Are vaccines the light at the end of the tunnel?

[Fouremco]

27 minutes ago, phoenix_dream said:

No, it does not end the pandemic.  What it would do is significantly lower the deaths.  A pandemic is defined by the number of people getting sick over a broad area, not the number of people dying.

 

From Merriam Webster:

Definition of pandemic (Entry 2 of 2)

1: an outbreak of a disease that occurs over a wide geographic area (such as multiple countries or continents) and typically affects a significant proportion of the population : a pandemic outbreak of a disease

And how does vaccination significantly lower the number deaths? By reducing the number of people getting infected in the first place. Barring the development of a miracle cure for those who become infected, reducing deaths by reducing cases through vaccination is the only viable way to end the pandemic.

 

Significant Vaccination ---> Significant Reduction in Cases ---> Significant Reduction in Deaths

[drarill]

32 minutes ago, TeeRick said:

I do not know specifics and maybe nobody does at this point.  So anybody should feel free to move to the next post and not pay any attention to my answer below.

 

We can maybe assume they are concerned about anaphylaxis since they talk about those people carrying epipens should avoid the vaccine for now. 

 

Some ideas (from me) for what it's worth. I do not have anything but speculation to offer.

 

The Pfizer vaccine like any other vaccine could stimulate a heightened but non-specific immune response leading to anaphylaxis in those prone to it.

 

1)The Pfizer vaccine formulation is mRNA with a lipid coating.

It is hard to imagine that mRNA per se would be the allergen since every cell in our bodies produce it continuously.  But a couple of things to consider.  The mRNA in the vaccine was made with slightly different chemical base modifications to enhance its stability once injected.  Also mRNA can fold itself into different unique structures depending on its sequence.  Either might make it look like a foreign antigen in some of the highly susceptible people.

 

2)The lipid +mRNA complex could be viewed as a foreign antigen.  Also the lipid coating itself.

 

3)Other components of the vaccine formulation mixture - but not sure what else is in it.  Vaccine formulation scientists have great knowledge from other vaccines about safe and inert components to use so this is probably not the source of the reactions.  Unless something new and untried was required for the mRNA-lipid complex.

Thanks Rick! I really appreciate your input.   I come to this thread almost every day to check everyone's opinions. All of you have make my research easier. We also received our first doses today and hope this means the beginning of the end.  

have a great day!!

Lydia

[D C]

2 hours ago, phoenix_dream said:

No, it does not end the pandemic.  What it would do is significantly lower the deaths.  A pandemic is defined by the number of people getting sick over a broad area, not the number of people dying.

 

From Merriam Webster:

Definition of pandemic (Entry 2 of 2)

1: an outbreak of a disease that occurs over a wide geographic area (such as multiple countries or continents) and typically affects a significant proportion of the population : a pandemic outbreak of a disease

That definition is quite generic and subjective.  I said that there appears to be no agreed-upon established criteria.  It seems that we've not had to define it beyond a subjective concept in the past.  

[lyndarra]

3 hours ago, D C said:

That definition is quite generic and subjective.  I said that there appears to be no agreed-upon established criteria.  It seems that we've not had to define it beyond a subjective concept in the past.  

Only because it does not agree with your criteria (definition).

"pandemic a & n (disease) prevalent over the whole country of a country or over the whole world." The Concise Oxford Dictionary"

[phoenix_dream]

We probably should stop arguing about the definition of a pandemic and get back to arguing about other things😄

[lyndarra]

6 minutes ago, phoenix_dream said:

We probably should stop arguing about the definition of a pandemic and get back to arguing about other things😄

You mean there's something else?😲😃

[markeb]

1 hour ago, lyndarra said:

You mean there's something else?😲😃

 

I thought about discussing this, but it's not needed tonight...

 

There has to be something else! The weather is predicting snow in the DC area on Wednesday. High adventure! And I have a very nice Washington State Rhone blend beside the computer (mostly Syrah) and that's always a good thing! On top of that, I found a Penfolds trying to bob up in the rack, so tomorrow could be good, too.

