Are vaccines the light at the end of the tunnel?

[Ken the cruiser]

I must have missed this with all the stuff that's been going on. I wonder how long it's going to take for the FDA to grant full approval for the Pfizer vaccine?

 

https://www.msn.com/en-us/news/scienceandtechnology/covid-vaccine-what-it-means-if-the-fda-grants-full-approval/ar-BB1gJsX2

[jgmorgan]

10 hours ago, Ken the cruiser said:

I must have missed this with all the stuff that's been going on. I wonder how long it's going to take for the FDA to grant full approval for the Pfizer vaccine?

 

https://www.msn.com/en-us/news/scienceandtechnology/covid-vaccine-what-it-means-if-the-fda-grants-full-approval/ar-BB1gJsX2

Interesting, thanks for posting.

 

One of the consequences of granting full approval to the Pfizer vaccine may be the elimination of FDA's authority under their rules to give other vaccines still under development an Emergency Use Authorization when have progressed through trials. It appears that an EUA is granted only when there are no approved alternatives.  I haven't kept up with it closely, but is seems like there were a number of trials that were underway and that the FDA had supported financially.  That may influence how quickly they proceed with Pfizer's application.

 

Or not.

[D C]

22 minutes ago, jgmorgan said:

Interesting, thanks for posting.

 

One of the consequences of granting full approval to the Pfizer vaccine may be the elimination of FDA's authority under their rules to give other vaccines still under development an Emergency Use Authorization when have progressed through trials. It appears that an EUA is granted only when there are no approved alternatives.  I haven't kept up with it closely, but is seems like there were a number of trials that were underway and that the FDA had supported financially.  That may influence how quickly they proceed with Pfizer's application.

 

Or not.

Do the EUAs have an expiry date? I would think they'd continue to be valid regardless of any subsequent full approval. 

[jgmorgan]

6 minutes ago, D C said:

Do the EUAs have an expiry date? I would think they'd continue to be valid regardless of any subsequent full approval. 

It looks like that an EUA is effective until revoked or until conditions no longer meet the EUA criteria.  This quote is taken from the FDA's most recent letter granting and EUA to Moderna (it is identical to the Pfizer letter):

 

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

 

I think this means that once granted, an EUA will be effective until the Secretary of HHS determines that circumstances no longer meet the criteria for the issuance of the EUA, e.g. (Public health emergency and inadequate approved alternatives available) or the vaccine authorized (in this case) doesn't appear to be safe and/or effective.

 

However, once a vaccine or vaccines are fully approved, granting further EUA's for Covid vaccines may be problematic.

 

[markeb]

1 hour ago, jgmorgan said:

Interesting, thanks for posting.

 

One of the consequences of granting full approval to the Pfizer vaccine may be the elimination of FDA's authority under their rules to give other vaccines still under development an Emergency Use Authorization when have progressed through trials. It appears that an EUA is granted only when there are no approved alternatives.  I haven't kept up with it closely, but is seems like there were a number of trials that were underway and that the FDA had supported financially.  That may influence how quickly they proceed with Pfizer's application.

 

Or not.

 

1 hour ago, D C said:

Do the EUAs have an expiry date? I would think they'd continue to be valid regardless of any subsequent full approval. 

 

In general, you need an emergency and a need that cannot be met by a licensed or approved product. Even when the Pfizer product is licensed, you'll still need more product (Moderna, J&J, etc.) to meet the need. There's never been a situation with one or more licensed products on the market and other similar products on EUAs, and how "unmet need" gets applied will be interesting. But licensure of the Pfizer vaccine in and of itself wouldn't end the EUA for other vaccines. It might create some hurdles for other vaccines, unless there's something different about another them (Novavax, for instance, has a more traditional subunit vaccine, so it might prove useful in some populations).

 

Even when the Pfizer and Moderna vaccines are licensed, if 16 and older, the EUAs could stay in place for younger populations until the license is extended to those populations.

[nocl]

1 hour ago, jgmorgan said:

Interesting, thanks for posting.

 

One of the consequences of granting full approval to the Pfizer vaccine may be the elimination of FDA's authority under their rules to give other vaccines still under development an Emergency Use Authorization when have progressed through trials. It appears that an EUA is granted only when there are no approved alternatives.  I haven't kept up with it closely, but is seems like there were a number of trials that were underway and that the FDA had supported financially.  That may influence how quickly they proceed with Pfizer's application.

