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Posted
8 minutes ago, Anastasis said:

The FDA adcom is redundant. How did they perform with the strain selection last year? You think maybe it could be reasonable to reassess their methodology and process? But be sure to @ me when it gets rescheduled. Maybe we could do something fun and see if the selection process this year has better or worse performance and outcomes than last year. 

Meanwhile, head of drug evaluation at FDA just went through the revolving door and named the new CMO for Pfizer. 

You certainly seem to have your eye on the ball. 

All three of your major tells on display.
You’re grasping and you know it. 

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Posted

Perhaps Cavazzoni having joined the FDA under Trump's first go 'round was tapped by Pfizer board member Scott Gottlieb since he was head of the FDA while she was there. I mean it's not like the upper levels of government officials are going to mill around waiting to be fired or want to deal with the Teen Tech Toddlers looking over their shoulders and causing headaches--they're going to leave when opportunity knocks and it's going to be in their field, not ditch digging. Isn't this what was wanted? No people, no regulations, and everyone for themselves.

Posted
2 minutes ago, Bozo_Casanova said:

You’re grasping and you know it. 

I've paid enough attention the adcom process to know that it is fundamentally broken. I am not going to lose my mind over a meeting getting canceled. If and when it results in worse strain selection outcomes and/or delays in delivery to market wake me up. 

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Posted
Just now, Mrs Whiggins said:

Perhaps Cavazzoni having joined the FDA under Trump's first go 'round was tapped by Pfizer board member Scott Gottlieb since he was head of the FDA while she was there. I mean it's not like the upper levels of government officials are going to mill around waiting to be fired or want to deal with the Teen Tech Toddlers looking over their shoulders and causing headaches--they're going to leave when opportunity knocks and it's going to be in their field, not ditch digging. Isn't this what was wanted? No people, no regulations, and everyone for themselves.

They should all be barred from cycling between pharma and the FDA. And I like Gottlieb and think that he was a pretty good FDA leader, but fuck hopping between the regulators and industry. That shit is fucking dirty. 

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Posted
Just now, Mrs Whiggins said:

One could say that about a lot of career fields with respect to government and industry but since many members of Congress and the Senate do it, don't hold your breath.

HHS isn't even the worst culprit. Looking at you DoD. And yes, congress as well. 

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Posted
51 minutes ago, Anastasis said:

I've paid enough attention the adcom process to know that it is fundamentally broken. I am not going to lose my mind over a meeting getting canceled. If and when it results in worse strain selection outcomes and/or delays in delivery to market wake me up. 


What if we can't wake you up because you're dead from the influenza outbreak? 

I guess we win the argument.

Posted
3 hours ago, Born to Run said:

How dare you sir, Scott Elder is a dealer by the people for the people. *   **

*He sells Mitsubishi; who buys those?

** He's a piece of shit that is known to visit various Lakeway watering holes whilst hammered with various womenz with gross bolt ons, purple teeth and mediocre boltons- so prolly post in DT

You said Bolt ons twice…

Posted
Just now, Horn Under a Bad Sign said:


What if we can't wake you up because you're dead from the influenza outbreak? 

I guess we win the argument.

Congrats in that scenario I guess. But if that is the case it most likely will not be due to outside the range mismatch in strain selection. Delay in delivery to market is the bigger risk. But if they doing a shitty job of strain selection, that one really doesn't matter. And the strain selection has been the primary issue recently. 

Posted
10 hours ago, BrickHorn said:

Trumpism is hedonism for assholes.

Chapter 4 of U.S. history in the 21st century.

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Posted
6 minutes ago, Horn Under a Bad Sign said:


What if we can't wake you up because you're dead from the influenza outbreak? 

I guess we win the argument.

What if there isn't an outbreak and we still don't wake him up? Just act like we forgot or it was someone else's fault.

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Posted
Just now, Brisketexan said:

So, clearly, the best answer is just to stop developing flu vaccines

No one is suggesting this here. But it is wild that any rethinking of the process, one that has multiple redundancies and fails to meet the objective goals is automatically rejected. If you want to really wild, look at what offit has said about the covid vaccine strategy and the role the FDA and CDC played in mucking that shit up. 

