wuhan - coronavirus

[ktgrok]

25 minutes ago, hopeallgoeswell said:

re: what the vaccine will or won't change 

From the letter: 

If a COVID-19 vaccine is licensed without an appropriate efficacy review, then any potential acceptance or mandate of these vaccines are likely to be based on inaccurate beliefs about the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others or that it will reduce severe COVID-19 disease and deaths. The trial protocols for Moderna’s mRNA-1273 (NCT04470427), 1 Pfizer’s BNT162b (NCT04368728), 2 AstraZeneca’s ChAdOx1 nCoV-19 (NCT04400838) 3 and Johnson & Johnson’s Ad26.COV2.S (NCT04505722) 4 are not currently designed to determine whether either of those objectives can be met.

https://www.icandecide.org/wp-content/uploads/2020/11/Ltr-to-Peter-Marks-re-Efficacy-COVID-19-vaccines.pdf

 

Hopefully, any and all vaccines that get approval will have transparency on these things and the limitations will be widely publicized.

is that website trying to say that the vaccines won't decrease transmission or illness or death???? That they do nothing at all? Cause if they don't reduce transmission OR severe illness OR death ....they do nothing. 

Which is not what I'm reading. In the Moderna trial they had a few people who did get Covid, but fewer than control group and no severe illness. 

Edited November 16, 2020 by ktgrok

[ktgrok]

Who gets vaccine first - one plan https://www.cnbc.com/2020/09/01/us-advisors-recommend-four-phases-for-distributing-coronavirus-vaccine-nationwide.html

My parents would be first, my sister second as a teacher unless her asthma put her in the first group

[Corraleno]

58 minutes ago, hopeallgoeswell said:

re: what the vaccine will or won't change 

From the letter: 

If a COVID-19 vaccine is licensed without an appropriate efficacy review, then any potential acceptance or mandate of these vaccines are likely to be based on inaccurate beliefs about the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others or that it will reduce severe COVID-19 disease and deaths. The trial protocols for Moderna’s mRNA-1273 (NCT04470427), 1 Pfizer’s BNT162b (NCT04368728), 2 AstraZeneca’s ChAdOx1 nCoV-19 (NCT04400838) 3 and Johnson & Johnson’s Ad26.COV2.S (NCT04505722) 4 are not currently designed to determine whether either of those objectives can be met.

https://www.icandecide.org/wp-content/uploads/2020/11/Ltr-to-Peter-Marks-re-Efficacy-COVID-19-vaccines.pdf

 

Hopefully, any and all vaccines that get approval will have transparency on these things and the limitations will be widely publicized.

 

I don't understand their claim that mild cases of covid shouldn't "count" in determining efficacy, and that companies should be separately required to prove that the vaccine significantly reduces severe cases and deaths and prevents transmission before vaccines are approved.  If the data so far are accurate, then it certainly seems to reduce the number of people who get infected, and presumably people who don’t have covid are not going to be hospitalized with it or die of it. So that part of the letter makes no sense to me and just seems like they are antivax and are trying to delay approval on principle.

ETA: OK, now I see that this letter is in fact from an anti-vax group that fights the "tyranny" of government and believes vaccines cause autism and UNICEF "is killing millions of children" with vaccines.  🙄 

Edited November 16, 2020 by Corraleno

[hopeallgoeswell]

22 minutes ago, ktgrok said:

is that website trying to say that the vaccines won't decrease transmission or illness or death???? That they do nothing at all? Cause if they don't reduce transmission OR severe illness OR death ....they do nothing. 

Which is not what I'm reading. In the Moderna trial they had a few people who did get Covid, but fewer than control group and no severe illness. 

Did you read the letter?  It doesn't say any of those things you asked about.  It just says that right now the studies aren't looking at certain outcomes or baseline markers and that those things, like preventing person-to-person transmission and testing to see if a person already has T cell immunity, are important to include.  If a vaccine is touted to be 94% effective, but no one says anything about what that actually means, people are going to be screaming that is should be mandated for everyone so we can all "get back to normal".  Mandates, in that case, would not help decrease cases and getting it would not prevent you from spreading it to others.

[ktgrok]

6 minutes ago, hopeallgoeswell said:

Did you read the letter?  It doesn't say any of those things you asked about. 

This is a direct quote from it, part of what you quoted:

inaccurate beliefs about the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others or that it will reduce severe COVID-19 disease and deaths. 

In other words thy are saying that it doesn't stop transmission, lessen severe illness, or prevent death - so um..pointless. Which is NOT true. 

[hopeallgoeswell]

24 minutes ago, Corraleno said:

 

I don't understand their claim that mild cases of covid shouldn't "count" in determining efficacy, and that companies should be separately required to prove that the vaccine significantly reduces severe cases and deaths and prevents transmission before vaccines are approved.  If the data so far are accurate, then it certainly seems to reduce the number of people who get infected, and presumably people who don’t have covid are not going to pass it on or be hospitalized with it or die of it. So that part of the letter makes no sense to me and just seems like they are antivax and are trying to delay approval on principle.

ETA: OK, now I see that this letter is in fact from an anti-vax group that fights the "tyranny" of government and believes vaccines cause autism and UNICEF "is killing millions of children" with vaccines.  🙄 

I try to look at all information.  What part of their letter was not factual?