 

Or not.

The requirement is that there must be an unmet medical need. Even with full approval of one vaccine the others that have already been approved would fall into that category with the number of unvaccinated, the potential need for boosters, etc.

 

Would probably prevent others from getting EUA status however.

 

The FDA would not fund vaccine development.  Other agencies under DHHS would but not FDA. Since it is the approving agency that would pose a conflict of interest. 

[nocl]

1 hour ago, D C said:

Do the EUAs have an expiry date? I would think they'd continue to be valid regardless of any subsequent full approval. 

According to the law an EUA is for either until the Sec of HHS emergency declaration is revoked, or for 1 year after application approval. Whichever is shorter. Though the application can be renewed if needed.

Edited May 15, 2021 by nocl

[jgmorgan]

2 hours ago, markeb said:

Even when the Pfizer and Moderna vaccines are licensed, if 16 and older, the EUAs could stay in place for younger populations until the license is extended to those populations.

 

1 hour ago, nocl said:

According to the law an EUA is for either until the Sec of HHS emergency declaration is revoked, or for 1 year after application approval. Whichever is shorter. Though the application can be renewed if needed.

Good points all.

[nocl]

It appears strain B.1.617 the strain that it impacting India so severely is now starting to raise problems in other areas. The Seychelles is reporting that 30% of its cases are in vaccinated individuals (AZ and Sinopharm), the UK is seeing the strain and is speeding up second doses for at risk individuals.  Singapore is tightening up after seeing a cluster of cases including vaccinated individuals (Pfizer and Moderna).

 

B.1.617 appears to be even more infectious than the B.117 which is more infectious than the original strain.

 

Statements in the media do indicate that Pfizer vaccine is effective against B.1.617, but less so than against other strains.  Cannot not find any quantitative data only the qualitative statement.

Edited May 15, 2021 by nocl

[Ride-The-Waves]

Its not over yet.  The "fat lady" is still waiting to sing despite all the clamoring at the CDC.  The need to have both Pfizer/Moderna inoculations to reengage with the "public" is now even more acute.  Still need to practice good safety protocols in groups.  This is what the 4th metamorphosis of COVID-19?

[4774Papa]

Royal Caribbean just provided a lengthy guidance on privacy and likely cruise requirements, which include:

 

"As the vaccination program is under way, it is very likely that we will ask adults for confirmation of vaccination (both doses) before you can cruise with us."

[nocl]

24 minutes ago, 4774Papa said:

Royal Caribbean just provided a lengthy guidance on privacy and likely cruise requirements, which include:

 

"As the vaccination program is under way, it is very likely that we will ask adults for confirmation of vaccination (both doses) before you can cruise with us."

Unfortunately "very likely" is not the same as "you must"

 

One of the reason I want to see the cruise lines sign the attestation documents that cruises will meet the 95 and 98% vaccination levels.  That way the cruise lines cannot just drop the requirement on a whim or allow unannounced exceptions.

[D C]

42 minutes ago, nocl said:

Unfortunately "very likely" is not the same as "you must"

 

One of the reason I want to see the cruise lines sign the attestation documents that cruises will meet the 95 and 98% vaccination levels.  That way the cruise lines cannot just drop the requirement on a whim or allow unannounced exceptions.

Agreeing to that seems like the fastest way forward (until the CDC creates some other roadblock) 

[Ken the cruiser]

1 hour ago, nocl said:

Unfortunately "very likely" is not the same as "you must"

 

One of the reason I want to see the cruise lines sign the attestation documents that cruises will meet the 95 and 98% vaccination levels.  That way the cruise lines cannot just drop the requirement on a whim or allow unannounced exceptions.

Attestation documents? Are those part of the Phase 2A protocol plan or something else?

 

Update: ok, I just went and looked back at all the posts that referred to attestation. I take it it's just part of the Phase 2A plan where each applicable cruise ship certifies they will be making sure at least 95% of the passengers show proof they will be vaccinated. But does that attestation only apply to the Phase 4 restricted cruises or for an unspecified amount of time, e.g., until the pandemic has been downgraded by the W.H.O worldwide or sometime in the middle determined at some later date by the CDC?