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Posted

Cannot have a meeting AND discuss rethinking an approach. Nope, that must be absolute and entrusted to someone who is not an expert in infectious disease, production, distribution.

 

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Posted
8 hours ago, Willfully Horn said:

This ought to be mentioned.

image.thumb.png.a1c3c9e4e665812e9601ba1809cb9657.png

That shit ain't happening on a Friday at the end of the month when the working class gets paid.

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Posted
Just now, immamac said:

The flu vaccine failed? Fucking news to me. Are you completely braindead? 

Effectiveness rates range historically from like 20-60%. Last year was not very good, and varied depending on what outcomes you look at (secondary infection vs. hospitalization).  

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Posted
Just now, Anastasis said:

Effectiveness rates range historically from like 20-60%. Last year was not very good, and varied depending on what outcomes you look at (secondary infection vs. hospitalization).  

Yeah, that's pretty fucking good even when it's "bad". Stop trolling holy fucking shit. 

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Posted
3 minutes ago, immamac said:

Yeah, that's pretty fucking good even when it's "bad". Stop trolling holy fucking shit. 

Are you braindead? Get stoked over social media outrage over a redundant meeting getting cancelled. The strain selection process will proceed and flu vaccines will come to market. 

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Posted
But it is wild that any rethinking of the process, one that has multiple redundancies and fails to meet the objective goals is automatically rejected.

Classic red herring. The basis for concluding that is happening is…nothing.
If the meeting was repurposed to have that discussion, you might be on to something.
It wasn’t.
Because that’s not why the meeting was cancelled. And the thing you suggest…is not happening.
You’re cooking up excuses for this admin that even THE ADMIN isn’t cooking up.
“See guys, this is happening because Trump loves us SO MUCH, And he’s probably developing a super-flu vaccine all on his own, and the flu will go away forever!”
That’s a plausible an explanation as yours.
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Posted

We're just going to do this social media induced outrage over everything including the timing of strain selection for the flu vaccine. Man this is going to be exhausting. Hey look, if the delay in strain selection results in a meaningful delay in vaccine to market over prior years, I will come back and eat the crow.  

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Posted
2 minutes ago, Anastasis said:

We're just going to do this social media induced outrage over everything including the timing of strain selection for the flu vaccine. Man this is going to be exhausting. Hey look, if the delay in strain selection results in a meaningful delay in vaccine to market over prior years, I will come back and eat the crow.  

Maybe, Just maybe the concern is valid due to Mr Antivax brainworm being in charge?

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Posted
We're just going to do this social media induced outrage over everything including the timing of strain selection for the flu vaccine. Man this is going to be exhausting. Hey look, if the delay in strain selection results in a meaningful delay in vaccine to market over prior years, I will come back and eat the crow.  

Why did they cancel the meeting?
I mean, an actual reason, not the one you completely fabricated because you simply must, in every possible circumstance, stan for this admin. Give us that. Or fuck off and go simp for this admin somewhere else.
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Posted

It's not like delaying the selection of the strains for inclusion is a novel concept.  

https://academic.oup.com/jid/article/230/1/131/7455219

DISCUSSION

Our study investigated the potential benefit of revising the current selection and formulation schedule for the next generation of influenza vaccines. We systematically assessed past influenza vaccine decisions (2012–2020), identifying 2 seasons where antigenically drifted viruses emerged postdecision, with detectable activity before the season started.

The antigenic characteristics of new variants and the timing of when new variants emerged were highly variable in the past, emphasizing the challenges faced in improving vaccine effectiveness. For example, in February of 2014, WHO recommended no change to the influenza A(H3N2) vaccine strain for 2014–2015 season, based on the observation that a majority of A(H3N2) viruses detected in the surveillance system were antigenically similar to the 2013–2014 vaccine reference virus (A/Texas/50/2012) [38]. However, antigenically drifted viruses belonging to the 3C.2a subclade began appearing in May 2014 and accounted for >80% of A(H3N2) viruses detected in the influenza vaccine effectiveness network in 2013–2014 [38, 39]. Similarly, B/Victoria viruses in 2019–2020 showed increasing diversity with emergent viruses poorly inhibited by the recommended vaccine component. [40]. These 2 seasons exemplify the case where additional data collected after February could have informed the selection of a more antigenically similar vaccine virus and improved vaccine effectiveness.

