Pfizer 2022 Annual Report

Adolescent with bandaid after getting vaccine

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Advancing a Potential Meningococcal Vaccine to Simplify Vaccine Schedules

On September 15, 2022, Pfizer announced the top line results from its Phase 3 clinical trial showing that its investigational pentavalent meningococcal vaccine (MenABCWY) demonstrated non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y.)

Today, there are approximately 52 million adolescents and young adults who are in the age range recommended for meningococcal vaccination according to Centers for Disease Control and Prevention (CDC) guidance. However, less than a third of U.S. adolescents receive even one dose of a neisseria meningitidis group B (MenB) vaccine, and fewer complete the two-dose series, resulting in many adolescents being unprotected against meningococcal disease caused by serogroups A, B, C, W, and Y.*^1,2* Routine use of a MenABCWY vaccine could help improve meningococcal vaccination rates and coverage, thereby helping to reduce cases of invasive meningococcal disease and associated mortality.*^3*

"We are very pleased with these positive Phase 3 data, which are the first for a MenABCWY vaccine candidate. A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease," said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

If approved, this vaccine candidate may help protect more young people from meningococcal disease and supports Pfizer's resolve to become a global leader in the prevention of this disease.

Helping Protect Patients Against Pneumococcal Pneumonia

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A Step Closer in the Fight Against Respiratory Syncytial Virus

Photomicrograph of respiratory syncytial virus (RSV)

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U.S. Travelers Get New Vaccine Option

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Working to Advance Care for People Living With Ulcerative Colitis

As of 2019, it is estimated that ulcerative colitis (UC) affects 2.6 million people in Europe and an estimated 1 million people in the US.*^1,2* It is a chronic, life-long immune-mediated inflammatory disease associated with unpredictable patterns of relapse and remission. The disease causes irritation and ulcers on the inner lining of the large intestine. It is one of a group of diseases called inflammatory bowel disease (IBD). Signs of ulcerative colitis often present as recurring diarrhea, which may contain blood, mucus or pus, abdominal pain, and urgency amongst further symptoms. UC is associated with lower patient quality of life that is comparable to other serious chronic conditions and is worse in inadequately controlled patients. Sphingosine-1-phosphate (S1P) modulates the inflammatory pathway by regulating the egress of lymphocytes from lymph nodes, and lymphocytes have a pivotal role in the pathogenesis of inflammation in patients with IBD.*^3* Etrasimod, a once-daily, oral, S1P receptor modulator selectively activates S1P receptor subtypes 1, 4, and 5, which are believed to be involved in modulating the body's immune response by limiting movement of lymphocytes to sites of inflammation, while avoiding S1P receptors (S1P2,3) associated with serious AEs.



In May 2022, we announced positive results from our phase 3 trials demonstrating potential substantial positive benefits of etrasimod. In the 52-week study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 and was 32.1% compared to 6.7% at week 52. In the 12-week study, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo. Safety findings were consistent with those reported in previous studies of etrasimod. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. These data were presented as a late-breaker presentation at Digestive Disease Week (DDW) 2022.*^4* Additional subgroup analyses presented at United European Gastroenterology Week (UEGW) 2022 suggest that etrasimod may be particularly efficacious in patients naïve to or with one prior advanced therapy.*^5* Many patients living with ulcerative colitis might never achieve or maintain remission with the currently available treatment options. If approved by regulatory authorities, etrasimod has the potential to provide a new once-daily, oral option that could be an attractive first-line advanced therapy for patients with moderately-to-severely active ulcerative colitis. Key potential differentiators for etrasimod are that the data may support once-daily oral dosing without a complex dose titration scheme to start treatment. Lack of titration combined with its 30 hour half-life provide a fast onset of symptom relief along with fast offset/washout which can be advantageous in family planning and when the rate of immune reconstitution is critical.

“Etrasimod could offer a meaningful clinical profile for people living with moderately-to-severely active ulcerative colitis considering the clear benefit it has shown over 52 weeks in
a treat-through trial design, its mechanism of action, and its unique pharmacologic properties,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “Patients often need multiple options to help manage their disease, and there is a significant need for new therapies. In the ELEVATE clinical program, etrasimod has shown an encouraging balance of efficacy and safety that we believe could have a meaningful impact for patients and physicians if approved.”

MYFEMBREE® Offers a Treatment Option in Two Woman’s Health Conditions

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Advancing Care for Pediatric Growth Hormone Deficiency

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How Two Alopecia Areata Advocates Found and Spread Support on Social Media

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Harnessing the Power of mRNA to Transform Medicine

The COVID–19 pandemic crystalized the scientific opportunity of mRNA, and the application of this adaptable novel technology platform has far-reaching potential. Messenger RNA or mRNA is a set of instructions that cells in the body follow to make specific proteins. Proteins play many essential roles in our bodies, including helping to prevent infections and potentially treat diseases. Many of the advantages of mRNA technology—its flexibility, speed, and potency—have scientists around the globe excited about its potential future applications.

