Are vaccines the light at the end of the tunnel?

[nocl]

6 hours ago, CRUISEFAN0001 said:

4 people per million hardly represents anything. Exceptions exist to nearly every rule, and it's also proven that underlying conditions lead to immunity sustainability.

 

If vaccination is mandatory for all passengers and crew, and the vaccines themselves also exponentially reduce symptoms for the 0.4% of anyone who contracts COVID...you can pretty much put a fork in this pandemic...it's virtually done.

WAs not talking about the 4 cases in Oregon which has nothing to do with what I was talking about.  The Oregon cases are merely those that the vaccine was not efficacious for, which in a million immunized would be about 50,000.

 

I was referring to those that have not been vaccinated, but have been previously infected.  Data is now showing that previous infection from the original strain will not protect one from at least 1 of the new strains.

[nocl]

3 hours ago, jagoffee said:

Thanks, very interesting.  It would appear that those that were pushing the narrative that the current vaccines will not be effective against the new variants  instead of may not (because it has not been tested) were incorrect.

No one is pushing that narrative, except when it comes to AZ where there is the results of a trial in SA against the SA variant.

 

What I am saying is that data is starting to indicated that natural immunity due to being infected with the original strain does not hold up against at least one of the new strains, the SA variant.  There are an increasing number of documented cases where someone was infected with the original strain, now getting reinfected with the SA strain.  While the vaccines might be less efficacious against that variant. it certainly appears that natural immunity from previous infection is having even less benefit.

 

In at least some of the reinfection cases, the new infection is serious including hospitalization.

[nocl]

20 minutes ago, markeb said:

Well, Ken...

 

Let's see how things go with J&J. I'm a little surprised they don't have more doses on hand in the US, but they apparently are delivering elsewhere around the world.

 

I don't know what to make of AstraZeneca. They will have to present ALL data, regardless of source of the trial. And they're going to have to be able to explain it. I frankly think an EUA is unlikely, but not impossible. If J&J had 100M doses ready to deliver once an EUA is granted, or if Moderna and Pfizer are able to produce enough doses to exceed downstream vaccination capabilities, then I'd go with impossible instead of improbable.

 

There's a brief note in the WAPO today that South Africa has initiated their vaccine program with the J&J product after the AZ trial showed no protection against mild and moderate effects of the circulating variant. I don't see AZ restarting their trial in South Africa to look for protection against severe effects if they can get enough other vaccines. And if the article you linked is accurate, I'm concerned they've lost control of their global manufacturing process. Which you really don't want to do during clinical trials. You want a clean process through the trials, then bridge to other manufacturers.

 

The AZ vaccine always had a lot of promise, and a lot of potential problems. I probably didn't think efficacy was really one of them, but throw that on top of some of the other challenges, and they've got problems. And the FDA doesn't like problems...

The AZ clinical process has been problematic at best. The SA trail results and their decision to stop using the vaccine, at a time when they did not have a supply of other vaccine pretty much indicates their opinion.

 

I tend to doubt that AZ will get approved in the US.  Especially if there is a good supply of other, more efficacious vaccine. After all an EUA requires an unmet medical need and if there is a good supply of better vaccines than there is not an unmet medical need.

[LGW59]

4 minutes ago, nocl said:

No one is pushing that narrative, except when it comes to AZ where there is the results of a trial in SA against the SA variant.

 

What I am saying is that data is starting to indicated that natural immunity due to being infected with the original strain does not hold up against at least one of the new strains, the SA variant.  There are an increasing number of documented cases where someone was infected with the original strain, now getting reinfected with the SA strain.  While the vaccines might be less efficacious against that variant. it certainly appears that natural immunity from previous infection is having even less benefit.

 

In at least some of the reinfection cases, the new infection is serious including hospitalization.

You seem to have caught the LGW59 need to respond to every post...I am slowly weening myself away from it, feels good too!

[nocl]

Just now, LGW59 said:

You seem to have caught the LGW59 need to respond to every post...I am slowly weening myself away from it, feels good too!

Only those that are related to something I posted, especially when there seems to be some misunderstanding of what I posted.

[TeeRick]

Here is a nice article published today in the Atlantic.  A good read.  Talks about the dropping cases in the US, Canada and Europe.  And the possible factors for these drops.  A bit of overall good news.

