Concise Summary of the Pfizer Phase III Data a... - CLL Support

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Concise Summary of the Pfizer Phase III Data and an Update on Eligibility (USA Patients)

cujoe profile image
9 Replies

Here is a link to an excellent, concise summary of Pfizer's Phase III data for their COVID-19 vaccine. At the end it also provides links to the complete FDA and Pfizer documents for those who want more detail.

The second link is to a 12 December update on eligibility by the same author. Please note the following statement from that update:

IMMUNOCOMRPOMISED PERSONS

Can get the vaccine but must have a conversation with their healthcare provider first. They need to be well-informed about the unknowns and tradeoffs.

Phase III data

yourlocalepidemiologist.com...

Eligibility for Pfizer Vaccine

yourlocalepidemiologist.com...

Be Safe/Stay Well - K9

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cujoe profile image
cujoe
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cajunjeff profile image
cajunjeff

IMMUNOCOMRPOMISED PERSONS

Can get the vaccine but must have a conversation with their healthcare provider first. They need to be well-informed about the unknowns and tradeoffs.

My translation of the above is as follows. The vaccine was not tested on immunocompromised people so there is no data to definitively say it’s safe or it works in that population. That said, based on our knowledge of how vaccines work in general and based on the data from the Pfizer trials, we have no reason to believe the vaccine is not safe. Everyone should discuss with their doctor if the vaccine is appropriate for them.

Whether it works for us is a separate question. The fact it worked so well with elderly people in trials is very encouraging to me.

And I think the timing is good with healthcare workers getting vaccinated first. By the time it is available for most of us, millions will have taken it and we can see if any unknown side effects pop up.

Each state in the US will decide the order in which we get vaccines. I think it will be something along the lines of frontline healthcare workers first, then people in nursing homes, and then vulnerable people like us or perhaps us right after people in key service jobs and teachers.

I think that might work out to late January or February for some of us depending on where we live.

cujoe profile image
cujoe in reply to cajunjeff

Jeff, Thanks for your insights.

Brian Koffman reported on the fireside chat session that opened the recent ASH conference at CLL Society. That chat was between Dr. Fauci and the current ASH President and Dr. Koffman summed it up as follows:

**************************************************************

ASH officially started early Saturday Dec. 5th with a fireside chat between ASH president, Dr. Stephanie Lee and Dr. Anthony Fauci the director of the NIH’s NIAID (National Institute of Allergy and Infectious Diseases) since 1984.

Dr. Fauci have been at NIAID since the beginning of the HIV crisis, and during that time, nothing has come close to the challenge of the present COVID-19 pandemic.

He shares his recommendation that immunosuppressed patients with blood cancers, like us, get the vaccine, because some immunity is better than none. He is confident that we can crush COVID-19, but it won’t be quick, and it will require getting billions of doses of the vaccine to everyone, all around the world. (emphasis added here.)

******************************************************************

And then there is this strange prolonged COVID infection of a CLL patient for us to ponder while we wait for better information:

Case Study: Prolonged Infectious SARS-CoV-2 Shedding from an Asymptomatic Immunocompromised Individual with Cancer

cell.com/cell/fulltext/S009...

Strange, Indeed.

Stay Safe - K9

Psmithuk profile image
Psmithuk in reply to cujoe

Thank you, plenty of reading matter, and some information. Is it about time someone started looking into the 'known unknowns' and perhaps the 'unknown unknowns.....'?

BluMts profile image
BluMts in reply to cujoe

Thank you for the link. Wow! So much unknown.

Jonquiljo profile image
Jonquiljo

As far as vaccinating immune compromised, I suspect all vaccines will have similar results on any one person. It will matter as to the extent and nature of immunocompromisation. Perhaps we will be best with 3 shots. But either we can mount an immune response or not - or something in between. I would expect that most CLL patients will do fine with these high efficiency vaccines.

I personally think the side effects (whatever they may be) will be worth it. COVID is not something an older person wants to get - CLL or not.