The next wave of scientific innovation is upon us and Pfizer is working hard to harness the power of mRNA. We believe our expertise in disease biology, along with our robust, rapid manufacturing capabilities and talented scientific minds, will help propel the potential of this technology forward. In 2022, we’ve advanced our work and collaborated with new partners to help realize this incredible technology’s full potential and expand our ability to leverage this scientific platform beyond COVID–19.

Our current exploration of mRNA is focused on infectious diseases with development programs in flu and shingles, as well as exploring mRNA’s versatility in the areas of rare genetic diseases. Throughout the past year, we have made significant progress.

### Influenza or Flu  
Flu continues to cause hospitalizations and deaths across the world every year, so we recognize an important opportunity to develop a potentially more efficacious vaccine. In 2022, we started our pivotal Phase 3 studies for an mRNA-based influenza vaccine candidate. The ability to nimbly “edit” mRNA could provide a huge benefit when it comes to vaccines that must be updated annually. With traditional flu vaccines, scientists try to predict many months in advance which strains might circulate and match the vaccines to the predicted strains. mRNA technology could be leveraged to generate vaccines much closer to the onset of each flu season, which could result in better matches to circulating strains. This flexibility, paired with the ability to rapidly manufacture mRNA vaccines, could potentially allow greater reliability of supply and better strain match, which could lead to improved efficacy.

### Shingles
Shingles is a debilitating, disfiguring and painful disease that affects people all over the world. In January, we announced a collaboration with BioNTech to develop a potential first mRNA-based vaccine for the prevention of shingles. We plan to start human studies for this vaccine candidate in 2023.

### Rare genetic diseases 
We’ve established a research collaboration with Beam Therapeutics to develop mRNA technology as a potential new approach to gene editing, which is a form of gene therapy. Gene editing works by delivering “tools” encased in lipid nanoparticles (fatty bubbles) that have the potential to replace, remove, or correct faulty genes in patients with rare diseases— providing a potential one-time treatment for these debilitating conditions. Our work is focused on rare genetic diseases of the liver, muscle, and central nervous system.

Of course, Pfizer’s work in COVID–19 continues. We are also working to address emerging variants of concern with the introduction of the BA.1 and BA.4/5 bivalent vaccines to many countries across the world. Along with our collaboration partner BioNTech, we are advancing the next-generation of vaccines for SARS-CoV-2 and investigating a novel combination vaccine candidate against COVID–19 and influenza that could provide protection against these two infections with one vaccine.

We are looking forward to more scientific advances with Pfizer’s mRNA efforts in 2023 and beyond.

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Support networks can be life changing for individuals who are experiencing something people in their regular social circles don’t understand – as was the case for Kylie Bamberger and Supriya Surender, two women who have alopecia areata.

When Kylie first lost her hair at 12 years old, there weren’t many online support systems where people could discuss the impact hair loss had on them. She would create hand-written notes to pass out at school to help people understand why she looked different.


Late one night in college, she was inspired to do something impactful: share [her first bald photo](https://www.instagram.com/p/CUNnnoFpKse/?utm_source=ig_web_copy_link) on social media. “When I lost my hair, there wasn’t much in terms of alopecia areata awareness. There weren’t online support groups or social media outlets. I knew I had to break that trend,” said Kylie. The response to her post was overwhelming and made Kylie, who has now amassed a large social media following, realize the true power of awareness and support.

Supriya began to lose her hair in her early 30s. She spent a lot of time feeling alone and in denial, but eventually found her first support group through social media, where she connected with a group of individuals also living with alopecia areata, including Kylie. “Connecting with the alopecia areata community completely changed my perspective on what my life could be,” said Supriya. “I was inspired by incredible women, like Kylie, who so effortlessly lived in their truth and owned the disease.”

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Supriya was inspired to start growing her own social media platform. Now, she shares her journey with alopecia areata with her social media followers, emphasizing the importance of a support system when navigating hair loss.

Supriya and Kylie are now sharing their stories as part of a Pfizer campaign, called [Reflections of Alopecia Areata](https://www.reflectionsofalopeciaareata.com), to help raise awareness, dispel myths and drive understanding of the autoimmune disease.

“Many people don’t know that alopecia areata is more than just hair loss — it’s an autoimmune disease. By sharing my story through my platform and through Reflections of Alopecia Areata, I hope to help raise awareness about this disease and the experience of those living with it,” said Kylie. “Alopecia areata can be a very isolating and emotional disease, and I want others to know they aren’t alone ... they have a huge support system full of people like me who understand first- hand what they’re going through.”

