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‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Fernie Free Press

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At age 70, retired nurse Donna Lessard can expect to be towards the front of the line for a COVID-19 vaccine when supply and distribution expands in coming months.

But instead, she’s opted for an unproven vaccine candidate she can have now – a two-dose product by the Quebec City-based biopharmaceuticalMedicago currently running Phase 2 clinical trials.

Because the trials are blinded, the Montrealer doesn’t know if last month she received a second dose of the prospective vaccine or a placebo, and may not know for a year – well after most Canadians are expected to receive one of several licensed vaccines.

Lessard admits her decision could put her at risk of COVID-19 infection much longer than other seniors, but says there are many people who need approved vaccines more urgently than she does.

“I’m not in a nursing home, I’m in excellent health,” says Lessard, who was a nurse for 50 years before retiring in 2020. “There are a lot of other people, rightly so, that would go before me.”

Despite the willingness of senior trial participants like Lessard, whether and how to include seniors in COVID-19 vaccine trials poses thorny ethical questions now that effective vaccines are available and more are soon to come, says University of Toronto bioethicist Kerry Bowman.

Seniors, by far, have been hardest hit by the novel coronavirus, with about 70 per cent of Canada’s COVID-19 deaths involving people aged 80 and older, and nearly 20 per cent between the ages of 70 and 80.

The emergence of more infectious variants adds even more uncertainty to the pandemic, especially after one version was linked to a devastating outbreak that engulfed a Barrie, Ont., long-term care facility and killed dozens of residents.

“I generally don’t think it’s justifiable right now having senior citizens in completely blinded trials,” says Bowman.

“We can’t fully quantify risks, which I think is significant…. The variants are the wild card now. We don’t even know which way this is going and the whole situation could get a lot worse very quickly.”

Still, there can be exceptions for healthy volunteers such as Lessard, especially if the trial is designed to minimize potential harms, Bowman allows.

The Medicago trial limits its use of placebos as one way to do that – the company says that for every volunteer who gets a saline injection, five participants receive the proposed vaccine.

That’s instead of splitting volunteers equally between the placebo and treatment groups, more typical in double-blinded trials trying to assess how effective a proposed drug really is.

Given the risks posed by the ongoing pandemic, infectious disease physician Zain Chagla suggests it would more appropriate to compare vaccine hopefuls to already proven options, which in Canada are by Pfizer-BioNTech and Moderna.

It’s hard for researchers to say they’re not causing harm if they effectively deny someone a proven drug, says Chagla, an associate professor of medicine at McMaster University in Hamilton.

“Many of these trials will have to eventually have some implementation of a standard-of-care drug, which might be Pfizer,” Chagla says of placebo arms.

“And then at the end, make sure that everyone who got the (tested) drug also gets Pfizer,” says Chagla, adding the caveat that there are still uncertainties about what happens when someone takes two different COVID-19 vaccines.

All clinical trials undergo multiple ethics and protocol reviews by the drug developer and Health Canada to ensure patient safety remains paramount, says Karri Venn, president of research at LMC Manna Research, which is running multiple trials for various biotechs, including Medicago’s vaccine trial.

And trials don’t typically start with seniors or other vulnerable groups. Only if Phase 1 establishes safety among healthy adults would studies expand to older volunteers, with later trials adding in adolescents, children and pregnant women.

Venn says COVID-19 has added novel complications to scientific research, and suspects it could soon become difficult to recruit and keep seniors committed to clinical trials if they know an approved vaccine is imminent.

“This is for the first time posing a lot of challenges for the traditional way in how you would do research, to be honest with you,” says Venn, expecting some volunteers sign up planning to quit as soon as they’re eligible for other, approved options.

“They may say, ‘I’m going to take (this proposed vaccine) and in nine months I’m going to say, “You know what? Unblind me.”’ … There’s all of that happening, too. It’s a very unusual time.”

It’s very rare to unblind a participant partway through a trial, Venn adds, and if it does happen, it’s almost always for a medical or safety reason.

But all trials must release any participant who wants to quit, no matter the reason, she says, and their data wouldn’t be included in the final results.

Giving seniors a placebo is out of the question for Providence Therapeutics CEO Brad Sorenson, who is planning Phase 2 trials for his COVID-19 vaccine hopeful.

