Tens of thousands of Americans have volunteered to test COVID-19 vaccines, but only about half of them got the real thing during trials.
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.
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.”
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.
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.”
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.”
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.
Marion Renault, The Associated Press
COVID: Less than 200 cases, 2 deaths in Manitoba Saturday – CHVN Radio
According to Public health officials, there have been 180 new cases of COVID-19 and two additional deaths in the province.
The deaths include a male in his 70s from the Rural East District in Southern Health-Santé Sud, and a male in his 80s from the Winnipeg Health Region.
The current five-day COVID-19 test positivity rate is 10.2%. As of 9:30 a.m. Saturday, 180 new cases of the virus have been identified bringing the total number of lab-confirmed cases in Manitoba to 27,322.
Of the 180 new cases announced Saturday, 10 are in Southern Health. One of those is in Steinbach and four are in the Niverville/Ritchot Health District.
Today’s COVID-19 data shows:
- 10 cases in the Interlake-Eastern health region.
- 69 cases in the Northern health region.
- Eight cases in the Prairie Mountain Health region.
- 10 cases in the Southern Health-Santé Sud health region.
- 83 cases in the Winnipeg health region.
The data also shows:
- 2,986 active cases and 23,575 individuals who have recovered from COVID-19.
- There are 122 people in hospital with active COVID-19 as well as 161 people in hospital with COVID-19 who are no longer infectious but continue to require care, for a total of 283 hospitalizations.
- There are 19 people in intensive care units with active COVID-19 as well as 17 people with COVID-19 who are no longer infectious but continue to require critical care for a total of 36 ICU patients.
- The total number of deaths due to COVID-19 is 761. Due to a data error, one death that had been reported earlier has been removed.
Laboratory testing numbers show 2,043 tests were completed yesterday bringing the total number of lab tests completed since early February 2020 to 450,104. Case investigations continue and if a public health risk is identified, the public will be notified.
The chief provincial public health officer reminds Manitobans to self-isolate immediately at the onset of possible COVID-19 symptoms, no matter how mild. This means staying home from work, school, or other daily activities. Testing should be done as soon as possible once symptoms appear.
Manitobans should only leave their homes for essential purposes. When leaving the house to obtain essentials, be sure to physically distance, wear a mask in indoor public places, and avoid crowded spaces. Do not leave the home if you are sick, or when any member of your family is sick. Further, do not socialize with anyone from outside your household.
2 deaths, 180 COVID-19 cases announced in Manitoba Saturday – Global News
Manitoba public health officials confirm two additional deaths in people with COVID-19 have been reported.
The deaths are a man in his 70s from Southern Health-Santé Sud and a man in his 80s from the Winnipeg health region.
The current five-day COVID-19 test positivity rate is 10.2 per cent provincially and 7 per cent in Winnipeg.
As of 9:30 a.m. Saturday, 180 new cases of the virus have been identified and the total number of lab-confirmed cases in Manitoba has risen to 27,322.
The new cases are in the following regions:
- 10 cases in the Interlake-Eastern health region
- 69 cases in the Northern health region
- eight cases in the Prairie Mountain Health region
- 10 cases in the Southern Health-Santé Sud health region
- 83 cases in the Winnipeg health region.
The data also shows there are 2,986 active cases and 23,575 individuals who have recovered from COVID-19.
There are 122 people in hospital with active COVID-19 as well as 161 people in hospital with COVID-19 who are no longer infectious but continue to require care, for a total of 283 hospitalizations.
COVID-19 cases rising in the north
There are 19 people being treated for COVID-19 in intensive care units, as well as 17 people with COVID-19 who are no longer infectious but continue to require critical care, for a total of 36 ICU patients.
The total number of deaths due to COVID-19 is 761. Due to a data error, one death that had been reported earlier has been removed.
Laboratory testing numbers show 2,043 tests were completed Friday, bringing the total number of lab tests completed since early February 2020 to 450,104.
An outbreak has been declared at Lynn Lake Hospital in northwestern Manitoba. The site has been moved to Critical (red) on the Pandemic Response System.
The outbreak at Seven Oaks General Hospital, 4U4-7 in Winnipeg is now declared over.
Coronavirus: Over half of Canadians think vaccine should be mandatory, Ipsos poll shows
Local epidemiologist Cynthia Carr says while it has been challenging to follow health restrictions, it has made a difference.
“These restrictions and the work we have done together really does matter on the serious of levels. working together we have saved almost 2,000 lives. It might have been 1,700, 1,800 or 1,600 but the reality is it mattered,” she said.
And while our numbers remain steady for now, there are still obstacles in certain regions — particularly the North.
Carr says if the pandemic hasn’t ripped the issue of housing wide open in other areas, she doesn’t know what will.
“This is an ongoing challenge. When I go to a community and do community health assessments and I talk to leadership about health, they won’t say we need a fancy hospital, X-ray machines, etc., one of the first things will be the foundation of housing.”
She says infrastructure is absolutely related to health, and it hasn’t been attended to in our northern communities.
–With files from Anya Nazeravich
© 2021 Global News, a division of Corus Entertainment Inc.
One of Canada's oldest seniors, at 110 years old, gets COVID-19 vaccine at Surrey care home – Cowichan Valley Citizen
JaHyung Lee, a resident at a Newton care home, received his COVID-19 vaccine at the age of 110.
Amenida Seniors Community said in a news release that residents at the facility received the first dose of their vaccines on Thursday (Jan. 14). JaHyung Lee is one of Canada’s oldest seniors to be inoculated.
The second dose of the Pfizer/BioNTech vaccine will be administered “in the coming weeks.”
“We are extremely lucky that we have received enough supplies to vaccinate all of our residents in care,” said Rosa Park, general manager at Amenida.
“As many of our seniors are elderly and require complex care, we can feel safer knowing that the virus won’t be spreading within our community.”
A reporter with the Now-Leader attended Lee’s 109th birthday in 2019. He was born on Aug. 27, 1910.
Meantime, Fraser Health says it has completed 151 vaccine clinics for long-term care and assisted living in the health region.
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