Same here in Holland.Recommendation vitamin D is 800 IU for certain groups and vitamin C only 70 mg.Strange enough no recommendation for vitamin K, while they found out in Nijmegen that patients on the ICU had low vitamin K status.
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Coronavirus.. outlook
- Thread starter Medfinder
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Same here in Holland.Recommendation vitamin D is 800 IU for certain groups and vitamin C only 70 mg.Strange enough no recommendation for vitamin K, while they found out in Nijmegen that patients on the ICU had low vitamin K status.
Nearing 200,000 dead from Sars-Corona-19 in the USA.
If DJT promoted "Herd Mentality", even at 1%, there would be ~16,400,000 DEATHS in the USA alone.
Not a good plan.
Better to take the necessary time to make sure vaccine WORKS. Likely not until 2-3rd Quarter of 2021.
If DJT promoted "Herd Mentality", even at 1%, there would be ~16,400,000 DEATHS in the USA alone.
Not a good plan.
Better to take the necessary time to make sure vaccine WORKS. Likely not until 2-3rd Quarter of 2021.
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Medfinder
Chemon 91
Coronavirus Cases:
30,471,783
view by country
Deaths:
951,910
Recovered:
22,164,412
ACTIVE CASES
7,355,461
Currently Infected Patients
7,294,334 (99%)
in Mild Condition
61,127 (1%)
Serious or Critical
Show Statistics
CLOSED CASES
23,116,322
Cases which had an outcome:
22,164,412 (96%)
Recovered / Discharged
951,910 (4%)
Deaths
30,471,783
view by country
Deaths:
951,910
Recovered:
22,164,412
ACTIVE CASES
7,355,461
Currently Infected Patients
7,294,334 (99%)
in Mild Condition
61,127 (1%)
Serious or Critical
Show Statistics
CLOSED CASES
23,116,322
Cases which had an outcome:
22,164,412 (96%)
Recovered / Discharged
951,910 (4%)
Deaths
Switcher56
Comfortably numb!
That there...
Herd Mentality has a nice ring to it. I'll have a Berdger with Convfefe to go with that, please.
Last edited:
I think all this started when they killed obomacare, and then appropriately cut a billion from the NIH budget last year. Foochie was just spending the money having the chicoms develop viruses, which is illegal to do in the USofA. So he did it there. Hang the bastard.
The med mafia is out for revenge.
The med mafia is out for revenge.
Jeez. Calm down dude. There is so much anger and indignation in your writing.
Take a deep breath of some tasty bud, relax, then note that Planet Earth continues to rotate along its ordained axis and trajectory, per schedule.
This Bergder's for you !
Can corona merge with another virus into a Frankenstein virus?
The new coronavirus probably originated from two other viruses that came together in an infected animal. It is possible that the virus will mutate in the same way in a human being.
Some virologists are concerned about the possibility that a 'Frankenstein virus' will soon emerge. SARS-CoV-2, the virus that causes COVID-19, was almost certainly created by the fusion of two different coronaviruses. The exact details are uncertain, but genome research on the virus indicates that this mash-up happened in a bat about a decade ago. The bat was co-infected with two closely related coronaviruses, which together formed a new hybrid virus. "If you look at the coronavirus family tree, such recombination is common," says virologist Samuel Díaz-Muñoz of the University of California, Davis.
Smelter
This merging happens for two reasons. First, coronaviruses are tolerant to co-infection. That is, unlike many other viruses, they allow a second virus to enter an already infected cell.
Second, the way coronaviruses replicate their genome makes fusion not only possible, but probable. Coronaviruses are RNA viruses. This type of virus mutates very regularly because the enzymes that copy their RNA have no proofreading function. The multiple mutation enables a virus to rapidly develop resistance to the immune response of the infected person.
Coronaviruses are the exception among RNA viruses because their replicase enzymes do proofread. SARS-CoV-2 has thus proven to be very resistant to mutation. According to Díaz-Muñoz, only six mutants have surfaced so far.
The different coronaviruses originate from something else: recombination. Their replicase enzymes often jump from one part of the RNA template to another. This allows them to make a new mix of their own genome and thus create variants. This process also allows them to steal genetic material from other closely related coronaviruses.
