Coronavirus: How dangerous a threat?

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I tried to get into the Novavax phase III arm here since it was enrolling earlier this month, but I did not fit the criteria. I wasn't old enough (lol) or in a public facing profession that would lead to a lot of potential virus exposure. I figured the 2/3 chance of getting a real vaccine now would beat the unknown likelihood of getting one in July or whenever.
 
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According to this a single dose of the Pfizer vaccine is maybe just over 50% effective and is not designed to be used as a single dose.


Trying to do it as a single dose will result in a lot more people refusing the vaccine all together. We already have a mutation of the virus in California that might be partially resistant to the vaccine as it is. Doing this BS single dose idea could lead to more mutations that are even more vaccine resistant. I'll take it as the company says, or I'll refuse the vaccine.

I suspect we really need the J&J actually designed as a single dose vaccine to work well.
 
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I tried to get into the Novavax phase III arm here since it was enrolling earlier this month, but I did not fit the criteria. I wasn't old enough (lol) or in a public facing profession that would lead to a lot of potential virus exposure. I figured the 2/3 chance of getting a real vaccine now would beat the unknown likelihood of getting one in July or whenever.
Go figure. The closest place to me enrolling for it is about a 3 hour drive. If I currently live where they are doing the trial I'd see about getting into to, but not with where I currently live. (Duke and UNC Chapel Hill are both doing trials for Novavax along with the other vaccines [Pfizer, Moderna, AZ, J&J]).
 
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According to this a single dose of the Pfizer vaccine is maybe just over 50% effective and is not designed to be used as a single dose.


Trying to do it as a single dose will result in a lot more people refusing the vaccine all together. We already have a mutation of the virus in California that might be partially resistant to the vaccine as it is. Doing this BS single dose idea could lead to more mutations that are even more vaccine resistant. I'll take it as the company says, or I'll refuse the vaccine.

I suspect we really need the J&J actually designed as a single dose vaccine to work well.
But there is no way to guarantee that you'll get the second shot. Like I posted before, they can give you an appointment for your second dose, and then not have any vaccine (probably not highly likely).
 
What is the holdup on AZ? Are they waiting for more data?
AZ requested EU approval last week, but EMA is not satified with the data, as far as I am aware, yes. A decision is due for next week, but the numbers they presented do not seem to fulfill the requirements for full approval, which is apparently likely to lead to the fact that the vaccine may only be approved to be used for people 55 or younger, if at all.

On the one hand, this would be better than nothing of course, but it could also raise more uncertainties and doubts, and be counter-effective in the end.
 
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But there is no way to guarantee that you'll get the second shot. Like I posted before, they can give you an appointment for your second dose, and then not have any vaccine (probably not highly likely).
I won't accept it without 100% guarantee I get second shot on time. Although not like I'm eligible for right now anyway. To me a single shot that might be 50% effective isn't good enough and certainly not worth my time. I'll wait til there's plenty available to get the second dose or hope the J&J is highly effective and get that one.
 
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Chris Gadsden

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This... is not good news if accurate. 30 to 40% vaccination rate ain't going to get it done.

“There’s going to be a lot of intense demand even in younger cohorts, but I think once we get to 100 million, maybe 120 million vaccines, the demand is going to get soft,” Gottlieb said, basing his forecast on the number of U.S. adults who received a flu shot this past year.

“Those were people who were worried about getting Covid going out and getting flu vaccines. That may be the universe of people who really have significant demand for a Covid vaccine,” he added.
 
I won't accept it without 100% guarantee I get second shot on time. Although not like I'm eligible for right now anyway. To me a single shot that might be 50% effective isn't good enough and certainly not worth my time. I'll wait til there's plenty available to get the second dose or hope the J&J is highly effective and get that one.
I'm not sure if anyone will give you a guarantee. I have a vaccination card with an appointment for my second shot, but that is by no means a guarantee. I have however heard that St Al's (where I got mine) and St. Luke's (the two hospitals in town) are all but guaranteeing second shots (Moderna) because they want to stick with the science. I assume that you are correct that the longer we get into this the better your chances are because there will be less people who need vaccination, and there will be more supply/options (more from more).
 
