Now, with the first vaccine rollouts and a surge in coronavirus infections, experts are debating what to do about the half that got a dummy shot.
Should everyone now be offered a vaccine? Or should the two groups in the Pfizer and Moderna studies remain intact in order to collect long-term data on how well the vaccines work?
“There’s a real tension here,” said Dr. Jesse Goodman, an infectious disease specialist and former chief scientist at the U.S. Food and Drug Administration. “There’s not an easy answer.”
How vaccine studies work
New drugs, vaccines or treatments usually go through rigorous tests and evaluations before reaching regulators for approval.
For vaccines, researchers compare what happens when a large group of volunteers gets the shots, versus what happens to another large group that doesn’t. They compare side effects in each group. And they measure the vaccine’s effectiveness by looking at how many in each group pick up infections.
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To do this fairly, researchers randomly assign participants to receive a vaccine or a dummy shot, usually a dose of salt water.
Volunteers know there’s a 50-50 chance they could be put in either group — and they are not told which group they landed in. Often, the researchers or others involved in the testing are also “blinded” and don’t know either.
Should test volunteers be told?
About 17,000 of Moderna’s study participants received a placebo, as did about 22,000 people in Pfizer’s trial.
With the ongoing coronavirus crisis, health experts worry about leaving them in the dark and unprotected. They argue they should be given a vaccine now in recognition of their willingness to be a part of the trials during the pandemic.
“Volunteers have been instrumental,” said Moncef Slaoui, chief scientist of the government’s Operation Warp Speed program. “They should be rewarded for it.”
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The companies would have to “unblind” or “unmask” the studies, revealing whether participants got the vaccine or the dummy shot.
Unmasking is usually done at the end of testing. Moderna and Pfizer, though, designed their studies to last two years to do long-term follow-up.
“I don’t think there’s anybody who thinks it’s reasonable or feasible to keep the people blinded for two years,” said Susan Ellenberg, an expert in clinical trials at the University of Pennsylvania.
“Given we have a pandemic, people are ready to settle for the short-term results.”
Pros and cons of “unmasking’
With the rollout of vaccines and the uncertainty of their status, volunteers could decide to drop out once they are eligible to get one. They might stay in the study if they’re told what they got, said Dr. Ana Iltis, a bioethicist at Wake Forest University.
“Participants could leave in droves. They could say, ‘If you don’t tell me what I got, I’m out of here,’” said Iltis. “You cannot force people to stay.”
In an ideal world, participants could hold off to discover whether they received the dummy shot or the vaccine. But experts agree the current circumstances are extraordinary.
Still, unmasking participants would undoubtedly affect the trials’ scope and results.
If someone learns they’ve already been vaccinated, for example, they may stop social distancing or wearing masks — increasing their potential exposure to the virus and possibly spreading it. It’s not yet known if vaccinated people can still carry and transmit the virus.
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On the flip side, if a person finds out they only received the dummy shot, they might take precautions they wouldn’t otherwise.
Either outcome, Goodman said, “means the trial has basically come to an end.”
Before granting its emergency use approval, the FDA required Pfizer and Moderna to provide two months of follow-up data. If studies are cut short, it becomes harder to get long-term effects, including how long immunity lasts.
“There’s a reason we do clinical research in a certain way,” Iltis said. “We should not abandon our norms and our principles. Are we going to be happy with short-term evidence in a year?”
What the companies say
Pfizer plans to eventually vaccinate all its study participants. It’s opting for a more gradual, voluntary process. The company will offer that option to those who got dummy shots as soon as they would have access to the vaccine outside of the study.
Moderna is considering immediately offering the vaccine to all who got dummy shots. More than one-quarter of them are health-care workers and first in line for the vaccine anyway, the company noted.
“Many have already left. Sadly, it’s not a small number,” said Dr. Lindsey Baden, who’s involved in testing Moderna’s vaccine at Brigham and Women’s hospital in Boston. “This is not theoretical. It’s happening.”
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British pharmaceutical company AstraZeneca, which has enrolled at least 23,000 so far in its ongoing U.S. study, recently decided to offer individual participants the opportunity to be unmasked as they become eligible for the approved vaccines.
“You never really want to unblind,” said Dr. William Hartman, a researcher for AstraZeneca’s trial at the University of Wisconsin-Madison.
However, he added, the pandemic has complicated things.