“It's one of the things that makes it easy to get from one species to another. I think there is no doubt that recombination in a bat is behind the creation of SARS-CoV-2, ”says Díaz-Muñoz. The fear is that it could happen again now, this time in an infected human.
Combination candidates
Research by Huiguang Yi at Southern University of Science and Technology in Shenzhen, China, implies that SARS-CoV-2 recombines its genome in human cells. Yi has analyzed 84 SARS-CoV-2 genome sequences from human patients. In it he found a number that could only have arisen through recombination.
There are also many cases where cells are infected by SARS-CoV-2 as well as other viruses, including influenza, rhinovirus, RS virus and the seasonal coronaviruses that cause common colds.
It is the latter category that concerns virologists in particular, as these viruses are quite closely related to SARS-CoV-2. So they can potentially form a hybrid virus with it.
There are four of these seasonal coronaviruses in circulation. In addition, there is the original SARS virus, which caused an epidemic from 2002 to 2004. Although this virus is no longer in circulation, virologists fear it could make a comeback . Finally, there is also the MERS coronavirus, which emerged in 2012 and is still circulating in low numbers.
The fear is that if a human becomes simultaneously infected with both SARS-CoV-2 and a second coronavirus, that person could be a melting pot for the emergence of a new virus. That could even lead to a second pandemic.
Unlikely?
But caution about that conclusion is warranted. In medical circles, co-infection means that one patient has been infected by two or more pathogens. That does not mean that the same cells of the patient are actually infected. We do not yet know whether such a simultaneous contamination with SARS-CoV-2 can occur at the cellular level, says Díaz-Muñoz. But given what we know about other coronaviruses, that possibility is there.
"We are concerned about the flu, but we need to pay more attention to the seasonal coronaviruses," says Díaz-Muñoz. 'They are now flying under the radar. What will happen to the seasonal corona is one of the most important questions at the moment. '
It is not known whether SARS-CoV-2 can recombine with a regular coronavirus, but we cannot rule it out. "Combining the genome material from two viruses effectively is more difficult when the viruses are very different," says physicist Raúl Rabadán of Columbia University in New York. "If there is a co-infection with a common coronavirus and SARS-CoV-2, it is unlikely, but not impossible, that potential combined variants will be viable."
Frankenstein's properties
Yi told New Scientist he is not really concerned about a recombination between SARS-CoV-2 and a seasonal coronavirus that causes the common cold, as their genomes are not closely related enough. The SARS and MERS viruses, or as yet unknown closely related coronaviruses, are a different story. The SARS virus most closely resembles SARS-CoV-2 in terms of genome, so it is the most dangerous, he says.
That sounds troubling, but a hybrid virus wouldn't necessarily be worse than SARS-CoV-2, Díaz-Muñoz points out. It could also combine the less virulent features of the two parent viruses and thus become a mild virus, like the common cold virus. 'That could be evolutionarily beneficial for the virus. People with such a mild virus don't stay at home, so it can spread more easily. '
Even though a mash-up is unlikely, recombination of SARS-CoV-2 is still a major problem, Yi says. It leads to genetic variations that can make the virus more virulent, more resistant to drugs, or better able to fight against our immune system. It could also render diagnostics based on RNA tests useless. So doctors and virologists should be concerned about these possibilities, he says.
NewScientist
The new coronavirus probably originated from two other viruses that came together in an infected animal. It is possible that the virus will mutate in the same way in a human being.
Some virologists are concerned about the possibility that a 'Frankenstein virus' will soon emerge. SARS-CoV-2, the virus that causes COVID-19, was almost certainly created by the fusion of two different coronaviruses. The exact details are uncertain, but genome research on the virus indicates that this mash-up happened in a bat about a decade ago. The bat was co-infected with two closely related coronaviruses, which together formed a new hybrid virus. "If you look at the coronavirus family tree, such recombination is common," says virologist Samuel Díaz-Muñoz of the University of California, Davis.
Smelter
This merging happens for two reasons. First, coronaviruses are tolerant to co-infection. That is, unlike many other viruses, they allow a second virus to enter an already infected cell.
