Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Monday, May 8, 2023

Pfizer's COVID-19 Vaccine - Projections for Future Sales

At Pfizer's Fourth Quarter 2022 Earnings Teleconference, the company provided the investing public with some interesting data on its sales and the projections for future sales.  In this posting, you'll see how important the COVID-19 pandemic has and will be to the company's past and future bottom line.

  

In the first slide of the presentation, the company brags about its 2022 results noting the following:

 

1.) it achieved historically high revenues, surpassing the $100 billion level (actually $100.330 billion, up from $81.288 billion in 2021 and $41.651 billion in 2020) for the first time in its 174-year history.

 

2.) it accelerated its research and development, maintaining "industry-leading clinical success rates and further improved cycle times".

 

This slide shows the key growth drivers for its fiscal year 2022 revenues:

 


Pfizer's pharmaceutical answers to the COVID-19 pandemic, Paxlovid and Comirnaty, are responsible for the lion's share of the company's revenues in 2022 with its other drugs coming in at far lower levels as shown on this table:

 


Here is a breakdown of revenues by nation as a percentage of total revenues showing the company's reliance on the American market:

 


The ill-health of Americans and the willingness of physicians to prescribe pharmaceuticals has been a very important part of Pfizer's business model.


Revenues from operations outside the U.S. of $57.9 billion accounted for 58% of the company's total revenues in 2022. Revenues exceeded $500 million in each of 24, 21 and 8 countries outside the U.S. in 2022, 2021 and 2020, respectively. The increase in the number of countries exceeding $500 million in revenues in 2022 and 2021 was primarily driven by Comirnaty as well as, in 2022, Paxlovid.

  

From this table, you can see that Pfizer is facing a significant number of patent expiries in the future and that both Comirnaty and Paxlovid will become increasingly important to the company's revenues, should the COVID-19 or a future coronavirus pandemic take place:

 

Given the importance of the COVID-19 pandemic to Pfizer's profitability and its share price, the company obviously has to project that the use of their pandemic-related products will continue to rise.  Here is a table showing the company's projections for long-term COVID-19 vaccination levels and resultant dosage sales for the United States:

 

 

Here is a slide showing the anticipated sale of Comirnaty doses in the United States out to 2026:

 

 

Of course, since Paxlovid makes up such an important part of Pfizer's product line, here is a slide showing the anticipated number of COVID-19 symptomatic infections globally (excluding China) and the resultant use of its "oral therapy":

 

 

Here is a slide showing the anticipated global sales (excluding China) of Paxlovid out to 2026:

 

 

Now, let's look at the bad news for Pfizer.  According to the company's 2023 guidance, revenues will drop by between 29 percent and 33 percent to between $67.0 billion and 71.0 billion.  Adjusted earnings per share will drop by 48 percent to 51 percent to $3.25 to $2.45 from $6.58 per share in 2022.  This should be of great concern to investors who are always looking for increased revenues and profitability.  What is of even more concern is the fact that Pfizer has become a "one trick pony" with a great deal of its present and future revenue and profitability being linked to its COVID-19 pandemic line of products.  Without those products, unless another pandemic plagues the world, Pfizer goes back to being a modestly profitable company that suffers from a product line that has led to significant legal issues, a partial listing of which is shown here:

 


Let’s close this posting with one final screen capture from Pfizer’s 2023 Proxy Statement which puts everything into perspective:

 

And that, my readers, is what it is ALL about.


Monday, April 3, 2023

Pfizer's COVID-19 Vaccine Biodistribution - Where is the Vaccine Going?

Throughout the vaccination phase of the COVID-19 pandemic, authorities have been assuring us that the  mRNA used in the vaccine products remain in the arm or, at most, travel to nearby draining lymph nodes.  Thanks to a Freedom of Information request made to Australia's Therapeutic Goods Administration (TGA), the nation's equivalent to the United States Food and Drug Administration, we now have proof of the biodistribution of the lipid nanoparticles which act as the delivery system and as protection for the vaccine's fragile active ingredient, the mRNA that stimulates cells to create the spike protein which results in an immune reaction.  I'm hoping that, in its infinite wisdom, Google doesn't decide to censor this posting given that the data contained within is sourced from a Western government document and Pfizer's own research, however, if there's anything that the past three years have taught me it's that we live in the post-truth era.

