This is a science and medicine thread that is supposed to give accurate information. I'd expect BS from certain people (who never let me down)BUT not from an administrator.
If you read the research study, (Even just the discussion part) you would retract what you wrote...........
This is a science and medicine thread that is supposed to give accurate information. I'd expect BS from certain people (who never let me down)BUT not from an administrator.
If you read the research study, (Even just the discussion part) you would retract what you wrote...........
I did read the entire JAMA Letter and since the Discussion section, which I posted in it's entirety, just said there were "significant increases in all sperm parameters" in mRNA vaccinated males. They cautioned their observations with this disclaimer:
...while semen analysis is the foundation of male fertility evaluation, it is an imperfect predictor of fertility potential.
So mRNA-vaccinated males have increases in all sperm parameters, these parameters are an imperfect measure of fertility. Therefore no one can claim whether or not the vaccine impacts fertility, either as an increase, decrease or status quo. Additional studies from others have detected virus in semen of COVID-infected males, but no one has demonstrated sexual transmission of COVID.
Therefore we have two unrelated semen-associated COVID observations which means there has yet to be any definitive studies showing that men have no valid reason to avoid an mRNA vaccine in fear that it would impact their ability to sire children.
If you're seeing something different in other publications, please post them...
Very interesting on a paleogenetics plane...
[A Coronavirus Epidemic Hit 20,000 Years Ago, New Study Finds]("https://www.nytimes.com/2021/06/24/science/ancient-coronavirus-epidemic.html?action=click&module=In%20Other%20News&pgtype=Homepage")
[HEADING=2]A Coronavirus Epidemic Hit 20,000 Years Ago, New Study Finds[/HEADING]
A few dozen human genes rapidly evolved in ancient East Asia to thwart coronavirus infections, scientists say. Those genes could be crucial to today’s pandemic.
Researchers have found evidence that a coronavirus epidemic swept East Asia some 20,000 years ago and was devastating enough to leave an evolutionary imprint on the DNA of people alive today.
The new [study]('https://doi.org/10.1016/j.cub.2021.05.067') suggests that an ancient coronavirus plagued the region for many years, researchers say. The finding could have dire implications for the Covid-19 pandemic if it’s not brought under control soon through vaccination.
“It should make us worry,” said David Enard, an evolutionary biologist at the University of Arizona who led the study, which was published on Thursday in the journal Current Biology. “What is going on right now might be going on for generations and generations.”
Until now, researchers could not look back very far into the history of this family of pathogens. Over the past 20 years, three coronaviruses have adapted to infect humans and cause severe respiratory disease: Covid-19, SARS and MERS. Studies on each of these coronaviruses indicate that they jumped into our species from bats or other mammals.
Four other coronaviruses can also infect people, but they usually cause only mild colds. Scientists did not directly observe these coronaviruses becoming human pathogens, so they have relied on indirect clues to estimate when the jumps happened. Coronaviruses gain new mutations at a roughly regular rate, and so comparing their genetic variation makes it possible to determine [when they diverged]('https://www.cell.com/trends/microbiology/fulltext/S0966-842X(16)30133-0?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0966842X16301330%3Fshowall%3Dtrue') from a common ancestor.
The most recent of these mild coronaviruses, called HCoV-HKU1, crossed the species barrier in the 1950s. The oldest, called HCoV-NL63, may date back as far as 820 years.
But before that point, the coronavirus trail went cold — until Dr. Enard and his colleagues applied a new method to the search. Instead of looking at the genes of the coronaviruses, the researchers looked at the effects on the DNA of their human hosts.
Over generations, viruses drive enormous amounts of change in the human genome. A mutation that protects against a viral infection may well mean the difference between life and death, and it will be passed down to offspring. A lifesaving mutation, for example, might allow people to chop apart a virus’s proteins.
But viruses can evolve, too. Their proteins can change shape to overcome a host’s defenses. And those changes might spur the host to evolve even more counteroffensives, leading to more mutations.
When a random new mutation happens to provide resistance to a virus, it can swiftly become more common from one generation to the next. And other versions of that gene, in turn, become rarer. So if one version of a gene dominates all others in large groups of people, scientists know that is most likely a signature of rapid evolution in the past.
In [recent years]('https://www.nytimes.com/2018/10/04/science/neanderthal-genes-viruses.html?searchResultPosition=42'), Dr. Enard and his colleagues have searched the human genome for these patterns of genetic variation in order to reconstruct the history of an array of viruses. When the pandemic struck, he wondered whether ancient coronaviruses had left a distinctive mark of their own.
