Pfizer starting another Vaccine trial

Re: Pfizer starting another Vaccine trial

David Weaver

Curious as to whether there's any data suggesting it's warranted.

Slightly off topic.... *LINK*

Mark Hennebury

I grew up in England in a town Called Folkestone, Pfizer had a facility there in 1952 and one in a nearby town called Sandwich. My mother worked at Pfizer in the 60's, they made perfume and flavorings where my mother worked. I seem to recall we got lots of samples of stuff like toothpaste with new flavors to try out. So we were the unpaid guinea pigs for lots of Pfizer products when we were kids.


2011 News story on the History of Pfizer

Re: Pfizer starting another Vaccine trial

Pete in Holland MI

Glad they're still pursuing their trials.

Yup.......the country's been in turmoil for over a year now. Tens of thousands have died. Yet......still.....question any attempt at a vaccine. "we are all guinnea pigs". A big company like Pfizer is not going to release anything into the market that could put them at risk of law suits. The federal government is also not going to release anything that knowingly puts every law maker at risk.

Have they been able to do a 10 year study? No. This virus was new. Are decision makers confident with their findings. Most likely. For the worry-warts who "heard bad things"......are you willing to wait 10 years, risking sickness or death, and keeping the country locked down during that time to have more confidence?

We got our shots as soon as we could a couple months ago. Never second guessed getting them.

Yes......some people feel sick after the second shot for a day or two. On the other hand, many friends that I know who got the virus, were down for 2-4 weeks. Can you afford to be out of work that long?

Get your shots people !

This is different...

David Weaver

..I got the pfizer vaccine as soon as it was available.

I like to watch data. For almost a year we've been hearing that antibodies disappear, but there's no data of reinfection of any significance (meaning that the folks who do test positive a second time are generally mild or more often caught due to regular testing routines and are asymptomatic - e.g., recent outbreak on the yankees where vaccinated and prior covid case individuals found out they tested positive only due to a test).

The scary stories in the news are "antibodies go away quickly", which doesn't mesh with the data (there's some info from Washington University med that the antibodies continue to be produced likely indefinitely, but at a lower level, and probably went undetected at that level...finally, something non-sensational).

We've been hearing from the beginning about the vaccine wearing off and needing a booster, but I wonder if there's any data showing that it's needed. I won't be getting a booster shot unless there is data that the 2 shot cohort fares considerably worse than a third shot cohort. It seems a little unusual to me that if we still have an active effective response that we'd do an end around on the immune system and barrage it with something it hates a third time. As in, introducing the vaccine the first time (and second) ensures a robust response.

But we're air dropping virus behind the lines and perhaps eliciting an increasingly yucky response for no good reason.

we are tracking all of this so closely (I still respond to the CDC app from time to time) that the chance of there being some kind of surprise outbreak is zero. There may be an outbreak, but it will be seen within days if it occurs.

Re: Pfizer starting another Vaccine trial

Wiley Horne

If the trial is big enough, it could shed light on how effective Pfizer is against the different variants. This would be in addition to whether a booster third shot is needed. So far, there have been various reports saying that Pfizer is proof against this or that variant.

This would be practical info if we were to have an outbreak this fall of a new variant.

Wiley

Pfizer data

Bill Tindall, E.Tn.

Pfizer continues to monitor us Trial participants weekly. If we get symptoms we will be tested. Pfizer can tell from blood what our antibody level is and what strain of virus we have been exposed to. A "booster" trial would most likely test efficacy to some newly formulated booster vaccine against any strain going around. Probably a simple goal, does a booster do any good.

Additionally Israel agreed to supply Pfizer data from the whole of the nation. Effectively there is a several million participant trial going on there. So far the data confirmed what was learned in the trial started last September.

Re: Pfizer starting another Vaccine trial

CJ in MPLS

The comparison that kind of floors me is that in the US, since World War I, there have been around 432000 combat deaths. We have had in the neighborhood of 594000 deaths from COVID in the US in the last two years.