The head of the Calgary-based biotech says his recently launched Phase 1 safety trials include a placebo group, but no seniors. Phase 2 will likely include seniors but no placebos.

“We don’t want to include a placebo group for people that are older and at a higher risk. Not when there’s a vaccine that would be available to them,” says Sorenson, musing on a possible workaround.

“We can do a comparative study where they get either our vaccine or a Moderna vaccine.”

Assuming the trial can get its hands on these approved vaccines – allotments from Moderna and Pfizer are both facing significant distribution delays in Canada.

Bowman sympathizes with volunteers who consider unknown protections of a trial vaccine to be better than nothing. He suggests those who consent to the terms of clinical trials do so “under duress.”

“Before Christmas, we were told we’d be swimming in vaccines by now, and we’re really, really not,” says Bowman.

“People have to protect their own lives and well-being.”

READ MORE: Trudeau says government foresaw short-term delays in vaccine deliveries to Canada, planned accordingly

Still, concrete data on how seniors respond to prospective COVID-19 vaccines is crucial, especially with relatively few therapies and so much still uncertain about the disease, says Medicago’s senior director of scientific and medical affairs.

“I know it’s a big request, but it’s part of science and that’s how it works and that’s how we make sure the product is good, that the people receiving it are safe,” says Nathalie Charland.

“There are constraints related to the trial, we are aware of that, and that’s why we say a big thank you to all those who are involved in our trials.”

Charland says Medicago’s Phase 2 trial has already collected the data it needs from hundreds of senior volunteers in Canada and the United States, but recruiting the thousands more needed in Phase 3 will be tougher.

Half of the 30,000 participants needed are seniors, and half of all volunteers would get a placebo, she says.

“We are already planning for dropouts. We are very conscious that this might – and probably will – happen but Phase 3 is an efficacy trial so we have to go in regions of the world where the virus is circulating a lot,” she says, noting prospective sites include Latin America and Europe.

“It will be in countries where there’s not that many vaccines distributed yet. So that should help recruit subjects.”

Lessard suspects she got Medicago’s vaccine candidate, citing a slight headache and sore arm after the first dose and another sore arm after the second dose.

But she says that was not her primary reason for joining the trial, expressing hope her involvement will serve a greater public good.

“There’s a lot of fear around the COVID vaccines and we still hear people saying, ‘Oh, I’m not going to take the vaccine until it’s perfect,’” says Lessard.

“And my attitude is: Well, how are we going to get it perfect if nobody volunteers? And if not now, when? It’s got to be done now.”

Cassandra Szklarski, The Canadian Press


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Today's coronavirus news: Ontario reporting 192 cases of COVID-19, one death; Mostly spectator-free opening ceremony kicks off Tokyo Games – Orangeville Banner

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Why are Covid cases rising among double vaccinated? – Deccan Herald

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By Jamie Hartmann-Boyce for The Conversation,

Sir Patrick Vallance, the UK’s chief scientific adviser, has announced that 40 per cent of people admitted to hospital with Covid in the UK have had two doses of a coronavirus vaccine.

At first glance, this rings very serious alarm bells, but it shouldn’t. The vaccines are still working very well.

There are several factors at play that explain why such a high proportion of cases are in the fully vaccinated.

Covid vaccines are extremely effective, but none 100 per cent so. This itself isn’t surprising – flu vaccines aren’t 100 per cent effective either.

Yet in the US alone flu vaccines are estimated to prevent millions of cases of illness, tens of thousands of hospitalisations and thousands of deaths every year. The Covid vaccines are doing the same in the UK right now – all one has to do is compare the curves from the winter wave with those from this summer.

As cases are rising, hospitalisations and deaths are rising too, but not at anywhere near the same level as they were in the winter. In the second half of December 2020 – a time when UK case rates were similar to what they are now – about 3,800 people were being admitted to hospital with Covid each day.

The average now is around 700. So though that’s still higher than we wish it was, it’s a lot lower than it was the last time we had this many infections.

Covid is also growing among the vaccinated because the number of people in the UK who have had both doses is continuing to rise. At the time of writing, 88 per cent of UK adults have had a first dose and 69 per cent a second. As more and more of the population is vaccinated, the relative proportion of those with Covid who have had both jabs will rise.

