Testing will be with us for quite awhile folks
Pfizer vaccine's storage needs puts chill in pandemic optimism
BY LAURA HENSLEY
ORIGINALLY PUBLISHED: NOV 12, 2020
Some vaccine candidates for COVID-19 require very, very cold temperatures for safe storage.
Getty
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Drugmaker Pfizer announced on Monday that its COVID-19 vaccine was more than 90 per cent effective based on an early analysis of its clinical trial — news that was happily received by people exhausted by the ongoing pandemic.
While promising news, experts say that the early results of Pfizer’s COVID-19 vaccineshould be received with a dose of caution. They point out critical information is missing in the drugmakers’ press release and want to see more data before celebrating.
What’s more, there’s concern around storing and transporting the vaccine as it needs to be kept at freezing cold temperatures — minus 70 degrees Celsius (-94 F). Typical freezers don’t get that cold, meaning hospitals or health care centres need to buy large, ultra-cold freezers which are costly — $10,000 to $15,000 each.
In a news conference on Monday, Prime Minister Justin Trudeau acknowledged that there are logistical challenges to distributing the vaccine because of its temperature requirements. An Ontario ultra-cold freezers manufacturer is already seeing a spike in inquiries given how niche the product is.
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, also expressed concerns at a conference on Wednesday saying that developing countries might have challenges storing the vaccine. There’s already a race in the U.S. for hospitals to obtain super freezers, creating a divide between wealthier urban health centres and rural, poorer ones.
Here’s everything we know about the Pfizer/BioNTech COVID-19 vaccine so far.
How it works
Pfizer and its German partner BioNTech SE are the first to release successful data from a large-scale clinical trial of a coronavirus vaccine. The drugmakers said results from its ongoing Phase 3 study found that participants who received two injections of the vaccine, given 28 days apart, showed 90 per cent protection against the virus. This protection was seen seven days after the second dose of the vaccine.
Pfizer and BioNTech’s vaccine is a mRNA vaccine that works by targeting the spike protein on the SARS-CoV-2 virus. Unlike traditional vaccines that use a weakened or “dead” form of a virus or bacteria, mRNA vaccines use part of the novel coronavirus’ own genetic code to stimulate an immune response.
So far, no mRNA vaccines are on the market, meaning, if approved, Pfizer and BioNTech’s mRNA vaccine would be the first.
The encouraging findings are based on an early analysis of 94 trial participants who contracted COVID-19. The group was split between those who got a placebo, and those who were vaccinated.
The trial, which began in July, has nearly 44,000 participants. The drugmakers say 39,000 have been given both doses of their vaccine and the clinical trial will continue until 164 cases of COVID-19 have occurred.
How safe and effective is the Pfizer/BioNTech vaccine?
Scientists are hopeful like the rest of us that a safe and effective COVID-19 vaccine will hit the market soon. But experts are warning that Pfizer’s press release is lacking important information.
“I think that the results are very promising, but of course, it is still early,” Matthew Miller, an associate professor of biochemistry and biomedical sciences at McMaster University, tells Healthing. “Most importantly, the full results of the clinical trial have not yet been published and subjected to the scrutiny of the scientific community.”
Miller says that one of the major limitations of the study is that “so far, it has only measured protection within seven days of the final vaccine dose.”
“This is a very short time frame and leaves open questions about how long the vaccine will last,” he says. “The results don’t mean that the vaccine will not be long-lasting, we just don’t know,” he says.
Another area of uncertainty, as medical outlet STAT points out, is that no information was released on whether the vaccine prevents severe cases of COVID-19 — those that cause hospitalization or death.
Pfizer and BioNTech’s trial will continue until there are 164 confirmed cases of COVID-19, and a median two months of safety data following the second and final dose — the amount of safety information the FDA wants. Volunteers in the trial will be monitored for “long-term protection and safety” for two years.
The drugmakers said so far no serious safety concerns have been observed in trial participants.
When will the Pfizer/BioNTech vaccine be available?
Before a COVID-19 vaccine is available to the Canadian public, it has to complete clinical trials and be approved by Health Canada.
On Monday, Trudeau said he hopes a vaccine will be coming to market early next year. “We’re seeing a light at the end of the tunnel,” he said at a news conference.
Canada has bought the rights to 20 million doses of Pfizer’s vaccine as it has with other leading vaccine contenders. Trudeau said on Monday that Canada will buy more doses of Pfizer’s vaccine if it proves to be safe and effective.