  

In case you aren't aware of the mechanism behind the COVID-19 mRNA vaccines, here is a video from John Hopkins Bloomberg School of Public Health explaining the process:

 


Lipid nanoparticles or LNPs are critical to the functioning of mRNA vaccines since mRNA is very fragile and has a very short life in the human body without the protection of lipids which act as a delivery system for the vaccine's active ingredient.


Here is one example of an expert, Dr. Bryn Boslett, an Associate Professor of Medicine at the University of California, San Francisco, weighing in on what happens to the vaccine when it is injected into a human body:  

 


Here's a "fact check" on the issue from Reuters which addresses the issue of vaccine-created spike proteins and their ability to travel throughout the human body:

 

 

Here is another example which, in the interest of keeping this posting to a reasonable length, you can read through on your own.

 

Now, let's look at the Therapeutic Goods Administration document dated January 2021 (i.e. just after the initial rollout of the Pfizer COVID-19 vaccine (Comirnaty) in Australia) keeping in mind that this document contains the data that the TGA used to approve the vaccine for use and that the data was provided by Pfizer and was peer-reviewed:

 


For the purposes of this study, we're going to focus on the biodistribution aspect of the vaccines from data supplied by Pfizer.  To track the vaccine, Pfizer's researchers injected a radioactive lipid marker into 63 Wistar Han rats which was used to track the progress of the lipid nanoparticles containing the mRNA throughout the rats' bodies as quoted here:

 

"The distribution of lipid nanoparticles (containing ALC-0315 and ALC-0159) encapsulating mRNA encoding luciferase, was investigated by monitoring of a radiolabelled (3H-) lipid-marker after IM administration to Wistar rats."

 

The lipid nanoparticle formulation size and composition (relative to mRNA concentration) and encapsulation efficiency was similar to the LNP used in Pfizer's Comirnaty vaccine.  In total, 42 of the rats were injected with a target dose of 50 micrograms of mRNA per animal and 21 were injected with 100 micrograms of mRNA per animal.  Total radioactivity was measured by liquid scintillation counting of blood, plasma and tissue samples collected at 15 minutes, 1, 2, 4, 8, 24 and 48 hours after dosage was administered.  Keep in mind that the study ended after 48 hours so we have no idea what the long-term distribution of lipid nanoparticles looked like.

  

Here is a table showing the widespread distribution and concentrations of the lipid nanoparticles (and, by extension, the mRNA) of the "vaccine that would stay in your arm" with my highlights showing some of the highest concentrations:

 

Here's what Pfizer saw:

 

"Mean total radioactivity was greatest at the injection site followed by the liver with much lower total recovery in spleen, adrenal glands and ovaries (Table 4-2). The total radioactivity recovery was less than 100% at all time-points (range = 20 – 60%) probably due to difficulty in collecting entirety of injection site samples and the presence of radioactivity in the carcass, faeces and urine, which were not analysed.

 

The tissue distribution pattern was similar in 100 μg mRNA/animal dose group as noted above for 50 μg mRNA/animal dose, with highest distribution into liver, adrenal glands and spleen.

 

Draining lymph nodes to the site of injection should have been collected and analysed for radioactivity, given the increased size of draining lymph nodes seen in other nonclinical studies after dosing."

 

This begs the question - why weren't the draining lymph nodes at the site of injection collected and analyzed?

 

Here are the conclusions of the biodistribution study according to Pfizer's researchers:

 

1.) Slow but significant distribution of lipid nanoparticles from the site of injection with major uptake into liver.

