Wikileaks~US Military Equipment In Afghanistan (2007): INDEX

US Military Equipment In Afghanistan (2007): INDEX

Index of Military Units

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Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call

Simply, we’re just not the same company we were a few short years ago. We went from delivering $40-plus billion in revenue to one that is expected to reach between $99 billion to $102 billion. Those are the figures that we’ve given you at Q3 earnings. So that’s kind of more than doubling our revenue in 2 short years. I’m

EVENT DATE/TIME: DECEMBER 12, 2022 / 6:00PM GMT

Before we get started, I know people have been asking about WiFi connectivity. So I’m just going to read the network name to you. It’s called Investor Day Guest, 3 separate words. You’ll find that if you look for the WiFi network and the password is 12, 1-2; December, D-E-C 2-0-2-2. So 12DEC2022. So today’s date in other words, hopefully, that’s simple.
All right. So thank you all for coming. I need to make my favorite part of the day, the forward-looking statements. So today, we are going to make some forward-looking statements. These statements are valid only as of today, and we undertake no obligation to update them in the future. And if you have questions about our forward-looking statements, you can see our SEC Forms 10-Q and 10-K, the latest ones for more information, specifically under the section entitled Risk Factors and information about forward-looking statements.
All right. All the material for today — well, most of the material for today is posted already on the IR section of our website under Events and Presentations. And at the end of the day, we will post updated materials, which include an appendix and other material right at the end. And in addition, there will be some posters and other things. that you can access on that portion of our website as well under the event.
Okay. The focus of the day is going to be what we’ve been talking about very recently, these 19 high-impact launches in the near term. So we ask you to focus on the launches and the next wave of pipeline behind them. So any questions not on that, we’re happy to handle that offline with the IR team or in another setting, but we want to keep the questions as much as possible, tightly focused on the agenda for today.
In terms of logistics, there are going to be 2 main sessions, 1 session now, and then we’re going to have a brief break, and then there’s going to be a second section, which is going to be followed by a Q&A, and then we’ll come back for closing remarks and then a reception.
And just to remind you, when it’s about time for the Q&A section to start, only then do we ask that you queue up on these 2 mics that are here on line, 1 on the right of the stage, 1 on the left of the stage. In addition, for those of you who are viewing us online, thank you for viewing us remotely, and there’s a section towards the bottom of your screen where you’ll be able to ask questions that we’ll be able to respond to.
And again, if there’s any questions any of you have that we’re not able to answer today, we can take them offline and answer them later. Okay. So I guess that is it. Now we have our first session, which is going to be hosted by my colleague, Angela Hwang. And then our second session will be hosted by Andy Schmeltz, my other colleague from c\Commercial Strategy and Innovation. And then we will have a closing from Dave Denton, and then we will have a reception after that, as I said, on site here.
And now I would like to invite my colleague, Angela Hwang to come up to the stage. Angela, as you know, is our Chief Commercial Officer and our President of Pfizer’s Biopharmaceutical Business. Angela? Please.
Angela Hwang – Pfizer Inc. – Chief Commercial Officer & President of Global Biopharmaceuticals Business
Thank you, Chris, and hi, everyone. It is great to be here. I am super proud to be in front of all of you and to help set the stage for our first in-person
Investor Day since before the pandemic. So you can imagine how excited we are to be here.
There’s great energy in the room. I’m hoping you guys will ask all the questions that you have on your mind because we plan to be here today to show how confident we are in our pipeline, in our business and particularly the launches that are coming up.
As Chris mentioned, our goal is for all of you to walk away with strong confidence in Pfizer’s growth story and specifically to understand our near-term launches and select pipeline products. But before handing it over to our leaders, and you’re going to hear from all of our business leaders today, what I wanted to do was to share some perspectives around why we believe we are truly in the most unique and exciting time in Pfizer’s history.
Simply, we’re just not the same company we were a few short years ago. We went from delivering $40-plus billion in revenue to one that is expected to reach between $99 billion to $102 billion. Those are the figures that we’ve given you at Q3 earnings. So that’s kind of more than doubling our revenue in 2 short years.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
Of course, this is a direct result of the remarkable innovations in our COVID franchise, but this level of revenue growth is unprecedented and would be absolutely a first in the pharmaceutical industry. Applying the lessons that we have learned from both COMIRNATY and PAXLOVID, we are now pushing ourselves to reimagine our traditional ways of working so that we can move at maximum speed but also efficiency across our entire portfolio. We want to bring these breakthroughs. This is what we call our Lightspeed behaviors.
And we do this, of course, while still operating under the highest integrity and the highest scientific standards. Reputationally, we’re seeing tremendous gains. As you all know, Pfizer has become a household name. The powerful brand equity that we have built over the last 170 years has now been further enhanced over the past 2 years.
And according to a recent survey, our brand awareness now stands at an impressive 82% and the latest round of reputation polling shows that 61% of the general population views Pfizer favorably, and that is compared to 42% for the industry as a whole. And this represents a significant 3-point increase since June.
Following the industry-wide declines and the economic pessimism that we saw this year related to factors such as the conflict in Ukraine, high energy costs, lessened consumer confidence across all sectors of industries.
Now if you go back to January 2020, only 28% of the general population viewed Pfizer favorably then. So of course, we’re so encouraged that we’ve been able to sustain our reputation gains. We are also steeped in our customer transformation through the evolution of our go-to-market model.
And this is important because the speed of change is so high, and you see it everywhere with our governments, with our competitors, with our customers and we, in turn, are responding with agility, creativity and impact. In our company and in our industry, it’s all about, what’s next? The next breakthrough medicine or vaccine, the next game-changing technology that make solution to an unmet patient need. And this continued pursuit of what’s next is embedded in our DNA. And it’s a foundational driver of our purpose, which you all know is breakthroughs that change patients’ lives. And it’s also why we have confidence that our story is one of growth.
We have a growth plan from now to 2030. In the 2020 to the ’25 period, we believe that we are on track to achieve a 6% revenue CAGR in our current in-line business. So this would mean that we exclude foreign exchange, COVID-19 revenues, future business development.
Additionally, even with the anticipated flattening out of our COVID franchise after the decline from its peak in 2022 sales we believe that this franchise will remain a multibillion-dollar revenue generator for the foreseeable future. So that’s why it is important to see COVID as a growth — as a contributor in our portfolio and part of our growth story.
As we previously said, we expect a negative impact of approximately $17 billion through LOEs in the ’25 to 2030 time frame. However, we believe that we have the substrate to not only mitigate that loss but to grow beyond it. So let’s take a look at each one of those expected growth contributors. Our strong capital position has given us the ability to pursue business development opportunities with the potential to add at least $25 billion of risk-adjusted revenues to our 2030 top line.
When we review sell-side models, the market estimates that we’re approximately 1/3 of the way to delivering this $25 billion — and this would come from the recent BD deals that we did in Arena, Biohaven and Global Blood Therapeutics.
Next, we have an exciting wave of expected launches from our own R&D pipeline in the next 18 months. And we believe that these have the potential to generate $20 billion in revenue. And then beyond the next 18 months, we have the potential for launches beyond that throughout the back half of the decade. And that would include interferon beta, GLP-1, inclacumab, GBT 601, our mRNA vaccines that include flu, zoster as well as a flu-COVID combo.