The transport and storage issues will need to be worked out before Canadians across the country will have access to the vaccine.
“We don’t have the infrastructure in place now to store the vaccine but I’m confident it will be in place in January,” a government source, who requested anonymity, told Reuters. “We won’t be able to get supplies into every pharmacy, certainly not immediately.”
What experts are saying
Miller says one of the strengths of Pfizer and BioNTech’s trial is that it includes “a very large number of participants” — 43,538 — “with significant ethnic diversity.”
“It was also tested over a large range of ages (individuals 12 years of age and older),” he says.
Still, there are unknowns, including whether the efficacy of the vaccine differs within different age groups, Miller says. “We also don’t yet know how the vaccine will perform in children since they were not enrolled in the trial.”
Dr. Tedros Adhanom, director-general of the World Health Organization, tweeted on Monday that he welcomes the “encouraging vaccine news” from the drugmakers and salutes scientists and partners around the globe “who are developing new safe, efficacious tools to beat #COVID19.”
“The world is experiencing unprecedented scientific innovation & collaboration to end the pandemic,” he wrote.
Morris, who is also a professor of medicine at the University of Toronto, tweeted that Canadians can’t ignore the fact that the COVID-19 pandemic is still a huge health threat. Cases continue to climb in parts of Canada and across the world.
“It will be a huge mistake if we take our eye off the ball re: COVID-19 control in anticipation of a potentially effective vaccine,” Morris wrote.
“The urgency is no less: the morbidity and mortality of COVID-19 will continue to progress until we have a well-vaccinated population.”
With files from Reuters and files from National Post’s Sharon Kirkey.
Laura Hensley is a writer with Healthing.ca
Don’t miss the latest on COVID-19, reopening and life. Subscribe to Healthing’s daily newsletter COVID Life.
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Pfizer vaccine's storage needs puts chill in pandemic optimism
BY LAURA HENSLEY
ORIGINALLY PUBLISHED: NOV 12, 2020
Some vaccine candidates for COVID-19 require very, very cold temperatures for safe storage.
Getty
Google+
Drugmaker Pfizer announced on Monday that its COVID-19 vaccine was more than 90 per cent effective based on an early analysis of its clinical trial — news that was happily received by people exhausted by the ongoing pandemic.
While promising news, experts say that the early results of Pfizer’s COVID-19 vaccineshould be received with a dose of caution. They point out critical information is missing in the drugmakers’ press release and want to see more data before celebrating.
What’s more, there’s concern around storing and transporting the vaccine as it needs to be kept at freezing cold temperatures — minus 70 degrees Celsius (-94 F). Typical freezers don’t get that cold, meaning hospitals or health care centres need to buy large, ultra-cold freezers which are costly — $10,000 to $15,000 each.
In a news conference on Monday, Prime Minister Justin Trudeau acknowledged that there are logistical challenges to distributing the vaccine because of its temperature requirements. An Ontario ultra-cold freezers manufacturer is already seeing a spike in inquiries given how niche the product is.
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, also expressed concerns at a conference on Wednesday saying that developing countries might have challenges storing the vaccine. There’s already a race in the U.S. for hospitals to obtain super freezers, creating a divide between wealthier urban health centres and rural, poorer ones.
Here’s everything we know about the Pfizer/BioNTech COVID-19 vaccine so far.
How it works
Pfizer and its German partner BioNTech SE are the first to release successful data from a large-scale clinical trial of a coronavirus vaccine. The drugmakers said results from its ongoing Phase 3 study found that participants who received two injections of the vaccine, given 28 days apart, showed 90 per cent protection against the virus. This protection was seen seven days after the second dose of the vaccine.
Pfizer and BioNTech’s vaccine is a mRNA vaccine that works by targeting the spike protein on the SARS-CoV-2 virus. Unlike traditional vaccines that use a weakened or “dead” form of a virus or bacteria, mRNA vaccines use part of the novel coronavirus’ own genetic code to stimulate an immune response.
So far, no mRNA vaccines are on the market, meaning, if approved, Pfizer and BioNTech’s mRNA vaccine would be the first.
The encouraging findings are based on an early analysis of 94 trial participants who contracted COVID-19. The group was split between those who got a placebo, and those who were vaccinated.
The trial, which began in July, has nearly 44,000 participants. The drugmakers say 39,000 have been given both doses of their vaccine and the clinical trial will continue until 164 cases of COVID-19 have occurred.
