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Want to join a coronavirus vaccine trial? Consider these 5 things first. – The Daily Briefing

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The United States’ effort to produce a coronavirus vaccine is in full throttle, and drugmakers are now seeking hundreds of thousands of volunteers to test their experimental candidates. Writing for the New York Times, Heather Murphy addresses five things patients should know before volunteering for a coronavirus vaccine trial.

Is it ethical to infect volunteers with the new coronavirus? Experts weigh in.

1. How vaccine clinical trials works

Vaccine clinical trials have three phases, Murphy notes, and participating in a Phase 1 trial would mean you’re one of the first people to receive an experimental vaccine. According to Murphy, Phase 1 vaccine trials typically focus on safety, looking to see whether the vaccine candidate causes humans to experience negative side effects. If you participate in a Phase 1 vaccine trial, researchers “[t]ypically … will monitor you and a few dozen other subjects closely after each dose, and then check in periodically for about a year,” Murphy writes.

Researchers usually use Phase 2 trials to further observe any potential side effects of experimental vaccines and to see whether a vaccine candidate generates an immune response, Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and leader of the Covid-19 Prevention Network, told Murphy. These trials typically involve a few hundred participants.

But even if vaccine candidates in Phase 2 trials cause participants to generate an immune response, that doesn’t necessarily mean the experimental vaccines will protect participants against infection from the targeted pathogen—in this case, the novel coronavirus.

That’s where Phase 3 clinical trials come in, according to Murphy. For Phase 3 trials, researchers look to enroll up to hundreds of thousands of participants and seek to determine whether the vaccine effectively prevents infection. Researchers will administer their vaccine candidates to at least half of the participants, forming a test group. The remaining participants receive a placebo or alternative treatment and serve as the trial’s control group.

In Phase 3 trials for coronavirus vaccine candidates, researchers won’t expose any of the participants to the virus intentionally. Instead, researchers intend to enroll a lot of participants from locations with high numbers of coronavirus cases. The researchers will track participants in both the test and control groups to see how many contract the new coronavirus. The researchers then will try to determine whether the experimental vaccine reduced the frequency of infection or the severity of Covid-19, the disease caused by the coronavirus, among the test group when compared with the control group.

Currently, there are no ongoing trials in which participants are intentionally exposed to the novel coronavirus, Murphy writes. Clinical trials in which participants are intentionally exposed to pathogens, which are known as challenge trials, have been the subject of a long-standing debate—and they’ve invoked particular concern when it comes to the new coronavirus, because there currently is no proven treatment or cure for Covid-19, which can be deadly.

However, some public health experts have argued that challenge trials could speed up the vaccine development and approval processes, and researchers at Oxford University in July announced that they would soon start recruiting participants for a coronavirus vaccine challenge trial. Some drugmakers in the United States have said they, too, are considering conducting such trials.

2. You can’t guarantee you’ll be in a test group

Murphy notes that, because vaccine candidates are experimental, “there’s no guarantee that you’ll actually be protected from the coronavirus at any phase” of a vaccine clinical trial. Moreover, if you participate in a Phase 3 trial, you may end up in the control group, meaning you won’t receive the vaccine candidate.

Nir Eyal, director of the Center for Population-Level Bioethics at the Rutgers School of Public Health, explained that control groups are a required to assess the effectiveness of an experimental vaccine. Without a control group, the trial would tell researchers “basically nothing,” Eyal told Murphy.

3. You’ll get paid—but you’ll also face risks

Participants in clinical trials for coronavirus vaccine candidates will be compensated, Murphy writes, and the amount participants will receive “varies by the trial.” According to Murphy, the amount can range from between a few hundred dollars to a few thousand dollars.

Daniel Hoft, director of the Saint Louis University Center for Vaccine Development, told Murphy that researchers pay trial participants to compensate them for their “time and trouble.”

But Arthur Caplan, a bioethicist, warned that people who find the compensation as an “extraordinarily attractive” incentive to participate in a vaccine trial also need to consider the risks associated with receiving an experimental vaccine. “You don’t want to let compensation blind you to the need to pay attention to the risks.”