“A lot of people are nervous and scared,” Hartman said. “And everyone comes into the trial hoping they’ll get the vaccine.”
© 2021 The Canadian Press
Could new virus variants derail COVID-19 vaccination efforts? Scientists hope not – CBC.ca
After the virus behind COVID-19 spent 2020 wreaking havoc around the globe, this year started with a bit more hope — vaccination efforts were ramping up, after all — and a tinge of fear.
Multiple new coronavirus variants have been discovered across several continents, from Europe to Africa to South America. Confirmed cases keep popping up in dozens of countries, Canada included.
Scientists are now racing to understand these sets of mutations, all while concerns are growing over their ability to infect people more easily or, in some cases, potentially evade the army of antibodies we create after being infected or vaccinated.
And since widespread transmission means this virus has ample opportunities to mutate again and again and again, these variants won’t be the last. They’re just the ones we know about.
“The more opportunity we give to the virus to replicate, to make more viruses, the more opportunity there is to see that variant of concern — one that won’t be mitigated by our vaccines that we’ve developed,” warned Alyson Kelvin, a virologist at Dalhousie University and the IWK Health Centre in Halifax.
After months of work to develop safe, effective vaccines against SARS-CoV-2, the scientific community now faces a race against time to ward off that scenario.
There’s also a looming question: What happens if we don’t?
Variants could ‘very rapidly’ become prevalent
Kelvin, one of the many Canadian researchers involved in vaccine development, said preliminary data shows that the sets of mutations identified so far don’t yet seem to be an issue for current coronavirus vaccines.
That’s the good news. It’s the “yet” she finds troubling.
“We have to stay on top of this problem,” Kelvin said.
But while new variants might throw a wrench in efforts to suppress transmission by popping up like a game of global whack-a-mole, those ongoing mutations were actually expected, not surprising.
That’s because each virus has a singular goal of replicating itself. With tens of millions of people helping move the coronavirus back and forth between hosts, that means countless replications. Some of those contain random, insignificant mistakes. And when the mistakes prove beneficial to the virus, helping it produce more copies, those errors can become a new normal of sorts — a variant.
It’s just evolution at work, said Angela Rasmussen, a virologist at Georgetown University’s Center for Global Health Science and Security in Washington, D.C., and incoming research scientist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Saskatoon.
“What concerns me the most is that the epidemiological data that goes along with some of these variants suggests they could very rapidly become very prevalent — effectively out-competing the other variants in a given area — in a short period of time,” she said.
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Could new variants decrease immune response?
Researchers speculate that may be what happened with B117. The variant was first discovered in the U.K. late last year and is now the country’s dominant strain of the coronavirus — with various officials suggesting it’s at least 50 per cent more transmissible. (Cases have been confirmed in several provinces in Canada as well, and testing is ongoing.)
In the short term, more transmission means more infections, hospitalizations and deaths, Rasmussen said, which offers an incentive for countries to slow case growth. Doing so would both save lives and cut off channels for the virus to spread and mutate.
“It’s also possible that variants may arise that decrease the effectiveness of our immune response to the virus,” said Matthew Miller, a member of the Institute for Infectious Disease Research at McMaster University and the McMaster Immunology Research Centre in Hamilton.
“But also, of course — and perhaps more worryingly — the immune responses elicited by the currently approved vaccines.”
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For scientists in Brazil, there’s already legitimate cause for alarm.
“We have detected a new variant circulating in December in Manaus, Amazonas state, north Brazil, where very high attack rates have been estimated previously,” read the preliminary findings posted online by a research team led by Imperial College London virologist Nuno Faria.
The new lineage, dubbed P1, contains a “unique constellation” of mutations in the crucial spike protein, which helps the virus penetrate human cells, the report continues. The variant was detected in 42 per cent of samples collected during a stretch in December, but not in samples collected in the months before.
Those new cases also appeared even though an estimated three-quarters of people living in Manaus, the largest city in the Amazon region, had already been infected.
Faria’s report stressed that could mean an increase in transmissibility — the same issue with B117 — or even an ability to reinfect people.
Vaccines ‘modifiable’ in face of new mutations
According to Rasmussen, antibodies seem to have a reduced capacity to neutralize this kind of virus variant based on the spike protein mutations. Echoing Kelvin and Miller’s concerns, she said that’s a key problem, “because if you acquire enough of those mutations, you may get to a point where you have a variant capable of evading vaccine-induced immunity completely.”