 

2.) Minor distribution in spleen, adrenal glands and ovaries over 48 h.

 

3.) Mean blood:plasma ratios of 0.5-0.6 indicating nanoparticles mainly present in plasma fraction of blood with peak concentrations in plasma at approx. 2 h post-dose.

 

As I mentioned above, the study ended with the sacrificing of all animals in the trial after 48 hours; what is important is that the concentration of lipid nanoparticles was still rising in the majority of the samples/organs so we have no idea when the peak would have occurred or what the peak level would have been.


Just in case you were curious, here is a study by Katharine Roltgen et al which shows that the vaccine mRNA and spike antigen remain in the germinal centers (in the lymph nodes) for up to 8 weeks after vaccination:


 

It is quite apparent that Pfizer's COVID-19 vaccine does not remain at or near the injection site or, at most, travel to the nearby draining lymph nodes.  It is distributed throughout the human body, unlike what we have been told by "the experts".  What is of greatest concern are the higher levels of concentration in the liver, ovaries, spleen, adrenal glands (hormone producing glands that control heart rate, response to stressors, blood flow and metabolism) and bone marrow (produces white and red blood cells).  We don't know or aren't yet privy to the information regarding the impact of multiple COVID-19 vaccinations on the human body and given the short 48 hour timeframe of the biodistribution study released by the TGA, we can't be certain of the medium- and long-term impact of the vaccines on human health.  What is particularly galling is that this information was available to regulators and yet, they approved Pfizer's vaccine.


Thursday, January 26, 2023

Pfizer and Directed Evolution of COVID Viruses - Why Are We Trusting Big Pharma?

Thanks to the journalists at Project Veritas we have a fascinating confessional from Dr. Jordon Trishton Walker, Pfizer's Director of Research and Development - Strategic Operations and mRNA Scientific Planning

  

As background and thanks to Brian O'Shea, here is some information on Dr. Walker:

  

1.) New York State licence:

 


2.) Profile on Doximity:

 

 

3.) UT Southwestern Medical Center Match Day 2018 webpage:

 

 

4.) University of Texas Southwestern Medical School Class of 2018 Academic Hooding Ceremony (found under Cary College/Andrian Salazar, M.D.:

 


 

5.) U.S. News Health website:

 


 

6.) C.V. noting the following:


Director, Worldwide R&D Strategic Operations and mRNA Scientific Planning (Pfizer, Oct 2019 - Present) 


 

7.) Apollo:




Here's the video from Project Veritas which has been Archived for posterity:

 


Let's look at some quotes:

 

PV - Pfizer ultimately is thinking about mutating COVID?

 

JTW - Well that's not what we say to the public. No.  We're exploring like you know, how the virus keeps mutating. Well, one of the things we're exploring is like, why don't we just mutate it ourselves so we could, we could create preemptively develop mew vaccines, right?  So, we have to do that.  If we're gonna do that though, there's a risk of like, as you could imagine, no one wants to be having a pharma company mutating fucking viruses.  You have to be very controlled to make sure that this virus that you mutate doesn't create something like, you know, goes everywhere."

 

PV - It sounds like Gain-of-Function to me.

 

JTW - I don't know, it's' a little bit different.  I think it's different. It's like this, it's definitely not Gain-of-Function.

 

PV - It sounds like it is, I mean, it's okay.

 

JTW - No, no, no.  But directed evolution is very different.  Well, you're not supposed to do Gain-of-Function research with the viruses.  They'd rather we not but we do these selected structure mutations to try to see if we can make them more potent.  So there is research ongoing about that.


A distinction without a difference.

 

At the 6 minute and 17 second mark, we find this exchange:


PV - What's the goal for Pfizer doing that (COVID mutations)?


JTW - So, part of what they want to do is try to figure out, to some extent, try to figure out like you know how there's all these new strains and variants that just pop up?   Why don't we try to like catch they before they pop up in nature and we can develop a vaccine prophylactically  before like new variants...so that if it comes out later on, in the public, then you already have a vaccine kind of working.  