Edited December 15, 2020 by markeb

[lyndarra]

1 hour ago, markeb said:

 

I thought about discussing this, but it's not needed tonight...

 

There has to be something else! The weather is predicting snow in the DC area on Wednesday. High adventure! And I have a very nice Washington State Rhone blend beside the computer (mostly Syrah) and that's always a good thing! On top of that, I found a Penfolds trying to bob up in the rack, so tomorrow could be good, too.

You've inspired me to pop in the fridge a bottle of Piggs Peake Hogshead Chardonnay for later tonight. I'm all out of reds but they're for winter anyway. I feel better already.😇

 

[Arizona Wildcat]

11 hours ago, TeeRick said:

I do not know specifics and maybe nobody does at this point.  So anybody should feel free to move to the next post and not pay any attention to my answer below.

 

We can maybe assume they are concerned about anaphylaxis since they talk about those people carrying epipens should avoid the vaccine for now. 

 

Some ideas (from me) for what it's worth. I do not have anything but speculation to offer.

 

The Pfizer vaccine like any other vaccine could stimulate a heightened but non-specific immune response leading to anaphylaxis in those prone to it.

 

1)The Pfizer vaccine formulation is mRNA with a lipid coating.

It is hard to imagine that mRNA per se would be the allergen since every cell in our bodies produce it continuously.  But a couple of things to consider.  The mRNA in the vaccine was made with slightly different chemical base modifications to enhance its stability once injected.  Also mRNA can fold itself into different unique structures depending on its sequence.  Either might make it look like a foreign antigen in some of the highly susceptible people.

 

2)The lipid +mRNA complex could be viewed as a foreign antigen.  Also the lipid coating itself.

 

3)Other components of the vaccine formulation mixture - but not sure what else is in it.  Vaccine formulation scientists have great knowledge from other vaccines about safe and inert components to use so this is probably not the source of the reactions.  Unless something new and untried was required for the mRNA-lipid complex.

The BBC on the morning news said anaphylaxis.  What is interesting is we have not heard of any others with a similar reaction and no description of the reaction as to severity.  Of course severity is subjective.

Surely there would have been others who had a reaction.  Makes little sense.  Maybe someone in the UK has heard some additional info.

[mimbecky]

I heard today that vaccines were being delivered to our local military hospital.  It dawned on me that I have never seen active duty military mentioned in any vaccine phase, anywhere.  I am sure they are getting it, and I am sure it is somewhat privileged information, but am just wondering how their vaccine numbers and projected distributions figure into all of this.  

 

[markeb]

33 minutes ago, mimbecky said:

I heard today that vaccines were being delivered to our local military hospital.  It dawned on me that I have never seen active duty military mentioned in any vaccine phase, anywhere.  I am sure they are getting it, and I am sure it is somewhat privileged information, but am just wondering how their vaccine numbers and projected distributions figure into all of this.  

 

Looks very similar to overall CDC guidance. Press release from 9 Dec https://www.defense.gov/Newsroom/Releases/Release/Article/2440556/dod-announces-covid-19-vaccine-distribution-plan/

[TeeRick]

10 hours ago, Arizona Wildcat said:

The BBC on the morning news said anaphylaxis.  What is interesting is we have not heard of any others with a similar reaction and no description of the reaction as to severity.  Of course severity is subjective.

Surely there would have been others who had a reaction.  Makes little sense.  Maybe someone in the UK has heard some additional info.

Not any cases noted in the phase 3 trials.  The 2 cases in the UK occurred early (first day?) and that was probably enough to publicize broadly.  So maybe that is why there have been no more cases.  The US FDA knew of the UK cases before they approved the EUA and had a warning about severe allergies.  So the process is working.  Not sure about the cases in the UK if they were definitely anaphylaxis.  But they did change their guidance to say the vaccine should not be administered to people with a history of anaphylaxis.  Not "severe allergies" as originally stated.

https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine

Edited December 15, 2020 by TeeRick

[TeeRick]

8 hours ago, mimbecky said:

I heard today that vaccines were being delivered to our local military hospital.  It dawned on me that I have never seen active duty military mentioned in any vaccine phase, anywhere.  I am sure they are getting it, and I am sure it is somewhat privileged information, but am just wondering how their vaccine numbers and projected distributions figure into all of this.  