We believe that all of these have the potential to bring more growth towards 2030.
So these are the building blocks to our growth plan. And because we’re already executing against this plan, we have the confidence that we can achieve our 2030 growth goals. So let’s look more closely at the expected launches in the next 18 months. We expect to have up to 19 new products
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
or indications in the market, including 5, Ngenla, the COVID vaccine variant; Cibinqo, Nurtec, Oxbryta, that have already begun commercializing this year. These 19 launches, of which we believe that more than 2/3 of them have the potential to be blockbusters would be the most ever in Pfizer’s history in such a short period of time.
The 15 internally developed projects alone could potentially represent $20 billion in 2030 sales, which would more than offset the expected LOE impact. And many of these programs are already largely derisked from a clinical perspective.
Now beyond that, we know that we have to deliver and execute these launches successfully. So we need to look at our launch planning and execution, and we need to redefine what it means to be best-in-class at bringing products to market at speed and at scale.
We believe that we have to establish a standard of excellence that will enable us to outperform our internal expectations, external expectations and formidable competition. So we’ve approached this in 2 ways. First, we’re evolving our go-to-market model to create a more relevant and impactful engagement with physicians and patients.
Second, we’ve reorganized our biopharma business to help us simplify decision-making, resource prioritization and execution, as well as fortifying our industry-leading capabilities in marketing, medical and access, all of this to support our new go-to-market model.
So let’s talk more about this model. We began this evolution in 2019, but the pandemic has really served as an accelerant of this because during this time, many of our health care professional partners and patients required greater flexibility in their interactions with us.
And we all relied on digital tools and technology to meet their health care needs. This new model is focused on delivering a superior customer experience via an omnichannel approach that is centered around the established and strong in-person relationships that our representatives already have with customers.
Specifically, what we want to do is to give our customers a more personalized experience that is customized to their needs. For some, that could be a high-touch in-person interaction, right, much like what you know today, while others may want more of a hybrid engagement. Equally important is access to medical experts on demand who can answer specific questions when and where our physicians need it in order to help them treat their patients.
Our omnichannel offerings are underpinned by data and predictive analytics. So this is what enables us to better customize our engagement with our customers to meet their needs and their questions. And in doing so, what we will do is to create more memorable and more impactful customer and patient experiences.
So we first launched this new approach in the U.K. in late 2021. And this was followed by the U.S. in April of 2022. And then ensuing from there with 68 markets that are now leveraging this new approach. So that’s not where it ends. This is planned to grow to 78 countries by the end of this year. And our final 2 major markets, which are Japan and China, will progress in 2023.
We have also enhanced our customer-facing capabilities by including a wider range of roles that serve our customers. So for example, we have more medical roles, more access roles, more virtual reps all of this beyond the traditional in-person sales rep that we all know and love.
And the thousands of customer-facing colleagues we have globally are now better equipped with hybrid engagement tools to support the customers when and how they want. And recent customer feedback tells us that we’re on track, we’re on the mark, and Pfizer remains a leader in customer experience.
Once fully scaled, we believe that this will be a truly differentiating capability and we are very excited to continue to advance this go-to-market model.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
Now let me talk more about how we reorganized our biopharma business. Biopharma has been constantly evolving since we launched the BU or the business unit construct in 2016. After spinning off Upjohn, we were able to pivot to a pure innovative pharma company, and it was this focus that enabled us to create COMIRNATY and PAXLOVID in record time as well as deliver on the pipeline that you’re hearing about today.
We reorganized our commercial operations into 3 global customer-focused units. So that would be Primary Care, Specialty Care and Oncology as well as 3 geographies, the U.S., international developed markets and the emerging markets. In addition, we have streamlined our in-country structure and decision-making processes. We’ve created a much greater connectivity between the development of global strategy and local execution. And we’ve enhanced our marketing, medical and access capabilities globally.
And we believe that our new organizational construct, coupled with this new go-to-market model will amplify our patient impact, help us to focus on the most important priorities and in that way, deliver on these world-class execution launches. Overall, our confidence to execute this plan stems from our leadership track record. And let me just give you a few examples of what we’re particularly proud of.
Pfizer’s U.S. field force continues to rank #1 in the industry and now for the fourth year in a row in the 2022 Sales Force IQVIA rankings. The Pfizer field team has also moved to #1 position with several key customer segments, including cardiology, nurse practitioners, OB/GYNs and urologists.
We were also recognized as one of the world’s most ethical companies by Ethisphere. And finally, Pfizer ranked #4 on Fortune’s annual Most Admired Companies list, the highest ranking that we’ve ever received. So hopefully, with all of this, I’ve been able to convey to you why we have such great confidence in our growth plan and how well Pfizer is positioned for both near-term as well as long-term sustainable growth.
So now let’s turn to the next segment of our program, which is a review of some of our expected key launches in 2023. And for the next section, you’ll be hearing directly from our senior leaders of each of these therapeutic areas. All of the presentations that you’re seeing today, including the details on certain other expected key launches can be found on our website.
And so now it is my pleasure to turn it over to Rodrigo Puga, Pfizer’s U.S. Commercial and Global Business Lead for Internal Medicine, who’s going to kick off our first session for us. So thank you, and welcome, Rodrigo.
Rodrigo Puga – Pfizer Inc. – U.S. Commercial & Global Business Lead for Internal Medicine
Thank you very much, Angela. It is a real pleasure for me to be with all of you today to talk about our recently acquired migraine portfolio. I am Rodrigo Puga and I lead the Internal Medicine business, the U.S. commercial and the business globally. And I am here to talk about migraine. I have 2 main goals for the next 10 minutes or so. The first one is I want to demonstrate why NURTEC ODT is truly a breakthrough medication. And the second 1 is to share why we believe our potential CGRP portfolio has the potential to reach $6 billion of revenues at peak.
And since the brand launch in early 2020, we have received countless of messages from patients expressing their gratitude. It has been incredible to witness the impact that this medication is having on patients and on the treatment paradigm and even more so to imagine the growth that this could generate in the near future.
Migraine is a huge market. And migraine is not just a headache. Migraine is a life-disrupting disease affecting more than 1 billion people worldwide. In the U.S. alone, we have 40 million people living with migraine. 1 in 5 women need to fight with this disabling disease.
And it’s not only about the burden on patients and their families. It’s also about the significant impact that this disease is having on the global economy, accounting for around 5.6% of the global disease burden. Migraine alone, it’s more than all the other neurological diseases combined.
And at the same time, unfortunately, 30% to 40% of the patients cannot found or have not found the right solution for their migraine yet. Let’s talk about the disease and the treatment approaches. Migraine, again, is a debilitating neurological disease and it can be categorized in episodic if you have 14 or less headache days per month or chronic, if you have 15 or more.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
