the WHO’s emergencies program, told an online briefing it can sometimes take a number of publications to determine a drug’s efficacy.
 
“Clearly we have the randomized control trials that are underway both in the U.K. and U.S, the ‘Solidarity trials’ with WHO. Remdesivir is one of the drugs under observation in many of those trials. So I think a lot more data will come out,” he said.
 
Ryan added: “But we are hopeful this drug and others may prove to be helpful in treating COVID-19.” 

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