 

https://www.theatlantic.com/ideas/archive/2021/02/why-covid-19-cases-are-falling-so-fast/618041/

[TeeRick]

26 minutes ago, nocl said:

No one is pushing that narrative, except when it comes to AZ where there is the results of a trial in SA against the SA variant.

 

What I am saying is that data is starting to indicated that natural immunity due to being infected with the original strain does not hold up against at least one of the new strains, the SA variant.  There are an increasing number of documented cases where someone was infected with the original strain, now getting reinfected with the SA strain.  While the vaccines might be less efficacious against that variant. it certainly appears that natural immunity from previous infection is having even less benefit.

 

In at least some of the reinfection cases, the new infection is serious including hospitalization.

I think we should see if the natural immunity eventually gives way to re-infections and if so,  the time frame. Or will it be mostly related to re-infections by variants (such as SA).  Hopefully it will not happen to a large extent but that will keep the vaccine makers in the money for years with annual booster shots (like Flu).  So far there are not an overwhelming number of cases reported.  But we always knew it could (might) happen to some degree.  In fact this is one reason that people who recovered from their virus infections are still being recommended for vaccination.

[K.T.B.]

1 hour ago, TeeRick said:

Here is a nice article published today in the Atlantic.  A good read.  Talks about the dropping cases in the US, Canada and Europe.  And the possible factors for these drops.  A bit of overall good news.

 

https://www.theatlantic.com/ideas/archive/2021/02/why-covid-19-cases-are-falling-so-fast/618041/

 

One reason is right now 70% of the US is covered with snow and people just aren't going out now.

[drarill]

2 hours ago, TeeRick said:

Here is a nice article published today in the Atlantic.  A good read.  Talks about the dropping cases in the US, Canada and Europe.  And the possible factors for these drops.  A bit of overall good news.

 

https://www.theatlantic.com/ideas/archive/2021/02/why-covid-19-cases-are-falling-so-fast/618041/

Rick, yesterday my son got his second dose on the Novavax trial.  He was told that in two months he will get a third shot with the opposite of what he got the first two times, and a fourth shot three weeks after the third.  They are doing this with everyone on the trial.  I guess this way they keep everyone blinded, but at the same time all the participants know that they are getting the vaccine.  

[TeeRick]

15 hours ago, drarill said:

Rick, yesterday my son got his second dose on the Novavax trial.  He was told that in two months he will get a third shot with the opposite of what he got the first two times, and a fourth shot three weeks after the third.  They are doing this with everyone on the trial.  I guess this way they keep everyone blinded, but at the same time all the participants know that they are getting the vaccine.  

Very interesting strategy! I am trying to find information on this as the original trial protocol has perhaps been amended to account for the other successful vaccines now available.  Here is a story from a current Novavax trial participant and his choices going forward.  It does mention something about an amended study with a blinded crossover:

 

"Another option would be to stay in the study and, at some point, get the real Novavax vaccine. The company has amended the study protocol to incorporate a blinded crossover system. While details aren't immediately available, that means I'll be given the opposite of what I'm getting now at some point: If I'm currently getting the placebo, I'll be switched to the experimental vaccine."

 

https://www.medpagetoday.com/infectiousdisease/covid19/91144

Edited February 18, 2021 by TeeRick

[TeeRick]

Here is a nice Vaccine Tool (by state) developed by NPR.

 

https://www.npr.org/sections/health-shots/2021/02/18/967448680/how-to-sign-up-for-a-covid-19-vaccine-in-your-state

[Ken the cruiser]

Here's an interesting article regarding the findings of 2 Canadian researchers from reviewing the Pfizer data submitted to the FDA. We're still getting our second dose on March 1, but if true it sure made my DW feel better when she heard what the short term efficacy might be just two weeks after the first dose (92.6%). 

 

The vaccine had an efficacy of 92.6% after the first dose, Danuta Skowronski and Gaston De Serres said, based on an analysis of the documents submitted by the drugmaker to the U.S. Food and Drug Administration (FDA). These findings were similar to the first-dose efficacy of 92.1% reported for Moderna Inc's mRNA-1273 vaccine, according to the letter

 

Researchers urge delaying Pfizer vaccine's second dose as first highly effective (msn.com)

[Ken the cruiser]

Here's another article regarding the Pfizer vaccine efficacy level associated with the SA variant.