A JAMA article from 2018 suggested that the death rate from infectious diseases in the US as of 2014 was about 34.10/100000 persons or about 102000 persons. This was down about 19% from 1980.

Kind of a big jump in the wrong direction with COVID.

I see this generally went unanswered...

David Weaver

..I am pfizer vaccinated.

I suspect no further vaccine may be necessary, but pfizer will be looking for any reason to provide a booster shot as the machine is in place to do it and generate revenue.

I've heard no data or updates re: prior covid cases or vaccine efficacy over the long term except some updates showing that we seem to have much longer lasting protection than initially thought (this again isn't difficult to figure out following the data. As in, much focus was made about the fading of antibodies in large quantities, but not much focus was given to the fact that almost nobody gets significant sickness twice unless there's a very good reason. Focusing on the antibody level instead of the actual outcome is predictable for media and officials, but it's misguided at best).

SARS COV-1 reactivity remains and is accurate after 20 years.

I've read a few articles in the last several weeks - one claiming that vaccination will not be long lasting, and that covid infection will not provide long lasting proection, but that infection with vaccine following recovery will likely provide long lasting protection, and possibly lifetime (low level antibody production in bone marrow not previously detected - no surprise).

I remain skeptical about the claim that mild or asymptomatic (or any - but mild

infection is described as providing more accurate long term response than severe) infection may not provide protection beyond 11 months without vaccination as again - we're beyond 12 months now for many cases, and where's the data on people getting moderate or worse reinfection?

Instead of vaccinated folks getting a booster, it would seem smarter for them to get a mild case of covid if such a thing would even happen. This wouldn't be very popular to study (if covid then vaccine is better than vaccine only, then why would more vaccine be better than covid after vaccine for folks who never had it?) because nobody can sell anything.

I'm baffled, though, when we're tracking individuals by their status and collecting constant data, why we wouldn't rely on outcomes. Some fraction of the cohort is being monitored constantly. Many months later, I still answer the CDC app about having had no symptoms of anything - I'm sure many do. This data would sound an alarm in combination with test data almost immediately. Put the outcomes in charge of further policy.

(that aside, if some group of pfizer vaccine recipients wants to continue to get poked, that's up to them. The idea that you're blasting something your body isn't fond of past a defense system that it's set up and that is active doesn't seem like a great idea to me without good reason to do it, though).

Re: I see this generally went unanswered...

Wiley Horne

Pfizer’s booster test is timely. Here’s why:

1. This Nation is about half-vaccinated at the moment.

2. The Delta variant is taking hold around the world, and the US is experiencing cases. So we have a natural experiment setting up for this fall, between the vaccinated and unvaccinated cohorts.

3. Pfizer’s program adds another cohort, creating 3 cohorts: the vaccinated, the unvaccinated, and the vaccinated/boosted.

The data should shed light on:

—If the unvaccinated fare well, then a lot of immunity has built up simply through exposure—the old-fashioned route to immunity, as Bill T. puts it.

—If the unvaccinated fare poorly, but the vaccinated do well, then the un-vaxxed folks have a decision to make.

—If the vaccinated get sick, but the vaccinated/boosted do not, then a booster is in fact needed.

—If the vaccinated and vaccinated/boosted both get sick, then the Delta variant needs its own shot developed.

Wiley….who hopes Pfizer does make money for its developmental work (I don’t own the stock]

The delta variant is here...

David Weaver

It's been here for a while and is creeping up on being 10% of the cases if it's not already.

We already have data about what two -shot pfizer and moderna do (which is how they were designed to work).

For folks who aren't vaccinated and haven't had covid yet (which is a shrinking cohort, but in some areas that are more remote, can still be large since covid isn't spread as easily with sparse population), well...

.... that's everyone else's choice, I guess. The data was pretty clear on the vaccines from the start, without significant side effects across the board for two shots.

I see this a little bit more cynically, but if the cohort is voluntary (of course it is), to me more data points good. I have less faith that what's going to be done with the data is that objective, though. There is a jellyfish supplement that is supposedly "proven" to work for memory. The way it's "proven" is to parse data until something that looks significant is found. If you change parameters enough and look through random data, you're going to be able to retrospectively find something usable for the purpose - something that likely wouldn't show up if you then did a randomized test for the same effect.