I'm not sure if anyone will give you a guarantee. I have a vaccination card with an appointment for my second shot, but that is by no means a guarantee. I have however heard that St Al's (where I got mine) and St. Luke's (the two hospitals in town) are all but guaranteeing second shots (Moderna) because they want to stick with the science. I assume that you are correct that the longer we get into this the better your chances are because there will be less people who need vaccination, and there will be more supply/options (more from more).
I know a couple of vaccination sites here are holding vaccines specifically for second doses and won't deviate from them. Of course those two sites are also trial sites for all the vaccines. I would think the longer we get into this the more supply will be available and hopefully we'll have more vaccines available as well. Yes, also the longer the vaccines are out there the more people will get it and have both doses and thus less people needing it. Thus, I'm not saying I won't take one at all. I will, just not currently, unless of course the J&J one continues to show what the first data showed, then I may try to get that one. Unfortunately it's going to be in short supply to begin with as well. The only difference is, it's a one dose vaccine, so you don't need to worry about a second dose being available when you need it.
 
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Chris Gadsden

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Day one of progressive liberty.

Bloomberg says:

Daily Vaccinations in the U.S.
An average of 912,497 shots were recorded each day for the last week

17.2 million vaccines have been administered.


So by end of business on Friday, April 30, there will be at least 117.2 million vaccines administered. Which is about where Scott Gottlieb says demand will peter out. So we shall hold the new admin to this number. I hope they get it done.

Mask requirements.

Biden's first executive order mandated mask wearing on federal property, by federal employees and contractors. He is also starting a “100 days masking challenge” urging Americans to wear masks and state and local officials to implement public measures to prevent the spread of the virus.


Kinda think this ship has sailed. Biden's EO here won't get a single person who isn't already wearing a mask to wear one. So this is lipstick on a pig.

Rejoining the World Health Organization.

Mr. Biden reversed a move by the Trump administration to withdraw from the W.H.O., a United Nations agency. Dr. Anthony Fauci, the nation’s top infectious disease expert, plans to participate in a W.H.O. executive board meeting in Geneva tomorrow, marking a high-profile return.


This is the organization that that on January 14, 2020 tweeted "there is no clear evidence of human-to-human transmission of the novel coronavirus only to be outdone by waiting until March 11, 2020 to call it a global pandemic. So this is considered a brilliant move.

Designating a Covid coordinator.

Mr. Biden signed an executive order to bring back a National Security Council position — the director for global health security and biodefense, which was created by the Obama administration after the 2014 Ebola epidemic. The office was scrapped by the Trump administration, a move that Biden aides say made the U.S. less prepared for the pandemic.

This isn't deserving of a comment.

Pandemic relief.

Mr. Biden extended a pause on student loan payments and extended eviction moratoriums meant to help those struggling during the pandemic.

Ok. Good. Doing what the last guy did. Excellent. I know I, for one, am breathing easier today.
 
I figured the 2/3 chance of getting a real vaccine now would beat the unknown likelihood of getting one in July or whenever.
So 1/3 of the subjects get a placebo? It was 50% in the Pfizer trials.


I assume that patients don't know what they're getting. But can't you tell from the side effects? If the placebo is just saline, the body is not going to react in the same way. There may be soreness in the arm just from having a needle go in, but there will be no immune response. Whereas, what I'm hearing anecdotally is that people who receive the actual vaccine have very noticeable other, systemic symptom, such as fever and weakness for 24 hours or so. So wouldn't you know right away if you got the vaccine?

Couldn't that knowledge affect your behavior? I'd think that people who know they have the actual vaccine, regardless of how they're cautioned, will be a little looser with social interactions, even if only unconsciously, than people who know they haven't received a vaccine. That could bias the results, making those who receive the vaccine more likely to get exposed to the virus, relative to the placebo, than would be the case if everyone was blind, and behaved more or less the same. IOW, the determined efficacy would be lower than it would actually be.