Important for you to understand is that 94% of the patients are in the episodic stage of the disease and only 6% are chronic migraine patients. In terms of treatment approaches, you can treat migraine acutely or preventively. And it’s also important to understand that all patients, even if they are taking a preventive treatment, will need at some point some acute treatment when they experience a breakthrough migraine.
And all this is important because later on, I will talk and explain how our potential CGRP portfolio has the potential or the possibility to cover the full migraine spectrum. Unfortunately, when we talk about the current standard of care, there are many limitations. If we talk about acute treatment where treatments are the standard of care. They face tolerability issues, cardiovascular contraindication, the need for repeat dosing, the risk of developing medication overuse headache which actually exacerbates the frequency and the severity of the migraine, which is exactly the opposite of what you’re trying to obtain with the migraine treatment.
If we talk about preventive treatment, again, patients face tolerability issues, suboptimal discontinuation rate. The long duration of time required to obtain efficacy and many of the available treatments are injectable treatments that, as you can imagine, is not the most preferred route of administration for patients.
And this is why we believe that Nurtec or Vydura, which is the brand approved in the European Union can help address the needs of many, many patients. On the acute setting, it has demonstrated strong efficacy with 86% of the patients not needing a rescue medication. It has not been associated with the risk of medication overuse headache. It does not have cardiovascular contraindications. And if we talk about the safety and tolerability profile, the most common adverse event is nausea at 2% versus placebo, 0.4% giving this new medication a very good safety and tolerability profile.
Talking about the preventive indication. Again, strong efficacy. This drug has demonstrated to reduce 30% the number of migraine days at week 1. It’s an oral treatment, and it’s preferred in most cases, over injectable and very well tolerated. Adverse events, the most common adverse events are again nausea at 2.7%, abdominal pain and dyspepsia are 2.4% versus 0.8% of placebo in both cases.
And something that I want to highlight is, if you remember, if you see the rates in the acute setting and the preventive setting, they are very similar. And for the preventive indication, you are taking this medication every other day. So a very good safety and tolerability profile.
Before NURTEC ODT, there was a in the migraine treatment paradigm because you either had options to only treat acute or only treat prevention. And NURTEC bridges that gap being the first and only approved for both acute and prevention, providing flexibility to physicians and patients in managing both with only 1 pill.
And this is why we believe this new drug is changing the treatment paradigm. And we believe that this is a unique characteristic that will only continue to differentiate the brand over time. On top of that, NURTEC ODT is the only CGRP that comes in an oral disintegrated tablet, which is very convenient for patients because they don’t require water for the intake.
Talking about the clinical profile of this new medication. On the acute setting, it has demonstrated freedom of pain and the most bothersome symptoms at 2 hours. In a secondary endpoint in the pivotal clinical trial also demonstrated pain relief and return to normal function in as little as 60 minutes. And for the 4 endpoints that I’ve just mentioned, the effect was sustained during 48 hours, again, with only 1 dose.
If we talk about the prevention indication, it reduces the monthly migraine days, more than 50% in half of the patients at month 3, and it has a strong safety and tolerability profile.
But let’s talk now and let’s see how this clinical profile is being translated into market results. And the first thing that you can see on the slide is that NURTEC ODT is already the market leader. It’s the most prescribed oral CGRP, and it has more than 50% of the market with 50 — more than 50% of the TRx share.
And something that I would like to highlight is that since we announced the acquisition in May this year, we see — we saw no disruption. On the contrary, we keep separating from the competitors, and we gained 6.4% in TRx share. In the U.S. alone, NURTEC ODT was already used by more than 600,000 unique patients and also by more than 90,000 unique prescribers.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
If we talk about the most important leading indicator, new-to-brand prescriptions, we are also leading there with 51.6% of share. So this is why we only expect even stronger growth in the coming months and year for this brand. And if we review the migraine market dynamics, what we can see is a high-growth brand in a high-growth market.
We believe this market could grow in the next 5 years to 40 million prescriptions. And despite being new, the oral CGRPs are disrupting the broader U.S. market. Biohaven mentioned many times that it was a matter of time for our CGRPs to overtake the injectable CGRP monoclonal antibodies.
And this is exactly what happened during this summer, as you can see on the screen. But also, they are disrupting the standard of care in general. If we talk about acute where triptans are the standard of care. You can see on the chart how triptans are declining. If we talk about preventive, you can see how topiramate, which is the standard of care is also declining. Still, if you see the right-hand side of the slide, oral CGRPs only represent 16% of the TRx share and 23% of the NBRx which tells about the significant growth opportunity ahead. And again, in this new market, NURTEC is the market leader.
And this is why we believe oral CGRPs can be the first line of therapy and can reach around 40% of the overall migraine market. One additional data point that I want to leave with you is, today, only 22% of NURTEC ODT scripts are coming from primary care physician, a space where Pfizer really excels and where we are planning to leverage all our capabilities.
This slide shows you how we are building a franchise in the CGRP and in the migraine space to meet the needs of the patients. I mentioned that you can treat migraine acutely or preventively. And the prescription will depend on the number of headache days per month and the severity of those.
NURTEC ODT can cover all the blue space that you can see there. The full acute range for both episodic and chronic migraine and also it’s indicated for episodic prevention, where you can find the majority of the patients, actually 94% of the patients and is already the market leader.
But on top of that, if approved by the FDA, we are planning to launch zavegepant who has the potential to be the first CGRP in an intranasal formulation for the acute treatment of migraine. This new drug has demonstrated pain relief in as little as 15 minutes, and we believe it could be suitable for patients where speed of onset is paramount.
And also, it could be very suitable for patients who experience nausea and vomiting who would, of course, preclude them of taking an oral medication. And we are developing these NURTEC and zavegepant together, we think, are complementary. And as you can see, the only missing space is the chronic prevention. We are not participating in that space. And this is why we are developing a Phase III clinical trial as an oral formulation for zavegepant for the prevention of chronic migraine. And if successful, and the takeaway here is that we are working to build a franchise that can help the full migraine spectrum.
Now I want to share with you our key revenue assumptions and why we believe this could be a $6 billion franchise. The data that you can see on the screen is the data that we are using for our forecast and that you can use for modeling purposes. We think that if you run the numbers, you will be able to get — you have here rimegepant, which is NURTEC or Vydura, and you have zavegepant, both in the intranasal and in the oral formulation.
And if you run those numbers, you will be able to get to our assumption, which is that this portfolio could reach $6 billion at peak. I would like now to highlight some of the key commercial strategies that we are putting together to amplify this portfolio.
So starting from the very successful foundation that Biohaven built, we are adding more to that equation. We are leveraging the Pfizer scale, deploying our best-in-class key account management organization to the 250 leading health care system in the United States and that — those systems cover 75% of all the patient care and 88% of all the health care practitioners.
We have already doubled the number of sales reps covering an additional number of 72,000 HCPs. We have multiplied 8x the number of medical field support for this brand. And again, these are some of the things that we are doing by leveraging the Pfizer scale to take the migraine portfolio to the next level.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