 

If the people in the vaccine trials are not getting tested frequently, then how can the manufacturers claim that the vaccine reduces infection?  From what I have read, the companies are only taking self-reported data of symptoms and testing only those with symptoms.  The people who have taken the vaccine could have gotten infected and just been asymptomatic, yes?  Some of the people could have already gotten T cell immunity to the virus before they entered the vaccine trial, which would take them out of the actual pool, right?  

[ktgrok]

This is from the Moderna vaccine info - are those letter writers trying to say it was totally a coincidence that 90 of the 95 cases of symptomatic people were in the placebo group? Or are they saying that an equal number caught it in the vaccine group but just happened to all be asymptomatic, and all the people in the placebo group just happened to be symptomatic? Or that the vaccine group just happened to have a lot more natural immunity that we don't really even know fully how to test for, despite having comorbidities, etc?

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

[Corraleno]

4 hours ago, hopeallgoeswell said:

I try to look at all information.  What part of their letter was not factual?

 

If the people in the vaccine trials are not getting tested frequently, then how can the manufacturers claim that the vaccine reduces infection?  From what I have read, the companies are only taking self-reported data of symptoms and testing only those with symptoms.  The people who have taken the vaccine could have gotten infected and just been asymptomatic, yes?  Some of the people could have already gotten T cell immunity to the virus before they entered the vaccine trial, which would take them out of the actual pool, right?  

For this argument to have any validity, there would have to have been a significant number of people with prior immunity, and the vast majority of those people would have had to be randomly assigned to the treatment group, with few or none in the placebo group. The likelihood of that is vanishingly small.  And even if there were undetected asymptomatic cases in both groups (for which there is no current evidence), the fact that there were far fewer symptomatic cases in the vaccine group is significant in its own right.

The idea that a vaccine should not be approved until a significant number of the placebo group have died, in order to directly prove that the vaccine reduces deaths as well as infections, seems seriously unethical to me.

Their claim that protecting the vaccinated person against disease is not adequate grounds for vaccine approval, and that manufacturers must also prove that it prevents transmission to unvaccinated people, has not been a requirement for previous vaccines, because protection of the vaccinated person is itself valuable. It seems like ICAN is basically fishing for data that antivaxers can use to justify not getting vaccinated — we'll let all those deluded sheep get it, while we get the benefits of the vaccine (no transmission to the unvaccinated) with no risk.

 

Edited November 17, 2020 by Corraleno

[Ausmumof3]

1 hour ago, ktgrok said:

is that website trying to say that the vaccines won't decrease transmission or illness or death???? That they do nothing at all? Cause if they don't reduce transmission OR severe illness OR death ....they do nothing. 

Which is not what I'm reading. In the Moderna trial they had a few people who did get Covid, but fewer than control group and no severe illness. 

I think if they are relying on detecting covid via people showing up for tests they won’t know if people in the vaccine group had it asymptomatically.  They would need to swab and test everyone in the trial regularly (maybe weekly) to rule that out.

 

One issue from what I understand with some of the trials is that they had a certain health requirement to be met to be part of the trial. They did accept older people but ruled out people with some health issues which may have had a side effect of eliminating people from the trial most likely to get severe covid disease, making it difficult to work out if the vaccine is actually preventing that. 

Edited November 17, 2020 by Ausmumof3

[Corraleno]

2 hours ago, Ausmumof3 said:

One issue from what I understand with some of the trials is that they had a certain health requirement to be met to be part of the trial. They did accept older people but ruled out people with some health issues which may have had a side effect of eliminating people from the trial most likely to get severe covid disease, making it difficult to work out if the vaccine is actually preventing that. 

I don't know about Pfizer, but of the 30,000 people in the Moderna trial, 42% were considered medically high risk (over 65, diabetes, severe obesity, cardiac disease) and 37% were nonwhite. And they did have some severe cases, all of which were all in the placebo group, so that seems very promising.

Whether it can prevent severe disease or death in the very highest risk categories is the kind of data they can really only get once the vaccine is in widespread use. It seems like it would be either unproductive or unethical to include participants in the very highest risk groups, because those people really need to be isolating — in which case they are not good indicators of the effectiveness of the vaccine. And you can't exactly ask a diabetic 80 yr old with heart disease to knowingly expose themselves when there's a 50% chance they're in the placebo group.

No vaccine is 100% effective, we already know that some people who get the vaccine will still get covid, and some of those could possibly die — just like with every other vaccine. Even if these vaccines turn out to not work especially well in the oldest and most vulnerable, if it works well for the majority of the population, that in itself will help protect the most vulnerable, by reducing the chances they will be exposed to it to begin with.

[Ausmumof3]

27 minutes ago, Corraleno said:

I don't know about Pfizer, but of the 30,000 people in the Moderna trial, 42% were considered medically high risk (over 65, diabetes, severe obesity, cardiac disease) and 37% were nonwhite. And they did have some severe cases, all of which were all in the placebo group, so that seems very promising.

Whether it can prevent severe disease or death in the very highest risk categories is the kind of data they can really only get once the vaccine is in widespread use. It seems like it would be either unproductive or unethical to include participants in the very highest risk groups, because those people really need to be isolating — in which case they are not good indicators of the effectiveness of the vaccine. And you can't exactly ask a diabetic 80 yr old with heart disease to knowingly expose themselves when there's a 50% chance they're in the placebo group.

