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‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Clearwater Times

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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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Worldwide coronavirus cases cross 161.42 million, death toll at 3,488,751

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More than 161.42 million people have been reported to be infected by the novel coronavirus globally and 3,488,751​ have died, according to a Reuters tally.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

Interactive graphic tracking global spread of coronavirus: open https://tmsnrt.rs/2FThSv7 in an external browser.

Eikon users can click  for a case tracker.

The following table lists the top 50 countries by the number of reported cases. A complete list is available with the above links.

COUNTRIES AND TOTAL DEATHS CONFIRMED DEATHS PER

TERRITORIES CASES 10,000

INHABITANTS

United States 584,768 32,926,288 17.9

India 262,317 24,046,809 1.94

Brazil 430,417 15,433,989 20.55

France 107,423 5,848,154 16.04

Turkey 44,301 5,095,390 5.38

Russia 254,590 4,922,901 17.62

United Kingdom 127,668 4,446,824 19.21

Italy 123,927 4,146,722 20.51

Spain 79,339 3,604,799 16.95

Germany 85,903 3,579,871 10.36

Argentina 69,254 3,242,103 15.56

Colombia 79,760 3,067,879 16.06

Poland 71,311 2,849,014 18.78

Iran 76,433 2,732,152 9.34

Mexico 219,901 2,375,115 17.43

Ukraine 47,620 2,143,448 10.67

Peru 65,316 1,873,316 20.02

Indonesia 47,823 1,734,285 1.79

Czech Republic 29,857 1,651,178 28.09

South Africa 55,012 1,605,252 9.52

Netherlands 17,423 1,589,282 10.11

Canada 24,825 1,312,408 6.7

Chile 27,520 1,266,601 14.69

Iraq 15,910 1,134,859 4.14

Philippines 18,958 1,131,467 1.78

Romania 29,413 1,070,605 15.11

Sweden 14,275 1,037,126 14.03

Belgium 24,645 1,026,473 21.56

Pakistan 19,384 873,220 0.91

Portugal 16,999 841,379 16.53

Israel 6,379 839,076 7.18

Hungary 29,041 796,390 29.71

Bangladesh 12,102 779,535 0.75

Jordan 9,203 722,754 9.24

Serbia 6,646 705,185 9.52

Switzerland 10,179 679,510 11.96

Japan 11,396 673,821 0.9

Austria 10,455 635,780 11.83

United Arab Emirates 1,626 543,610 1.69

Lebanon 7,569 534,968 11.05

Morocco 9,091 514,670 2.52

Malaysia 1,822 462,190 0.58

Nepal 4,669 439,658 1.66

Saudi Arabia 7,134 431,432 2.12

Bulgaria 17,194 413,320 24.48

Ecuador 19,442 405,783 11.38

Slovakia 12,168 387,162 22.34

Greece 11,322 373,881 10.55

Belarus 2,681 373,351 2.83

Panama 6,288 369,455 15.05

Source: Reuters tally based on statements from health ministries and government officials

Generated at 10:00 GMT.

 

(Editing by David Clarke)

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Canada plots course to fully vaccinated return to gatherings in fall

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Canada on Friday said there would be a gradual return to a world with indoor sports and family gatherings as more people get vaccinated, but it did not go as far as the United States in telling people they could eventually ditch their masks.

Canada has administered one dose of a COVID-19 vaccine to just over half its adult population, and the country may be over the worst of its current third wave of infections, Chief Public Health Officer Theresa Tam said.

On Thursday, the U.S. Centers for Disease Control and Prevention (CDC) advised that fully vaccinated people do not need to wear masks outdoors and can avoid wearing them indoors in most places, guidance the agency said will allow life to begin to return to normal.

On Friday, Canada‘s public health agency offered guidelines to the 10 provinces, which are responsible for public health restrictions.

The agency says once 75% of Canadians have had a single dose and 20% are fully vaccinated, some restrictions can be relaxed to allow small, outdoor gatherings with family and friends, camping, and picnics.

Once 75% of those eligible are fully vaccinated in the fall, indoor sports and family gatherings can be allowed again.