He and his colleagues compared the DNA of thousands of people across 26 different populations around the world, looking at a combination of genes [known to be crucial]('https://www.nytimes.com/2020/03/17/science/coronavirus-treatment.html') for coronaviruses but not other kinds of pathogens. In East Asian populations, the scientists found that 42 of these genes had a dominant version. That was a strong signal that people in East Asia had adapted to an ancient coronavirus.
But whatever happened in East Asia seemed to have been limited to that region. “When we compared them to populations around the world, we couldn’t find the signal,” said Yassine Souilmi, a postdoctoral researcher at the University of Adelaide in Australia and a co-author of the new study.
The scientists then tried to estimate how long ago East Asians had adapted to a coronavirus. They took advantage of the fact that once a dominant version of a gene starts being passed down through the generations, it can gain harmless random mutations. As more time passes, more of those mutations accumulate.
Dr. Enard and his colleagues found that the 42 genes all had about the same number of mutations. That meant that they had all rapidly evolved at about the same time. “This is a signal we should absolutely not expect by chance,” Dr. Enard said.
They estimated that all of those genes evolved their antiviral mutations sometime between 20,000 and 25,000 years ago, most likely over the course of a few centuries. It’s a surprising finding, since East Asians at the time were not living in dense communities but instead formed small bands of hunter-gatherers.
Aida Andres, an evolutionary geneticist at the University College London who was not involved in the new study, said she found the work compelling. “I’m quite convinced there’s something there,” she said.
Still, she didn’t think it was possible yet to make a firm estimate of how long ago the ancient epidemic took place. “The timing is a complicated thing,” she said. “Whether that happened a few thousand years before or after — I personally think it’s something that we cannot be as confident of.”
Scientists looking for drugs to fight the new coronavirus might want to scrutinize the 42 genes that evolved in response to the ancient epidemic, Dr. Souilmi said. “It’s actually pointing us to molecular knobs to adjust the immune response to the virus,” he said.
Dr. Anders agreed, saying that the genes identified in the new study should get special attention as targets for drugs. “You know that they’re important,” she said. “That’s the nice thing about evolution.”
Very interesting on a paleogenetics plane...
[A Coronavirus Epidemic Hit 20,000 Years Ago, New Study Finds]('https://www.nytimes.com/2021/06/24/science/ancient-coronavirus-epidemic.html?action=click&module=In%20Other%20News&pgtype=Homepage')
[HEADING=2]A Coronavirus Epidemic Hit 20,000 Years Ago, New Study Finds[/HEADING]
A few dozen human genes rapidly evolved in ancient East Asia to thwart coronavirus infections, scientists say. Those genes could be crucial to today’s pandemic.
Researchers have found evidence that a coronavirus epidemic swept East Asia some 20,000 years ago and was devastating enough to leave an evolutionary imprint on the DNA of people alive today.
The new [study]('https://doi.org/10.1016/j.cub.2021.05.067') suggests that an ancient coronavirus plagued the region for many years, researchers say. The finding could have dire implications for the Covid-19 pandemic if it’s not brought under control soon through vaccination.
“It should make us worry,” said David Enard, an evolutionary biologist at the University of Arizona who led the study, which was published on Thursday in the journal Current Biology. “What is going on right now might be going on for generations and generations.”
Until now, researchers could not look back very far into the history of this family of pathogens. Over the past 20 years, three coronaviruses have adapted to infect humans and cause severe respiratory disease: Covid-19, SARS and MERS. Studies on each of these coronaviruses indicate that they jumped into our species from bats or other mammals.
Four other coronaviruses can also infect people, but they usually cause only mild colds. Scientists did not directly observe these coronaviruses becoming human pathogens, so they have relied on indirect clues to estimate when the jumps happened. Coronaviruses gain new mutations at a roughly regular rate, and so comparing their genetic variation makes it possible to determine [when they diverged]('https://www.cell.com/trends/microbiology/fulltext/S0966-842X(16)30133-0?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0966842X16301330%3Fshowall%3Dtrue') from a common ancestor.
The most recent of these mild coronaviruses, called HCoV-HKU1, crossed the species barrier in the 1950s. The oldest, called HCoV-NL63, may date back as far as 820 years.
But before that point, the coronavirus trail went cold — until Dr. Enard and his colleagues applied a new method to the search. Instead of looking at the genes of the coronaviruses, the researchers looked at the effects on the DNA of their human hosts.
Over generations, viruses drive enormous amounts of change in the human genome. A mutation that protects against a viral infection may well mean the difference between life and death, and it will be passed down to offspring. A lifesaving mutation, for example, might allow people to chop apart a virus’s proteins.
But viruses can evolve, too. Their proteins can change shape to overcome a host’s defenses. And those changes might spur the host to evolve even more counteroffensives, leading to more mutations.