If you imagine a hypothetical scenario in which 100 per cent of the population is double vaccinated, then 100 per cent of people with Covid, and in hospital with Covid, will also have had both jabs. As with deaths, this doesn’t mean the vaccine isn’t working. It just means the vaccine rollout is going very well.

Also read: WHO warns of ‘long term’ Covid impact on mental health

We also need to remember that the vaccine rollout in the UK has systematically targeted people at the highest risk from Covid.

Older people and people with health conditions that make them more vulnerable were the first to get vaccinated. Once vaccinated, these people (including me) are at much lower risk from Covid than they would have been otherwise – but they are still at risk.

That means that when we compare people with both vaccinations being hospitalised to those who haven’t had both doses, we aren’t comparing like with like. People with both vaccinations are more likely to have been at greater risk from Covid in the first place. This makes them both more likely to be hospitalised and more likely to have already received both of their vaccine doses.

Is Covid different in the vaccinated?

The latest data from Public Health England suggests that against the delta variant, which is now dominant in UK, two doses of any of the vaccines available in Britain are estimated to offer 79 per cent protection against symptomatic Covid and 96 per cent protection against hospitalisation.

We don’t have clear estimates yet from Public Health England on the level of protection against death caused by the delta variant – fortunately, this is partly driven by the fact deaths have been relatively low during this third wave in the UK.

But for the alpha variant, Public Health England data estimates the Pfizer vaccine to be between 95 per cent and 99 per cent effective at preventing death from Covid-19, with the AstraZeneca vaccine estimated to be between 75 per cent and 99 per cent effective. The evidence we have so far doesn’t suggest that the delta variant substantially changes this picture.

There’s lots we still need to learn about how people with both vaccine doses respond to getting infected with the virus. The UK’s Covid Symptom Study is looking at this.

One of the key questions that remain is who is at most risk. Emerging data – released in a preprint, so yet to be reviewed by other scientists – suggests people who are overweight or obese, poorer people, and people with health conditions causing frailty seem to be more likely to get infected after having both jabs.

The preprint also suggests that age itself doesn’t seem to affect chances of developing Covid after being vaccinated, nor does having a long-term condition such as asthma, diabetes or heart disease – but we need more data on this to be sure of these findings.

Generally, the Covid Symptom Study has found that people report the same Covid symptoms whether or not they’ve been vaccinated, but that people who’ve been vaccinated have fewer symptoms over a shorter period of time, suggesting less serious illness. The most commonly reported symptoms in people who had had both doses were headache, runny nose, sneezing, sore throat and loss of smell. 

(The author is a Senior Research Fellow, Departmental Lecturer and Director of Evidence-Based Healthcare DPhil Programme, Centre for Evidence-Based Medicine, University of Oxford)

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Canada’s and Zimbabwe’s paths for COVID-19 vaccination are worlds apart – The Globe and Mail

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A forklift carries a pallet of the Sinopharm COVID-19 vaccine from China upon its arrival at Robert Mugabe International airport in Harare.

Tsvangirayi Mukwazhi/The Associated Press

When mother-of-three Amanda Wood heard that hundreds of coronavirus shots were available for teens, only one thing prevented her from racing to the vaccination site at a Toronto high school – her 13-year-old daughter’s fear of needles.

Wood told Lola: If you get the vaccine you’ll be able to see your friends again. You’ll be able to play sports. And enticed by the promise of resuming a normal, teen life, Lola agreed.

In Zimbabwe, more than 8,000 miles (13,000 kilometers) and a world away from Canada, immunity is harder to obtain.

On a recent day, Andrew Ngwenya sat outside his home in a working-class township in Harare, the capital, pondering how he could save himself and his family from COVID-19.

Ngwenya and his wife De-egma had gone to a hospital that sometimes had spare doses. Hours later, fewer than 30 people had been inoculated. The Ngwenyas, parents of four children, were sent home, still desperate for immunization.

“We are willing to have it but we can’t access it,” he said. “We need it, where can we get it?”

The stories of the Wood and Ngwenya families reflect a world starkly divided between vaccine haves and have nots, between those who can imagine a world beyond the pandemic and those who can only foresee months and perhaps years of illness and death.