A New Option to Treat and Prevent Migraines for Patients in Europe

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On February 15, 2022, the European Medicines Agency (EMA) authorized the use of Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV20) under the brand name APEXXNAR®. The vaccine is approved in the European Union (EU) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumonia in individuals 18 years of age and older.

Anyone can become ill with potentially serious infectious respiratory diseases, including invasive pneumococcal disease and pneumonia. However, adults who are 65 years of age or older are 10 times more likely to be hospitalized with pneumococcal pneumonia than adults younger than 50.*^1,2* Pneumococcal disease is also a major cause of communicable disease morbidity and mortality in Europe and the rest of the world.*^3*

“APEXXNAR is the first pneumococcal conjugate vaccine to help protect adults against the 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia. It offers the broadest serotype protection of any available pneumococcal conjugate vaccine in Europe and is a testament to our ongoing commitment to help protect patients against certain potentially serious infectious respiratory diseases," said Luis Jodar, Infectious Disease and Evidence Generation, Chief Medical Affairs Officer, Pfizer.

APEXXNAR helps address the burden of pneumococcal disease in adults and is one example of Pfizer’s growing vaccine portfolio.

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Working to Deliver a Potential Breakthrough in a Type of Prostate Cancer

Approximately 1.4 million new cases of prostate cancer are diagnosed worldwide each year, making prostate cancer the second most common cancer in men and the fourth most common cancer overall.*^1* It is so common that all men are at risk for developing the cancer, but factors such as age, family history, and obesity increase the odds. Prostate cancer also has one of the widest racial disparities of any cancer, and these disparities are prevalent at every stage of the cancer continuum.

For those diagnosed with prostate cancer, the majority occur in the early stages *^2*, where the disease is considered curable with definitive therapy, such as surgery or radiation therapy. But a proportion of patients will progress after definitive therapy, or worse, be diagnosed at an advanced stage of the disease. It is often then considered incurable. The median overall survival for patients who have increasing levels of the protein prostate-specific antigen (PSA) after localized treatment survive between eight and nine years.*^3* For those with a certain type of advanced prostate cancer, known as metastatic castration-resistant prostate cancer (mCRPC), the prognosis is dire – survival is only about 13 months.*^4,5*

Research over the past decade has focused on improving outcomes for men with mCRPC, and while advances have been made with the introduction of therapies known as novel hormonal therapies (NHTs), some patients eventually develop resistance and are left with no other treatment options.

This is where Pfizer is aiming to deliver the next scientific breakthrough.

Pfizer's R&D efforts have led to a robust pipeline allowing us to explore various therapeutic approaches of potential benefit to patients in clinical trials. One such trial is the Phase 3 TALAPRO-2 trial which found that the combination of TALZENNA® (talazoparib), our oral poly ADP-ribose polymerase (PARP) inhibitor, with XTANDI®* (enzalutamide) yielded a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared with placebo plus XTANDI. Benefits in other key endpoints, such as overall survival, prostate-specific antigen (PSA) response, time to PSA progression, and overall response rate, were also observed.

“For men with mCRPC, time is especially important, and we want to give people living with this disease the possibility of more time with their loved ones,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “If approved, we believe TALZENNA may offer a new treatment option.”

TALAPRO-2 is a two-part, two-cohort, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of 1,095 patients with mCRPC. TALZENNA or the combination of TALZENNA plus XTANDI has not been approved by any regulatory agency for the treatment of mCRPC.

“TALAPRO-2 underscores our long-term commitment to men living with advanced prostate cancer,” said Suneet Varma, Global Oncology and U.S. President, Pfizer.“ Based on the compelling combination data from TALAPRO-2, we believe TALZENNA in prostate cancer may become the next potential blockbuster opportunity in our leading Pfizer Oncology portfolio, subject to regulatory approval.”

**Pfizer and Astellas jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.*

LORVIQUA® Authorized as First-Line Treatment in European Union

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Harnessing Digital Health Solutions to Improve Patients’ Lives

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Precision medicine has transformed cancer care in recent decades, often enabling doctors to pinpoint and then precisely target the sub-cellular abnormality from which the cancer sprung. Even so, by the time cancer has spread to the brain, it is often difficult to treat.

That’s because of the blood-brain barrier, which evolved to block pathogens and toxins from entering the brain and can also prevent the passage of beneficial medications. LORVIQUA® (lorlatinib), available in the U.S. under the brand name LORBRENA®, is a third-generation medicine developed by Pfizer to treat advanced non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive. The drug was designed to specifically break through the blood-brain barrier.*^1*

Approximately 25 to 40% of patients with ALK+ NSCLC either have brain metastases - cancer that has spread to the brain, at baseline, or develop brain metastases within two years of diagnosis.*^2*

[Now](https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-lorviquar-lorlatinib-first), adults with advanced ALK+ NSCLC living in the European Union (EU) have access to LORVIQUA monotherapy as a first- line treatment under a marketing authorization granted by the European Commission in January 2022. Previously, LORVIQUA was available in the EU only under a conditional marketing authorization and only to a subset of patients with advanced ALK+ NSCLC whose cancer progressed after earlier ALK- targeting therapies.