 

You are speaking about the USA I am presuming.

 

For months the Chinese government has been vaccinating their military with the CanSino adenovector vaccine and they claim it has been highly effective.  

https://www.globaltimes.cn/content/1207517.shtml

 

Same is true for Russia.

https://www.newsweek.com/russia-begins-vaccinating-400000-military-personnel-against-covid-1550739

[D C]

10 minutes ago, TeeRick said:

You are speaking about the USA I am presuming.

 

For months the Chinese government has been vaccinating their military with the CanSino adenovector vaccine and they claim it has been highly effective.  

https://www.globaltimes.cn/content/1207517.shtml

 

Same is true for Russia.

https://www.newsweek.com/russia-begins-vaccinating-400000-military-personnel-against-covid-1550739

I'm not sure that I would trust any claims coming from either the Chinese or Russian governments. 

[TeeRick]

4 minutes ago, D C said:

I'm not sure that I would trust any claims coming from either the Chinese or Russian governments. 

I was not referring to claims from the government but just answering the question about vaccinating the military.

[D C]

10 minutes ago, TeeRick said:

I was not referring to claims from the government but just answering the question about vaccinating the military.

Understood.  Just sayin 🙂  

[markeb]

18 minutes ago, TeeRick said:

Not any cases noted in the phase 3 trials.  The 2 cases in the UK occurred early (first day?) and that was probably enough to publicize broadly.  So maybe that is why there have been no more cases.  The US FDA knew of the UK cases before they approved the EUA and had a warning about severe allergies.  So the process is working.

 

I tend to think of anaphylaxis as a "lightning strike" event. A little more likely in someone with a previous history, but otherwise almost unpredictable. The CDC Advisory Committee on Immunization Practices reports an incidence of approximately 1 per million doses (https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html#:~:text=Although allergic reactions are a,for many vaccines (5).), so even in the large scale trials of tens of thousands of participants, you wouldn't 'expect' an anaphylactic reaction. And the vaccine components are pretty much all small molecules that you wouldn't normally associate with an allergic response. (Ingredients are in the EUA Fact sheet https://www.fda.gov/media/144414/download.) No proteins, no cross-linking sugars, sucrose sounds like an ingredient in the solution.

 

The original press was an anaphylactoid reaction, which would be a non IgE (the primary antibody component of allergic responses) mediated degranulation. Same appearance, treatment, and end result, but not through the typical allergy cascade. I guess the newer terminology is 'nonimmunologic anaphylaxis' to de-emphasize the difference in causation and emphasize the effects.

 

Two cases on the first day still sounds like incredibly bad luck, like those reports of someone being struck by lightning twice in their life.

[TeeRick]

3 minutes ago, markeb said:

 

I tend to think of anaphylaxis as a "lightning strike" event. A little more likely in someone with a previous history, but otherwise almost unpredictable. The CDC Advisory Committee on Immunization Practices reports an incidence of approximately 1 per million doses (https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html#:~:text=Although allergic reactions are a,for many vaccines (5).), so even in the large scale trials of tens of thousands of participants, you wouldn't 'expect' an anaphylactic reaction. And the vaccine components are pretty much all small molecules that you wouldn't normally associate with an allergic response. (Ingredients are in the EUA Fact sheet https://www.fda.gov/media/144414/download.) No proteins, no cross-linking sugars, sucrose sounds like an ingredient in the solution.

 

The original press was an anaphylactoid reaction, which would be a non IgE (the primary antibody component of allergic responses) mediated degranulation. Same appearance, treatment, and end result, but not through the typical allergy cascade. I guess the newer terminology is 'nonimmunologic anaphylaxis' to de-emphasize the difference in causation and emphasize the effects.

 

Two cases on the first day still sounds like incredibly bad luck, like those reports of someone being struck by lightning twice in their life.