Additional samples collected close to influenza season can improve vaccine effectiveness and consequently reduce the influenza burden. The epidemiological impact of a delayed vaccine selection and production schedule depends on many factors, including the degree to which vaccine effectiveness can improve when the vaccine and circulating viruses are antigenically similar and the relative frequency of the influenza subtype or lineage during the season. Our simulation showed that updating the A(H3N2) vaccine component of the 2014–2015 season in the Northern Hemisphere could have resulted in a substantial decrease in the number of hospitalizations in the US. However, updating the B/Victoria component of the in the 2019–2020 vaccine did not yield a similar benefit, even under the assumption of greatly improved vaccine effectiveness with an antigenically more similar vaccine virus. The discrepant benefit of updating the relevant vaccine component in these 2 seasons resulted in part from the fact that A(H3N2) accounted for 83% of influenza cases in 2014–2015 whereas B/Victoria accounted for only 36.5% of influenza cases in 2019–2020 [30–36]. These results highlight the importance of improving vaccine effectiveness, especially for the subtypes or lineages that are more likely to predominate in the season, such as A(H1N1)pdm09 and A(H3N2) that have predominated the historical influenza seasons [30–36].

WHO has twice postponed selection for A(H3N2) component by 1 month—once in 2003 and again in 2019—to enable review of additional information on emergent influenza viruses [41]. Non-egg-based vaccines, with their capacity for rapid production, potentially allow more time to assess emerging influenza viruses before selecting candidate vaccine viruses. On the other hand, the proposed timeline with delayed decision on vaccine strain entails the risk of delaying the supply and delivery of influenza vaccine. The influenza vaccine supply shortage due to license suspension of a major vaccine manufacturer in 2004, for instance, underscores the need for careful examination of risks and benefits of revising vaccine formulation schedules [42]. Even after the vaccine formulation recommendation is made and vaccines are produced, the remaining steps for regulatory approval by the US Food and Drug Administration and distribution can take an additional 3–4 weeks [43]. Potential delays in availability of influenza vaccine may result in missed opportunities for vaccination, resulting in reduced vaccine uptake. Hence, the benefits of delaying strain selection need to be balanced with providing adequate and timely influenza vaccine supply.

This study quantifies the modeled impact of delaying influenza vaccine selection but acknowledges several limitations. First, the transition away from the egg-based platform, as envisioned in our study, may take a significant amount of time due to the current heavy reliance on egg-based vaccines [18]. In addition, even if the influenza surveillance period were shifted to reduce the period between decision making and the subsequent season, updating vaccine formulation would only be possible if a suitable candidate vaccine virus (CVV) were available. WHO Collaborating Centers annually identify several potential CVVs grown in both eggs and qualified mammalian cell lines. Ideally, these potential CVVs or another virus from the same genetic group are raised in ferrets and tested in hemagglutination inhibition against circulating viruses and are also used in serological assays to assess whether antibodies induced by current vaccines inhibit growth of these viruses. These processes take time and require advanced identification of a new antigenically distinct group soon after it emerges, which may not be realistic. Second, our assumption that increased antigenic similarity between vaccine and circulating viruses leads to higher vaccine effectiveness does not consider factors such as vaccine type, age, or prior vaccination status, which can influence the degree of improvements [44–46]. We varied the relative vaccine effectiveness values in our analysis to address this limitation. Additionally, we studied 2 past influenza seasons where only 1 vaccine component could have potentially been updated, offsetting its benefit by increased circulation of the other subtype or lineage of which vaccine component was not changed. However, additional surveillance data are likely to improve all vaccine components. Last, our estimation of the impact of delaying vaccine decision making is specific to US influenza epidemics. Given the hemisphere-wide nature of vaccine decisions, considering substantial heterogeneity in predominant subtypes and lineages and in the predominant clades within each subtype or lineage is crucial for a comprehensive assessment [47].