In the pivotal Phase 3 head-to-head CROWN clinical trial, ALK+ NSCLC patients who received LORVIQUA had 72% lower risk of progression or death than those who received XALKORI® (crizotinib).*^4* Importantly, 82% of participants with brain metastases that could be measured saw their brain tumors shrink or disappear entirely following LORVIQUA treatment, compared to 23% for XALKORI, which also works by targeting ALK protein but with less brain penetration.*^5* Out of 112 patients who did not have brain metastases when enrolled in the trial who were treated with LORVIQUA, only one developed brain metastases.

XALKORI is another Pfizer product and was [authorized](https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_european_approval_to_expand_use_of_xalkori_crizotinib_to_first_line_treatment_of_adults_with_alk_positive_advanced_non_small_cell_lung_cancer) in the EU as a first-line treatment for ALK+ NSCLC in 2015. But we didn’t stop there. We kept pushing the envelope.

And now, in 2022, the success of LORVIQUA is a testament to our culture of never settling. At Pfizer, we continue to work tirelessly to help address unmet needs for people living with advanced, biomarker-driven lung cancers.










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Breakthroughs in the Fight Against Antimicrobial Resistance

The COVID–19 pandemic has been a stark reminder of the health and economic hardships caused by infectious diseases. It has also worsened drug-resistant infections and reinforced the need to invest in responsible antimicrobial use, diagnostics, surveillance, and research and development to help minimize the impact of future global health crises – like antimicrobial resistance (AMR).*^1,2*

AMR is one of the biggest threats to global health today and can affect anyone, of any age, in any country. If it continues to rise unchecked, minor infections could become life- threatening, serious infections could become impossible to treat, and many routine medical procedures could become too risky to perform.*^3,4* Without action by governments, industry, and society, AMR is expected to cause 10 million deaths each year by 2050.*^4*

As a global anti-infective leader, we’re committed to tackling AMR. Pfizer was proud to start the year ranked as a joint industry leader by the Access to Medicines Foundation AMR Benchmark report, which highlighted our innovative policies to improve access to our medicines and our leadership in antimicrobial stewardship.*^5*

Good antimicrobial stewardship – a systematic, rational approach to the responsible use of antimicrobials – is foundational to help curb AMR.

Diagnostics can play an important role in stewardship practices and are an under-used resource. This year, Pfizer announced a collaboration with BD (Becton, Dickinson and Company) and Wellcome to better understand the role of diagnostics in advancing antimicrobial stewardship practices around the world.*^6*

Antimicrobial surveillance – the monitoring of changes in populations of microbes to help understand patterns of resistance to anti-infectives – is critical for effective infection prevention. Access to such data allows key decision-makers to better adapt antimicrobial stewardship programs to help combat the spread of resistant pathogens.

In 2022 we led the way as a founding contributor to the non-profit Vivli’s AMR Register, sharing raw antimicrobial surveillance data from our pioneering Antimicrobial Testing Leadership and Surveillance (ATLAS) database.*^7* Vivli’s AMR Register will allow researchers, national governments, and multi-lateral organizations to access multiple industry datasets in one place to aid in identifying the emergence of new antimicrobial-resistant pathogens.

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A robust pipeline of new antimicrobials is essential to restoring the balance against increasing rates of AMR. However, significant economic hurdles have made research and development in this area a challenge. No novel class of antibiotics has been launched for almost 40 years, and even when newly approved treatments come to market, they may be used sparingly to support good antimicrobial stewardship practices – making it difficult to recover the high cost associated with development. New reimbursement models that more fully reflect the complete value of antimicrobials are critical.

We continued our leadership in finding creative solutions to address AMR in 2022 in a world-first cross-industry innovative reimbursement model for antimicrobials.

In June, Pfizer partnered with NHS England, NICE, and the UK Government on an innovative ‘subscription-type’ model for antibiotics.*^8* The model aims to move away from reimbursement based on number of prescriptions and instead focus on the value antibiotics bring to the public. This encourages the appropriate use of existing antibiotics and incentivizes the discovery of new ones—both crucial tools in our arsenal against AMR.

This pilot could help to inspire change on a global scale. It’s hoped that this model will set a precedent for governments across Europe and beyond to progress their own incentive and reimbursement models to attract much-needed investment in antimicrobial research and development.