Second, the way coronaviruses replicate their genome makes fusion not only possible, but probable. Coronaviruses are RNA viruses. This type of virus mutates very regularly because the enzymes that copy their RNA have no proofreading function. The multiple mutation enables a virus to rapidly develop resistance to the immune response of the infected person.
Coronaviruses are the exception among RNA viruses because their replicase enzymes do proofread. SARS-CoV-2 has thus proven to be very resistant to mutation. According to Díaz-Muñoz, only six mutants have surfaced so far.
The different coronaviruses originate from something else: recombination. Their replicase enzymes often jump from one part of the RNA template to another. This allows them to make a new mix of their own genome and thus create variants. This process also allows them to steal genetic material from other closely related coronaviruses.
“It's one of the things that makes it easy to get from one species to another. I think there is no doubt that recombination in a bat is behind the creation of SARS-CoV-2, ”says Díaz-Muñoz. The fear is that it could happen again now, this time in an infected human.
Combination candidates
Research by Huiguang Yi at Southern University of Science and Technology in Shenzhen, China, implies that SARS-CoV-2 recombines its genome in human cells. Yi has analyzed 84 SARS-CoV-2 genome sequences from human patients. In it he found a number that could only have arisen through recombination.
There are also many cases where cells are infected by SARS-CoV-2 as well as other viruses, including influenza, rhinovirus, RS virus and the seasonal coronaviruses that cause common colds.
It is the latter category that concerns virologists in particular, as these viruses are quite closely related to SARS-CoV-2. So they can potentially form a hybrid virus with it.
There are four of these seasonal coronaviruses in circulation. In addition, there is the original SARS virus, which caused an epidemic from 2002 to 2004. Although this virus is no longer in circulation, virologists fear it could make a comeback . Finally, there is also the MERS coronavirus, which emerged in 2012 and is still circulating in low numbers.
The fear is that if a human becomes simultaneously infected with both SARS-CoV-2 and a second coronavirus, that person could be a melting pot for the emergence of a new virus. That could even lead to a second pandemic.
Unlikely?
But caution about that conclusion is warranted. In medical circles, co-infection means that one patient has been infected by two or more pathogens. That does not mean that the same cells of the patient are actually infected. We do not yet know whether such a simultaneous contamination with SARS-CoV-2 can occur at the cellular level, says Díaz-Muñoz. But given what we know about other coronaviruses, that possibility is there.
"We are concerned about the flu, but we need to pay more attention to the seasonal coronaviruses," says Díaz-Muñoz. 'They are now flying under the radar. What will happen to the seasonal corona is one of the most important questions at the moment. '
It is not known whether SARS-CoV-2 can recombine with a regular coronavirus, but we cannot rule it out. "Combining the genome material from two viruses effectively is more difficult when the viruses are very different," says physicist Raúl Rabadán of Columbia University in New York. "If there is a co-infection with a common coronavirus and SARS-CoV-2, it is unlikely, but not impossible, that potential combined variants will be viable."
Frankenstein's properties
Yi told New Scientist he is not really concerned about a recombination between SARS-CoV-2 and a seasonal coronavirus that causes the common cold, as their genomes are not closely related enough. The SARS and MERS viruses, or as yet unknown closely related coronaviruses, are a different story. The SARS virus most closely resembles SARS-CoV-2 in terms of genome, so it is the most dangerous, he says.
That sounds troubling, but a hybrid virus wouldn't necessarily be worse than SARS-CoV-2, Díaz-Muñoz points out. It could also combine the less virulent features of the two parent viruses and thus become a mild virus, like the common cold virus. 'That could be evolutionarily beneficial for the virus. People with such a mild virus don't stay at home, so it can spread more easily. '
Even though a mash-up is unlikely, recombination of SARS-CoV-2 is still a major problem, Yi says. It leads to genetic variations that can make the virus more virulent, more resistant to drugs, or better able to fight against our immune system. It could also render diagnostics based on RNA tests useless. So doctors and virologists should be concerned about these possibilities, he says.
NewScientist
Viruses mutate. It's possible they can "merge". Super bugs as they call them that are antibiotic resistant is an example.