No vaccine is 100% effective, we already know that some people who get the vaccine will still get covid, and some of those could possibly die — just like with every other vaccine. Even if these vaccines turn out to not work especially well in the oldest and most vulnerable, if it works well for the majority of the population, that in itself will help protect the most vulnerable, by reducing the chances they will be exposed to it to begin with.

That does sound promising.  The Coronacast that raised this was before the new Moderna data came out so it’s possible that has a better overall study design.  Haven’t had much time between kids school and trying to keep up with locations and new restrictions for much else the last two days.

[Bootsie]

52 minutes ago, Corraleno said:

I don't know about Pfizer, but of the 30,000 people in the Moderna trial, 42% were considered medically high risk (over 65, diabetes, severe obesity, cardiac disease) and 37% were nonwhite. And they did have some severe cases, all of which were all in the placebo group, so that seems very promising.

Whether it can prevent severe disease or death in the very highest risk categories is the kind of data they can really only get once the vaccine is in widespread use. It seems like it would be either unproductive or unethical to include participants in the very highest risk groups, because those people really need to be isolating — in which case they are not good indicators of the effectiveness of the vaccine. And you can't exactly ask a diabetic 80 yr old with heart disease to knowingly expose themselves when there's a 50% chance they're in the placebo group.

No vaccine is 100% effective, we already know that some people who get the vaccine will still get covid, and some of those could possibly die — just like with every other vaccine. Even if these vaccines turn out to not work especially well in the oldest and most vulnerable, if it works well for the majority of the population, that in itself will help protect the most vulnerable, by reducing the chances they will be exposed to it to begin with.

I have looked but cannot find anything about how long ago the second dose of the vaccine was given to know how long since the vaccine was given that it is that participants have not become ill.  Is that information available somewhere?

Did the participants then go about daily life--so how much opportunity did they have to be exposed to COVID?

Am I understanding the methodology correctly that it is set up so that after 100 people in the study have COVID then they look to see how many of that 100 fall into the placebo vs vaccinated group?  And, that one of the criticisms/concerns was that is too low of a threshold of when to start measuring?

[Corraleno]

1 hour ago, Bootsie said:

Am I understanding the methodology correctly that it is set up so that after 100 people in the study have COVID then they look to see how many of that 100 fall into the placebo vs vaccinated group?  And, that one of the criticisms/concerns was that is too low of a threshold of when to start measuring?

Pfizer originally planned to do a preliminary analysis at 32 cases, another interim analysis at 62, and a final analysis at 164, but they got a lot of criticism for the idea of releasing info at only 32 cases. So they decided to skip 32 and just do an interim analysis at 62, but then by the time the independent panel completed the interim analysis they already had 94 cases. The next analysis should be at 164, which experts seem to consider standard for assessment of efficacy (e.g. this article in the Annals of Internal Medicine discusses best practices for covid vaccine studies and specifically cites 160 cases as adequate).

ETA:  It looks like Moderna's research design called for the first analysis at 53 cases, but they also had far more than that (95) by the time the analysis happened, and their final analysis is at 151. 

(These "endpoints" are just the targets that Pfizer and Moderna felt they needed to reach before applying for an Emergency Use Authorization, obviously they're not going to stop collecting and analyzing data at those points.)

The vaccine companies themselves do not have access to the data as the trial is underway, they only get the data after the independent analysis has been done, and the timing of those analyses are built into the study design.

Edited November 17, 2020 by Corraleno

[Ausmumof3]

5 new cases today.  14 suspected based on symptoms and close contact. 4 are know to be linked to the cluster 1 has just come in so still being interviewed.  Around 4000 people are being quarantined for now (I think that includes self isolation).  A fourth school has been temporarily closed.  The current cluster has been genomically linked to a person who arrived on the second of November and tested positive on the third so probably doesn’t pre date that time.  Obviously the number of linked locations is still growing and everyone who was at one of the big pools in the city between certain hours on Saturday is being asked to self isolate for 14 days.  People are being asked to consider carefully the need to go out at this point.  Masking is advised but not mandated.  

[Ausmumof3]

Also testing is being overwhelmed with people waiting 5-6 hours.  It’s going to be 33c tomorrow so hopefully they have cleared some of the back log as people really can’t be out in the sun in the heat waiting when they’re unwell.

Also people who are in hotel quarantine even near the end have to do another fourteen days.  And they believe it is surface contamination spread.  

[Bootsie]

47 minutes ago, Corraleno said:

Pfizer originally planned to do a preliminary analysis at 32 cases, another interim analysis at 62, and a final analysis at 164, but they got a lot of criticism for the idea of releasing info at only 32 cases. So they decided to skip 32 and just do an interim analysis at 62, but then by the time the independent panel completed the interim analysis they already had 94 cases. The next analysis should be at 164, which experts seem to consider standard for assessment of efficacy (e.g. this article in the Annals of Internal Medicine discusses best practices for covid vaccine studies and specifically cites 160 cases as adequate).

ETA: It looks like Moderna's research design called for the first analysis at 53 cases, but they also had far more than that (95) by the time the analysis happened. 