Edited May 16, 2021 by Ken the cruiser

[nocl]

30 minutes ago, Ken the cruiser said:

Attestation documents? Are those part of the Phase 2A protocol plan or something else?

 

Update: ok, I just went and looked back at all the posts that referred to attestation. I take it it's just part of the Phase 2A plan where each applicable cruise ship certifies they will be making sure at least 95% of the passengers show proof they will be vaccinated. But does that attestation only apply to the Phase 4 restricted cruises or for an unspecified amount of time, e.g., until the pandemic has been downgraded by the W.H.O worldwide or sometime in the middle determined at some later date by the CDC?

WHO view does not matter.  The emergency declaration signed by the President is what matters in the US.

 

The attestation documents would apply to any cruises done while the CSO remains in force (most likely some form will exist as long as the presidential emergency order remains in force).  They would apply to all of the cruise until either the attestation is withdrawn or the cruise line requests and the CDc grants a change.

[Ride-The-Waves]

Funny thing is that the CDC announcement shifts the emphasis for adherence and safety to the actual cruiser, not the government or cruise line.  "Certify" that you are vaccinated when you are not carries with it legal ramifications for AMCITs in US courts.

[Ken the cruiser]

If Sanofi and GlaxoSmithKline are going to perform their Phase 3 trial, in part, in the US to obtain FDA approval, how are they going to get 35,000 volunteers when a variety of COVID vaccines are currently available at a nearby pharmacy right now? But, since they didn't mention the FDA specifically, maybe they're going to perform their trial in some countries that are being hit hard now like India?

 

Sanofi and GlaxoSmithKline say their COVID-19 vaccine triggers a strong immune response, bolstering the late-comer program's potential as a booster shot (msn.com)

 

Edited May 17, 2021 by Ken the cruiser

[TeeRick]

51 minutes ago, Ken the cruiser said:

If Sanofi and GlaxoSmithKline are going to perform their Phase 3 trial, in part, in the US to obtain FDA approval, how are they going to get 35,000 volunteers when a variety of COVID vaccines are currently available at a nearby pharmacy right now? But, since they didn't mention the FDA specifically, maybe they're going to perform their trial in some countries that are being hit hard now like India?

 

Sanofi and GlaxoSmithKline say their COVID-19 vaccine triggers a strong immune response, bolstering the late-comer program's potential as a booster shot (msn.com)

 

Ken you have hit the nail on the head (for the US and probably UK anyway).  It will be hard to recruit 35,000 volunteers in countries with high vaccination rates.  The remainder of the population are the vaccine resistant so I don't see many of them volunteering.  And less COVID around means longer trials to reach an efficacy endpoint.  I would guess that their phase III will be global and it would recruit in countries with high COVID and low vaccinations.  It will come out soon on the clinical trial sites so we will know.  One thing is that the GSK/Sanofi vaccine is like the Novavax vaccine in that it is a traditional protein subunit vaccine.  Some vaccine-hesitant that do not want to take a chance on the "unproven" mRNA or adenovector vaccines might go for these more traditional approaches.

[TeeRick]

Good general discussion on herd immunity and current thinking with vaccines.

 

https://www.npr.org/sections/health-shots/2021/05/18/997461471/its-time-for-americas-fixation-with-herd-immunity-to-end-scientists-say

 

 

[terrydtx]

It looks like the EU will soon  start allowing US citizens who are fully vaccinated to travel into EU member countries without Covid tests and/or quarantine, this is great news for cruises this summer and fall.  The CDC vaccination cards will also be accepted for US citizens once approved by the EU.

 

Americans set to learn if they will be allowed to fly to Europe (msn.com)

[D C]

25 minutes ago, TeeRick said:

Good general discussion on herd immunity and current thinking with vaccines.

 

https://www.npr.org/sections/health-shots/2021/05/18/997461471/its-time-for-americas-fixation-with-herd-immunity-to-end-scientists-say

 

 

We've been too fixated on an undefined, incalculable number for over a year now.  In the past 100 years, have we ever predicted and calculated herd immunity for any human disease?  