PV - Oh my God, that's perfect.  Isn't that the best business model though?  Just control nature before nature even happens itself, right?


JTW - Who knows?  I mean either way it's going to be a cash cow.  COVID will probably be a cash cow for us for a while going forward."


Here is a link to the entire story from Project Veritas.

  

And to think that the vast majority of us trusted Big Pharma with its unprecedented and experimental response to the COVID-19 pandemic?


Addendum:


Here is a tweet from Project Veritas' Twitter account with a video that shows a followup to the video that was posted in the first part of this posting:



Here is the video since Twitter's embedding code seems to not be working properly for me:





Here is the link to an archived version of the video.

And, here is an article co-authored by Jordon Walker entitled "The Near-Term Outlook for COVID-19 Therapeutic Treatments" from May 2020 showing that he is familiar with COVID-19 therapeutics:

Addendum 2:

Here is Pfizer's rather weak response which appeared nearly 48 hours after the "allegations" were made, noting that they say nothing about their employee (or former employee) Dr. Walker but plenty about their COVID-19 product line:


Trust us, we'd never lie to you.

Wednesday, July 6, 2022

Pfizer's Comirnaty and the Great Unknowns

On its COVID-Vaccine website, the Canadian government recently posted an updated product monograph dated June 1, 2022 for Comirnaty, the Pfizer-BioNTech mRNA COVID-19 vaccine that has been heavily promoted by the Canadian government and provincial public health officials:

 

Let's look at some of the interesting sections/subsections, keeping in mind that Canadians have been repeatedly assured that the vaccine is perfectly safe for virtually everyone:

  

1.) Pregnant Women:

 

2.) Breastfeeding:

 


Here is what the Canadian government has to say about COVID-19 vaccination, pregnancy and breastfeeding:

 

Apparently, Health Canada knows more about Comirnaty's safety than the manufacturer knows about its own product!

 

3.) Drug Interactions:

 


The fine folks at the Mayo Clinic have some ideas on drug interactions with COVID-19 vaccines:

 

 

...as do those at the Cleveland Clinic:

 


...this research that appears on the NIH website:

 


...and even the physicians in Manitoba, Canada offer conflicting/confusing advice on potential drug interactions:

 


4.) Genotoxicity: defined as the ability of a chemical compound to cause alterations at the genetic level



5.) 
Carcinogenicity:



How on earth does Pfizer know that both genotoxicity and carcinogenicity are not "relevant to this vaccine" if the drug has been administered for less than two years?


Pfizer has had over two years to fully understand the possible contraindications of its COVID-19 vaccine and since December 14, 2020 when the first Canadian received the vaccine to explore four of the key variables that could impact post-vaccination patient health.  But then again, as Canada's high school drama teacher and current Prime Minister Justin Trudeau said back in May 2021:

 

"Make sure you get your shot when it's your turn. We are continuing to recommend to everyone to get vaccinated as quickly as possible so we can get through this…



...because he knows all about vaccine "syense".


Tuesday, January 11, 2022

Albert Bourla and the Vaccine Solution to Omicron

A recent interview with Pfizer CEO Albert Bourla on CNBC is quite eye-opening particularly given the very rapid growth in the number of COVID-19 cases around the world, particularly among the vaccinated.  

 

Here is the interview with Meg Tirrell:

 


Here is a partial transcript of the interview with my bolds:

 

MT - "What is your expectation in terms of whether we're going to see an update to that vaccine that we just spoke of with Stephane Buncell from Moderna in the last hour who suggested, really the focus is on the fall for figuring out the right strains for them but, of course, we're already seeing Israel giving fourth booster doses so what do you think the future holds in terms of when we'll be getting the next boosters and what those boosters are going to contain?"