4. You may end up paying the costs for care if you have an adverse reaction

While participants will be compensated for taking part in a vaccine clinical trial, if they have an adverse reaction to a vaccine candidate, it’s possible that they’ll be on the hook for the costs of any care they receive for the reaction.

“Insurance companies will rarely pay anything if you are hurt in an experiment,” Caplan said. And if the vaccine developer agrees to cover any costs related to care for an adverse reaction, they typically commit only to reimbursing a participant’s health insurer for those costs, he explained.

Corey recommends that people ask trial administrators about what compensation or support they’ll receive if they are harmed by the vaccine candidate.

Corey also noted that, in some instances, participants who are harmed by an experimental vaccine may be eligible for restitution under the Public Readiness and Preparedness Act or, in the case of experimental coronavirus vaccines, under the federal government’s epidemic relief fund.

5. How to enroll

People looking to enroll in a coronavirus vaccine trial can visit ClinicalTrials.gov, which lists all coronavirus vaccine studies that are currently active. In addition, the National Institute of Allergy and Infectious Diseases has established the Covid-19 Prevention Network website to connect volunteers to coronavirus vaccine trials.

Further, COVID Dash—which is managed by a group of clinical researchers, doctors, and students trying to encourage people to volunteer in coronavirus clinical trials—is a portal that helps people volunteer for coronavirus-related studies throughout the world, Murphy writes.

Murphy also notes that people can visit the 1 Day Sooner website to sign up for future coronavirus vaccine challenge trials (Murphy, New York Times, 8/5).

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Health Canada approves updated Moderna COVID-19 vaccine

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TORONTO – Health Canada has authorized Moderna’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The mRNA vaccine, called Spikevax, has been reformulated to target the KP.2 subvariant of Omicron.

It will replace the previous version of the vaccine that was released a year ago, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Health Canada is also reviewing two other updated COVID-19 vaccines but has not yet authorized them.

They are Pfizer’s Comirnaty, which is also an mRNA vaccine, as well as Novavax’s protein-based vaccine.

This report by The Canadian Press was first published Sept. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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These people say they got listeria after drinking recalled plant-based milks

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TORONTO – Sanniah Jabeen holds a sonogram of the unborn baby she lost after contracting listeria last December. Beneath, it says “love at first sight.”

Jabeen says she believes she and her baby were poisoned by a listeria outbreak linked to some plant-based milks and wants answers. An investigation continues into the recall declared July 8 of several Silk and Great Value plant-based beverages.

“I don’t even have the words. I’m still processing that,” Jabeen says of her loss. She was 18 weeks pregnant when she went into preterm labour.

The first infection linked to the recall was traced back to August 2023. One year later on Aug. 12, 2024, the Public Health Agency of Canada said three people had died and 20 were infected.

The number of cases is likely much higher, says Lawrence Goodridge, Canada Research Chair in foodborne pathogen dynamics at the University of Guelph: “For every person known, generally speaking, there’s typically 20 to 25 or maybe 30 people that are unknown.”

The case count has remained unchanged over the last month, but the Public Health Agency of Canada says it won’t declare the outbreak over until early October because of listeria’s 70-day incubation period and the reporting delays that accompany it.

Danone Canada’s head of communications said in an email Wednesday that the company is still investigating the “root cause” of the outbreak, which has been linked to a production line at a Pickering, Ont., packaging facility.

Pregnant people, adults over 60, and those with weakened immune systems are most at risk of becoming sick with severe listeriosis. If the infection spreads to an unborn baby, Health Canada says it can cause miscarriage, stillbirth, premature birth or life-threatening illness in a newborn.

The Canadian Press spoke to 10 people, from the parents of a toddler to an 89-year-old senior, who say they became sick with listeria after drinking from cartons of plant-based milk stamped with the recalled product code. Here’s a look at some of their experiences.