 

A new report published in the New England Journal of Medicine on Wednesday (Feb 17) suggests that Pfizer-BioNTech's Covid-19 vaccine can protect people against concerning new coronavirus variants, including one first seen in South Africa called B.1.351.

 

While the blood serum samples produced less neutralizing antibody activity, it was still enough to neutralize the virus, they wrote in a letter to the journal. This is in line with other studies. And it's well within what is seen with other viruses, one of the researchers said.

 

Pfizer, Moderna vaccines can protect against coronavirus variant, lab studies suggest (msn.com)

 

Edited February 18, 2021 by Ken the cruiser

[TeeRick]

48 minutes ago, Ken the cruiser said:

Here's another article regarding the Pfizer vaccine efficacy level associated with the SA variant.

 

A new report published in the New England Journal of Medicine on Wednesday (Feb 17) suggests that Pfizer-BioNTech's Covid-19 vaccine can protect people against concerning new coronavirus variants, including one first seen in South Africa called B.1.351.

 

While the blood serum samples produced less neutralizing antibody activity, it was still enough to neutralize the virus, they wrote in a letter to the journal. This is in line with other studies. And it's well within what is seen with other viruses, one of the researchers said.

 

Pfizer, Moderna vaccines can protect against coronavirus variant, lab studies suggest (msn.com)

 

A good signal from the lab anyway.    My guess (not a fact) is that if the two mRNA vaccines were in trials a bit later and in more countries, after some variants had emerged, their overall efficacy would likely be less than 95%.  But probably still very good and still protective for severe cases, hospitalizations and deaths.  Pfizer and Moderna have both publicly stated that they are developing variant specific vaccines "just in case". 

[jagoffee]

A couple very hopeful posts.  Thanks.

 

I suspect that it will become more difficult to recruit vaccine trial participants, especially if they are elderly or have other underlining conditions.  I would think people would want to get the vaccines that have already been approved instead of taking the risk.  
Perhaps the  trials will be conducted in places that do not have other vaccines available.  People 65 years old and above in the US that want the vaccine will most likely be vaccinated before any new trial would be completed.  

[markeb]

17 minutes ago, jagoffee said:

A couple very hopeful posts.  Thanks.

 

I suspect that it will become more difficult to recruit vaccine trial participants, especially if they are elderly or have other underlining conditions.  I would think people would want to get the vaccines that have already been approved instead of taking the risk.  
Perhaps the  trials will be conducted in places that do not have other vaccines available.  People 65 years old and above in the US that want the vaccine will most likely be vaccinated before any new trial would be completed.  

 

Since we're dealing with EUAs here, not fully approved products, things may or may not proceed as "normal", but generally, once you have approved, effective products, you change your future clinical trial protocols to compare your new product to the existing product. It generally becomes unethical to continue a placebo control when you know you have an effective drug or vaccine. You're then into FDA buzzword bingo territory of demonstrating "non-inferiority"; the product is no worse than the approved product (or as good as, but the terminology is actually written the other way...). 

 

But, yes, recruiting volunteers even with that criteria could be difficult.

[jagoffee]

Markeb, thank you for the explanation.  Logical explanation.  

[nocl]

3 hours ago, markeb said:

 

Since we're dealing with EUAs here, not fully approved products, things may or may not proceed as "normal", but generally, once you have approved, effective products, you change your future clinical trial protocols to compare your new product to the existing product. It generally becomes unethical to continue a placebo control when you know you have an effective drug or vaccine. You're then into FDA buzzword bingo territory of demonstrating "non-inferiority"; the product is no worse than the approved product (or as good as, but the terminology is actually written the other way...). 

 

But, yes, recruiting volunteers even with that criteria could be difficult.

Such trials would require the new product to be tested against the standard of care.

 

I expect that the vaccine players that are going to be in the market in the US are those already running trials.  For someone to play catchup will be very expensive and it will be hard to take market share.  A new player would need something unique and better than the others (room temperature, single dose, long duration, etc.)

 

For the established players such as Moderna and Pfizer you can expect that future trials for boosters, new strains will be much smaller, faster trials looking at safety, dosing, along with lab work demonstrating antibody production.