But again, it’s not all dire news. Just because antibodies are less effective doesn’t necessarily mean someone would have reduced immune protection, Rasmussen explained, since the body’s immune response is looking at the entire spike protein, not just certain areas that might have a set of mutations.
Miller also noted that while the spike protein tends to be most prone to changing in the face of immunological pressure, there are other vaccine candidates in development that are designed to elicit broader immune responses against a greater array of viral targets to stay one step ahead.
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“Even in the worst-case scenario, that we see some of these variants spreading and we get a partial response, it’s probably going to mean that the health-care complications, the deaths, are still going to be greatly controlled by a mass vaccine campaign,” said Dr. Zain Chagla, an infectious disease specialist at McMaster University.
And, thankfully, research teams can also pivot, redeveloping existing coronavirus vaccines to target any variants that may prove capable of evading the ones already rolling out globally.
The novel mRNA vaccines, including the Pfizer-BioNTech and Moderna options currently approved in Canada, are among those that can be more easily tweaked. Those vaccines provide instructions — messenger RNA — to cells, allowing them to make their own spike protein, which someone’s immune system can recognize and fight off in the future.
“That is their genius, that they’re completely and rapidly modifiable,” Chagla said. “The packaging is there, the delivery method is there, all you need to do is change the mRNA sequence.”
The sooner people get vaccinated, ‘the better’
But while the flexibility of vaccination development is reassuring for the long term, it doesn’t tackle the problem at hand: COVID-19 still has its grip on much of the world, the death toll keeps climbing and vaccination efforts remain a race against time as emerging variants keep throwing a wrench in efforts to curb transmission.
“The sooner that we can get a vaccine into people, the better,” Kelvin said.
To save lives and keep health-care systems from collapsing while vaccination programs scale up, she stressed that Canadians also need to ramp up the basic public health precautions that should now be routine.
Physical distancing, mask-wearing, hand-washing, staying away from crowds and enclosed spaces — it all matters, perhaps now more than ever, to slow transmission and give the virus fewer opportunities to spread and evolve.
That buys time for Canada to hit its tenuous goal for 2021: getting everyone vaccinated, without any variants getting in the way.
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“We need to do everything we can now … to get transmission as low as we possibly can,” said Harvard University’s Dr. Michael Mina. “The best way to prevent mutant strains from emerging is to slow transmission.”
So far, vaccines seem to remain effective, but there are signs that some of the new mutations may undermine tests for the virus and reduce the effectiveness of antibody drugs as treatments.
“We’re in a race against time” because the virus “may stumble upon a mutation” that makes it more dangerous, said Dr. Pardis Sabeti, an evolutionary biologist at the Broad Institute of MIT and Harvard.
Younger people may be less willing to wear masks, shun crowds and take other steps to avoid infection because the current strain doesn’t seem to make them very sick, but “in one mutational change, it might,” she warned. Sabeti documented a change in the Ebola virus during the 2014 outbreak that made it much worse.
MUTATIONS ON THE RISE
It’s normal for viruses to acquire small changes or mutations in their genetic alphabet as they reproduce. Ones that help the virus flourish give it a competitive advantage and thus crowd out other versions.
In March, just a couple months after the coronavirus was discovered in China, a mutation called D614G emerged that made it more likely to spread. It soon became the dominant version in the world.
Now, after months of relative calm, “we’ve started to see some striking evolution” of the virus, biologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle wrote on Twitter last week. “The fact that we’ve observed three variants of concern emerge since September suggests that there are likely more to come.”
One was first identified in the United Kingdom and quickly became dominant in parts of England. It has now been reported in at least 30 countries, including the United States.
Soon afterward, South Africa and Brazil reported new variants, and the main mutation in the version identified in Britain turned up on a different version “that’s been circulating in Ohio … at least as far back as September,” said Dr. Dan Jones, a molecular pathologist at Ohio State University who announced that finding last week.
“The important finding here is that this is unlikely to be travel-related” and instead may reflect the virus acquiring similar mutations independently as more infections occur, Jones said.
That also suggests that travel restrictions might be ineffective, Mina said. Because the United States has so many cases, “we can breed our own variants that are just as bad or worse” as those in other countries, he said.