Yes agree.  Thank you for the fact sheet too.  I have been trying to find the ingredients in the Moderna vaccine formulation to compare to the Pfizer formulation.  Maybe the Moderna fact sheet will come this week after their EUA is approved.

[TeeRick]

I did just find the Moderna vaccine info in the FDA briefing document for the EUA meeting.

https://www.fda.gov/media/144434/download

[Ken the cruiser]

Just curious, with the Moderna EUA hopefully getting approved by the end of the week, which of the other vaccines in Phase 3 trials look to be the most promising for getting the next EUA?

[markeb]

9 minutes ago, TeeRick said:

Yes agree.  Thank you for the fact sheet too.  I have been trying to find the ingredients in the Moderna vaccine formulation to compare to the Pfizer formulation.  Maybe the Moderna fact sheet will come this week after their EUA is approved.

 

I found the fact sheet last night somehow. I think it was off a link where the author was suggesting the polyethylene glycol as a possible culprit. The FDA is posting the fact sheets; not Pfizer.

[TeeRick]

7 minutes ago, Ken the cruiser said:

Just curious, with the Moderna EUA hopefully getting approved by the end of the week, which of the other vaccines in Phase 3 trials look to be the most promising for getting the next EUA?

Until recently I would have bet on the AZ/Oxford vaccine but if we are specifically talking about a US EUA I do not think that will happen until after the US phase 3 trial is completed.  Remember the US was delayed for quite a while due to adverse events needing to be studied.  The company and Operation Warp Speed have recently said that the 1/2 vs full dose effect will be clarified in the US trial.  But maybe it will be approved before that in the UK.  So I would place my bet at this point on the J&J vaccine in the US for an EUA.  

[markeb]

6 minutes ago, TeeRick said:

Until recently I would have bet on the AZ/Oxford vaccine but if we are specifically talking about a US EUA I do not think that will happen until after the US phase 3 trial is completed.  Remember the US was delayed for quite a while due to adverse events needing to be studied.  The company and Operation Warp Speed have recently said that the 1/2 vs full dose effect will be clarified in the US trial.  But maybe it will be approved before that in the UK.  So I would place my bet at this point on the J&J vaccine in the US for an EUA.  

 

That's pretty much what I'm thinking as well. The AZ product is going to get a lot of scrutiny in the US at this point, and I don't know when they're looking at reporting results. Transitions between any administrations regardless of circumstances are a slow time for routine as well, later in the spring for AZ might ultimately be a shorter time from data to approval. And J&J is quietly moving along and may make up the head start. 

[Ken the cruiser]

18 minutes ago, TeeRick said:

Until recently I would have bet on the AZ/Oxford vaccine but if we are specifically talking about a US EUA I do not think that will happen until after the US phase 3 trial is completed.  Remember the US was delayed for quite a while due to adverse events needing to be studied.  The company and Operation Warp Speed have recently said that the 1/2 vs full dose effect will be clarified in the US trial.  But maybe it will be approved before that in the UK.  So I would place my bet at this point on the J&J vaccine in the US for an EUA.  

Thanks! Sounds like a safe bet. From the following Dec 9th article it looks like J&J could apply for an EUA in February.

 

Johnson & Johnson said on Wednesday it has cut enrollment for its pivotal COVID-19 vaccine trial to 40,000 volunteers from its original plan for 60,000, as higher rates of COVID-19 infections amid a worsening pandemic should generate the data it needs with fewer study subjects.

 

J&J says cutting enrollment for COVID-19 vaccine trial by 20,000 as cases rise | Reuters 

[markeb]

7 minutes ago, Ken the cruiser said:

Johnson & Johnson said on Wednesday it has cut enrollment for its pivotal COVID-19 vaccine trial to 40,000 volunteers from its original plan for 60,000, as higher rates of COVID-19 infections amid a worsening pandemic should generate the data it needs with fewer study subjects.

 

 

Sad but true. Easier to complete a vaccine trial with a relatively high disease prevalence...