Taking PAXLOVID® from the Lab to Patients to Combat COVID–19

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Vaccine Boosters: A Year in Review for Our COVID–19 Vaccination

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Evolving with the Virus

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Growth hormone deficiency (GHD) is a rare disease that can take a substantial toll on children living with the condition and their families.*^1* Without treatment, affected children will have persistent growth attenuation, very short height in adulthood, and puberty may be delayed.*^1* Children may also experience other problems with physical health and mental well-being.*^1,2*

The earlier GHD is identified, and consistent treatment is provided, the better a child’s chances will be to achieve near- normal height.*^1*

Prior to once weekly options, for decades, children living with GHD have been treated with daily injectable treatments, which often are administered for several years.*^3* While effective and safe, daily injections require patience, flexibility, and can take an emotional toll on parents and caregivers.*^4,5,6* In fact, it’s estimated that up to two-thirds of children with GHD may miss more than one daily dose per week, which could negatively affect treatment outcomes.*^4*

Pfizer has been focused on solutions to help minimize the disease management burden and to increase treatment adherence for children, their caregivers, loved ones, and healthcare providers.

In February 2022, Pfizer received marketing authorization in the European Union (EU) for NGENLA® (somatrogon), a once-weekly injection to treat children and adolescents from three years of age with growth disturbance due to insufficient secretion of growth hormone.*^7,8* NGENLA provides pediatric patients, their caregivers and healthcare providers with a treatment option for GHD that reduces the frequency of required injections from once daily to once weekly. *^7,8*

“Growth hormone deficiency takes a substantial toll on children living with this rare disease and their families, and for many years, daily injections have been the standard of care, adding to the challenges they face,” noted a Pfizer leader at the time of approval. “With NGENLA, we are proud to continue to advance the care of children in Europe who are impacted by growth hormone deficiency with a new, longer-acting option that significantly reduces treatment burden from once-daily to once-weekly injections.”

For decades, Pfizer has remained committed to helping the GHD community. This commitment will continue as we work to deliver this treatment, addressing unmet needs for the pediatric GHD community and raise awareness for this rare disease.

For full efficacy and safety information about NGENLA, please see the full prescribing information [here](https://www.ema.europa.eu/en/documents/product-information/ngenla-epar-product-information_en.pdf).


Two Alopecia Areata Advocates Found Support on Social Media

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In April 2022, VYDURA® (rimegepant) became the first medicine approved for both acute and prophylactic treatment of migraine in the European Union (EU). Migraine is a leading cause of disability worldwide, with approximately one in ten people living with the condition in Europe alone.*^1* The burden of illness causes a large economic impact, with the EU spending an estimated ~€50-111 billion in 2011.*^2* Globally, migraine disproportionately affects women by three to four times compared to men, and over 1 billion patients suffer from migraine.*^3,4* It is a prevalent and disabling illness, and the personal impact causes missed moments with family, friends, and everyday life.*^5*

“Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” said Professor Peter Goadsby, Director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London. “VYDURA’s promising efficacy and favorable benefit-risk profile spark hope for people in need of new migraine treatment options.”

VYDURA has been found to be safe and efficacious. A trial in acute migraine demonstrated statistically significant differences versus placebo on pain freedom, freedom from most bothersome symptoms, and ability to function normally at two hours post-dose, and the effects were sustained in some patients through 48 hours.*^6,7* In a prevention trial, rimegepant taken every other day provided superior reduction in the number of days per month with migraine in weeks 9–12 of the 12-week treatment period compared to placebo.*^6* The most frequent adverse event in clinical trials with VYDURA was nausea, occurring in 3% of patients compared to 1% with placebo, while hypersensitivity reactions including rash occurred in less than 1% of patients.*^7*

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“This approval has the potential to advance the standard of care for migraine in the EU and I believe it will be an important new treatment option for the many people living with the burden of this prevalent neurological disease,” Goadsby said.

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Over the past four decades, the world has seen many changes—from varying heads of states to technological advances, new cultural phenomena to global crises. One constant in this time has been Pfizer’s tick-borne encephalitis (TBE) vaccine, FSME-Immun®/TicoVac™. In 1976 the vaccine was first introduced to the pharmaceutical market in Austria, with over 170 million doses of the vaccine having been distributed since launch.*^1,2*

In 2022, following an approval by the U.S. Food and Drug Administration (FDA) in 2021, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices’ (ACIP) voted to recommend* TicoVac for active immunization to prevent TBE in U.S. populations one year of age and older who travel or move to TBE endemic areas and will have exposure to ticks, and laboratory workers with potential exposure to the TBE virus (TBEV).

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#### The burden of TBE

TBE is a rare infection involving the central nervous system, affecting the brain and spine.*^3* It can lead to serious and complicated long-term consequences, including cognitive changes, muscle weakness or permanent paralysis.*^3,4*

There is currently no cure or specific treatment for TBE, only management of symptoms.*^5* Therefore, it’s important to help protect against TBE if spending time outdoors in an area where there is a risk of being infected with the TBE virus.