Sanniah Jabeen, 32, Toronto

Jabeen says she regularly drank Silk oat and almond milk in smoothies while pregnant, and began vomiting seven times a day and shivering at night in December 2023. She had “the worst headache of (her) life” when she went to the emergency room on Dec. 15.

“I just wasn’t functioning like a normal human being,” Jabeen says.

Told she was dehydrated, Jabeen was given fluids and a blood test and sent home. Four days later, she returned to hospital.

“They told me that since you’re 18 weeks, there’s nothing you can do to save your baby,” says Jabeen, who moved to Toronto from Pakistan five years ago.

Jabeen later learned she had listeriosis and an autopsy revealed her baby was infected, too.

“It broke my heart to read that report because I was just imagining my baby drinking poisoned amniotic fluid inside of me. The womb is a place where your baby is supposed to be the safest,” Jabeen said.

Jabeen’s case is likely not included in PHAC’s count. Jabeen says she was called by Health Canada and asked what dairy and fresh produce she ate – foods more commonly associated with listeria – but not asked about plant-based beverages.

She’s pregnant again, and is due in several months. At first, she was scared to eat, not knowing what caused the infection during her last pregnancy.

“Ever since I learned about the almond, oat milk situation, I’ve been feeling a bit better knowing that it wasn’t something that I did. It was something else that caused it. It wasn’t my fault,” Jabeen said.

She’s since joined a proposed class action lawsuit launched by LPC Avocates against the manufacturers and sellers of Silk and Great Value plant-based beverages. The lawsuit has not yet been certified by a judge.

Natalie Grant and her seven year-old daughter, Bowmanville, Ont.

Natalie Grant says she was in a hospital waiting room when she saw a television news report about the recall. She wondered if the dark chocolate almond milk her daughter drank daily was contaminated.

She had brought the girl to hospital because she was vomiting every half hour, constantly on the toilet with diarrhea, and had severe pain in her abdomen.

“I’m definitely thinking that this is a pretty solid chance that she’s got listeria at this point because I knew she had all the symptoms,” Grant says of seeing the news report.

Once her daughter could hold fluids, they went home and Grant cross-checked the recalled product code – 7825 – with the one on her carton. They matched.

“I called the emerg and I said I’m pretty confident she’s been exposed,” Grant said. She was told to return to the hospital if her daughter’s symptoms worsened. An hour and a half later, her fever spiked, the vomiting returned, her face flushed and her energy plummeted.

Grant says they were sent to a hospital in Ajax, Ont. and stayed two weeks while her daughter received antibiotics four times a day until she was discharged July 23.

“Knowing that my little one was just so affected and how it affected us as a family alone, there’s a bitterness left behind,” Grant said. She’s also joined the proposed class action.

Thelma Feldman, 89, Toronto

Thelma Feldman says she regularly taught yoga to friends in her condo building before getting sickened by listeria on July 2. Now, she has a walker and her body aches. She has headaches and digestive problems.

“I’m kind of depressed,” she says.

“It’s caused me a lot of physical and emotional pain.”

Much of the early days of her illness are a blur. She knows she boarded an ambulance with profuse diarrhea on July 2 and spent five days at North York General Hospital. Afterwards, she remembers Health Canada officials entering her apartment and removing Silk almond milk from her fridge, and volunteers from a community organization giving her sponge baths.

“At my age, 89, I’m not a kid anymore and healing takes longer,” Feldman says.

“I don’t even feel like being with people. I just sit at home.”

Jasmine Jiles and three-year-old Max, Kahnawake Mohawk Territory, Que.

Jasmine Jiles says her three-year-old son Max came down with flu-like symptoms and cradled his ears in what she interpreted as a sign of pain, like the one pounding in her own head, around early July.

When Jiles heard about the recall soon after, she called Danone Canada, the plant-based milk manufacturer, to find out if their Silk coconut milk was in the contaminated batch. It was, she says.

“My son is very small, he’s very young, so I asked what we do in terms of overall monitoring and she said someone from the company would get in touch within 24 to 48 hours,” Jiles says from a First Nations reserve near Montreal.