The vaccine companies themselves do not have access to the data as the trial is underway, they only get the data after the independent analysis has been done, and the timing of those analyses are built into the study design.

Thanks for the explanation  

[Corraleno]

3 minutes ago, Ausmumof3 said:

Also testing is being overwhelmed with people waiting 5-6 hours.  It’s going to be 33c tomorrow so hopefully they have cleared some of the back log as people really can’t be out in the sun in the heat waiting when they’re unwell.

Also people who are in hotel quarantine even near the end have to do another fourteen days.  And they believe it is surface contamination spread.  

Oh man, that must be so demoralizing to have been in quarantine for almost two weeks and think you're finally about to be released, and then have to start all over again. ☹️  

[Ausmumof3]

Just now, Corraleno said:

Oh man, that must be so demoralizing to have been in quarantine for almost two weeks and think you're finally about to be released, and then have to start all over again. ☹️  

I know.  Also in some cases people that have been trying to get back to Australia since April or so and have only just got in.  Prepping to see family for the first time in six months etc.

I think if they can identify for sure where the contamination happened they will end it sooner.  I do hope the people don’t have to pay for the extra time.

We also know some people who have been waiting to see family in WA.  They just opened the border and then the next day this happened so they got across and then got told they had to quarantine.  They are being allowed to do it in their caravan though not in a hotel and have been offered grocery delivery.  They haven’t been anywhere near Adelaide as they’ve been travelling for some time.  

[Bambam]

I haven't seen this discussed, but if it was and I missed it, please direct me to the thread/page.

Re re-infections, if it turns that that natural immunity (you had COVID, you get it the second time) is short, will that impact the length of protection the vaccine (either of the current ones) last?  I have two friends who had COVID in March and are pretty sure they have it again (tested yesterday, but currently experiencing loss of smell/taste and other of the symptoms).  

[hopeallgoeswell]

19 hours ago, ktgrok said:

This is a direct quote from it, part of what you quoted:

inaccurate beliefs about the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others or that it will reduce severe COVID-19 disease and deaths. 

In other words thy are saying that it doesn't stop transmission, lessen severe illness, or prevent death - so um..pointless. Which is NOT true. 

There are many influenza studies which show that vaccination does not decrease mortality, especially in the over 65 population, or transmission, but the manufacturers only looked at the decrease in confirmed cases, so they can say the vaccine is "effective".  Let's go with your previous post of Moderna's latest data: 90 symptomatic people were in the control group, 5 were in the vaccine group.  If they don't report severity, how do we know if the number of people who had to be hospitalized are/aren't similar in both groups?  How do we know if the number of deaths are/aren't similar in each group?  If we don't know, then it should be made clear and widely known that those things were not tested for.  

This has a clear explanation of why the severity of outcomes and transmission interruption should be endpoints that are being tracked but aren't: https://www.bmj.com/content/371/bmj.m4037.

Two passages I found pertinent:

"Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, 'Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.'”

and

"But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. 'The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,' he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out."

[Corraleno]

3 minutes ago, hopeallgoeswell said:

There are many influenza studies which show that vaccination does not decrease mortality, especially in the over 65 population, or transmission, but the manufacturers only looked at the decrease in confirmed cases, so they can say the vaccine is "effective".  Let's go with your previous post of Moderna's latest data: 90 symptomatic people were in the control group, 5 were in the vaccine group.  If they don't report severity, how do we know if the number of people who had to be hospitalized are/aren't similar in both groups?  How do we know if the number of deaths are/aren't similar in each group?  If we don't know, then it should be made clear and widely known that those things were not tested for.  

This has a clear explanation of why the severity of outcomes and transmission interruption should be endpoints that are being tracked but aren't: https://www.bmj.com/content/371/bmj.m4037.

Two passages I found pertinent:

"Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, 'Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.'”

and

"But Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks adequate statistical power to assess those outcomes. 'The trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here,' he said.

Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out."

The Moderna trial did have 11 severe cases, and they were all in the placebo group. 

How do you propose that a short-term trial assess the effectiveness of the vaccine in preventing death? How many people in trial do you think would need to die before that would be statistically significant? 

The problem with requiring stats on hospitalization and death before even granting an EUA, is that most hospitalizations and deaths occur in the highest risk groups, and it is unethical to ask people who have the highest risk of dying of covid to participate in a trial where they will be asked to expose themselves to a deadly disease with a 50/50 chance they are in the placebo group.

Do you understand that the current phase 3 trials are only designed to show enough efficacy to get an Emergency Use Authorization? Your posts imply that you think the manufacturers are doing something dodgy or underhanded by not designing their studies to show the kind of data that you simply cannot get (and do not need) from a short term study of 30K people. If you don't trust the data from the phase 3 trials, then you can choose not to get the vaccine until there is a lot more data. But the vaccine developers are doing exactly what they need to do to meet the FDA requirements for an EUA.

[hopeallgoeswell]

19 hours ago, Corraleno said:

For this argument to have any validity, there would have to have been a significant number of people with prior immunity, and the vast majority of those people would have had to be randomly assigned to the treatment group, with few or none in the placebo group. The likelihood of that is vanishingly small.  And even if there were undetected asymptomatic cases in both groups (for which there is no current evidence), the fact that there were far fewer symptomatic cases in the vaccine group is significant in its own right.