In one country, early stumbles in the fight against COVID-19 were overcome thanks to money and a strong public health infrastructure. In the other, poor planning, a lack of resources and the failure of a global mechanism intended to share scarce vaccines have led to a desperate shortage of COVID-19 shots – and oxygen tanks and protective equipment, as well.

With 70% of its adult population receiving at least one dose of a COVID-19 vaccine, Canada has among the world’s highest vaccination rate and is now moving on to immunize children, who are at far lower risk of coronavirus complications and death.

Meanwhile, only about 9% of the population in Zimbabwe has received one dose of coronavirus vaccine amid a surge of the easier-to-spread delta variant, first seen in India. Many millions of people vulnerable to COVID-19, including the elderly and those with underlying medical problems, are struggling to get immunized as government officials introduce more restrictive measures.

Ngwenya said the crush of people trying to get vaccinated is disheartening.

“The queue is like 5 kilometers (about 3 miles) long. Even if you are interested in a jab you can’t stand that. Once you see the queue you won’t try again,” he said

Vaccines weren’t always plentiful in Canada. With no domestic coronavirus vaccine production, the country got off to a sluggish start, with immunization rates behind those in Hungary, Greece and Chile. Canada was also the only G7 country to secure vaccines in the first round of deliveries by a U.N.-backed effort set up to distribute COVID-19 doses primarily to poor countries known as COVAX.

Prime Minister Justin Trudeau said it had always been Canada’s intention to secure vaccines through COVAX, after investing more than $400 million in the project. The vaccines alliance, Gavi, said COVAX was also meant to provide rich countries with an “insurance policy” in case they didn’t have enough shots.

COVAX’s latest shipment to Canada – about 655,000 AstraZeneca vaccines – arrived in May, shortly after about 60 poor countries were left in the lurch when the initiative’s supplies slowed to a trickle. Bangladesh, for example, had been awaiting a COVAX delivery of about 130,000 vaccines for its Rohingya refugee population; the shots never arrived after the Indian supplier ceased exports.

Canada’s decision to secure vaccines through the U.N.-backed effort was “morally reprehensible,” said Dr. Prabhat Jha, chair of global health and epidemiology at the University of Toronto. He said Canada’s early response to COVID-19 badly misjudged the need for control measures including aggressive contact tracing and border restrictions.

“If not for Canada’s purchasing power to procure vaccines, we would be in bad shape right now,” he said.

Weeks after the COVAX vaccines arrived, more than 33,000 doses were still sitting in warehouses in Ottawa after health officials recommended Canadians get shots made by Pfizer-BioNTech or Moderna instead – of which they had bought tens of millions of doses.

The Wood children got the Pfizer vaccine. When Canada began immunizing children aged 12 and over, Wood, who works with children in the entertainment industry and her architect husband didn’t hesitate.

Wood said her children, who are all avid athletes, have been unable to play much hockey, soccer or rugby during repeated lockdowns. Lola has missed baking lemon loaves and chocolate chip cookies with her grandmother, who lives three blocks away.

“We felt we had to do our part to keep everyone safe, to keep the elderly safe, and to get the economy going again and the kids back to school,” she said.

In Zimbabwe, there is no expectation of a return to normal anytime soon, and things are likely to get worse – Ngwenya worries about government threats to bar the unvaccinated from public services, including transport.

Although Zimbabwe was allocated nearly 1 million coronavirus vaccines through COVAX, none have been delivered. Its mix of purchased and donated shots – 4.2 million – consist of Chinese, Russian and Indian vaccines.

Official figures show that 4% of the country’s 15 million population are now fully immunized.

The figures make Zimbabwe a relative success in Africa, where fewer than 2% of the continent’s 1. 3 billion people have been vaccinated, according to the World Health Organization. Meanwhile, the virus is spreading to rural areas where the majority live and health facilities are shambolic.

Ngwenya is a part-time pastor with a Pentecostal church; he said he and his flock have had to rely on their faith to fight the coronavirus. But he said people would rather have vaccines first, and then prayer.

“Every man is scared of death,” he said. “People are dying and we can see people dying. This is real.”

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