 

That's a peculiar article.  I read it twice and the second time, I realised that it's a mash-up of various quotes from various people, which gives it a bit of incoherence.   One statement talks about the inaccuracy of models and another is throwing out fairly narrow estimates for when we'll reach her immunity.  

 

Herd immunity aside, we must surely be below the epidemic threshold for deaths in the US by this point (or very near).

[D C]

2 minutes ago, terrydtx said:

It looks like the EU will soon  start allowing US citizens who are fully vaccinated to travel into EU member countries without Covid tests and/or quarantine, this is great news for cruises this summer and fall.  The CDC vaccination cards will also be accepted for US citizens once approved by the EU.

 

Americans set to learn if they will be allowed to fly to Europe (msn.com)

Good news. Let's hope the UK follows suit.

[TeeRick]

5 minutes ago, D C said:

We've been too fixated on an undefined, incalculable number for over a year now.  In the past 100 years, have we ever predicted and calculated herd immunity for any human disease?  

 

That's a peculiar article.  I read it twice and the second time, I realised that it's a mash-up of various quotes from various people, which gives it a bit of incoherence.   One statement talks about the inaccuracy of models and another is throwing out fairly narrow estimates for when we'll reach her immunity.  

 

Herd immunity aside, we must surely be below the epidemic threshold for deaths in the US by this point (or very near).

Yes some general statements and quotes.  But the point really is the need to stop worrying about some milestone called herd immunity that likely will never be achieved.  And so what?  We will hopefully manage the virus and variants going forward with the current and normal medical infrastructure in the USA.

[D C]

2 minutes ago, TeeRick said:

Yes some general statements and quotes.  But the point really is the need to stop worrying about some milestone called herd immunity that likely will never be achieved.  And so what?  We will hopefully manage the virus and variants going forward with the current and normal medical infrastructure in the USA.

"And so what?"  Exactly. Once vaccinated, you're immune. 🙂

Some will willfully never be part of the immune herd

Some pockets will have extremely high immunity

Some pockets will have low immunity and may well continue to see cases

 

At some point we'll be at (or past) the point at which if the current state of covid was as bad as it ever got, we wouldn't have freaked out about it to begin with.  With deaths continuing to drop, we'll hopefully be there soon. 

[cangelmd]

13 minutes ago, D C said:

We've been too fixated on an undefined, incalculable number for over a year now.  In the past 100 years, have we ever predicted and calculated herd immunity for any human disease?  

 

That's a peculiar article.  I read it twice and the second time, I realised that it's a mash-up of various quotes from various people, which gives it a bit of incoherence.   One statement talks about the inaccuracy of models and another is throwing out fairly narrow estimates for when we'll reach her immunity.  

 

Herd immunity aside, we must surely be below the epidemic threshold for deaths in the US by this point (or very near).

The big thing we haven't known in the entire pandemic is how many people have actually had the disease (we also don't know how long immunity lasts, but for the purposes of argument let's assume long enough and that most people who were infected still have some immunity). What ever herd immunity is, it will require vaccination, but it will also be fueled by some level of natural immunity.

 

I went back and looked at our state data - in Alabama we have basically had a flat line for hospitalizations and an almost flat line for deaths (the death curve is still almost imperceptively declining) since about March 18, two months. That's roughly 4 cycles of virus and includes an "event", spring break, which in Alabama is the same week of March for most schools and mid-April for the rest. You can see tiny blips in the cases following spring break and Easter, but these are tiny. There is only the tiniest of blips in the hospitalizations and none in deaths.

What this tells me is that we are close to having immunity in the most susceptible populations for death and severe disease and that we should see another stepwise drop in hospitalizations and deaths when children can be vaccinated, but we will never get to herd immunity as we see it in some viral diseases without a much higher vaccination rate. I actually think the herd immunity % vaccinated may be lower than some have postulated (more like 60-65%), but even that will require the vaccine to be mandated for some activities - school attendance, certain jobs maybe - and we are a ways from that happening.

As long as a lot of adults refuse vaccination and children can't get the vaccine, I think we are stuck here at around 350 hospitalized at any one time statewide and a death or two a day - but I think we may have interrupted the exponential chain of infection, at least until peoples' immunity starts to wane.