The idea that a vaccine should not be approved until a significant number of the placebo group have died, in order to directly prove that the vaccine reduces deaths as well as infections, seems seriously unethical to me.

Their claim that protecting the vaccinated person against disease is not adequate grounds for vaccine approval, and that manufacturers must also prove that it prevents transmission to unvaccinated people, has not been a requirement for previous vaccines, because protection of the vaccinated person is itself valuable. It seems like ICAN is basically fishing for data that antivaxers can use to justify not getting vaccinated — we'll let all those deluded sheep get it, while we get the benefits of the vaccine (no transmission to the unvaccinated) with no risk.

 

re: the bolded

If a vaccine doesn't prevent transmission from a vaccinated person to an unvaccinated person, how is that different from an unvaccinated person spreading it to an unvaccinated person or from a vaccinated person spreading it to a vaccinated person.  If the vaccine doesn't prevent transmission, people who don't take the vaccine aren't getting benefits from people who do take the vaccine.  You have to take the vaccine to get any benefits and even then it's only personal benefits, not "herd" benefits.

 

I thought the letter brought to light an important point, if the vaccine isn't tracking severity outcomes or transmission interruption, people should know.  If not, when someone gets the vaccine, they can still get the virus, be asymptomatic (or symptomatic), and spread it to anyone.  If the mortality for the older age group is the same in both the vaccine and control groups (like with influenza vaccine), people should be more cautious when interacting with them.  

[ktgrok]

18 minutes ago, hopeallgoeswell said:

There are many influenza studies which show that vaccination does not decrease mortality, especially in the over 65 population, or transmission, but the manufacturers only looked at the decrease in confirmed cases, so they can say the vaccine is "effective".  Let's go with your previous post of Moderna's latest data: 90 symptomatic people were in the control group, 5 were in the vaccine group.  If they don't report severity, how do we know if the number of people who had to be hospitalized are/aren't similar in both groups?  How do we know if the number of deaths are/aren't similar in each group?  If we don't know, then it should be made clear and widely known that those things were not tested for.  

 

But...they are tracking severity. Did you read what I posted? The only severe cases were in the placebo group 

[hopeallgoeswell]

5 hours ago, Bambam said:

I haven't seen this discussed, but if it was and I missed it, please direct me to the thread/page.

Re re-infections, if it turns that that natural immunity (you had COVID, you get it the second time) is short, will that impact the length of protection the vaccine (either of the current ones) last?  I have two friends who had COVID in March and are pretty sure they have it again (tested yesterday, but currently experiencing loss of smell/taste and other of the symptoms).  

This article might be helpful: https://www.msn.com/en-us/health/medical/immunity-to-the-coronavirus-may-last-years-new-data-hint/ar-BB1b6dwt?ocid=mailsignout&li=BBnb7Kz.

From the article:

The research, published online, has not been peer-reviewed nor published in a scientific journal. But it is the most comprehensive and long-ranging study of immune memory to the coronavirus to date.

 

“That amount of memory would likely prevent the vast majority of people from getting hospitalized disease, severe disease, for many years,” said Shane Crotty, a virologist at the La Jolla Institute of Immunology who co-led the new study.

The findings are likely to come as a relief to experts worried that immunity to the virus might be short-lived, and that vaccines might have to be administered repeatedly to keep the pandemic under control.

And the research squares with another recent finding: that survivors of SARS, caused by another coronavirus, still carry certain important immune cells 17 years after recovering.

[Corraleno]

2 minutes ago, hopeallgoeswell said:

I thought the letter brought to light an important point, if the vaccine isn't tracking severity outcomes or transmission interruption, people should know.  If not, when someone gets the vaccine, they can still get the virus, be asymptomatic (or symptomatic), and spread it to anyone.  If the mortality for the older age group is the same in both the vaccine and control groups (like with influenza vaccine), people should be more cautious when interacting with them.  

It's true of every vaccine that some people will still catch the virus, no vaccine is 100% effective. If people don't know that, that's not the vaccine manufacturer's fault. Even after vaccination, people should still be cautious around those who are highest risk.

And they are tracking severity, but in a trial of this size and speed they cannot guarantee that the data on severity will be statistically significant, so that was not designed into the phase 3 study protocol as a specific endpoint. Instead the endpoint is a specific number of symptomatic cases that will give statistically significant results. But it's not like they stop collecting data as soon as they submit the EUA application!  Of course they will continue to track data on severity and hospitalization and death and adverse side effects, etc.

 

2 minutes ago, hopeallgoeswell said:

If a vaccine doesn't prevent transmission from a vaccinated person to an unvaccinated person, how is that different from an unvaccinated person spreading it to an unvaccinated person or from a vaccinated person spreading it to a vaccinated person.  If the vaccine doesn't prevent transmission, people who don't take the vaccine aren't getting benefits from people who do take the vaccine.  You have to take the vaccine to get any benefits and even then it's only personal benefits, not "herd" benefits.