[drarill]

7 hours ago, TeeRick said:

A good signal from the lab anyway.    My guess (not a fact) is that if the two mRNA vaccines were in trials a bit later and in more countries, after some variants had emerged, their overall efficacy would likely be less than 95%.  But probably still very good and still protective for severe cases, hospitalizations and deaths.  Pfizer and Moderna have both publicly stated that they are developing variant specific vaccines "just in case". 

news about the Novavax trial  https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

[zanderblue]

16 hours ago, TeeRick said:

Very interesting strategy! I am trying to find information on this as the original trial protocol has perhaps been amended to account for the other successful vaccines now available.  Here is a story from a current Novavax trial participant and his choices going forward.  It does mention something about an amended study with a blinded crossover:

 

"Another option would be to stay in the study and, at some point, get the real Novavax vaccine. The company has amended the study protocol to incorporate a blinded crossover system. While details aren't immediately available, that means I'll be given the opposite of what I'm getting now at some point: If I'm currently getting the placebo, I'll be switched to the experimental vaccine."

 

https://www.medpagetoday.com/infectiousdisease/covid19/91144

@TeeRick not the Novavax trial protocol per se, but see below an extract from an email I received from doctor managing trial at the hub I attend.

 

”Thank you for getting in touch with us about your NHS appointment. I will try and give you a call tomorrow - apologies as we have received a very high volume of calls.

 

In the meantime I wanted to explain that there are two options going forward.

 

Following the news of Novavax's vaccine efficacy of 89.3%, Novavax is on the way to change to format of this trial. This will involve all our participants getting the Novavax vaccine. How this will work is that everyone will get injected with two courses of placebo or vaccine; the opposite of what they received the first-time round. This will mean that everyone will be ensured a vaccine without breaking the blind of the original injection.

 

If you decide to wait for the Novavax vaccine, this will require that you wait for this change to implemented, and this will occur end of March / beginning of April until approval is received by the governing body. The advantage is that unlike the NHS schedule, you can receive both shots within 3-4 weeks as opposed to waiting 12 weeks for your second injection.

 

If you would prefer to get vaccinated sooner, we would ideally arrange an unblinding visit 1-2 days before to take a blood sample before we unblind you. This would be a short visit and once done, your original fourth visit can be skipped. After that, we would keep you in the trial unblinded and continue the antibody tests. (The visit only applies if you have not already attended a fourth visit.)

 

Once you have considered the options, let us know what you decide, and we can make a plan going forward. Feel free to get in touch again if you have any other questions.”

 

The doctor did call me the following day and discussed more detail. The dates provided are expected to be improved upon, and are subject to vaccine receiving timely approval. 
I have decided to forego my NHS vaccination this week and stay blinded in the trial, at least for now. Very much a watching brief though...........

[UnorigionalName]

6 hours ago, drarill said:

news about the Novavax trial  https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

 

"In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative."

 

hmmm.... not a comforting 95% CI

[drarill]

3 hours ago, UnorigionalName said:

 

"In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative."

 

hmmm.... not a comforting 95% CI

Pfizer and South African variant: https://www.nbcnews.com/news/us-news/pfizer-says-south-african-variant-could-significantly-reduce-vaccine-protection-n1258198

 

[hcat]

Question for Science People posting here:

 

What are the differences ( in simple language) in the variants that make the current vaccines less effective protection..?

How and why did the variants evolve?

What are the chances it will change again?

Will adjustments in a  booster vaccines be able  to challenge the variants?

 

Thanks much!

 

[shiphound]

On 2/3/2021 at 10:48 PM, shiphound said:

My wife and I got the first dose of Pfizer vaccine last week.  Cannot wait to get second dose. 

Got my second dose this week.  My wife gets hers tomorrow.  There really is a sense of euphoria about getting the vaccine.  I feel as if I am getting my life back.

[shiphound]

On 2/17/2021 at 1:58 PM, nocl said:

The point I was making is that while the vaccines may provide some protection from the variants, data is starting to appear that infection from the original strain may not.  As such one may not be able to count the previously infected in looking at numbers for herd immunity if some of the new strains (SA for example) get wide spread.

From what I have read, there is some thinking that having had the virus may in many cases be like getting the first of the two doses of the vaccine.  There is at least some thought that people who have had the virus may only need one dose of vaccine.