“I think masks might be the last layer of that multi-layer protection that we’ll advise people to remove,” Tam told reporters, noting that in Canada colder temperatures meant people would start spending more time indoors in the fall.

“We are taking a bit of a different approach to the United States,” she added. While in most of Canada masks are not required outdoors, they are mandatory indoors.

Less than 4% of Canada‘s adult population has been fully vaccinated compared to more than 36% of Americans.

Prime Minister Justin Trudeau, who has promised that everyone who wants to can be fully vaccinated by September, this week spoke of a “one-dose summer” and a “two-dose fall” without explaining what that might look like.

 

(Reporting by Steve Scherer and David Ljunggren; Editing by Hugh Lawson)

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Delayed 2nd Pfizer/BioNTech shot boosts antibodies in elderly; COVID-19 obesity risk higher for men

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The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Delaying second Pfizer/BioNTech dose boosts antibodies in elderly

Delaying the second dose of the Pfizer/BioNTech COVID-19 vaccine beyond the originally recommended three-week gap used by the companies in clinical trials appears to induce a stronger antibody response in the elderly, UK researchers found. Shortly after the vaccine became available, UK health officials advised that the second dose should be given 12 weeks after the first to allow more people to get protected by a first dose early on. In a new paper seen by Reuters and expected to appear on medRxiv on Friday ahead of peer review, researchers found that among 175 people ages 80 to 99, those who got their second dose at 12 weeks had antibody responses that were 3.5 times higher than those who got it after three weeks. Antibodies are only one part of the immune system, and vaccines also generate T cells that fight infections. The peak T cell responses were higher in the group with a three-week interval between doses, and the authors cautioned against drawing conclusions on how protected individuals were based on which dosing schedule they received. (https://reut.rs/3wjPK9B)

Impact of obesity on COVID-19 risks may be greater in men

The known increased risk of severe COVID-19 and death linked to obesity may be even more pronounced for men than women, new data suggest. Researchers studied 3,530 hospitalized COVID-19 patients with an average age of 65, including 1,469 who were obese. In men, moderate obesity was associated with a significantly higher risk of developing severe disease, needing mechanical breathing assistance and dying from COVID-19. (The threshold for moderate obesity is a body mass index (BMI) of 35. In an 5-foot, five-inch tall (1.65 m) adult, that would correspond to a weight of 210 pounds (95 kg). In women, however, only a BMI of 40 or higher, indicating severe obesity, was linked with the increased risks. In a report published in European Journal of Clinical Microbiology & Infectious Diseases, the researchers note that while obesity is known to be linked with body-wide inflammation, patients’ levels of inflammatory proteins did not appear to explain the association between obesity and severe illness. For now, they conclude, “particular attention should be paid” to protecting patients with obesity from the coronavirus, “with priority to vaccination access, remote work, telemedicine, and other measures given the higher risk of adverse outcomes once they are diagnosed with COVID-19.” (https://bit.ly/3eO6GiA)

COVID-19 testing rates low among symptomatic Americans

Sick Americans appear to be passing up opportunities to get tested for coronavirus and thus are likely unknowingly spreading the infection throughout their communities, new research shows. Among 37,000 adults across the United States who participated in a smartphone app survey between March and October 2020, nearly 2,700 reported at least one episode of fever and chills. But according to a report published in JAMA Network Open, only a small fraction reported receiving a COVID-19 test result within seven days of the onset of illness. At first, as tests became more accessible, the numbers improved. In early April 2020, less than 10% of survey participants reporting illness with fever received test results within a week. By late July, that proportion had increased to 24.1%. Throughout the summer and fall, as tests became easier to find, the number of sick participants who reported getting tested remained flat. By late October, only 26% reported receiving a test result within a week of febrile illness. “It’s shocking to me that when people have a fever they’re still not getting tested,” said coauthor Dr. Mark Pletcher of the University of California, San Francisco. “Tests are easy to come by. People might have coronavirus, might be spreading it to their friends and neighbors, and they’re not getting tested.” (https://bit.ly/2QUyMzf)

Open  in an external browser for a Reuters graphic on vaccines in development.

 

(Reporting by Nancy Lapid, Alistair Smout and Ronnie Cohen; Editing by Bill Berkrot

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