 

My point was that the antivax group are trying to force the manufacturers to provide them with data they can use to refuse the vaccine. If they force the manufacturer to prove that it prevents tranmission before they can even apply for an EUA, then they not only significantly postpone the EUA, which I think is a goal in itself for them, but they also require the manufacturers to give them data they can use to claim they don't need to be vaccinated since other people's vaccinations will protect them. This would be used to challenge school mandates for example. So the antivaxers are trying to prevent those who want the vaccine from getting it soon, while simultaneously hedging their bets against any future mandates.

 

[Ausmumof3]

https://thehill.com/policy/healthcare/526370-cdc-quietly-removes-guidance-pushing-for-school-reopenings?amp&__twitter_impression=true
 

CDC has removed guidance encouraging school reopening?  

[Corraleno]

34 minutes ago, Ausmumof3 said:

https://thehill.com/policy/healthcare/526370-cdc-quietly-removes-guidance-pushing-for-school-reopenings?amp&__twitter_impression=true
 

CDC has removed guidance encouraging school reopening?  

There has been an ongoing tug-of-war between CDC scientists and political appointees in Health & Human Services over what is published on the CDC website. HHS Public Affairs spokesperson Michael Caputo has been trying to get control over CDC publications, including requiring that the weekly morbidity and mortality reports be edited by him personally before they could be released. HHS also changed the way states and hospitals report data, requiring that they now go through a new portal run by a private data company that answers to HHS rather than going through CDC as it always has in the past.

CDC has gotten a lot of criticism for flip-flopping and putting out conflicting advice, but I don't think many people realize how much of what has appeared on the CDC website is the result of heavy political pressure — and even outright editing and rewriting — by those outside the CDC.

[Ausmumof3]

Flinders University has been closed for cleaning after a positive test in someone who attended an on-site English language course there.

[Ausmumof3]

We are going into a six day circuit breaker lockdown.  Not to leave the house except one person once a day for food or to access medical care, bank, post office.  
 

mandatory masking.  Schools shut except for kids of essential workers.  Grocery stores open, banks and post offices at limited capacity.  No outdoor exercise.  We have today to get whatever needed to stay put for six days.

Personally we are pretty right I think/hope. I stocked up on chook food last week and had grocery delivery this morning.  Not sure what will happen for DHs work yet.  

They have been doing all the tracing to figure out how it has spread.  Two workers in two separate quarantine hotels infected and they couldn’t track down the connection. it turns out one of them worked a second job at a pizza bar and the other one had bought a takeaway pizza there so the connection wasn’t through hotels.  
 

They are worried about how quickly it’s being transmitted - in at least one case it appears to have been passed on by an asymptomatic person within 24 hours.  She talked about this strain being very transmissible though I’m not sure on what basis.  WA and VIC are providing assistance with contact tracing and testing.  Military have been made available if required.  
 

The health minister said the difference this time that’s making them respond more quickly is that previously it was overseas travellers so somewhat easier to track whereas we have local spread making it more difficult.

The genomic testing shows the original case came from the UK.
 

 

[Melissa in Australia]

that is an even stricter lockdown than we had here in Victoria, We were still allowed out to exercise. Hopefully they get on top of it quickly

[Ausmumof3]

29 minutes ago, Melissa in Australia said:

that is an even stricter lockdown than we had here in Victoria, We were still allowed out to exercise. Hopefully they get on top of it quickly

Yes.  Except we don’t have the 5km radius.  Also it’s applying to the whole state because there’s no really effective way to “ring fence” Adelaide.  Hoping the six days is effective enough that they can soften it a little after that time.   Tossing up whether to run around and buy some extra chook food etc but I’m assuming that they won’t keep fodder stores etc closed indefinitely because animals have to eat.

[Melissa in Australia]

I found this very interesting in explaining the reason for the rapid complete 6 day lockdown for South Australia. the strain there is transmittable in less than 24 hours. and from the first infection on the 2nd or 3rd November they are already up to the 5th generation of transmission   https://www.news.com.au/world/coronavirus/sa-lockdown-terrifying-coronavirus-strain-gripping-the-state/news-story/442ee88b61168a0540c3bb71f7ce9cf1

[Ausmumof3]

1 hour ago, Melissa in Australia said:

I found this very interesting in explaining the reason for the rapid complete 6 day lockdown for South Australia. the strain there is transmittable in less than 24 hours. and from the first infection on the 2nd or 3rd November they are already up to the 5th generation of transmission   https://www.news.com.au/world/coronavirus/sa-lockdown-terrifying-coronavirus-strain-gripping-the-state/news-story/442ee88b61168a0540c3bb71f7ce9cf1

I think there’s some questions over that.  The health minister mentioned “this strain” and the news jumped on it but at this point there’s no evidence that it’s a different strain particularly.  It is spreading rapidly but in part I suspect because it came into a pretty relaxed environment.  We will know a bit more soon hopefully.

[Ausmumof3]

Japan had record cases today with around 2000. In some good non Covid related news looks like the Ebola epidemic is officially over in DR Congo. Haven’t updated here much because I’ve been running through last minute stuff checking we are ok for the next few days.  