And I think that you all know that we do have the global scale to launch this asset that today is only in the U.S. to launch it globally. And we are working, as Angela mentioned, at Lightspeed to launch NURTEC or Vydura around the world. This medication is already approved in the European Union, the U.K. and some parts of the Middle East, and we are expecting regulatory approvals from around the world in the coming months and years.
We have also submitted for the acute indication in China and if successful, we will be able to help the 130 million people living with migraine in that country. And on top of that, as I mentioned, we are expecting the approval of zavegepant intranasal as the potential first-in-class intranasal formulation and working with a Phase III clinical trial with zavegepant oral.
And this is why we believe that Pfizer is well positioned to be a leader in migraine. We have potentially a best-in-class portfolio for migraine. We have the history of building blockbusters. Our sites are set high for this recently acquired asset, and we are aiming to help the 1 billion migraine sufferers around the world with a high unmet need.
So I hope that by now, I was able to achieve my 2 goals, which is to demonstrate why NURTEC ODT is truly a breakthrough medication and that our potential CGRP portfolio has the potential to reach $6 billion of revenues at peak.
Thank you very much. And I would like now to hand it over to Sinan Atlig. Thank you again.
Sinan Atlig – Pfizer Inc. – U.S. Commercial & Global Business Lead for Vaccines
Good afternoon, everyone. My name is Sinan Atlig and I am the U.S. Commercial and Global Business Lead for Vaccines. It is my 22nd year now at
Pfizer, and I have worked across a variety of geographies and brands.
In my previous role, I was leading Pfizer Vaccines in international developed markets and have been the face of Pfizer to the European Commission and to different governments around the world during the launch of our COVID-19 vaccine together with our partner, BioNTech.
But today, I won’t be talking about COVID-19 but another contagious virus that can cause serious — potentially serious respiratory illness, which is RSV, Respiratory Syncytial Virus. I feel very proud to be talking about RSV vaccine candidates because of the unmet need that we see across the globe.
There is not a day that goes by in which we don’t see a news clip or an article about RSV epidemic in the U.S. and across the world. In the U.S., ICU beds have been overflowing and there are recent calls to declare public health care emergency.
As you see on the first point in the slide for the maternal, the unmet medical need for babies is clear and well characterized. But there is also a significant burden for older adults, which is similar to influenza. As there are currently no vaccine or specific treatment options available, RSV is causing a significant burden on the health care system, on the economic system and on the individual level, whether we talk about older adults, babies, caregivers or parents.
That is why I am so proud to present our unique approach to RSV. Our vaccine candidate is a bivalent protein-based vaccine, helping protect against both RSV A and RSV B strains. Because of this, our vaccine candidate does not rely on cross protection. Another very important aspect of our vaccine is that it does not include any adjuvant or viral vector components. We have 1 single vaccine candidate, the same formulation that we are filing regulatory applications for 2 distinct indications based on the compelling data in these 2 separate populations.
Our vaccine candidate is the only late-stage asset with potential indications in both older adults and maternal immunization. As you may have heard, last week, we have announced the BLA acceptance and the priority review for our older adult indication by the FDA with a PDUFA date in May of 2023.
And as we have announced earlier in the year in our older adult Phase 3 study, our vaccine candidate showed strong efficacy and more importantly, higher efficacy in more severe symptomatic cases. In addition, we have seen consistent efficacy different — across different patient subgroups.
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DECEMBER 12, 2022 / 6:00PM, PFE.N – Pfizer Inc Pfizer Near-Term Launches + High-Value Pipeline Day Call
The DMC noted that the vaccine was well tolerated with no safety concerns for vaccinated individuals. And again, I want to emphasize that our investigational vaccine does not have any adjuvant or viral vector component. Before going over the Phase III interim study results on maternal indication, I would like to underline Pfizer’s pioneering approach in RSV prevention, immunizing women during pregnancy to help provide protection for their babies immediately at birth and continuing up to 6 months, which is the — which is the period with the highest vulnerability for the infants.
Seeing this innovative approach producing these results makes me again feel very proud. As we shared earlier in the year, at the recommendation of the independent data monitoring committee and in consultation with the FDA, we have stopped enrollment in our trial and plan to submit our BLA to the FDA by the end of the year.
The Phase 3 data results demonstrate our vaccine candidate has a high level of efficacy, and the DMC indicated it was well tolerated with no safety concerns for either the vaccinated mothers or their infants. If approved, this will be the first investigational vaccine to help prevent RSV immediately at birth or better set from the first breath.
At Pfizer, we are uniquely positioned to commercialize our vaccine candidate in both indications. We rely on our best-in-class commercial capabilities and decades of launch excellence that we have recently proven with our COVID-19 vaccine rollout and our Prevnar 20 adult launch in this indication. We have robust and differentiated contract model — contracting models, both with IDNs, the integrated delivery networks and with retailers.
We also have proven reliable manufacturing supply and distribution capabilities and expertise in educating customers across various channels. As we look towards the commercial opportunity and the significant unmet need, we believe we have the potential to make a public health impact.
Based on our Phase 3 interim analysis results in both potential indications, coupled with the unmet need, we project potential blockbuster revenues for our vaccine candidates. First, there are 2 distinct and big population groups that can benefit from this protection. Although the pregnant women population is relatively smaller, the burden of RSV is much better characterized with a clear need.
Hence, we believe we can potentially reach a high uptake rate between 60% to 70%. As there are no other maternal immunization candidates in late-stage development, we anticipate 100% market share. If approved, we anticipate our data to support a favorable and year-round recommendation by ACIP.
Monoclonal antibodies can be important complementary options, especially for babies who may need additional protection if they are approved. Let’s move to the older adult side. For older adults, the burden of the disease is less well known and often mistaken with flu and other causes of respiratory diseases. Despite this, we believe our vaccine can reach peak uptake rates of 50% to 60%.
In this indication, we will have competition. But based on our vaccines clinical profile, our commercial capabilities and our anticipated launch timing, we believe we can potentially reach and sustain a market share between 45% to 60%. If approved, we anticipate our data to support a routine and age-based recommendation by ACIP.
The key to success will be education. Educating everyone on the burden of the disease and on the favorable profile of our vaccine candidate, whether they are HCPs, providers, retailers, expecting mothers, older adults or caregivers. That will be the key to launch our investigational vaccine to address the significant unmet need and to reach our vaccine candidate’s potential which rolls up to be a potential multibillion dollar opportunity, again, if approved and recommended.
Finally, our RSV vaccine candidate has the potential to strengthen our ever-growing respiratory portfolio of Prevnar franchise and COVID-19 franchise. Like with COVID-19, Pfizer’s commitment does not stop at the vaccine candidate, complementing our efforts to advance our RSV vaccine candidate, we also have Sisunatovir, an investigational therapeutic with the potential to help treat RSV-related illness. That is why we believe Pfizer is uniquely positioned to deliver successful launches and build upon our legacy as a leader in helping prevent and treat respiratory diseases.
Thank you all for your attention. I would now like to hand it over to Kevin Sullivan, who leads our Specialty Care business globally, and who will provide details on Etrasimod and Ritlecitinib.
10
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Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

