Understanding and Explaining mRNA COVID-19 Vaccines (CDC - November 24, 2020)
- Like all vaccines, COVID-19 mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States.
- mRNA technology is new, but not unknown. They have been studied for more than a decade.
- mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person.
- mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.
COVID-19 mRNA Vaccines Will Be Rigorously Evaluated for Safety
COVID-19 mRNA vaccines have gone through the same rigorous safety assessment as all vaccines before they were authorized for use in the United States by the Food and Drug Administration. This includes large clinical trials and data review by a safety monitoring board.
Researchers fast-track coronavirus vaccine by skipping key animal testing first (Live Science - March 13, 2020)
A clinical trial for an experimental coronavirus vaccine has begun recruiting participants in Seattle, but researchers did not first show that the vaccine triggered an immune response in animals, as is normally required.
Now, biomedical ethicists are calling the shortcut into question, according to Stat News.
Typically, vaccine development can take 15 to 20 years, start to finish, Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat News. The lengthy process requires that scientists first give the vaccine to animals to determine whether it's safe and effective at preventing the disease in question. Only after passing through iterative tests in animal models, and being adjusted along the way, can a formulation be tested in human trials.
"When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches," Feinberg said.
The Fiasco Of The 1976 ‘Swine Flu Affair’ (BBC - September 21, 2020)
- Like all vaccines, COVID-19 mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States.
- mRNA technology is new, but not unknown. They have been studied for more than a decade.
- mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person.
- mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.
COVID-19 mRNA Vaccines Will Be Rigorously Evaluated for Safety
COVID-19 mRNA vaccines have gone through the same rigorous safety assessment as all vaccines before they were authorized for use in the United States by the Food and Drug Administration. This includes large clinical trials and data review by a safety monitoring board.
Researchers fast-track coronavirus vaccine by skipping key animal testing first (Live Science - March 13, 2020)
A clinical trial for an experimental coronavirus vaccine has begun recruiting participants in Seattle, but researchers did not first show that the vaccine triggered an immune response in animals, as is normally required.
Now, biomedical ethicists are calling the shortcut into question, according to Stat News.
Typically, vaccine development can take 15 to 20 years, start to finish, Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat News. The lengthy process requires that scientists first give the vaccine to animals to determine whether it's safe and effective at preventing the disease in question. Only after passing through iterative tests in animal models, and being adjusted along the way, can a formulation be tested in human trials.
"When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches," Feinberg said.
The Fiasco Of The 1976 ‘Swine Flu Affair’ (BBC - September 21, 2020)
The swine flu affair, the New York Times concluded, had been a “sorry debacle” and “fiasco” marked by political expediency and unwarranted confidence
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