Early findings showing Pfizer vaccine is...

[cabmandone]

Well then, I'll give em a good dose of ghostly stink eye and haunt them! That'll teach em!

[pmax]

Originally Posted by red-beard

I feel fine...

They probably feel fine as well.

[Tobra]

Originally Posted by jyl

Put another way, I am not sure how herd immunity levels are calculated if vaccinated persons are still able to contract and transmit the virus to each other and to the unvaccinated.

If true, it seems that herd immunity does not really occur.

Originally Posted by MBAtarga

Any of you "experts" understand how Pfizer and Moderna vaccines are unique from the others? They are using a new technology - mRNA - which has never been used in vaccines. I've read of some experts that are concerned with it's approach. It actually changes every cell in the human body..

https://www.independent.co.uk/voices/coronavirus-vaccine-covid-19-cure-doctor-moderna-novavax-oxford-a9523091.html

Many vaccines, like for influenza a.k.a flu, use an inactivated virus that is destroyed by heat or chemicals like formaldehyde so that it can elicit an immune response without infecting you. Others — like for measles, mumps, and rubella — use a live attenuated virus that is cultivated in such a way that it makes the virus weak and unable to hurt you but still able to train your immune system to fight it. Moderna’s messenger RNA vaccine, on the other hand, is completely new and revolutionary to say the least. It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus. In this case, Moderna’s mRNA-1273 is programmed to make your cells produce the coronavirus’ infamous spike protein that gives the virus its crown-like appearance (“corona” is crown in Latin) for which it is named.

In many ways, the vaccine almost behaves like an RNA virus itself except that it hijacks your cells to produce the parts of the virus, like the spike protein, rather than the whole virus. Some messenger RNA vaccines are even self-amplifying. That means they encode not only the protein antigen of interest to elicit an immune response but also produce their own RNA dependent RNA polymerase, so that they can force the cell to replicate more copies of it. At that point, it will be hard to convince conspiracy theorists and anti-vaxxers that a self-amplifying messenger RNA vaccine is not an artificially created self-replicating virus. In fact, public acceptance of this new paradigm is not something to be easily dismissed nor taken for granted. There are unique and unknown risks to messenger RNA vaccines, including the possibility that they generate strong type I interferon responses that could lead to inflammation and autoimmune conditions.

An mRNA vaccine, with blanket immunity for the people producing it.

I am sure it will be just fine

[Mahler9th]

We'll see what happens, of course.

To me it is helpful to remember that the companies that are working on this globally are indeed companies. So there's that.

It is also helpful to remember that the Pandemic is global. And that things like Covax reinforce that: https://www.who.int/initiatives/act-accelerator/covax.

And that some of the companies are or may conduct Phase 3's in areas of the world where there is more virus around.

And that statistics are important, including patient demographics.

And that, for example if a company like Pfizer applies for EAU or approval and get it, their study work won't stop of course.

[DanielDudley]

Originally Posted by Tobra

If true, it seems that herd immunity does not really occur.


An mRNA vaccine, with blanket immunity for the people producing it.

I am sure it will be just fine

If you are saying you have trepidation about mass distribution without further testing, I would tend to agree. I am assuming you mean blanket immunity from liability of unforeseen side effects, but I'm not 100% sure I am interpreting your meaning correctly.

[red-beard]

Originally Posted by Neilk

I read that Pfizer didn’t take govt money and is not part of Warp Speed, so I guess they can hose us with the price.

Actually, they are part of Warp speed, according to their own website and posts

Here is Pfizer announcing they are part of "Warp Speed"

PFIZER AND BIONTECH ANNOUNCE AN AGREEMENT WITH U.S. GOVERNMENT FOR UP TO 600 MILLION DOSES OF MRNA-BASED VACCINE CANDIDATE AGAINST SARS-COV-2
July 22, 2020
U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).

https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-Announce-an-Agreement-with-U.S.-Government-for-up-to-600-Million-Doses-of-mRNA-based-Vaccine-Candidate-Against-SARS-CoV-2/default.aspx?linkId=94692381&fbclid=IwAR2hXEPQxyNsg-nuwQUSvwMcFyvv6NUJ_ixOFAbv2S3Z_Avy92U_-bqoffw


https://www.facebook.com/Pfizer/photos/a.390855402242/10158440104377243/?type=3

[pmax]

Originally Posted by cabmando

Well then, I'll give em a good dose of ghostly stink eye and haunt them! That'll teach em!

Well with 40K+ enrolled, a few deaths would be expected based on current numbers. None so far, I suppose or not reported.

The critical question to me is how many of those took the vaccine.

[Mahler9th]

I think the OWS deal with Pfizer may have been primarily focused on "manufacturing at risk" and not much, if at all on financially supporting development and safety and efficacy evaluation. That may be a subtle distinction for some. For most it likely does not matter.

Folks wanting to learn more can start on the HHS web site. Here is a quote:

"July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th."

Here is the web site:

https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

[jyl]

Originally Posted by pmax

The grievance would be a waste of time since these will be administered under a blanket immunity.