[mlktwins]

This just popped up on my FB feed.  It is our local paper.  https://www.insidenova.com/headlines/fda-approves-in-home-rapid-result-covid-19-test/article_d6e8920c-2959-11eb-9899-73786ced8b61.html?fbclid=IwAR3qlGvx41F8Nh6MX3ZZNKL8bbXcOjhZ7vJQbwVzlDTrNWSvlaa5qCemtqM#utm_campaign=blox&utm_source=facebook&utm_medium=social

[BeachGal]

On 11/16/2020 at 11:00 PM, Corraleno said:

Pfizer originally planned to do a preliminary analysis at 32 cases, another interim analysis at 62, and a final analysis at 164, but they got a lot of criticism for the idea of releasing info at only 32 cases. So they decided to skip 32 and just do an interim analysis at 62, but then by the time the independent panel completed the interim analysis they already had 94 cases. The next analysis should be at 164, which experts seem to consider standard for assessment of efficacy (e.g. this article in the Annals of Internal Medicine discusses best practices for covid vaccine studies and specifically cites 160 cases as adequate).

ETA:  It looks like Moderna's research design called for the first analysis at 53 cases, but they also had far more than that (95) by the time the analysis happened, and their final analysis is at 151. 

(These "endpoints" are just the targets that Pfizer and Moderna felt they needed to reach before applying for an Emergency Use Authorization, obviously they're not going to stop collecting and analyzing data at those points.)

The vaccine companies themselves do not have access to the data as the trial is underway, they only get the data after the independent analysis has been done, and the timing of those analyses are built into the study design.

Huzzah! Pfizer/BioNTech just reached their Phase 3 endpoints. Considering how rampant Covid is now, it’s not all that surprising. (If anyone is wondering, they will continue to gather and analyze data for quite awhile.)

Efficacy in adults over 65 was 94%. That is fantastic!

https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-Conclude-Phase-3-Study-of-COVID-19-Vaccine-Candidate-Meeting-All-Primary-Efficacy-Endpoints/default.aspx

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS

 

November 18, 2020

 

• Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
• Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
• Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
• Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
• Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
• The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
• Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world

Edited November 18, 2020 by BeachGal
correction

[kbutton]

https://www.whio.com/news/dayton-public-schools-extend-fall-break-through-end-2020/FYTVAK3LDRB4NPFRPLY2FWMEZQ/?fbclid=IwAR24Io7MBFW3F-EslpSJeYc5eh4cEVYE4pF7uiHVXR74X6yuj6G_CRgsEKs

Dayton, OH schools are not going back after Thanksgiving until 2021, and then it will be a hybrid system. They'll tack school days onto the end of the year and go all the way through June. 

[Ausmumof3]

https://mobile.reuters.com/article/amp/idUSKBN27Y2Q9?__twitter_impression=true
 

New cases and hospitalisations in France are continuing the downward trend.

[Ausmumof3]

(Reuters) - Italy has registered 34,283 new coronavirus infections over the past 24 hours, the health ministry said on Wednesday, up from 32,191 the day before.

The ministry also reported 753 COVID 19-related deaths, up from 731 on Tuesday and the highest daily tally since April 3, when the country was in full national lockdown.

There were 234,834 coronavirus swabs carried out in the past day, the ministry said, against a previous 208,458.

 

 

[Acadie]

Voluntary stay-at-home advisory announced today in my county in northeast Ohio, which includes Cleveland. They're recommending no travel, any schools that are in person go virtual after Thanksgiving, and going out for essential needs only.

If this doesn't help bring cases down, we can expect another shutdown. 

Edited November 18, 2020 by Acadie

[Tenaj]

4 minutes ago, Acadie said:

Voluntary stay-at-home advisory announced today in my county in northeast Ohio, which includes Cleveland. They're recommending no travel, any schools that are in person go virtual after Thanksgiving, and going out for essential needs only.

If this doesn't help bring cases down, we can expect another shutdown. 

Also Franklin County (Columbus), and Montgomery County (Dayton).  There may be more that I missed.

[Corraleno]

4 hours ago, BeachGal said:

Huzzah! Pfizer/BioNTech just reached their Phase 3 endpoints. Considering how rampant Covid is now, it’s not all that surprising. (If anyone is wondering, they will continue to gather and analyze data for quite awhile.)

Efficacy in adults over 65 was 94%. That is fantastic!

https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-Conclude-Phase-3-Study-of-COVID-19-Vaccine-Candidate-Meeting-All-Primary-Efficacy-Endpoints/default.aspx

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS

 

November 18, 2020

 

• Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
• Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
• Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
• Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
• Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
• The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
• Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world

I think the fact that the Pfizer and Moderna trials have almost identical stats is really encouraging, especially since the technology they're using is so new. Both had efficacy rates of 94-95% which applied across all demographics, and even their stats on severe disease are very similar — Moderna had 11 severe cases, all in the placebo group, and Pfizer had 10, of which 9 were in the placebo group. And side effects seem to be quite mild. This is really the best possible outcome we could have hoped for. Storage could be an issue, but Moderna is now saying theirs is stable for 30 days in regular refrigerator temperatures, which should make distribution easier.