 

AB - "I wouldn't say that the future is clearly predictable right now but what it think it is that we are doing everything we can so that we can stay ahead of the virus and let me start with I don't know if there is a need for a fourth booster, that's something that needs to be tested and I know that Israel already started some of these experiments and we will conduct also some of these experiments to make sure that if needed we use it.  I don't think we should do anything that is not needed.  Also, we are working on a new version of our vaccine, a version that will be effective against Omicron as well that will not be effective against the other variants but against Omicron as well.  The hope is that we will achieve something that will have way, way better particularly against infections because the protection against the hospitalizations and the severe diseases it is....reasonable right now with the current vaccines as you are having, let's say, the third dose.  This vaccine will be ready in March.  I don't know if we will need it.  I don't know if and how it will be used but will be ready, in fact, we already starting manufacturing some of these quantities of  threes so if there is a need for that vaccine that we will have some immediately because there are a lot of governors that would like to see it immediately.  And clearly...this is where most of the efforts of most of the governments is moving."

 

I found it interesting that he claimed that Pfizer's COVID-19 vaccine provides "reasonable protection" once you have the third dose.  You can be certain of one thing; if the head of Pfizer is saying that the company's COVID-19 vaccine provides "reasonable protection", he is putting lipstick on a pig.  It is, in all likelihood, far, far worse than that as studies and real world data are starting to show.  Don't forget that this is coming from a company that claimed that their product was 95 percent effective when it was first approved.  And, just as we all suspected, Israel is ground zero for Pfizer's experiment with its COVID-19 vaccine.  His comments on the timing of Pfizer's new Omicron-specific "concoction" are also interesting given that governments around the world are heavily promoting a booster with the same old vaccine formulation that has, by Bourla's own admission, provided only "reasonable" protection.

 

Here's a graphic from the United Kingdom's Health Security Agency dated December 31, 2021 showing the vaccine effectiveness against both the Delta and Omicron variants plotted against time in weeks since being fully vaccinated with three doses of Pfizer's BNT162b2 and Moderna's mRNA-1273:

 

 

I would think that a vaccine effectiveness of only 60 percent for 2 doses of Pfizer's vaccine for the Delta variant at 25 weeks or more and a vaccine effectiveness of only 50 percent against Omicron at 10 weeks or more can hardly be termed "reasonable".  But, then again, my expectations might be too high.

 

After a discussion about the company's new Paxlovid antiviral product, he also weighs in on the so-called "antivaxxers" when asked whether breakthrough cases of Omicron are going to have an impact over the longer term for boosters.

  

"I think this is a real risk because, you know, there is always the element of people who could get tired but I believe that this situation has unfortunately not fortunate but unfortunately a form to camps to different mindsets.  There is a mindset that they are very fanatic that they are don't want vaccine and there's a mindset of other people they want maximum protections I believe in the element of in this segment of the people that they do believe in the value of the vaccine the people that they want maximum protection I think they will follow at large the instructions of the healthcare authorities and their physician.  The other camp which is the ones that they are very skeptical I think they will remain skeptical and for the, I think unfortunately the solution only will be the pill if they get diseased.  And then there is in between which is the the number of people which is smaller this segment that it can go one way or another and this is where education needs to happen."


If its maximum protection that people are looking for they will be sadly disappointed in the degree of protection that the mRNA vaccines are providing.  In addition, according to Bourla, the relatively small minority of people that are skeptical about Pfizer's rushed-to-market COVID-19 vaccine will have only Pfizer's rushed-to-market COVID-19 antiviral pill to protect them from certain death.  Interesting, this drug is also touted to have a risk reduction for hospitalization and death of 89 percent, only slightly less than its "highly successful" BNT162b2 vaccine as shown here:

 

 

If you trust these numbers in light of Bourla's recent comments, I don't know how to help you.  As well and just in case you were curious, the Phase 2/3 trial for PAXLOVID used 1219 adults who were enrolled by September 29, 2021 and yet, despite the very short trial of less than three months, the FDA granted the company an Emergency Use Authorization for PAXLOVID on December 22, 2021.