  • SearchHamburgerPfizer Signs Agreement to Provide the European Union with PAXLOVID™Wednesday, November 23, 2022 – 11:00amShare

    New agreement to supply up to 3.4 million treatment courses to countries across Europe; this deal supplements the courses provided to 17 EU member states under existing bilateral agreementsDeliveries to participating countries commencing imminently NEW YORK, November 23, 2022Pfizer Inc. (NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement, negotiated with the Health Emergency Preparedness and Response Authority (HERA) of the EC, is in addition to the bilateral agreements Pfizer has previously signed with 17 EU Member States. This agreement will supply participating countries up to 3.4 million treatment courses upon orders being placed. Under the terms of the agreement, Pfizer will begin delivery of the initial treatment quantities ordered by the participating countries in November, in parallel to deliveries underway as part of existing bilateral agreements.“Clinical data and real-world evidence for PAXLOVID have shown that it can be an important tool in helping to reduce hospitalizations and deaths in those at increased risk of serious illness from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As the region prepares for winter and a possible resurgence in COVID-19 infections, the accessibility and availability of treatment options is of the utmost importance. We are pleased to be working with the European Commission to make PAXLOVID available to more patients across Europe.”PAXLOVID is currently authorized for conditional or emergency use in more than 70 countries across the globe. Following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize PAXLOVID, a conditional marketing authorization (CMA) for PAXLOVID was granted in January 2022 for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. Europe plays a critical role in the delivery of PAXLOVID to patients across the globe, as the site of four of Pfizer’s key PAXLOVID manufacturing facilities.About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
    PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2 and BA.4.PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.Our Commitment to Access
    Pfizer is committed to working toward equitable access to our oral COVID-19 treatment, PAXLOVID, for high-risk patients in need, aiming to deliver safe and effective oral treatment as soon as possible and at an affordable price. If authorized or approved, during the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe; high and upper-middle income countries will pay more than lower-income countries. Pfizer has established a comprehensive strategy in close partnership with worldwide governments, international global health leaders, including WHO’s Access to COVID-19 Tools Accelerator (ACT-A), and global manufacturers to optimize supply and access of PAXLOVID all around the world. This includes:

    • Multilateral Supply Agreements: Agreements in place with UNICEFfor the supply of up to 4 million treatment courses to 137 low- and middle-income countries and with Global Fund for up to 6 million treatment courses for supply to 132 Global-Fund grant-eligible countries, subject to regulatory approval or authorization.Expanding Access to Patent-Protected Medicines in Lower-Income Countries: Launched An Accord for a Healthier World, a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 billion people living in lower-income countries. Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. or European Union, including PAXLOVID, on a not-for-profit basis to 45 lower-income countries around the world and will collaborate with government and global health leaders to address barriers that limit access beyond supply, like diagnosis, education, infrastructure, storage and more.Accelerating Testing and Treatment: Joined the COVID Treatment Quick Start Consortium, a joint initiative implemented by Duke University, the Clinton Health Access Initiative (CHAI), COVID Collaborative and Americares with support from Pfizer, Open Society Foundations and the Conrad Hilton Foundation. Pfizer will provide treatment courses of PAXLOVID, as well as financial support, to support the Consortium’s efforts to accelerate COVID-19 testing and improve access to treatments in under-resourced parts of the world. The consortium has launched test and treat initiatives in partnership with ten countries in Africa and Southeast Asia. Humanitarian Treatment Donation: As part of its humanitarian response, Pfizer donated 200K treatment courses of PAXLOVID to Ukraine.Voluntary Licensing: Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries.

    U.S. FDA Emergency Use Authorization Statement
    PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
    The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.AUTHORIZED USE
    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.LIMITATIONS OF AUTHORIZED USE

    • PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19PAXLOVID is not authorized for use for longer than 5 consecutive days

    PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

    PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:

    • Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to assess renal and hepatic function; and Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.