As innovative influenza vaccines emerge with the potential for improving production speed and vaccine effectiveness, the current formulation, production, and regulatory process for seasonal influenza vaccines need to be carefully reassessed. Our study investigated the potential benefit of delaying vaccine formulation decisions to enable the use of more up-to-date surveillance data, which could be feasible with next-generation vaccines. Importantly, the additional time afforded by a later decision could increase the number of potential candidate vaccines available, which may enable selection of a better candidate. Our study concluded that revising the timeline for vaccine selection could result in substantial epidemiological benefits, particularly at times when additional data help improve the vaccine effectiveness through better antigenic match between vaccine and circulating viruses. However, the uncertainty in timing of antigenic variant emergence and the risk of delaying vaccine decision, along with the harm of transitioning away from egg-based vaccines, should be carefully examined.

Posted
It's not like delaying the selection of the strains for inclusion is a novel concept.  
https://academic.oup.com/jid/article/230/1/131/7455219
DISCUSSION
Our study investigated the potential benefit of revising the current selection and formulation schedule for the next generation of influenza vaccines. We systematically assessed past influenza vaccine decisions (2012–2020), identifying 2 seasons where antigenically drifted viruses emerged postdecision, with detectable activity before the season started.
The antigenic characteristics of new variants and the timing of when new variants emerged were highly variable in the past, emphasizing the challenges faced in improving vaccine effectiveness. For example, in February of 2014, WHO recommended no change to the influenza A(H3N2) vaccine strain for 2014–2015 season, based on the observation that a majority of A(H3N2) viruses detected in the surveillance system were antigenically similar to the 2013–2014 vaccine reference virus (A/Texas/50/2012) [38]. However, antigenically drifted viruses belonging to the 3C.2a subclade began appearing in May 2014 and accounted for >80% of A(H3N2) viruses detected in the influenza vaccine effectiveness network in 2013–2014 [38, 39]. Similarly, B/Victoria viruses in 2019–2020 showed increasing diversity with emergent viruses poorly inhibited by the recommended vaccine component. [40]. These 2 seasons exemplify the case where additional data collected after February could have informed the selection of a more antigenically similar vaccine virus and improved vaccine effectiveness.
Additional samples collected close to influenza season can improve vaccine effectiveness and consequently reduce the influenza burden. The epidemiological impact of a delayed vaccine selection and production schedule depends on many factors, including the degree to which vaccine effectiveness can improve when the vaccine and circulating viruses are antigenically similar and the relative frequency of the influenza subtype or lineage during the season. Our simulation showed that updating the A(H3N2) vaccine component of the 2014–2015 season in the Northern Hemisphere could have resulted in a substantial decrease in the number of hospitalizations in the US. However, updating the B/Victoria component of the in the 2019–2020 vaccine did not yield a similar benefit, even under the assumption of greatly improved vaccine effectiveness with an antigenically more similar vaccine virus. The discrepant benefit of updating the relevant vaccine component in these 2 seasons resulted in part from the fact that A(H3N2) accounted for 83% of influenza cases in 2014–2015 whereas B/Victoria accounted for only 36.5% of influenza cases in 2019–2020 [30–36]. These results highlight the importance of improving vaccine effectiveness, especially for the subtypes or lineages that are more likely to predominate in the season, such as A(H1N1)pdm09 and A(H3N2) that have predominated the historical influenza seasons [30–36].
WHO has twice postponed selection for A(H3N2) component by 1 month—once in 2003 and again in 2019—to enable review of additional information on emergent influenza viruses [41]. Non-egg-based vaccines, with their capacity for rapid production, potentially allow more time to assess emerging influenza viruses before selecting candidate vaccine viruses. On the other hand, the proposed timeline with delayed decision on vaccine strain entails the risk of delaying the supply and delivery of influenza vaccine. The influenza vaccine supply shortage due to license suspension of a major vaccine manufacturer in 2004, for instance, underscores the need for careful examination of risks and benefits of revising vaccine formulation schedules [42]. Even after the vaccine formulation recommendation is made and vaccines are produced, the remaining steps for regulatory approval by the US Food and Drug Administration and distribution can take an additional 3–4 weeks [43]. Potential delays in availability of influenza vaccine may result in missed opportunities for vaccination, resulting in reduced vaccine uptake. Hence, the benefits of delaying strain selection need to be balanced with providing adequate and timely influenza vaccine supply.
This study quantifies the modeled impact of delaying influenza vaccine selection but acknowledges several limitations. First, the transition away from the egg-based platform, as envisioned in our study, may take a significant amount of time due to the current heavy reliance on egg-based vaccines [18]. In addition, even if the influenza surveillance period were shifted to reduce the period between decision making and the subsequent season, updating vaccine formulation would only be possible if a suitable candidate vaccine virus (CVV) were available. WHO Collaborating Centers annually identify several potential CVVs grown in both eggs and qualified mammalian cell lines. Ideally, these potential CVVs or another virus from the same genetic group are raised in ferrets and tested in hemagglutination inhibition against circulating viruses and are also used in serological assays to assess whether antibodies induced by current vaccines inhibit growth of these viruses. These processes take time and require advanced identification of a new antigenically distinct group soon after it emerges, which may not be realistic. Second, our assumption that increased antigenic similarity between vaccine and circulating viruses leads to higher vaccine effectiveness does not consider factors such as vaccine type, age, or prior vaccination status, which can influence the degree of improvements [44–46]. We varied the relative vaccine effectiveness values in our analysis to address this limitation. Additionally, we studied 2 past influenza seasons where only 1 vaccine component could have potentially been updated, offsetting its benefit by increased circulation of the other subtype or lineage of which vaccine component was not changed. However, additional surveillance data are likely to improve all vaccine components. Last, our estimation of the impact of delaying vaccine decision making is specific to US influenza epidemics. Given the hemisphere-wide nature of vaccine decisions, considering substantial heterogeneity in predominant subtypes and lineages and in the predominant clades within each subtype or lineage is crucial for a comprehensive assessment [47].
As innovative influenza vaccines emerge with the potential for improving production speed and vaccine effectiveness, the current formulation, production, and regulatory process for seasonal influenza vaccines need to be carefully reassessed. Our study investigated the potential benefit of delaying vaccine formulation decisions to enable the use of more up-to-date surveillance data, which could be feasible with next-generation vaccines. Importantly, the additional time afforded by a later decision could increase the number of potential candidate vaccines available, which may enable selection of a better candidate. Our study concluded that revising the timeline for vaccine selection could result in substantial epidemiological benefits, particularly at times when additional data help improve the vaccine effectiveness through better antigenic match between vaccine and circulating viruses. However, the uncertainty in timing of antigenic variant emergence and the risk of delaying vaccine decision, along with the harm of transitioning away from egg-based vaccines, should be carefully examined.