How safe and effective is the Pfizer/BioNTech vaccine?
Scientists are hopeful like the rest of us that a safe and effective COVID-19 vaccine will hit the market soon. But experts are warning that Pfizer’s press release is lacking important information.
“I think that the results are very promising, but of course, it is still early,” Matthew Miller, an associate professor of biochemistry and biomedical sciences at McMaster University, tells Healthing. “Most importantly, the full results of the clinical trial have not yet been published and subjected to the scrutiny of the scientific community.”
Miller says that one of the major limitations of the study is that “so far, it has only measured protection within seven days of the final vaccine dose.”
“This is a very short time frame and leaves open questions about how long the vaccine will last,” he says. “The results don’t mean that the vaccine will not be long-lasting, we just don’t know,” he says.
Another area of uncertainty, as medical outlet STAT points out, is that no information was released on whether the vaccine prevents severe cases of COVID-19 — those that cause hospitalization or death.
Pfizer and BioNTech’s trial will continue until there are 164 confirmed cases of COVID-19, and a median two months of safety data following the second and final dose — the amount of safety information the FDA wants. Volunteers in the trial will be monitored for “long-term protection and safety” for two years.
The drugmakers said so far no serious safety concerns have been observed in trial participants.
When will the Pfizer/BioNTech vaccine be available?
Before a COVID-19 vaccine is available to the Canadian public, it has to complete clinical trials and be approved by Health Canada.
On Monday, Trudeau said he hopes a vaccine will be coming to market early next year. “We’re seeing a light at the end of the tunnel,” he said at a news conference.
Canada has bought the rights to 20 million doses of Pfizer’s vaccine as it has with other leading vaccine contenders. Trudeau said on Monday that Canada will buy more doses of Pfizer’s vaccine if it proves to be safe and effective.
The transport and storage issues will need to be worked out before Canadians across the country will have access to the vaccine.
“We don’t have the infrastructure in place now to store the vaccine but I’m confident it will be in place in January,” a government source, who requested anonymity, told Reuters. “We won’t be able to get supplies into every pharmacy, certainly not immediately.”
What experts are saying
Miller says one of the strengths of Pfizer and BioNTech’s trial is that it includes “a very large number of participants” — 43,538 — “with significant ethnic diversity.”
“It was also tested over a large range of ages (individuals 12 years of age and older),” he says.
Still, there are unknowns, including whether the efficacy of the vaccine differs within different age groups, Miller says. “We also don’t yet know how the vaccine will perform in children since they were not enrolled in the trial.”
Dr. Tedros Adhanom, director-general of the World Health Organization, tweeted on Monday that he welcomes the “encouraging vaccine news” from the drugmakers and salutes scientists and partners around the globe “who are developing new safe, efficacious tools to beat #COVID19.”
“The world is experiencing unprecedented scientific innovation & collaboration to end the pandemic,” he wrote.
Morris, who is also a professor of medicine at the University of Toronto, tweeted that Canadians can’t ignore the fact that the COVID-19 pandemic is still a huge health threat. Cases continue to climb in parts of Canada and across the world.
“It will be a huge mistake if we take our eye off the ball re: COVID-19 control in anticipation of a potentially effective vaccine,” Morris wrote.
“The urgency is no less: the morbidity and mortality of COVID-19 will continue to progress until we have a well-vaccinated population.”
With files from Reuters and files from National Post’s Sharon Kirkey.
Laura Hensley is a writer with Healthing.ca
Don’t miss the latest on COVID-19, reopening and life. Subscribe to Healthing’s daily newsletter COVID Life.
Related Tags
How will we know if a vaccine is safe?
The Canadian connection to the Pfizer vaccine
Scientists want more data to confirm Pfizer's vaccine efficacy
Read the feature rich experience
YOU MAY ALSO LIKE
Do face masks protect the wearer too?
Why are gyms considered high-risk COVID environments?
Opinion: A powerful way to combat COVID
How will we know if a vaccine is safe?
The made-in-Canada vaccine with promising early results
DISEASES AND CONDITIONS › CORONAVIRUS › COVID-19 VACCINE
© 2020 Postmedia Network Inc. All rights reserved. Unauthorized distribution, transmission or republication strictly prohibited.
365 Bloor St East, Toronto, ON, M4W3L4
www.postmedia.com
Privacy - Updated
Terms
Copyright
Digital Ad Registry