Remdesivir comes to mind, too - the super strong push to get that used despite no significance in results while pushing out other things.

In short, what do I think Pfizer will do? I think that even when there's no need, if they can find a tiny improvement in a boosted group (perhaps the boosted group is, let's say, 94% effective against delta while unboosted is 91%) and lobby hard to get that recommended. And perhaps some things that are worth reporting (Such as the initial myocarditis in younger individuals that was blown off and now isn't blown off quite as fast) won't be reported.

it would be lovely if on something ...

David Weaver

..this important, if the data could be collected and analyzed by a third party, and testing conducted by same.

Re: I see this generally went unanswered...

TomD

So if your interest is in comparing outcomes among vaccinated people and unvaccinated people, you may be interested in how the data is being stacked.

This is CDC policy

"As of May 1, 2021, CDC transitioned from monitoring all reported vaccine breakthrough cases to focus on identifying and investigating only hospitalized or fatal cases due to any cause. This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance."

They are also using a lower PCR cycle thresholds for people who are vaccinated which creates a significant difference in the detection rate in favour of the efficacy of vaccines.

A vaccine isn't any good if nobody takes it, but this is impacting the comparability of data if your interest in it is actually to guide your own medical decisions, rather than those of others.

https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

This video addresses the fact OSHA will not track cases where employer mandates to vaccinate lead to harm, which is presumably a rare outcome, but would be a subset of the official data. The interesting part is OSHA's reason for not doing it's job, and they are not shy about it. It is to reduce vaccine hesitancy. So the overall policy can certainly be justified, just so long as one understands what it is doing to data, or policy framework.

https://www.youtube.com/watch?v=QI8G8iodNms

Re: it would be lovely if on something ...

TomD

So if your interest is in comparing outcomes among vaccinated people and unvaccinated people, you may be interested in how the data is being stacked.

This is CDC policy

"As of May 1, 2021, CDC transitioned from monitoring all reported vaccine breakthrough cases to focus on identifying and investigating only hospitalized or fatal cases due to any cause. This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance."

They are also using a lower PCR cycle thresholds for people who are vaccinated which creates a significant difference in the detection rate in favour of the efficacy of vaccines.

A vaccine isn't any good if nobody takes it, but this is impacting the comparability of data if your interest in it is actually to guide your own medical decisions, rather than those of others.

https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

This video addresses that OSHA will not track cases where employer mandates to vaccinate lead to harm, which is presumably a rare outcome, but would be a subset of the official data. The interesting part is OSHA's reason for not doing it's job, and they are not shy about it. It is to reduce vaccine hesitancy. So the overall policy can certainly be justified, just so long as one understands what it is doing to data, or policy framework.

https://www.youtube.com/watch?v=QI8G8iodNms

Re: I see this generally went unanswered...

Bill Tindall, E.Tn.

I suspect no further vaccine may be necessary

It is pointless speculating. Pfizer aims to do a trail that will provide data for FDA to decide. I have every confidence that the decision will be entirely data driven and I will follow the recommendation.

Re: I see this generally went unanswered...

CJ in MPLS

The simple answer to your question was and remains 'yes, there is data'. I suspect, however, that wasn't your actual question as you did go on a bit. But I would ask that if you have an actual question about something as complicated as vaccination policy and are not simply interested in stating an opinion or soliciting a debate on said vaccination policies, you should be a bit more clear about the matter. Obviously we go off topic not infrequently, but this is a woodworking forum.

The current guidelines for vaccination can be found here: https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. You should be able to drill into the supporting data though subscriptions might be needed in some cases.

that data showing just under 900 deaths..

David Weaver

doesn't differentiate which vaccine, but I'm not sure it's necessary.

The definition is presence of covid in someone who is at least 2 weeks clear of their second shot.