These areas where there is a risk of TBE are increasing as geographical reach of TBE is expanding.*^5* To date, TBE has been reported in more than 36 countries, from across Western Europe to parts of Asia, meaning that U.S. citizens traveling to or living in these regions may be at risk of TBE if bitten by a tick.*^5*

#### Providing a new option for protection

Following discussions amongst the TBE Vaccine Work Group and a detailed analysis of extensive data from more than 20 years of evidence of use from outside the U.S., ACIP voted to recommend TicoVac for specific groups of at-risk individuals in February 2022. These included:
- Persons who are moving or traveling to a TBE-endemic area and will have extensive exposure to ticks based on their planned outdoor activities and itinerary
- Persons traveling or moving to a TBE-endemic area who might engage in outdoor activities in areas ticks are likely to be found may consider vaccination (where the decision to vaccinate should be based on an assessment of their planned activities and itinerary, risk factors for a poorer medical outcome, and personal perception and tolerance of risk)
- Laboratory workers with a potential exposure to the TBE virus (TBEV)

"This recommendation clearly demonstrates our ongoing commitment to patients, helping ensure that a vaccine with 46 years of heritage continues to be made available to new groups of at-risk individuals. This vote is important as it provides clear guidance for healthcare providers on when a TBE vaccine should be recommended to prevent infection, supporting conversations between patients and healthcare providers about whether vaccination is the right option for them,” said Alejandro Cane, VP, US/IDM Vaccines and Antivirals Medical and Scientific Affairs Lead, Pfizer.

As the world opens up again in the wake of COVID–19, this ACIP recommendation* means that U.S. individuals who are traveling or moving abroad to TBE-endemic areas in Europe or Asia, potentially including military personnel and their families, or those at risk of virus exposure through laboratory work have access to another option to help protect themselves.

Ensuring that broader populations have the option to help protect themselves from a potentially serious infection whilst traveling forms part of Pfizer’s ongoing commitment to helping address tick-borne diseases.

*\* ACIP recommendations are provisional until published in the Morbidity and Mortality Weekly Report (MMWR).*

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Pfizer colleagues and refugee program members

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Pfizer Refugee Leadership Initiative: Seen, Heard, and Cared For

We have all seen images of refugees whose lives have been upended by forces beyond their control, fleeing their homes for safety. Watching it as it unfolds means we have a choice to make: do nothing or find a way to help refugees rebuild their careers and their homes. Pfizer chose the latter.

We take pride in hiring the best qualified talent so we can achieve breakthroughs that change patients’ lives. Since many refugees have the talent and skills we are looking to hire, in late 2021, the Pfizer Refugee Leadership Initiative was created. To jumpstart the work, we joined the Tent Coalition for Afghan Refugees and later expanded the program to refugees from Ukraine and other refugees in need.

Our first hire, Mohammad Afzal Afzali, was a Chief of Staff at a university in Afghanistan and a translator for the U.S. Embassy. He had to leave Afghanistan with his family at a moment’s notice, and he finally joined Pfizer and settled in Texas. Throughout Pfizer, from the U.S. to Greece, Germany, Belgium, Italy, and other offices, we have seen an outpouring of support for the program. We hired more than 100 refugees in 2022 and have also announced our expanded aspirational goal of hiring 500 qualified refugees in the U.S. in the next three years. In addition, we committed to mentoring 300 refugees through 2025, 50 of whom are from the LGBTQ+ community.

In April 2022, Dr. Albert Bourla, Pfizer Chairman & Chief Executive Officer, and 34 other CEOs launched the Welcome.US CEO Council, pledging more than $75 million to support refugee resettlement organizations and non-profits to welcome Afghan and Ukrainian refugees coming to the U.S.

Since the Pfizer Refugee Leadership Initiative’s inception, Payal Sahni, Pfizer’s Chief People Experience Officer, has been a champion of the program. An Afghan refugee herself, she understands the importance of having access to opportunities and has made it her life’s calling to pay it forward and open doors for others. She now serves as a member of the Tent Advisory Council.

“The Pfizer Refugee Leadership Initiative opens up an untapped talent pool with amazing talent. Many managers have shared positive feedback on the refugee hires’ performance and work ethic. They have proven a diverse workforce and an inclusive environment are not only the right things to do but also a winning business strategy,” said Ramcess Jean-Louis, Pfizer's Chief Diversity, Equity and Inclusion Officer.

“The Pfizer Refugee Leadership Initiative is not a hand-out. These refugee hires have earned the opportunity and deserve to be here. We see the value they bring to the table and we, Pfizer, welcome their diverse perspectives and contributions. We always hire the most qualified candidates to ensure that candidates are in positions that reflect their education, skills and experiences,” said Mona Babury, Pfizer Director of Diversity, Equity and Inclusion and also the colleague who came up with the idea and built the initiative from scratch.