SARS-CoV-2, the virus that causes Covid-19, almost certainly originated from the hybridization of two different coronaviruses. The details remain hazy, but the virus’s genome sequence suggests that this mash-up occurred in a bat about a decade ago. The bat was simultaneously infected with two closely related coronaviruses, which merged into a new one.
With COVID, the current total of US deaths is 201,489 and the current number of closed cases is 4,322,063. Divide the former by the latter and you come up with the correct fatality rate which is 4.66%, a significantly higher rate than 2.97%. According to John Hopkins achieving herd immunity requires 70% to 90% immunity depending on how contagious an infection is, and Covid is pretty damn infectious!
I'll keep washing my cloth masks in antibacterial dish soap, rinse in hot water and air dry. I bought large containers of dish soap (less expensive than liquid hand soap) to refill my containers.
Went to the zoo today, always a fun trek. EVERYONE (participants, not zoo animals), including babies, had on masks!
NY TIMES 9/17/20:
At least 4 new coronavirus deaths and 158 new cases were reported in New Mexico on Sept. 17. Over the past week, there have been an average of 110 cases per day, a decrease of 14 percent from the average two weeks earlier.
As of Friday afternoon, there have been at least 27,199 cases and 836 deaths in New Mexico since the beginning of the pandemic, according to a New York Times database.
Having some of the lowest totals in the nation, the Coronavirus in New Mexico has updated public health order which allows camping, youth sports in small groups, pumpkin patch picking, swimming for fitness(no more than 10 in a group), and YES, mask wearing, hand washing.
SARS-CoV-2, the virus that causes Covid-19, almost certainly originated from the hybridization of two different coronaviruses. The details remain hazy, but the virus’s genome sequence suggests that this mash-up occurred in a bat about a decade ago. The bat was simultaneously infected with two closely related coronaviruses, which merged into a new one.
With COVID, the current total of US deaths is 201,489 and the current number of closed cases is 4,322,063. Divide the former by the latter and you come up with the correct fatality rate which is 4.66%, a significantly higher rate than 2.97%. According to John Hopkins achieving herd immunity requires 70% to 90% immunity depending on how contagious an infection is, and Covid is pretty damn infectious!
I'll keep washing my cloth masks in antibacterial dish soap, rinse in hot water and air dry. I bought large containers of dish soap (less expensive than liquid hand soap) to refill my containers.
Went to the zoo today, always a fun trek. EVERYONE (participants, not zoo animals), including babies, had on masks!
NY TIMES 9/17/20:
At least 4 new coronavirus deaths and 158 new cases were reported in New Mexico on Sept. 17. Over the past week, there have been an average of 110 cases per day, a decrease of 14 percent from the average two weeks earlier.
As of Friday afternoon, there have been at least 27,199 cases and 836 deaths in New Mexico since the beginning of the pandemic, according to a New York Times database.
Having some of the lowest totals in the nation, the Coronavirus in New Mexico has updated public health order which allows camping, youth sports in small groups, pumpkin patch picking, swimming for fitness(no more than 10 in a group), and YES, mask wearing, hand washing.
Last edited:
Medfinder
Chemon 91
Coronavirus Cases:
30,755,293
view by country
Deaths:
957,436
Recovered:
22,395,889
ACTIVE CASES
7,401,968
Currently Infected Patients
7,340,525 (99%)
in Mild Condition
61,443 (1%)
Serious or Critical
S
Show Statistics
CLOSED CASES
23,353,325
Cases which had an outcome:
22,395,889 (96%)
Recovered / Discharged
957,436 (4%)
Deaths
30,755,293
view by country
Deaths:
957,436
Recovered:
22,395,889
ACTIVE CASES
7,401,968
Currently Infected Patients
7,340,525 (99%)
in Mild Condition
61,443 (1%)
Serious or Critical
S
Show Statistics
CLOSED CASES
23,353,325
Cases which had an outcome:
22,395,889 (96%)
Recovered / Discharged
957,436 (4%)
Deaths
1887 new cases & 2 passed away today in Holland.
COVID-19 SEEMS TO STRIKE MORE EASILY WHEN ACCOMPANIED BY THE FLU VIRUS
It's bad news now that flu season is approaching.