Assuming 3 to 4 months of average time since vaccination (it's probably higher for the cohort that includes the deaths), I'd imagine that's about as good as zero for the average person.

That is, there are 900 deaths showing a positive covid result. If the vaccine efficacy is 95% and we expect about 250,000 deaths per month in the US, it would be diffcult to *not* have 100 or 200 have covid in a given month due to breakthrough, even if it's not particularly contributory to death.

....but even then, it very well may be given that cohort will include people who are deathly ill or who are on chemo, etc, who won't have proper immune response no matter what.

Personally, I find that data delightful. Not because of the deaths, but because of the lack of them. Life goes on here in my family (and extended family) due to pfizer and moderna. But I'm wary of recommendations of things that don't address the real issue (the rest of the world not being effectively vaccinated is what will keep this thing going).

The more specific comment about pfizer or moderna's trials is the bias that will exist in promoting a third shot even if there's no good reason to do it. The interpreter and miner of the data has interest in promoting use of the tested item. That's what I'd like to see handled by someone else - the conducting of the test, the management of the data and publication of results - as a one-off. If it were done symmetrically here for all trials, the labs doing the work would just be biased to a medicine favorability outcome in order to get the work, anyway, like a trial expert.

Naive..

David Weaver

..not to believe the results won't be data -related, but that the decision won't be biased, and the data that's not censored or truncated won't be biased.

That's not realistic.

My point isn't that there should be no booster. I speculated that it won't be needed - speculating isn't pointless. It creates a metric to test against. I made that speculation not based on nothing, but based on the reality is there is no significant data showing a decline in vaccine efficacy.

I'm not looking for a wide ranging recommendation of a third shot to get 2 points of extra effectiveness - or even 5. I'm looking to get something more significant than that.

Of course, we have a recommendation to use remdesivir for covid treatment, too, and statistical significance couldn't even be achieved. Prophylactic ivermectin use in poor countries appears to have efficacy of between 55-80%, but it's written off left and right. Is it something I champion? No, I got the vaccine instead - the data is better and I don't live in a poor country. But to pretend that we've just run off of the data for all of the recommendations so far as a pretty rosy view.

Re: I see this generally went unanswered...

David Weaver

My comment was in the trials for a third shot (in the hopes, let's be realistic, to generate revenue), where is the data showing that it's a good time to undertake a policy of giving a third shot?

It will take less than a week to see if a later variant breaks through. We're positing getting a third shot against what? Ineffectiveness of two? It doesn't exist. It would seem to be a whole lot smarter to wait until a booster would have benefit against something that the first two shots have become far less effective at preventing.

The CDC data that tom linked to is for January through June 28. There is almost a complete lack of breakthrough cases, even given the enormous cohort of compromised individuals. There's just no data there to suggest that a third shot is worthwhile.

I would imagine 95% or more of the cases (probably closer to 99%) of breakthrough don't originate from vaccinated individuals in the first place and the CDC data is incomplete with near certainty because it's mostly hospitalized patients (the number of asymptomatic cases is extremely low - there's probably a whole lot more breakthrough that's undetected or unreported, but the types of cases involved in that are low probability of spreading covid as they don't do much to launch droplets).

As the delta variant becomes more prevalent than 6-10%, we should see a small bump in total covid cases (including a small bump among the vaccinated - maybe, maybe not), but those would be related to transmissibility and not severity.

What's the lag time in learning of breakthrough? We know two different small clusters here - in both cases, symptoms appeared (all) between 2 and 4 days after exposure. The long possible tail didn't materialize. All of those individuals were unvaccinated.

(this all leads back to my original question - what data do we have that suggests that a third shot will be needed or useful? There isn't a need at this point, and it's not like one will creep up on us and surprise us).

Re: I see this generally went unanswered...

CJ in MPLS

David:

(this all leads back to my original question - what data do we have that suggests that a third shot will be needed or useful? There isn't a need at this point, and it's not like one will creep up on us and surprise us).

Your question has multiple premises, which is fine because you answered them yourself. Did you need to involve us in any of this?