It does bug me though that Moderna executives have personally collected millions of dollars for developing a vaccine that was largely funded by US taxpayers (nearly $1 billion) as well as donations from philanthropists. And Moderna's vaccine is also by far the most expensive at ~$35/dose (so $70 per person). Astra Zeneca also received some US funding and they have pledged to provide theirs at cost for the "duration of the pandemic," with an estimate of $3-4/dose. Pfizer did not take US funding and their price is $20/dose. The US has ordered 100 million doses each from Pfizer and Moderna (so enough for 100 million people in total) and 500 million from Astra Zeneca, which raises the issue of who gets what vaccine. Astra Zeneca's is not mRNA, and if it turns out to have significantly lower efficacy, that raises the possibility that the wealthy and well-insured will get the expensive 95% effective vaccines, while the poor and uninsured get the $4 shots. 😕

 

[Ausmumof3]

0 new cases so far today.  

[BeachGal]

4 hours ago, Corraleno said:

I think the fact that the Pfizer and Moderna trials have almost identical stats is really encouraging, especially since the technology they're using is so new. Both had efficacy rates of 94-95% which applied across all demographics, and even their stats on severe disease are very similar — Moderna had 11 severe cases, all in the placebo group, and Pfizer had 10, of which 9 were in the placebo group. And side effects seem to be quite mild. This is really the best possible outcome we could have hoped for. Storage could be an issue, but Moderna is now saying theirs is stable for 30 days in regular refrigerator temperatures, which should make distribution easier.

It does bug me though that Moderna executives have personally collected millions of dollars for developing a vaccine that was largely funded by US taxpayers (nearly $1 billion) as well as donations from philanthropists. And Moderna's vaccine is also by far the most expensive at ~$35/dose (so $70 per person). Astra Zeneca also received some US funding and they have pledged to provide theirs at cost for the "duration of the pandemic," with an estimate of $3-4/dose. Pfizer did not take US funding and their price is $20/dose. The US has ordered 100 million doses each from Pfizer and Moderna (so enough for 100 million people in total) and 500 million from Astra Zeneca, which raises the issue of who gets what vaccine. Astra Zeneca's is not mRNA, and if it turns out to have significantly lower efficacy, that raises the possibility that the wealthy and well-insured will get the expensive 95% effective vaccines, while the poor and uninsured get the $4 shots. 😕

 

Pfizer's vaccine might be able to handle similar temps. That's what I've read but it's not known for sure. Fingers crossed.

I completely understand what you're saying about Moderna and agree. This is not the time to be money grubbers. And, IMO, vaccines should be free for anyone who wants one. It's really in the best interest of the economy and is, of course, morally the right thing to do. It is very exciting that a vaccine has been developed using this newish technology and that it works against a coronavirus. That's great news.

I do think if AZ is even 70-85%, it should still bode well. Hoping it will be even better, though. I heard they are supposed to reveal their data in a journal soon but I'm not sure.

Have you heard anymore about the in-home Covid test? Is it Abbott's BinaxNow test? I haven't had much time to check and am wondering how good it is. Anyone know?

[Corraleno]

32 minutes ago, BeachGal said:

Have you heard anymore about the in-home Covid test? Is it Abbott's BinaxNow test? I haven't had much time to check and am wondering how good it is. Anyone know?

Lucira's at-home rapid test was just approved, but I'm not sure when it will actually be available. It requires a prescription and costs $50. They are claiming 94% accuracy for positives and 98% accuracy for negatives, but I would assume that with people doing it themselves at home, the actual accuracy rates may be lower. 

NPR story on it yesterday

Lucira's website/press info

[BeachGal]

1 minute ago, Corraleno said:

Lucira's at-home rapid test was just approved, but I'm not sure when it will actually be available. It requires a prescription and costs $50. They are claiming 94% accuracy for positives and 98% accuracy for negatives, but I would assume that with people doing it themselves at home, the actual accuracy rates may be lower. 

NPR story on it yesterday

Lucira's website/press info

I suppose it's a step in the right direction but that is still on the pricey side and difficult to get if it involves a prescription. I agree that a diy test likely will be less accurate, too.

[Laura Corin]

Interesting analysis of what government and scientists knew and didn't know in the UK in the spring:

https://www.bbc.co.uk/news/health-54976192

[ktgrok]

18 hours ago, Corraleno said:

Lucira's at-home rapid test was just approved, but I'm not sure when it will actually be available. It requires a prescription and costs $50. They are claiming 94% accuracy for positives and 98% accuracy for negatives, but I would assume that with people doing it themselves at home, the actual accuracy rates may be lower. 

NPR story on it yesterday

Lucira's website/press info

especially since it is still a nasal swab test. 

I'm really hoping for a home saliva test. 

[Laura Corin]

https://www.theguardian.com/uk-news/2020/nov/19/scotland-hopes-to-begin-mass-covid-vaccination-in-early-december?CMP=Share_AndroidApp_Other

Vaccination to start in early December? 

[RootAnn]

Lots of chatter on talk radio about the Danish mask study that "proves masks don't prevent Covid." I also heard a doctor (MD) on the radio talking about the bootcamp study with the Marines but I have no idea what his point was on that one.

Also hearing questions from people pointing out low mortality percentages & "why should I care" if they get it or not (younger, healthy people). These are people who got tired very early on of all the media coverage (like 85% of the Hive who avoid this thread) and thus don't keep up on much besides the headlines from their favorite media source. I'm still trying to educate those around me.

If anyone can help me explain the Danish mask study results, I'd appreciate it. I know the researchers say "this was an important, well-designed study" but it sure didn't look well-designed to me! Or maybe it didn't seem well-executed.