At the beginning of this year, the newly discovered coronavirus SARS-CoV-2 hit hard in Europe. Fortunately, with the dawn of spring, the virus was quickly pushed back. It is generally believed that this is mainly due to strict measures taken by many European countries to stop the spread of the virus. But that's not the whole story, researchers at the Max Planck Institute for Infection Biology now suggest . According to the researchers, the number of infections also decreased in the spring, because the flu season ended during the same period.
Models
In their study - which has yet to undergo peer review, but can already be viewed on medRxiv - the researchers state that COVID-19 in the company of the flu virus makes victims much easier. And because the flu season ended in the spring of 2019, the number of infections also decreased slightly.
The researchers draw these conclusions from models. They modeled the course of the pandemic in Belgium, Norway, Italy and Spain: four countries in which the epidemic unfolded slightly differently. The models were based on what we currently know about the virus and its spread. The measures that the various countries took to contain the virus were also included in the models. Subsequently, an estimate of the number of infections and deaths was derived from these models.
Multiple simulations
The researchers performed various simulations with these models. During some simulations, the model assumed that the number of influenza infections increased. During other simulations, the model was set in such a way that the flu virus limited the number of infections. And yet other simulations were carried out under the assumption that the flu virus had no influence on the number of infections. The researchers then looked to what extent the number of deaths estimated by the model corresponded to reality.
Higher transmission
And time and again, the actual mortality data turned out to be best simulated in the presence of an influenza virus that promoted the transmission of the virus. In concrete terms, it appears that the transmission of the coronavirus in the company of the flu is on average about 2 to 2.5 times higher at the population level.
Receptor
It is unclear why the coronavirus in the company of the flu virus seems to make more victims. The design of this study does not lend itself to answer that question. The researchers do refer to the work of other research groups who recently showed that the flu virus may make the flu virus more susceptible to SARS-CoV-2, because the flu virus leads to an increased production of the ACE2 receptors that the coronavirus uses to enter human cells.
Previously, some researchers argued for the flu shot to be administered widely this year, in order to prevent hospitals from also filling up with flu patients in the future . Judging from this new research - which cautiously suggests that the flu facilitates SARS-CoV-2 - there is still a good reason to get the flu shot. For example, it can sometimes have a positive effect on the transmission of the corona virus.
More research is needed to gain real clarity about whether and how the flu virus affects SARS-CoV-2. “The model actually produces two testable predictions,” Matthieu Domenech de Cellès tells Scientias.nl . “That influenza is a risk factor for SARS-CoV-2 and that the influenza vaccine can therefore offer some protection against a SARS-CoV-2 infection. You could test the first hypothesis by setting up a prospective or retrospective epidemiological study comparing the risk of a SARS-CoV-2 infection for people who have just had the flu with that of people who have not had flu. The second hypothesis can be tested in a similar way, in fact: such a study has already been carried out in the US and this confirmed the hypothesis. ” From the investigationwhat Domenech de Cellès refers to, it turned out that people who had been given a flu shot had a lower chance of testing positive for COVID-19. “But more research is needed. Finally, as always in epidemiology, there must be a biological mechanism underlying the association found. I suspect that mechanism is an increase in ACE2 receptors caused by a flu infection. In that case, the influenza infection increases the susceptibility to a SARS-CoV-2 infection on an individual level and thus leads to what we see in our models: the faster spread of the virus at the population level. ”
Scientists.nl
COVID-19 SEEMS TO STRIKE MORE EASILY WHEN ACCOMPANIED BY THE FLU VIRUS
It's bad news now that flu season is approaching.
At the beginning of this year, the newly discovered coronavirus SARS-CoV-2 hit hard in Europe. Fortunately, with the dawn of spring, the virus was quickly pushed back. It is generally believed that this is mainly due to strict measures taken by many European countries to stop the spread of the virus. But that's not the whole story, researchers at the Max Planck Institute for Infection Biology now suggest . According to the researchers, the number of infections also decreased in the spring, because the flu season ended during the same period.