CJ

David, seen what Auto-immune Disease does?

1 Keith Newton

After getting my second Phizer shot I was greatly relieved. However about two weeks ago I heard that those of us with rheumatoid arthritis, taking the usual meds are likely to only be ~40% protected. Or put another way, those meds we have to take to prevent our immune system from attack our joints, will likely prevent us from producing antigens to prevent COVID, so I’m right back where I was about this time last year in a state with only about 30% vaccinated.

And if that isn’t discouraging enough, I’ll add aneurysm, and lung issues to my problem, so if I catch COVID, I will probably throw the numbers off a little.

Re: Pfizer starting another Vaccine trial

Don Stephan

Across the objective news stories I have heard or read, lkthere seem to have been several common points. First, the manufacturers conduct trials that have very detailed guidelines that must be followed, and the collected data is carefully evaluated by independent experts that make recommendations to CDC and/or FDA; the manufacturer is not making recommendations, and some manufacturers' vaccines were rejected by the independent review experts. Second, vaccine trials typically last a number of years before final conclusions can be made on effectiveness, longevity, et cetera; vaccines in use may prove effective over years of study, but that is not yet knowable. Third, COVID had a horrendous impact on American health care, lives, economy, . . . and a re-occurrence could be equally bad; is it better to prepare for a possible re-occurrence that might or might not happen and possible ways to mitigate if it does happen? Fourth, the very nature of RNA virus replication is that natural mutations occur, and it is quite possible one or more mutations will not be mitigated well by the current vaccines and/or the average body's response to the vaccines. Fifth, it will take years before all of the countries have sufficient levels of the current vaccines for their citizens, so mutations will be arising for years. Sixth, every variant that occurs may reach every other country.

Sounds like we are perhaps at the end of the first inning of a nine inning game, to use a baseball analogy. Your views may differ.

Re: Pfizer starting another Vaccine trial

David Weaver

I agree. My original point was this is long term. If we have no need in the short term for a booster shot (but could very well if there is a resistant variant, and perhaps need such a thing fast), wouldn't it be wise to save it for that?

This started a couple of weeks ago..

David Weaver

...which is when my question came up. I answered them but am more than willing to find out that what I was supposing (no documented significant drop in vaccine efficacy, finding so far that vaccine plus actual covid is more effective than just vaccine in the long term, etc) is wrong.

the data that tom showed is very encouraging to me - the number of cases and deaths is so small (And the balance of cases that are mild or asymptomatic doesn't make sense meaning they're more likely to be minor enough so as not to be noticed and not actually missing) that the outcome thus far couldn't be better.

Early on, we were barraged with "we'll need a booster shot by summer or fall".

Why, based on what? Same as the "antibodies are short lasting, we will get sick again". Really? Where?

We all generally had more reaction to the second shot than the first. I have more concern about worsening reactions than of covid at this point given that there's almost no report of the mild, moderate and asymptomatic cases. That could change fast with a mutation that is resistant - that's something we'll know within days or a week, though.

This is kind of like throwing the cutter. We're pitching in a game. At some point, we may need the cutter to get out of a bases loaded jam. But if we show it to a hitter five times, we may not be in a great spot to use it.

I have the feeling that pfizer is doing this for pfizer at this point. Call me a cynic. If there are willing folks for the trial, then that's fine. If we get a biased recommendation without real need - then I'm not a fan.

There's been some dud information from the start of this when it comes to this bias, about how nobody will make profit on a vaccine and it's a thankless job. Pfizer will probably make about $3B to $4B profit on the vaccine, perhaps just outside of that one way or another (on a margin in the high 20s).

The "pshaw, the margins are low" discussion is all fine and good, but it doesn't hurt to be realistic about which way recommendations go when there's a billion a quarter to be made (x2).

Re: David, seen what Auto-immune Disease does?

David Weaver

I have asthma and mild arthritis (but nothing like RA). I guess asthma is some kind of immune disorder, but that's beside the point.

If there's an issue with folks with RA, the should be studied independently of a general cohort.