Seems to me that there are some other thorny problems here. Once the vaccine has been authorized, those who received a placebo are supposed to be notified, and in many cases, they had previously been promised, as a reward for entering the trial, that they could receive the vaccine if they had been a placebo. But many times companies want to extend the lengths of the trials, to get more data on adverse effects. In fact, six months is required for permanent authorization, as opposed to emergency use that has been granted so far. People who were placebos aren't going to want to remain in this situation, when they have a chance to get the real vaccine.

There is also the problem with vaccines that are still in trials, and haven't been approved. If a new vaccine is approved, is someone who is in a trial for an unapproved vaccine going to want to remain in that study, not knowing if s/he is a placebo, when a vaccine that definitely works may be available? What about new vaccines that haven't reached phase 3 yet? Who's going to want to volunteer, knowing they might be a placebo?

the vaccine may only be approved to be used for people 55 or younger, if at all.
I'm over in the Phils, and now I hear that people my age may not get vaccinated, because of fears of bad reactions. The Pfizer-linked deaths in Norway also has the President here saying this confirms that Sinovac is better. My partner has some allergies, and supposedly people with that condition will also be barred from receiving the vaccine. What a mess.
 
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Rushing vaccines with limited trials for a virus that is constantly mutating is probably not ideal. What happened in Norway may be mostly age related but it's made a lot of people more nervous about that Vaccine. Some countries are not happy about the quality of the Chinese vaccine and so far not much has been said about the Russian one since their vaccinations started although some Russian doctors have gone on record stating that they won't be taking it.
 
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So 1/3 of the subjects get a placebo? It was 50% in the Pfizer trials.


I assume that patients don't know what they're getting. But can't you tell from the side effects? If the placebo is just saline, the body is not going to react in the same way. There may be soreness in the arm just from having a needle go in, but there will be no immune response. Whereas, what I'm hearing anecdotally is that people who receive the actual vaccine have very noticeable other, systemic symptom, such as fever and weakness for 24 hours or so. So wouldn't you know right away if you got the vaccine?

Couldn't that knowledge affect your behavior? I'd think that people who know they have the actual vaccine, regardless of how they're cautioned, will be a little looser with social interactions, even if only unconsciously, than people who know they haven't received a vaccine. That could bias the results, making those who receive the vaccine more likely to get exposed to the virus, relative to the placebo, than would be the case if everyone was blind, and behaved more or less the same. IOW, the determined efficacy would be lower than it would actually be.

Seems to me that there are some other thorny problems here. Once the vaccine has been authorized, those who received a placebo are supposed to be notified, and in many cases, they had previously been promised, as a reward for entering the trial, that they could receive the vaccine if they had been a placebo. But many times companies want to extend the lengths of the trials, to get more data on adverse effects. In fact, six months is required for permanent authorization, as opposed to emergency use that has been granted so far. People who were placebos aren't going to want to remain in this situation, when they have a chance to get the real vaccine.

There is also the problem with vaccines that are still in trials, and haven't been approved. If a new vaccine is approved, is someone who is in a trial for an unapproved vaccine going to want to remain in that study, not knowing if s/he is a placebo, when a vaccine that definitely works may be available? What about new vaccines that haven't reached phase 3 yet? Who's going to want to volunteer, knowing they might be a placebo?



I'm over in the Phils, and now I hear that people my age may not get vaccinated, because of fears of bad reactions. The Pfizer-linked deaths in Norway also has the President here saying this confirms that Sinovac is better. My partner has some allergies, and supposedly people with that condition will also be barred from receiving the vaccine. What a mess.
The article said 2/3. Double blinded with 21 days between shots. I didn't get far enough to ask any questions. Maybe there are two vaccine arms based on dose or maybe they thought upping the odds would help enrollment.


I don't know why another vaccine was not chosen as a placebo. Some of the AZ trial did that. Most people could use a tetanus booster, or HBV. There has been speculation in Facebook groups about whether people got the real thing in the mRNA trials based on their symptoms, so you are right that it influenced behavior in some undefined manner, which is not great from a design point of view.