We have seen amazing work from our refugee hires. We also want them to have peace of mind knowing they have joined a workforce where they are seen, heard, and cared for and find a true sense of community at Pfizer.

With Patients. For Patients: Our Unwavering Focus on Patient Centricity

Pfizer colleagues at Patient Focus Town Hall

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Pfizer at Essence Fest: Connecting with the Black Community

Pfizer brand ambassadors at Essence Fest booth

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Our Humanitarian Efforts and Response to the Crisis in Ukraine

Cargo airplane filled with Pfizer supplies

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Patient meeting with nurse having conversation

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Ensuring Diversity in Clinical Trials to Develop Breakthroughs for All™

While most people are likely familiar with the concept of a clinical trial, they may not be as familiar with its purpose. For Pfizer, delivering lifesaving treatments for all means ensuring that our clinical trials accurately represent the diverse communities impacted by the diseases we seek to treat or prevent. As part of these efforts, Breakthroughs for All™ is Pfizer’s commitment to diverse and inclusive participation in clinical trials through equitable access and practices.

Race, ethnicity, age, biological sex, and cultural background all inform how effective vaccines and medicines are for individual people. Pfizer has increased its efforts to design and conduct clinical trials that more accurately reflect the racial and ethnic diversity of the locations where our trials are conducted and the epidemiology of the diseases we intend to treat or prevent.

To accomplish this goal, we must proactively, intentionally, and regularly address the historic barriers that have partially resulted in underrepresentation in clinical trials, including community mistrust and lack of clinical trial awareness. Building trust and increasing awareness in diverse communities requires strong relationships with influential and embedded community organizations, including major universities, research organizations, and trusted community voices in local pharmacies, hospitals, and religious institutions.

One example is our recent partnership with the Tigerlily Foundation to launch Health Equity, Advocacy, and Leadership (HEAL) sessions to advance education around clinical trials for Black women with breast cancer. This effort is critically important as, in addition to historic underrepresentation in breast cancer clinical trials,*^1* Black women are often diagnosed at a later stage and have a worse prognosis compared to white women.*^2* During these sessions, we focus on shedding light on the breast cancer journey for women of color, improving access to breast cancer clinical trials, building trust and enhancing relationships between cancer patients and their care providers, and identifying barriers and solutions to improve access to trials, with the intent that this knowledge will be shared across other treatment areas.

“Every person deserves the right to a healthy life, and our effort to improve diversity in clinical trials to increase the overall population’s benefit from clinical research is a matter of equity. Our work alongside Tigerlily aims to empower Black women with breast cancer, who are at a higher risk of disease but less likely to enroll in a clinical trial that may prove to be lifesaving. Our goal – through this partnership and others like it – is to provide communities with the knowledge to feel more educated and supported to participate in clinical trials, furthering the real-life impact of important scientific discovery," said Judy Sewards, Pfizer Vice President, Head of Clinical Trial Experience.

Although there is still work to be done, we have made important progress in raising awareness, building trust, and increasing access to clinical trials for even more people. Breakthroughs for All™ are made possible by those who choose to participate in clinical trials, and we’re committed to working closely with all potential partners, including communities, their leaders, and industry professionals, to not only ensure that all who are interested in joining a clinical trial have the right information and opportunity to do so, but also that the therapies we bring to market are truly beneficial to patients and their families.

Breaking Industry Standards with Lightspeed

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A Team-First Approach to Patient Health

Pfizer employees during collaborative meeting

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Counterfeit Prescription Drugs: Combating Sale of Fake Meds

Persons hand stopping dominos from falling

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Respiratory syncytial virus (RSV) is a contagious, common and pervasive cause of acute respiratory illness among older adults and young children.*^1* In the U.S. alone, each year, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths, and in children younger than five years old, nearly 2.1 million outpatient visits and 58,000 hospitalizations.*^2*

The burden of this infectious disease is evident, but there is currently no U.S. Food and Drug Administration (FDA)- approved RSV vaccine on the market.

For more than five years, Pfizer has been advancing a novel vaccine candidate for RSV called PF-06928316 or RSVpreF.*^1* There has been significant progress in 2022 with Pfizer’s RSVpreF candidate:
- In December, Pfizer [announced](https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-biologics-license-0) that the U.S. FDA accepted for priority review a Biologics License Application (BLA) for its RSV vaccine candidate, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Priority Review designation by the FDA reduces the standard BLA review period by four months. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the RSVpreF application is in May 2023.*^7*
- In November, Pfizer [announced](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-global) positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (**MAT**ernal **I**mmunization **S**tudy for **S**afety and **E**fficacy) investigating RSVpreF when administered to pregnant participants to help protect their infants from RSV disease after birth.*^3*
- In August, Pfizer [announced](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-trial-older) top-line data from the Phase 3 clinical trial RENOIR (**R**SV vaccine **E**fficacy study i**NO**lder adults **I**mmunized against **R**SV disease) when administered to adults 60 years of age or older.*^4*
- In March, Pfizer announced two separate Breakthrough Therapy Designations from the U.S. FDA: one for the prevention of lower respiratory tract disease caused by [RSV in individuals 60 years of age or older](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-breakthrough-therapy-designation-0); and the second for [RSV-associated lower respiratory tract illness in infants](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-breakthrough-therapy-designation-0) from birth up to six months of age by active immunization of pregnant women.*^5,6*

Pfizer is currently the only company with an investigational vaccine with regulatory applications for both infants through maternal immunization and older adults to help protect against RSV disease.