    The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:

    • Sufficient information is not available to assess renal and hepatic function.Sufficient information is not available to assess for a potential drug interaction.Modification of other medications is needed due to a potential drug interaction.PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

    PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

    PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.IMPORTANT SAFETY INFORMATION
    PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.
    Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir.
    PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

    • Alpha1-adrenoreceptor antagonist: alfuzosinAntianginal: ranolazineAntiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidineAnti-gout: colchicineAntipsychotics: lurasidone, pimozideBenign prostatic hyperplasia agents: silodosinCardiovascular agents: eplerenone, ivabradineErgot derivatives: dihydroergotamine, ergotamine, methylergonovineHMG-CoA reductase inhibitors: lovastatin, simvastatinImmunosuppressants: voclosporinMicrosomal triglyceride transfer protein inhibitor: lomitapideMigraine medications: eletriptan, ubrogepantMineralocorticoid receptor antagonists: finerenoneOpioid antagonists: naloxegolPDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertensionSedative/hypnotics: triazolam, oral midazolamSerotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserinVasopressin receptor antagonists: tolvaptan

    PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

    • Anticancer drugs: apalutamideAnticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftorAntimycobacterials: rifampinHerbal Products: St. John’s Wort (hypericum perforatum)

    There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.
    Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

    • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medicationsClinically significant adverse reactions from greater exposures of PAXLOVIDLoss of therapeutic effect of PAXLOVID and possible development of viral resistance

    Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.Anaphylaxis and other hypersensitivity reactions have been reported with PAXLOVID. Cases of Toxic Epidermal Necrolysis and Stevens-Johnson syndrome have been reported with ritonavir, a component of PAXLOVID (refer to NORVIR prescribing information). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.
    Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and

China’s pandemic continues, more than 1.5 million deaths estimated

The pandemic continued in Beijing and the death toll has increased sharply. Videos circulating on the internet showed a long line of vehicles transporting dead bodies to a crematorium in Beijing, but China’s Health Commission reported there were no new deaths after December 7. In addition, there are rumors that Beijing plans to send unvaccinated elderly people to field hospitals for treatment to address the shortage of medical resources.

According to NTD, on December 16, the Chinese media Caixin reported that two senior journalists of the People’s Daily newspaper died in Beijing after being infected with COVID-19, at the age of 74. 

Although they died of COVID-19, the cause of death on the death certificate was pneumonia. (Photo)

The journal Nature Medicine estimates that within six months, China could trigger a new pandemic “tsunami.” As many as 112 million people will be infected, 2.7 million people will be admitted to the ICU, and 1.55 million people will die. Peak ICU demand will reach 1 million beds, more than 15.6 times the current capacity.

According to Sound of Hope, Zhang Fanghua (pen name), a Beijing resident, said that Beijing has released a large number of people from field hospitals and plans to use them for the unvaccinated elderly, just like Xiaotangshan hospital did during the SARS outbreak in Beijing in 2003.

She said that a person working at Xiaotangshan hospital told her, “Patients are provided with a bottle of mineral water every day, and buns or bread, not as good as you imagine. It’s not like that at all … You suffer on your own, you can come back if you are alive. Otherwise, you will get in the car (meaning will be a corpse). If you want to run away, maybe you will be beaten to death. These days, no one cares about you. It’s really terrible! Nationwide, 40% of the elderly are vaccinated, and 60% are not. So 60% of the elderly who are not vaccinated will be taken there.” (Recording)

On December 15, China’s National Medical and Health Commission issued a “Work plan to strengthen the control of the COVID-19 pandemic and health services in rural areas.” The commission proposes speeding up vaccinations in rural areas, especially the elderly, increasing the stock of ventilators and medicine in rural areas, and avoiding contact with the elderly. There are about 500 million people in rural China and there are about 17,000 county-level hospitals that are severely short of beds.

Zhang Wenhong, director of the Department of Infectious Diseases at Fudan University’s Huashan Hospital in Shanghai, recently predicted that ​it will take three to six months to overcome the pandemic, according to Sohu.

Tang Jingyuan, a political commentator, said: “The Chinese government has invested a large amount of health insurance funds including paying trillions of dollars to implement the ‘zero-COVID’ policy for three years, embarking on nationwide nucleic acid tests, building field hospitals everywhere, and hiring a large number of people to do quarantine work, implementing lockdowns and investigations. The but high quality vaccines and good drugs that are needed to fight the pandemic, including ICUs and ventilators, are in low supply. This is one of the most fundamental reasons leading to overcrowding and a lack of medical resources. This responsibility must certainly belong to the Chinese government.” (Recording 2)

Source: https://m.thebl.com/china/chinas-pandemic-continues-more-than-1-5-million-deaths-estimated.html

80X More Deaths Following COVID-19 Shots than Influenza Vaccines 2020 through 2022

December 18, 2022

80X More Deaths Following COVID-19 Shots than Influenza Vaccines 2020 through 2022

by Brian Shilhavy
Editor, Health Impact News

An examination of the U.S. Government’s Vaccine Adverse Events Reporting System(VAERS) reveals that since the Fall of 2020 through today, people injected with COVID-19 shots die 80 times more frequently following those shots, than people who die after being injected with the flu shots.

Also, people receiving a COVID-19 shot suffer side effects 40 times more frequently than people who are injected with flu shots.

Here are the current stats in VAERS for people receiving a COVID-19 shot since they were issued an emergency use authorization in December of 2020. (Source.)

Here are the stats for the flu shots since September of 2020 (beginning of the “Flu season”.) (Source.)

To determine the rate of side effects and deaths suffered from these shots, we need the number of doses distributed for these time periods, and we find those numbers on the CDC website.

Total doses of COVID-19 shots distributed to date are 931,341,585. (Source.)

Total doses of flu shots distributed from September 2020 through December 10, 2022 are 527,610,000. Number of doses for the 2020-2021 and 2021-2022 flu seasons are found here, and total doses for the current 2022-2023 flu season through December 10, 2022 are found here.

Based on these numbers supplied by the U.S. Government, one person dies for every 2,284,026 flu shots, while one person dies for every 28,370 COVID-19 shots, which is a rate 80 times higher than the flu shots.

One person is suffering a side effect for every 25,217 flu shots, while one person is suffering a side effect for every 629 COVID-19 shots, which is a rate 40 times higher than the flu shots.

What is interesting about the CDC’s report on doses of COVID-19 shots distributed, is that even though 931,341,585 doses have been distributed, only 660,400,812 doses have been administered. So only 70% of the COVID-19 “vaccines” the U.S. Government has purchased have actually been injected into people. The other 30% presumably were discarded, or will be discarded after they reach their expiration date.

That of course makes the rate of people dying and suffering injuries following injections of COVID-19 shots even higher!