TREATMENT, VACCINE, REINFECTION RISKS
Some lab tests suggest the variants identified in South Africa and Brazil may be less susceptible to antibody drugs or convalescent plasma, antibody-rich blood from COVID-19 survivors — both of which help people fight off the virus.
Government scientists are “actively looking” into that possibility, Dr. Janet Woodcock of the U.S. Food and Drug Administration told reporters Thursday. The government is encouraging development of multi-antibody treatments rather than single-antibody drugs to have more ways to target the virus in case one proves ineffective, she said.
Current vaccines induce broad enough immune responses that they should remain effective, many scientists say. Enough genetic change eventually may require tweaking the vaccine formula, but “it’s probably going to be on the order of years if we use the vaccine well rather than months,” Dr. Andrew Pavia of the University of Utah said Thursday on a webcast hosted by the Infectious Diseases Society of America.
Health officials also worry that if the virus changes enough, people might get COVID-19 a second time. Reinfection currently is rare, but Brazil already confirmed a case in someone with a new variant who had been sickened with a previous version several months earlier.
WHAT TO DO
“We’re seeing a lot of variants, viral diversity, because there’s a lot of virus out there,” and reducing new infections is the best way to curb it, said Dr. Adam Lauring, an infectious diseases expert at the University of Michigan in Ann Arbor.
Loyce Pace, who heads the non-profit Global Health Council and is a member of President-elect Joe Biden’s COVID-19 advisory board, said the same precautions scientists have been advising all along “still work and they still matter.”
“We still want people to be masking up,” she said Thursday on a webcast hosted by the Johns Hopkins Bloomberg School of Public Health.
“We still need people to limit congregating with people outside their household. We still need people to be washing their hands and really being vigilant about those public health practices, especially as these variants emerge.”
AP Medical Writer Carla K. Johnson in Seattle contributed reporting.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Marilynn Marchione, The Associated Press
Saskatchewan plans to create coronavirus vaccine TV ads – Global News
Health officials said Monday there were 210 people in hospital, with 30 patients receiving intensive care.
Four more residents, all 60 or older, also died from the virus.
Saskatchewan has recently had the highest rate of active cases per 100,000 population in Canada. And the regions of Saskatoon, North Battleford, Prince Albert and Regina are where many of the active infections are located.
Officials said more than 22,000 vaccine shots have gone into the arms of doctors and nurses working directly with COVID-19 patients, as well as staff and residents in long-term care homes and some seniors.
“Saskatchewan has significantly picked up the pace of COVID-19 vaccinations in recent days. Over 10,500 shots have been administered in the past four days,” Premier Scott Moe said in a tweet.
To encourage vaccinations, documents posted on the government’s procurement website show the Ministry of Health is shopping for a production company to shoot some TV ads next month.
“To get back to the things we love to do, and re-connect with family and friends, people need to get vaccinated. These spots will be used to raise public awareness about the importance of getting vaccinated,” the documents read.
Last week, the province’s chief medical health officer, Dr. Saqib Shahab, said he would recommend that the Saskatchewan Party government implement stricter public-health restrictions if he keeps seeing 300 or more infections reported daily.
The current public-health order prohibits household guests, as well as restricts business capacity and worship services. It is set to expire next Friday.
“The government and Dr. Shahab are continuously monitoring the case numbers and have not ruled out adjustments before that time,” Julie Leggott, Moe’s press secretary, said in a statement.
COVID-19 restrictions extended in Saskatchewan until Jan. 29
Questions about COVID-19? Here are some things you need to know:
Symptoms can include fever, cough and difficulty breathing — very similar to a cold or flu. Some people can develop a more severe illness. People most at risk of this include older adults and people with severe chronic medical conditions like heart, lung or kidney disease. If you develop symptoms, contact public health authorities.
To prevent the virus from spreading, experts recommend frequent handwashing and coughing into your sleeve. They also recommend minimizing contact with others, staying home as much as possible and maintaining a distance of two metres from other people if you go out. In situations where you can’t keep a safe distance from others, public health officials recommend the use of a non-medical face mask or covering to prevent spreading the respiratory droplets that can carry the virus. In some provinces and municipalities across the country, masks or face coverings are now mandatory in indoor public spaces.
For full COVID-19 coverage from Global News, click here.
© 2021 The Canadian Press
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