"Pfizer recognizes the urgency to get an RSV vaccine to the market—it’s a priority for us, especially given the highly contagious nature of this infectious disease. If approved, our RSVpreF vaccine candidate has the potential to help protect older adults and infants from RSV.*^3,4* We look forward to advancing our dialogue with regulatory authorities to help bring a potentially transformative solution for RSV to at-risk populations,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer.



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An Accord for a Healthier World

We live in a time when science is increasingly demonstrating the ability to take on the world’s most devastating diseases. Unfortunately, there exists a tremendous health equity gap in our world that too often determines who can access innovations – and who cannot. Equity is a core Pfizer value that drives our people and our work every single day. We believe better health is possible for everyone everywhere, and that all people deserve access to quality healthcare. It is this drive that led us to launch An Accord for a Healthier World, a new breakthrough initiative working to close the health equity gap.

Through this groundbreaking initiative, launched at the World Economic Forum in Davos, Switzerland in May 2022, we came together with leaders from Rwanda, Ghana, Malawi, Senegal, Uganda and the Bill & Melinda Gates Foundation to announce we will work towards sustained, equitable access of medicines and vaccines for 1.2 billion people living in 45 lower-income countries that have historically been most vulnerable to healthcare inequalities. Alongside governments and global health organizations, the Accord aims to co-create scalable solutions to address systemic barriers that often limit or prevent equitable access. We are focused on working together to find faster, more efficient pathways for supply of medicines and vaccines as well as strengthening the resources, capabilities and platforms that can enable quicker and more efficient access to healthcare innovation.

World map illustrating the countries that could benefit from Pfizer’s Accord for a Healthier World if enrolled.

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With the launch of the Accord in May 2022, Pfizer committed to provide all its patented medicines and vaccines available in the U.S or EU – both current and future products - on a not-for- profit basis to the 45 lower-income countries. Understanding that product supply is only one part of this challenge, we also put forth the call to action to global health leaders around the world to work with us and these governments to find new ways to remove access barriers and help ensure that these medicines and vaccines can reach those who need them. 

We immediately began engagement with a number of Accord-eligible countries, including Rwanda, Malawi, Ghana and Senegal, to identify the needs and opportunities for sustainable access. Within the first four months of the launch, Rwanda became the first country to procure products through the Accord, receiving nine medicines and vaccines that can help treat life-threatening infectious diseases, inflammatory diseases and certain cancers. Pfizer and the Rwanda Ministry of Health have also begun working together to provide professional healthcare education and training, and in November, Pfizer deployed a Global Health Team to the country to help identify opportunities for long-term supply chain optimization.

“In partnership with Pfizer and ‘An Accord for a Healthier World’, we are proud to provide rapid and affordable access to these Pfizer medicines and vaccines, which have the power to save and improve patient lives all across Rwanda,” said The Minister of Health, Dr. Daniel Ngamije. In these early engagements with country governments, we also heard resoundingly, that there is an immediate need for consistent access to a broader scope of high-quality products. Based on this feedback and our commitment to address unmet patient needs, in early 2023, Pfizer expanded on its initial commitment to offer all patented medicines and vaccines available in the U.S. or EU to now include the full portfolio for which we have global rights. This expanded portfolio offering will include off-patent medicines as well, bringing the product offering from 23 to nearly 500 products that can help to treat or prevent many of the greatest infectious and non-communicable disease threats faced today in lower-income countries. Nearly 40% of the medicines and vaccines now offered appear on the World Health Organization's list of essential medicines. And as Pfizer introduces new medicines and vaccines, those products will also be included in the Accord portfolio.

We will continue to call upon governments, global health leaders and industry who share our vision to join in this breakthrough effort and to work with us to address access barriers and help to close the health equity gap. 

"Only when all the obstacles are overcome can we end healthcare inequities and deliver for all patients,” said Pfizer Chairman & Chief Executive Officer Dr. Albert Bourla.

Explore breakthroughs from 2022

Approvals in rare disease and women’s health, advancing treatment for dermatological conditions and respiratory illnesses, and ongoing efforts to bring the COVID–19 vaccine to all regions of the world.