  • 1 death per 20,117 shots
  • 1 side effect per 446 shots

I do not know if statistics exist for the ratio of shots distributed to shots administered for the flu shots, which is why for comparison purposes we need to use the “shots distributed” statistics.

Governor DeSantis, Dr. Ladapo, and Other Florida Doctors are LYING About the Safety of Childhood Vaccines!

How about other vaccines that are approved by the FDA and part of the CDC childhood vaccination schedule?

At a recent event in Florida with Governor Ron DeSantis and his Surgeon General Joseph Ladapo, several other doctors sat a round table to discuss how COVID-19 shots were harmful and should NOT be recommended for children. See:

Why Hasn’t Governor DeSantis Stopped the COVID Vaccines in Florida When He Admits They are Killing People?

However, some of these doctors that sat at the table told parents to not stop injecting their children with other vaccines, and told them that these vaccines were “safe and effective.” One doctor, Dr. Joseph Friaman, even emphatically stated that other childhood vaccines had nearly no side effects. He said that they were rare, “1 in a million.”

Listen to their own words:

Let’s “fact check” this.

The U.S. National Vaccine Injury Compensation Program keeps stats on the number of doses distributed for all FDA-approved vaccines that are on the CDC childhood vaccination schedule. You can view those stats covering the time period of 01/01/2006 through 12/31/2021 at the U.S. Government website here.

During those years, there were over 4 billion doses of vaccines distributed (4,093,221,119).

Next, we can do a search in VAERS to see how many deaths and side effects were recorded from these vaccines during that same time period. The results are here.

During these years, there were 553,216 injuries and deaths recorded in VAERS from all non-COVID vaccines. That means a side effect from these vaccines was recorded in VAERS for about every 7,400 shots distributed.

That’s a lot more than 1 out of a million, as Dr. Friaman claimed! And of course the actual numbers are much HIGHER than this, because a report contracted out by the U.S. Government in 2011 found that less than 1% of all vaccine injuries are ever reported to VAERS. (Source.)

Here is the list of the vaccine manufacturers from VAERS that produced these vaccines that caused all these injuries and deaths, and each of these companies, especially the ones at the top of the list, have a criminal rap sheet where they have paid out $BILLIONS in criminal settlements.

So these doctors admit the COVID shots are bad, but they want you to trust them that all other vaccines, produced by the same corrupt companies, are somehow “safe”?

They can’t even prove these vaccines are effective! Dr. Bhattacharya mentioned the polio and MMR vaccines, and these are two of the biggest scams in the history of vaccines!

No child is dying in the U.S. today from measles, but many do die and are injured from the measles (MMR combo vaccine) vaccine.

All cases of polio today come from the vaccines. Please educate yourself on these non-COVID vaccines and the tremendous fraud surrounding them.

Here is an article I published earlier this year on the polio vaccine, and when you listen to Dr. Suzanne Humphries’ presentation on the history of the polio vaccine, you will see much of the same fraud we just observed with the COVID shots. The playbook doesn’t change much over the years.

The Polio Scam Makes a Comeback to Scare More Parents into Vaccinating Their Children – Vaccines NEVER Eradicated Polio: Vaccines CAUSE Polio

Also, the CDC has refused over the years to study the health of children who follow the CDC childhood vaccination schedule and are fully vaccinated versus parents who choose not to vaccinate their children, and for good reason, because unvaccinated children are clearly much healthier. See:

Unvaccinated Children are Healthier than Vaccinated Children – Most Censored Topic in the U.S.?

Source: https://healthimpactnews.com/

Doctors find Graphene is shedding from the COVID Vaccinated to the Unvaccinated, forming Blood Clots & decimating Blood Cells

Doctors find Graphene is shedding from the COVID Vaccinated to the Unvaccinated, forming Blood Clots & decimating Blood Cells

The Expose
The Expose

By The ExposéOctober 27, 2022

In his latest set of slides of blood samples taken from both “vaccinated” and unvaccinated people, Dr. Philippe van Welbergen demonstrated that the graphene being injected into people is organising and growing into larger fibres and structures, gaining magnetic properties or an electrical charge and the fibres are showing indications of more complex structures with striations.

He also demonstrated that “shards” of graphene are being transmitted from “vaccinated” to vaccine-free or unvaccinated people destroying their red blood cells and causing blood clots in the unvaccinated.


Let’s not lose touch…Your Government and Big Tech are actively trying to censor the information reported by The Exposé to serve their own needs. Subscribe now to make sure you receive the latest uncensored news in your inbox…


Dr. Philippe van Welbergen (“Dr. Philippe”), Medical Director of Biomedical Clinics, was one of the first to warn the public of the damage being caused to people’s blood by Covid injections by releasing images last year of blood samples under the microscope.

At the beginning of July 2021Dr. Philippe, was interviewed on a South African community channel, Loving Life TV.   He explained that when his patients started complaining about chronic fatigue, dizziness, memory issues, even sometimes paralysis and late onset of heavy menstruation (women in their 60s upwards), he took blood samples. Their blood had unusual tube-like structures, some particles which lit up and many damaged cells. Few healthy cells were visible. Until three months earlier, he had never seen these formations in blood.  We now know these tube-like structures are graphene.

Since then, Dr. Philippe has been a regular guest on Loving Life TV: blowing the whistle on the experimental Covid injection roll-out; providing updates on the increasing damage being done to blood by the experimental Covid injections over time; and, giving updates on the Covid situation in the UK and South Africa.

On 12 February 2022, Dr. Philippe returned again to Loving Life TV to release images of his latest slides of blood samples.  The live stream was lengthy so Loving Life TV separated it into two parts.

Part One is a discussion including answers to the audience’s questions.

In Part Two, Dr. Philippe presents the images of his latest blood slides and explains what the images are showing.  He discusses nearly 100 blood slides from both “vaccinated” and vaccine-free patients.  His slides show that vaccine-free patients have been “infected with vaccine toxins through shedding.”

Below is a short clip from Part Two courtesy of The Timeline Post channel on Telegram.Dr Philippe (Part Two), The Blood Slides, 12 February 2022

Below is an image of typical healthy red blood cells as seen with a microscope, what blood should look like. There is no coagulation or foreign objects in it.

The next image is of a person who has been injected with the experimental Covid drug. The blood is coagulated, the misshapen red blood cells are clumped together.  The cell encircled in the image is a healthy red blood cell, one of the few in the image, sitting alongside the graphene fibres.  You can see the size of the graphene fibres in relation to the size of a red blood cell. Fibres of this size will block capillaries. You can also see the graphene fibres are hollow and contain red blood cells.