Models
In their study - which has yet to undergo peer review, but can already be viewed on medRxiv - the researchers state that COVID-19 in the company of the flu virus makes victims much easier. And because the flu season ended in the spring of 2019, the number of infections also decreased slightly.
The researchers draw these conclusions from models. They modeled the course of the pandemic in Belgium, Norway, Italy and Spain: four countries in which the epidemic unfolded slightly differently. The models were based on what we currently know about the virus and its spread. The measures that the various countries took to contain the virus were also included in the models. Subsequently, an estimate of the number of infections and deaths was derived from these models.
Multiple simulations
The researchers performed various simulations with these models. During some simulations, the model assumed that the number of influenza infections increased. During other simulations, the model was set in such a way that the flu virus limited the number of infections. And yet other simulations were carried out under the assumption that the flu virus had no influence on the number of infections. The researchers then looked to what extent the number of deaths estimated by the model corresponded to reality.
Higher transmission
And time and again, the actual mortality data turned out to be best simulated in the presence of an influenza virus that promoted the transmission of the virus. In concrete terms, it appears that the transmission of the coronavirus in the company of the flu is on average about 2 to 2.5 times higher at the population level.
Receptor
It is unclear why the coronavirus in the company of the flu virus seems to make more victims. The design of this study does not lend itself to answer that question. The researchers do refer to the work of other research groups who recently showed that the flu virus may make the flu virus more susceptible to SARS-CoV-2, because the flu virus leads to an increased production of the ACE2 receptors that the coronavirus uses to enter human cells.
Previously, some researchers argued for the flu shot to be administered widely this year, in order to prevent hospitals from also filling up with flu patients in the future . Judging from this new research - which cautiously suggests that the flu facilitates SARS-CoV-2 - there is still a good reason to get the flu shot. For example, it can sometimes have a positive effect on the transmission of the corona virus.
More research is needed to gain real clarity about whether and how the flu virus affects SARS-CoV-2. “The model actually produces two testable predictions,” Matthieu Domenech de Cellès tells Scientias.nl . “That influenza is a risk factor for SARS-CoV-2 and that the influenza vaccine can therefore offer some protection against a SARS-CoV-2 infection. You could test the first hypothesis by setting up a prospective or retrospective epidemiological study comparing the risk of a SARS-CoV-2 infection for people who have just had the flu with that of people who have not had flu. The second hypothesis can be tested in a similar way, in fact: such a study has already been carried out in the US and this confirmed the hypothesis. ” From the investigationwhat Domenech de Cellès refers to, it turned out that people who had been given a flu shot had a lower chance of testing positive for COVID-19. “But more research is needed. Finally, as always in epidemiology, there must be a biological mechanism underlying the association found. I suspect that mechanism is an increase in ACE2 receptors caused by a flu infection. In that case, the influenza infection increases the susceptibility to a SARS-CoV-2 infection on an individual level and thus leads to what we see in our models: the faster spread of the virus at the population level. ”
Scientists.nl
Medfinder
Chemon 91
]Some scientists suspect that Covid-19 causes respiratory failure and death not through damage to the lungs, but the brain – and other symptoms include headaches, strokes and seizures.[
https://www.bbc.com/future/article/20200622-the-long-term-effects-of-covid-19-infection
https://www.bbc.com/future/article/20200622-the-long-term-effects-of-covid-19-infection
TychoMonolyth
Boreal Curing
From what I've heard, Red blood cells ability to absorb and distribute oxygen kills many Covid patients.
Medfinder
Chemon 91
Coronavirus Cases:
31,042,208
view by country
Deaths:
962,418
Recovered:
22,648,055
ACTIVE CASES
7,431,735
Currently Infected Patients
7,370,348 (99%)
in Mild Condition
61,387 (1%)
Serious or Critical
Show Statistics
CLOSED CASES
23,610,473
Cases which had an outcome:
22,648,055 (96%)
Recovered / Discharged
962,418 (4%)
Deaths
31,042,208
view by country
Deaths:
962,418
Recovered:
22,648,055
ACTIVE CASES
7,431,735
Currently Infected Patients
7,370,348 (99%)
in Mild Condition
61,387 (1%)
Serious or Critical
Show Statistics
CLOSED CASES
23,610,473
Cases which had an outcome:
22,648,055 (96%)
Recovered / Discharged
962,418 (4%)
Deaths
Im'One
Active member
AstraZeneca, Under Fire for Vaccine Safety,
Releases Trial Blueprints
Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.
AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.
Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.
AstraZeneca’s 111-page trial blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness — the same threshold that the Food and Drug Administration has set in its guidance for coronavirus vaccines. To determine with statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.
However, the plan anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorization from the government to release the vaccine for emergency use.
In allowing only one such interim analysis, AstraZeneca’s plan is more rigorous than the others that have been released, from Moderna and Pfizer, Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said in an interview. Moderna allows two such analyses, and Pfizer four.
He said the problem with looking at the data too many times, after a relatively small number of cases, is that it increases the odds of finding an appearance of safety and efficacy that might not hold up. Stopping trials early can also increase the risk of missing rare side effects that could be significant once the vaccine is given to millions of people.
Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.
Such plans are not usually shared with the public “due to the importance of maintaining confidentiality and integrity of trials,” Michele Meixell, a spokeswoman for AstraZeneca, said in a statement.
The company has released few details about the two cases of serious illness in its trial. The first participant received one dose of the vaccine before developing inflammation of the spinal cord, known as transverse myelitis, according to a participant information sheet for AstraZeneca’s vaccine from July. The condition can cause weakness in the arms and legs, paralysis, pain and bowel and bladder problems.
The case prompted a pause in AstraZeneca’s vaccine trials to allow for a safety review by independent experts. A company spokeswoman told the Times last week that the volunteer was later determined to have a previously undiagnosed case of multiple sclerosis, unrelated to the vaccine, and that the trial resumed shortly thereafter.
NY Times
Releases Trial Blueprints
Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.
AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.
Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.
AstraZeneca’s 111-page trial blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness — the same threshold that the Food and Drug Administration has set in its guidance for coronavirus vaccines. To determine with statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.
However, the plan anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorization from the government to release the vaccine for emergency use.
In allowing only one such interim analysis, AstraZeneca’s plan is more rigorous than the others that have been released, from Moderna and Pfizer, Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said in an interview. Moderna allows two such analyses, and Pfizer four.
He said the problem with looking at the data too many times, after a relatively small number of cases, is that it increases the odds of finding an appearance of safety and efficacy that might not hold up. Stopping trials early can also increase the risk of missing rare side effects that could be significant once the vaccine is given to millions of people.
Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.
Such plans are not usually shared with the public “due to the importance of maintaining confidentiality and integrity of trials,” Michele Meixell, a spokeswoman for AstraZeneca, said in a statement.
The company has released few details about the two cases of serious illness in its trial. The first participant received one dose of the vaccine before developing inflammation of the spinal cord, known as transverse myelitis, according to a participant information sheet for AstraZeneca’s vaccine from July. The condition can cause weakness in the arms and legs, paralysis, pain and bowel and bladder problems.
The case prompted a pause in AstraZeneca’s vaccine trials to allow for a safety review by independent experts. A company spokeswoman told the Times last week that the volunteer was later determined to have a previously undiagnosed case of multiple sclerosis, unrelated to the vaccine, and that the trial resumed shortly thereafter.
NY Times
1844 new cases today in Holland & 7 passed away.
Medfinder
Chemon 91
Coronavirus Cases:
31,279,849
view by country
Deaths:
965,661
Recovered:
22,853,985
ACTIVE CASES
7,460,203
Currently Infected Patients
7,398,944 (99%)
in Mild Condition
61,259 (1%)
Serious or Critical
CLOSED CASES
23,819,646
Cases which had an outcome:
22,853,985 (96%)
Recovered / Discharged
965,661 (4%)
Deaths
31,279,849
view by country
Deaths:
965,661
Recovered:
22,853,985
ACTIVE CASES
7,460,203
Currently Infected Patients
7,398,944 (99%)
in Mild Condition
61,259 (1%)
Serious or Critical
CLOSED CASES
23,819,646
Cases which had an outcome:
22,853,985 (96%)
Recovered / Discharged
965,661 (4%)
Deaths
2217 new cases & 2 passed away today in Holland.