If (a big if) these 1st gen vaccines do NOT prevent asymptomatic infection and subsequent transmission but DO protect the vaccinated from serious disease with high efficacy (Pfizer CEO just reiterated in interview that efficacy is “over 90%” and hinted that he doesn’t mean 90.1%), then after everyone who wants to be vaccinated has been, is there a compelling reason to devote too much effort to persuade vaccine refusers to get vaccinated? Should we simply say “whatever, take your chances”?

Normally I think you really want, nay, need the great majority to be vaccinated, but this situation might be different (?).

[jyl]

Originally Posted by Mahler9th

I think the OWS deal with Pfizer may have been primarily focused on "manufacturing at risk" and not much, if at all on financially supporting development and safety and efficacy evaluation. That may be a subtle distinction for some. For most it likely does not matter.

Folks wanting to learn more can start on the HHS web site. Here is a quote:

"July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th."

Here is the web site:

https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

I think the deal was we pay if your vaccine is approved, otherwise you are SOL. Pfizer has spent nearly $2 billion on this without any significant govt reimbursement.

[jyl]

Originally Posted by Mahler9th

We'll see what happens, of course.

To me it is helpful to remember that the companies that are working on this globally are indeed companies. So there's that.

It is also helpful to remember that the Pandemic is global. And that things like Covax reinforce that: https://www.who.int/initiatives/act-accelerator/covax.

And that some of the companies are or may conduct Phase 3's in areas of the world where there is more virus around.

And that statistics are important, including patient demographics.

And that, for example if a company like Pfizer applies for EAU or approval and get it, their study work won't stop of course.

I think they are trying to figure out if upon EUA they are obligated to immediately unblind the trial and vaccination everyone who got placebo. It sounds like they would like to keep the blinding until they reach the final stopping point of 164 events. Which should be in a little over a month. I suppose it won’t be too hard to finesse the dates to get to 164 while making diligent preparations to vaccinate the placebo arm.

[Mahler9th]

"I think they are trying to figure out if upon EUA they are obligated to immediately unblind the trial and vaccination everyone who got placebo. It sounds like they would like to keep the blinding until they reach the final stopping point of 164 events. Which should be in a little over a month. I suppose it won’t be too hard to finesse the dates to get to 164 while making diligent preparations to vaccinate the placebo arm. "

Not sure... my hypothesis is that something like what you describe is already baked into plans. What I meant by continue is ongoing surveillance. Not well understood by public, but I am sure that you understand. So the Phase 3 might or would end is some customary way, but activities related to customary surveillance would commence and/or be continued.

My FDA experience is with devices and capital equipment (510k and PMA) not drugs.

Sorry for any confusion caused by my improper terminology.

I am not sure what happens to a company that gets OWS funds to manufacture at risk but whose vaccine fails go through. I wonder if that is in the financial disclosures of the companies. I suspect that you could not take a $1-2B order with contingencies and not disclose them. And I expect that there is a chain, for example a company with OWS funds for MFG at risk likely has other public companies like Emergent Biosolutions in the chain.

I suspect we'll learn more in coming months. And I suspect some of what we learn will be a bit complex.

[cabmandone]

Originally Posted by jyl

I think the deal was we pay if your vaccine is approved, otherwise you are SOL. Pfizer has spent nearly $2 billion on this without any significant govt reimbursement.

That's not what I have read. We're buying vaccines in the event they are effective and to minimize risk to the manufacturers. The taxpayer is essentially absorbing the risk for many of these companies from what I've seen. I don't care, my great, great grandchildren are on the hook, not me!

[Mahler9th]

"If (a big if) these 1st gen vaccines do NOT prevent asymptomatic infection and subsequent transmission but DO protect the vaccinated from serious disease with high efficacy (Pfizer CEO just reiterated in interview that efficacy is “over 90%” and hinted that he doesn’t mean 90.1%), then after everyone who wants to be vaccinated has been, is there a compelling reason to devote too much effort to persuade vaccine refusers to get vaccinated? Should we simply say “whatever, take your chances”?

Normally I think you really want, nay, need the great majority to be vaccinated, but this situation might be different (?). "

I think this might be formed into some excellent questions for Osterholm. I suspect he would give informed answers. His podcasts are usually on Thursdays. I have listened to some previous ones and found them quite informative. Previous podcasts are available on the CIDRAP web site.

[pmax]

Originally Posted by jyl

If (a big if) these 1st gen vaccines do NOT prevent asymptomatic infection and subsequent transmission but DO protect the vaccinated from serious disease with high efficacy (Pfizer CEO just reiterated in interview that efficacy is “over 90%” and hinted that he doesn’t mean 90.1%),

OK, hypothetical but let's roll with it anyway ...

then after everyone who wants to be vaccinated has been, is there a compelling reason to devote too much effort to persuade vaccine refusers to get vaccinated? Should we simply say “whatever, take your chances”?

Normally I think you really want, nay, need the great majority to be vaccinated, but this situation might be different (?).

given those assumptions are true, even 50% vaccinated should suffice, don't you agree ?