A couple of weeks before the video below was made, Dr. Philippe began noticing a magnetic or electrical polarity effect on different sides of the graphene fibres.  In the image below, to the right of the fibre the cells are coagulated and on the left-hand side is what looks like a gap or roughly backwards “C” shaped spacing.  Dr. Philippe says that this “behaviour” was not seen before but now, all of a sudden, it is being seen in almost every sample.  It is an indication that “these things have changed, their reaction with surrounding blood cells has changed … and I don’t know what triggered it,” he said.

The image below is of a blood sample from a vaccine-free, or unvaccinated, three-year-old child.  It shows pieces or “shards” of graphene that “are the result of shedding,” in other words the graphene has been transmitted from “vaccinated” parents to their unvaccinated child.

Below is the image of a blood sample from an eight-year-old unvaccinated child whose blood has been contaminated and destroyed by the transmission of graphene from those around him/her who have had a Covid injection.  The child’s right arm and upper right leg are basically paralysed, the child is unable to lift his/her right arm and the thigh is not functioning properly.

Dr. Philippe’s presentation is truly eye opening and horrifying – a must watch, especially for those who proclaim Covid injections are “safe” and are insisting people be injected.  The Covid injections are weapons of genocide and how the people who have designed them are still walking free is incredible.

You can either watch the presentation below or on Loving Life TV HERE.Loving Life TV: Dr Philippe (Part Two), The Blood Slides, 12 February 2022 (90 mins)

Source: expose-news.com/2022/10/27/drs-find-graph-ene-shed-vax-to-unvax/

Pfizer vaccine less effective against India variant of SARS-CoV-2

Pfizer vaccine less effective against India variant of SARS-CoV-2

Pfizer-Biontech COVID-19 vaccine vial
Credit: Biontech SE

June 4, 2021

By Nuala Moran

LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10.

Blood samples taken from healthy volunteers at different time points after receiving one or two doses of the Pfizer vaccine had lower levels of neutralizing antibodies against the India variant than against the Kent and South Africa variants of concern.

In people who were fully vaccinated with two doses of the Pfizer vaccine, titers of neutralizing antibodies against the India variant were 5.8-fold lower than against the original Wuhan virus against which the Pfizer vaccine was designed.

That compares to a 2.6-fold reduction vs. wild type for the Kent variant, and 4.9-fold for the variant originally identified in South Africa.

The antibody response against the India variant was even lower after a single dose, with only 32% of serum samples showing a quantifiable neutralizing antibody response, compared to 79% for the wild type.

Levels of neutralizing antibodies were lower with increasing age and levels decline over time, suggesting that third, booster doses of vaccine will be needed later in the year.

The samples in the study came from 250 health care workers and staff at University College London and its associated hospital who have been making regular blood donations.

In total, 308 samples from different time points were tested with a new high-throughput viral neutralization assay developed at the Francis Crick Institute, London. The times ranged from 23 days after a first dose to 37 days after a second.

The high-throughput assay allowed serum to be tested against live samples of each virus variant in a single experiment, enabling direct comparison of neutralizing antibody titers.

The study, reported in The Lancet, relates only to Pfizer’s vaccine, but the researchers are now doing the same assessment for Astrazeneca plc’s COVID-19 vaccine.

Decline over time

A further study in a subgroup of 14 participants who donated blood between eight and 12 weeks after their second dose of the Pfizer vaccine also showed significantly reduced neutralizing antibody activity against all variants of concern. For 12 of those individuals, the reaction was high enough to block 50% of virus infection, but for two participants activity against the India and South Africa variants dropped below 40%.

The researchers said their findings raise the question of whether the U.K. should maintain its policy of administering two vaccine doses 12 weeks apart. That was shown to be the correct strategy at the start of the vaccination rollout, providing some level of protection to as many people as possible when vaccine supplies were limited.

With the data showing that after a single dose of vaccine neutralizing antibodies against the India and South Africa variants are below the quantitative limit of detection, extended dosing intervals may no longer be appropriate.

The India variant has now replaced its Kent counterpart as the dominant cause of infection in the U.K. Despite relatively high levels of vaccine coverage, with 50% of the adult population having received two doses and 75% one dose, the number of infections has started to rise again, and some experts saying this could be the start of a third wave.

The seven-day average was 3,853 cases per day in the week up to June 2; on June 3, 5,274 cases were reported; on June 4, 6,238. The number of PCR-confirmed cases per day is still low compared to the height of the second wave in March this year, but the India variant is showing signs of being more transmissible than the Kent variant.

There also has been an increase in hospital admissions in areas of the country where case levels are higher.

Taken together, the neutralizing antibody levels and the epidemiological data raise the possibility that the India variant presents a dual challenge of reduced vaccine efficiency and greater transmissibility. “It remains difficult to assess precisely to what extent the reduction in [neutralizing antibody titers] we observe will impact vaccine efficacy and increase disease severity in a vaccinated population, especially given the multiple factors that contribute to this process, such as long live humoral immunity,” the researchers said.

A single dose still provides more protection than no vaccination, but will give relatively less protection against the India variant. “The benefits of delaying the second dose must now be weighed against decreased efficacy in the short term, in the context of the spread of the India variant,” said the researchers.

The most important thing will be to ensure vaccine protection remains high enough to keep as many people out of the hospital as possible, said Emma Wall, consultant in infectious diseases, who is clinical lead for the study.

“Our results suggest the best way to do this is to quickly deliver second doses and provide boosters to those whose immunity may not be high enough against these new variants,” Wall said.

What’s in a name?

In other news, WHO has come up with a new naming system for key variants of SARS-CoV-2 that it said are easier to say and remember, using the Greek alphabet.

The Kent variant has become Alpha, South Africa is Beta, the Brazil variant Gamma and the Indian variant Delta. The labels do not replace the existing scientific names, such a B.1.1.7 for the Kent variant, which convey important scientific information.

But WHO said these scientific names can be difficult to say and recall. As a result, the default is to refer to variants by the places where they are first detected. That is “stigmatizing and discriminatory,” WHO said.

It may take time for the nomenclature to shift. The default since WHO announced the new names has been to use all three alternatives: B1.1.7, the Kent variant, now known as Alpha.

Source; https://www.bioworld.com/articles/507849-pfizer-vaccine-less-effective-against-india-variant-of-sars-cov-2