Awesome.
I can post a recipe for an apple tart, or perhaps some Star Trek fan fiction. They would be equally relevant to this discussion.
There is no evidence that your lengthy copy and paste has ANYTHING to do with an antivaxxer dude with literal brain worms canceling a vaccine planning meeting.
You are just flailing to try to come up with an excuse for an admin you support more vigorously and consistently than the folks around here support Texas football.
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Posted
7 hours ago, Brisketexan said:

"You can and should absolutely discuss 'free markets' and 'personal liberties,' but anything that has even a whiff of 'but also maybe have reasonable restraints on those things in the public interest' is grounds for immediate termination."

Liberty to grab women by the pussy, and rape them?  Write me that editorial!  An opinion that maybe, just maybe, it's wrong to grab women by the pussy and rape them, and we should have and enforce laws against those things?  You're fired.

Bezos is evil, film at 11:00.

Today I’ve written the editorial team with our new posture: Jeff Bezos should get to do whatever he wants.  We will of course discuss other ideas, like how all of Jeff Bezos’ friends should also get to do what they want; and how Jeff Bezos and his friends should have all your money.  But the core of our writing will be to defend the simple idea that Jeff Bezos should get to do whatever he wants. 
 

I of course recognize the right to other opinions and stances.  However, they will not be printed here. Allowing them to be conflicts with other core value of Jeff Bezos doing whatever he wants. 

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Posted
2 hours ago, 956 Worldwide said:

It is good to see Anastasis in his bag fighting the “semi-anti-vaxxer” fight vice foreign policy and defense policy knower. Adcom? 

Yeah but look at all the attention he gets out of it. 

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Posted
6 hours ago, Anastasis said:

If you are unable to get a flu vaccine this september I will come back and eat the crow. 

Make it a bat and you're on

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