Soon, all new trials will have to be comparison trials with one of the EUA approved vaccines. That will be relevant if the strains need to be changed too. Haven't heard what that will entail from a regulatory perspective.

Day one of progressive liberty.

Bloomberg says:

Daily Vaccinations in the U.S.
An average of 912,497 shots were recorded each day for the last week

17.2 million vaccines have been administered.


So by end of business on Friday, April 30, there will be at least 117.2 million vaccines administered. Which is about where Scott Gottlieb says demand will peter out. So we shall hold the new admin to this number. I hope they get it done.

Mask requirements.

Biden's first executive order mandated mask wearing on federal property, by federal employees and contractors. He is also starting a “100 days masking challenge” urging Americans to wear masks and state and local officials to implement public measures to prevent the spread of the virus.

Kinda think this ship has sailed. Biden's EO here won't get a single person who isn't already wearing a mask to wear one. So this is lipstick on a pig.

Rejoining the World Health Organization.

Mr. Biden reversed a move by the Trump administration to withdraw from the W.H.O., a United Nations agency. Dr. Anthony Fauci, the nation’s top infectious disease expert, plans to participate in a W.H.O. executive board meeting in Geneva tomorrow, marking a high-profile return.


This is the organization that that on January 14, 2020 tweeted "there is no clear evidence of human-to-human transmission of the novel coronavirus only to be outdone by waiting until March 11, 2020 to call it a global pandemic. So this is considered a brilliant move.

Designating a Covid coordinator.

Mr. Biden signed an executive order to bring back a National Security Council position — the director for global health security and biodefense, which was created by the Obama administration after the 2014 Ebola epidemic. The office was scrapped by the Trump administration, a move that Biden aides say made the U.S. less prepared for the pandemic.

This isn't deserving of a comment.

Pandemic relief.

Mr. Biden extended a pause on student loan payments and extended eviction moratoriums meant to help those struggling during the pandemic.

Ok. Good. Doing what the last guy did. Excellent. I know I, for one, am breathing easier today.
I remember when WHO had functional tests and we didn't. But WHO membership is not really meant to benefit us. It is like joining a church group doing meals on wheels. Collective action to benefit others who are more needy. Doing things like polio eradication and TB vaccine trials that are good for humanity. The big countries do it for stature too.
 
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Mod hat on:

We've been quite lenient in this thread because we fully understand that there will be some requirement to discuss politics in relation to the current pandemic. With that said, it's pretty clear that political discussions around the domestic attack on the US Capitol are well outside the scope of what is reasonable within that exception. We'd like to remind users that they should avoid replying to posts that break the rules and use the report function. If you continue a conversation that breaks the rules we may be forced to issue you with a ban.

Cheers,

KB.
 
The thing I don't like about the way this is being reported is that the headline is clearly pointing at the vaccine as the cause of death, even if the story does include "Health officials from Florida and the Centers for Disease Control and Prevention are investigating what role, if any, the vaccine played in the death of Dr. Gregory Michael...". This story will convince people not to get vaccinated even if the CDC determines a different cause of death.
 
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Just one point about this finding. This is the antibody isolated from infected individuals. There is good reason to think that immunization may provide higher levels of neutralizing antibody especially after a booster. There will be data from S. Africa about this before too long.

I'll let someone like dj provide the answer, but I think that (some/many/most?) vaccines are constantly adjusted. With Covid 19 being new to people I would expect several tweaks early on followed by yearly tweaks after that.
The mRNA vaccines will be easy to switch strains if necessary. Regulators will have to determine an immune correlate for protection as a baseline (i.e. levels of antibody) so that new vaccines do not require whole new trials if they meet that baseline in a small cohort. This is how flu vaccines can be changed as needed without new trials. These mutants seem to be optimizing themselves for cell entry, not immune evasion. A lot of virologists think immune escape variants are not imminent.
 

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