In the US, anyway, we will have a ling time to talk about it. What hasn’t been stated in the media is that the US has actually purchased very little of the Pfizer vaccine — enough initially to vaccinate 50 million people — with no more doses coming until Q3 2021. The US is trying to get the 2nd date moved to Q2 2021 — but I won’t hold my breath. Q3 2021 is July through September.

If the Moderna vaccine is approved, and it should be — it too will be slow in coming. They are a small company that has limited production capacity — for a country the size of the US. Our government didn’t pay them the kind of money they’d need to substantially scale up fast. So Moderna will likely be a slow output as well. What I have read is that we MAY have enough doses by the Summer of 2021 to have vaccinated 1/3 of the county. The time line when immunocompromised patients will bein the queue is still up for discussion.

AstraZeneca’s vaccine will be likely a nightmare to approve. At 70% efficiency, this is not really What most people would want. I certainly wouldn’t! So most vaccine hopes are in Johnson and Johnson and Novavax, who haven't finished their trials yet.

The bottom line is that I bet Europe will be vaccinated far faster than we will. Many other places will be also. So ... its masks and distancing likely until next fall. Right now we are well over 3000 deaths a day. Truly disappointing!

Sorry to be the bearer of not so exciting news - but we need to know — plan to wear masks and socially distance for quite a while yet.

cujoe profile image
cujoe in reply to Jonquiljo

With individual states determining who gets what vaccine and when they will get it, we will all be sitting on the sidelines watching as things unfold. My cynical side says what we are being told is overly optimistic about how the vaccine rollout will go. But, hey, I could be wrong.

Equally important, just when you think you can see the light at the end of the tunnel . . . the tunnel keeps getting longer:

who.int/csr/don/03-december...

reuters.com/article/health-...

In he immortal words of the the famous wordsmith, Yogi Berra, "It ain't over 'till it's over."

BS/SW - K9

Jonquiljo profile image
Jonquiljo in reply to cujoe

We are being told the overly optimistic story. How can you tell people that we didn't prepare correctly. The USA had repeated offers by Pfizer to buy 500M doses early on. Those offers were declined. What - for an extra $10B? Trade that for how many extra deaths? Considering total government pandemic related spending is north of $4T, this is a small sum to pay.

But this is what you get when bureaucrats and politicians are making the decisions. It's to be expected - unfortunately.

On the other hand, I don't think a Coronavirus mutation will affect things much. It could mutate to be less ineffective and easier for a vaccine to neutralize. You never know.

But the real story is that the US has maybe 100M doses max for the first few months. That's for 50M people (two doses per person). We have 330M people. Bad math considering we have lots invested in vaccines that have yet to finish their trials in Q1. And that is a good scenario!

Belfastbees profile image
Belfastbees in reply to Jonquiljo

I'm not sure your efficacy figure for the oxford/AZ vaccine is correct. It was found that this figure rose to 90% when the first dose was reduced. I think that is the vaccine which will make more difference to humanity. AZ have said they won't generate profit from it whilst the pandemic is ongoing and its 1/6 the price of the pfeizer vaccine. It also does not need to be frozen for storage or transport. These 2 factors make this the vaccine sure to travel the world and be taken up by poorer nations with remote communities.

Jonquiljo profile image
Jonquiljo in reply to Belfastbees

Perhaps. But I highly doubt that the US FDA will even approve it without a re-do of their trial. The "reduction" in the first dose was a mistake on the part of AZ. It's really hard to take what is supposedly scientific data when it is the result of a mistake. It just makes you wonder what other mistakes occurred.

Thinking about it, to get a good portion of the first doses wrong is not good. It may have been lucky that this produced a better result -- but AZ does not know why they had a better result. They had no rationale for doing so - it just happened by mistake. It's just a bad way to test a vaccine and when AZ figured out they had a problem with the dosing, they should have started over again.

It's unfortunate, but needs to be rectified. There are a couple of good vaccines due to end trials in Q1 - and they may work out better. Of course the Pfizer vaccine will not be appropriate for poorer and more rural countries. Storing it at -70 deg C is a difficult task.

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