“I never got a call back. I never got an email”

At home, her son’s fever broke after three days, but gas pains stuck with him, she says. It took a couple weeks for him to get back to normal.

“In hindsight, I should have taken him (to the hospital) but we just tried to see if we could nurse him at home because wait times are pretty extreme,” Jiles says, “and I don’t have child care at the moment.”

Joseph Desmond, 50, Sydney, N.S.

Joseph Desmond says he suffered a seizure and fell off his sofa on July 9. He went to the emergency room, where they ran an electroencephalogram (EEG) test, and then returned home. Within hours, he had a second seizure and went back to hospital.

His third seizure happened the next morning while walking to the nurse’s station.

In severe cases of listeriosis, bacteria can spread to the central nervous system and cause seizures, according to Health Canada.

“The last two months have really been a nightmare,” says Desmond, who has joined the proposed lawsuit.

When he returned home from the hospital, his daughter took a carton of Silk dark chocolate almond milk out of the fridge and asked if he had heard about the recall. By that point, Desmond says he was on his second two-litre carton after finishing the first in June.

“It was pretty scary. Terrifying. I honestly thought I was going to die.”

Cheryl McCombe, 63, Haliburton, Ont.

The morning after suffering a second episode of vomiting, feverish sweats and diarrhea in the middle of the night in early July, Cheryl McCombe scrolled through the news on her phone and came across the recall.

A few years earlier, McCombe says she started drinking plant-based milks because it seemed like a healthier choice to splash in her morning coffee. On June 30, she bought two cartons of Silk cashew almond milk.

“It was on the (recall) list. I thought, ‘Oh my God, I got listeria,’” McCombe says. She called her doctor’s office and visited an urgent care clinic hoping to get tested and confirm her suspicion, but she says, “I was basically shut down at the door.”

Public Health Ontario does not recommend listeria testing for infected individuals with mild symptoms unless they are at risk of developing severe illness, such as people who are immunocompromised, elderly, pregnant or newborn.

“No wonder they couldn’t connect the dots,” she adds, referencing that it took close to a year for public health officials to find the source of the outbreak.

“I am a woman in my 60s and sometimes these signs are of, you know, when you’re vomiting and things like that, it can be a sign in women of a bigger issue,” McCombe says. She was seeking confirmation that wasn’t the case.

Disappointed, with her stomach still feeling off, she says she decided to boost her gut health with probiotics. After a couple weeks she started to feel like herself.

But since then, McCombe says, “I’m back on Kawartha Dairy cream in my coffee.”

This report by The Canadian Press was first published Sept. 16, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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B.C. mayors seek ‘immediate action’ from federal government on mental health crisis

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VANCOUVER – Mayors and other leaders from several British Columbia communities say the provincial and federal governments need to take “immediate action” to tackle mental health and public safety issues that have reached crisis levels.

Vancouver Mayor Ken Sim says it’s become “abundantly clear” that mental health and addiction issues and public safety have caused crises that are “gripping” Vancouver, and he and other politicians, First Nations leaders and law enforcement officials are pleading for federal and provincial help.

In a letter to Prime Minister Justin Trudeau and Premier David Eby, mayors say there are “three critical fronts” that require action including “mandatory care” for people with severe mental health and addiction issues.

The letter says senior governments also need to bring in “meaningful bail reform” for repeat offenders, and the federal government must improve policing at Metro Vancouver ports to stop illicit drugs from coming in and stolen vehicles from being exported.

Sim says the “current system” has failed British Columbians, and the number of people dealing with severe mental health and addiction issues due to lack of proper care has “reached a critical point.”

Vancouver Police Chief Adam Palmer says repeat violent offenders are too often released on bail due to a “revolving door of justice,” and a new approach is needed to deal with mentally ill people who “pose a serious and immediate danger to themselves and others.”

This report by The Canadian Press was first published Sept. 16, 2024

The Canadian Press. All rights reserved.

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