When a random new mutation happens to provide resistance to a virus, it can swiftly become more common from one generation to the next. And other versions of that gene, in turn, become rarer. So if one version of a gene dominates all others in large groups of people, scientists know that is most likely a signature of rapid evolution in the past.
In [recent years]('https://www.nytimes.com/2018/10/04/science/neanderthal-genes-viruses.html?searchResultPosition=42'), Dr. Enard and his colleagues have searched the human genome for these patterns of genetic variation in order to reconstruct the history of an array of viruses. When the pandemic struck, he wondered whether ancient coronaviruses had left a distinctive mark of their own.
He and his colleagues compared the DNA of thousands of people across 26 different populations around the world, looking at a combination of genes [known to be crucial]('https://www.nytimes.com/2020/03/17/science/coronavirus-treatment.html') for coronaviruses but not other kinds of pathogens. In East Asian populations, the scientists found that 42 of these genes had a dominant version. That was a strong signal that people in East Asia had adapted to an ancient coronavirus.
But whatever happened in East Asia seemed to have been limited to that region. “When we compared them to populations around the world, we couldn’t find the signal,” said Yassine Souilmi, a postdoctoral researcher at the University of Adelaide in Australia and a co-author of the new study.
The scientists then tried to estimate how long ago East Asians had adapted to a coronavirus. They took advantage of the fact that once a dominant version of a gene starts being passed down through the generations, it can gain harmless random mutations. As more time passes, more of those mutations accumulate.
Dr. Enard and his colleagues found that the 42 genes all had about the same number of mutations. That meant that they had all rapidly evolved at about the same time. “This is a signal we should absolutely not expect by chance,” Dr. Enard said.
They estimated that all of those genes evolved their antiviral mutations sometime between 20,000 and 25,000 years ago, most likely over the course of a few centuries. It’s a surprising finding, since East Asians at the time were not living in dense communities but instead formed small bands of hunter-gatherers.
Aida Andres, an evolutionary geneticist at the University College London who was not involved in the new study, said she found the work compelling. “I’m quite convinced there’s something there,” she said.
Still, she didn’t think it was possible yet to make a firm estimate of how long ago the ancient epidemic took place. “The timing is a complicated thing,” she said. “Whether that happened a few thousand years before or after — I personally think it’s something that we cannot be as confident of.”
Scientists looking for drugs to fight the new coronavirus might want to scrutinize the 42 genes that evolved in response to the ancient epidemic, Dr. Souilmi said. “It’s actually pointing us to molecular knobs to adjust the immune response to the virus,” he said.
Dr. Anders agreed, saying that the genes identified in the new study should get special attention as targets for drugs. “You know that they’re important,” she said. “That’s the nice thing about evolution.”
I didn’t know they had labs back then in China ???
I just heard a report that if you had the J&J shot you will certainly need a booster and soon.
Do you have any info on this?
[USER=51]@Roccus7[/USER] what is the difference between an emergency vaccine approval and a
’full’ approval. Please try not to make my head explode.
I'll spare your gray matter and use the FDA explanation...
[HEADING=2]Emergency Use Authorization for Vaccines Explained[/HEADING]
FDA is globally respected for its scientific standards of vaccine safety, effectiveness and quality. The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.
FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.
[HEADING=1]What is an Emergency Use Authorization (EUA)?[/HEADING]
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
[HEADING=1]Are the COVID-19 vaccines rigorously tested?[/HEADING]
Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.
Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.
[HEADING=1]What safety and effectiveness data are required to be submitted to FDA for an EUA request for a vaccine intended to prevent COVID-19?[/HEADING]
COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer.
For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.
From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.
Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.
[HEADING=1]What is the process that manufacturers are following to potentially make a COVID-19 vaccine available by EUA?[/HEADING]
[LIST]
[*]Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID-19.
[*]When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA.
[*]After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission.
[*]While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use.
[*]Following the advisory committee meeting, FDA’s career professional staff will consider the input of the advisory committee members and continue their evaluation of the submission to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States.
[/LIST]
[HEADING=1]Who are the FDA career professionals evaluating EUAs for vaccines?[/HEADING]
The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States.
[HEADING=1]What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use?[/HEADING]
FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.
FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).
Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.
[HEADING=1]How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?[/HEADING]
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.
[HEADING=1]How is it that COVID-19 vaccines have been developed so quickly?[/HEADING]
In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.
Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated.
I'll spare your gray matter and use the FDA explanation...
[HEADING=2]Emergency Use Authorization for Vaccines Explained[/HEADING]
FDA is globally respected for its scientific standards of vaccine safety, effectiveness and quality. The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.
FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.
[HEADING=1]What is an Emergency Use Authorization (EUA)?[/HEADING]
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
[HEADING=1]Are the COVID-19 vaccines rigorously tested?[/HEADING]
Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.
Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.
[HEADING=1]What safety and effectiveness data are required to be submitted to FDA for an EUA request for a vaccine intended to prevent COVID-19?[/HEADING]
COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer.
For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.
From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.
Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.
[HEADING=1]What is the process that manufacturers are following to potentially make a COVID-19 vaccine available by EUA?[/HEADING]
[LIST]
[*]Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID-19.
[*]When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA.
[*]After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission.
[*]While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use.
[*]Following the advisory committee meeting, FDA’s career professional staff will consider the input of the advisory committee members and continue their evaluation of the submission to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States.
[/LIST]
[HEADING=1]Who are the FDA career professionals evaluating EUAs for vaccines?[/HEADING]
The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States.
[HEADING=1]What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use?[/HEADING]
FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.
FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).
Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.
[HEADING=1]How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?[/HEADING]
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.
[HEADING=1]How is it that COVID-19 vaccines have been developed so quickly?[/HEADING]
In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.
Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated.
Nice clear explanation but one question remains ie. what are the additional steps to go from an EAU to Full authorization?
One thing to also consider, this country has the most rigorous requirements when it comes to drug research, production, APPROVAL and manufacturing. You would be amazed at how many drugs don't make it to the market simply because they don't work or do more harm than good That's the good side of the FDA. The bad side is they make the process so prohibitively long and arduous that drug companies will not venture to find treatments to lesser known illnesses that are easily treated simply because its not economically feasible to do so.
Nice clear explanation but one question remains ie. what are the additional steps to go from an EAU to Full authorization?
Really nothing than more data, a longer period looking at possible adverse reactions and extensive mfg facilities inspections
he bad side is they make the process so prohibitively long and arduous that drug companies will not venture to find treatments to lesser known illnesses that are easily treated simply because its not economically feasible to do so.
They have the "Orphan Drug" rules for this problem. It's sort of a "EUA" scenario...
What is the current thinking on whether or not recovered COVID individuals should get a vaccine. My Brother recovered from COVID and the VA Hospital recommended he get vaccinated, which he did. Thanks.
Yes, as of June or so, it was recommended that all recovered COVID patients be vaccinated. Not sure if they need to get 2 shots of the mRNA vaccines or not. I do know they were told to wait a few months after recovery to get vaccinated.
Problem with those who were infected and recovered is the level of antibodies produced is unpredictable. That along with the constant mutation of the virus would lead me to recommend getting vaccinated even if you had covid.
Friend of mine has a15yr old daughter who was exposed at a volleyball tournament. She's tested positive and is now symptomatic.
This thing is sooooo unpredictable!
Yes, as of June or so, it was recommended that all recovered COVID patients be vaccinated. Not sure if they need to get 2 shots of the mRNA vaccines or not. I do know they were told to wait a few months after recovery to get vaccinated.
Would you think that means 12 - 16 weeks or something else?
This fall will likely see covid booster shots/Flu hybrid vaccines all based on the mRNA model.
Great Hybrid vaccines will they be FDA approved? Do they plan on filling people full of shots for every new strain until they get it right? Asking for a friend
Great Hybrid vaccines will they be FDA approved? Do they plan on filling people full of shots for every new strain until they get it right? Asking for a friend
The mRNA technology of Pfizer & Moderna will be approved in the next month or 2. If added, additional mRNA sequences will need approval, but it will be like the yearly flu vaccine, where they get quick approvals.
Will every variant need a new formulation? Depends on the variant. All the current vaccines are very effective against all the variants. As I've mentioned many times, the BEST thing about COVID-19 is it's method of cell invasion. It's distinctive and unique spike protein is its "key" to open a cell and luckily it's structure that binds to the cell, is very immunogenic, meaning our immune systems LOVE to make antibodies against it.
Also in our favor is that the spike protein must maintain a very specific structure, just like a door key, to "open" the cell, so it cannot change much without losing its ability to open the "cell door". The structural conservation of the spike protein means that the subtle changes in it between variants don't negatively impact the antibodies in vaccinated people. Therefor to date, the current vaccines are maintaining effectivity against all the variants in a person who is fully vaccinated.
Now we are battling evolutionary pressure here, and viruses mutate, especially if they are running rampant. Can a new mutation, change the spike protein's structure enough that even though it retains its ability to infect a cell, it can evade antibodies in vaccinated people? Who knows, anything is possible? That's why it's critical to contain the virus, shutting down its transmission which drops the frequency of mutation.
As far as boosters, the vaccine manufacturers are monitoring the antibody levels and strength in vaccinated people. Like the tetanus vaccine, your antibodies may loose potency over time and you get a booster. At this moment, there is debate when and if COVID vaccines will need to have a booster.
Tell your friend to roll up his sleeve...
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