Ceftaroline Fosamil

Data demonstrate diversity of vaccine and anti-infective portfolio and cutting-edge scientific approach to battling viral and bacterial infections Presentations of interest include a late-breaking abstract with the first full data of the efficacy and safety of Pfizer’s bivalent respiratory syncytial virus (RSVpreF) vaccine candidate in older adults; and new data regarding PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), including its effect on COVID-19-related hospitalizations and other medical visits Pfizer to host “RSV Data and COVID Vaccine Commercial Update” call with analysts at 4:30 p.m. (EDT) on October 20, 2022 NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will share data across its expansive infectious disease portfolio, including company-sponsored and collaborative research studies, spanning both licensed and investigational vaccines, and antibiotic and antiviral therapies at IDWeek 2022 held in Washington, D.C. October 19-23, 2022. Data from 35 abstracts involving Pfizer vaccines and anti-infective therapies will illustrate the diversity of the portfolio and the company’s cutting-edge scientific approach. This will include a late-breaking presentation of the full data from its Phase 3 (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) clinical trial, investigating its bivalent RSV A and B, stabilized RSV prefusion F subunit vaccine candidate, RSVpreF, when administered to adults 60 years of age and older. These data will also be presented on October 20, 2022, to the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). “The data presented at this year’s IDWeek showcase the breadth of Pfizer’s vaccine and therapeutic research and development portfolio and our continued commitment to working to overcome infectious diseases that still present a serious health risk,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We look forward to both sharing our exciting data, as well as connecting with the scientific community to determine how we can continue to work to bring transformative solutions to thwart infectious diseases.” The research to be presented includes new insights on bacterial and viral infections, including Lyme disease and C. difficile. Additionally, presentations will include Pfizer’s licensed vaccine, PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), and its investigational vaccine candidates RSVpreF and Group B Streptococcus, GBS6. Beyond vaccines, Pfizer is also presenting new data regarding PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), its authorized oral treatment for COVID-19. Key Pfizer sponsored, investigator-sponsored and collaborative research oral and poster presentations leveraging the depth of Pfizer’s scientific advances include: An oral presentation on the effect of nirmatrelvir/ritonavir versus placebo on COVID-19 related hospitalizations and other medical visits A poster presentation on sustained alleviation and resolution of targeted COVID-19 symptoms with nirmatrelvir/ritonavir versus placebo A poster presentation of a Phase 2 study evaluating the safety, tolerability, and immunogenicity of a booster dose of a Group B Streptococcus vaccine Details for the Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: Title/Abstract Number Presenting Author/Type Date/Time (EST) Location ORAL PRESENTATIONS 786 - Effect of Nirmatrelvir/Ritonavir versus Placebo on COVID-19─Related Hospitalizations and Other Medical Visits Jennifer Hammond, PhD Oct 20 3:30 – 3:45 PM US ET 147 AB 91 - Establishing Proof of Concept for a Bivalent RSVpreF Subunit Vaccine for Maternal Immunization Kimberly J. Center, M.D. Oct 20 10:30 – 10:45 AM US ET 144 ABC LATE BREAKING VACCINE STUDIES LB748 - Efficacy And Safety Of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Older Adults Edward E. Walsh, MD Oct 20 2:21 – 2:33 PM US ET 209 ABC POSTERS - PFIZER PRESENTING COVID-19 1156 - Sustained Alleviation and Resolution of Targeted COVID-19 Symptoms with Nirmatrelvir/Ritonavir versus Placebo Jennifer Hammond, PhD Oct 21 12:15 – 1:30 PM US ET Hall B + C 1077 - Understanding the Psychosocial Burden Associated with Hospitalization Among Adults Diagnosed with COVID-19 in the United States Wajeeha Ansari, MPH Oct 21 12:15 – 1:30 PM US ET Hall B + C C. difficile 117 - Preferences for Clostridioides difficile Vaccine Attributes Among Adults in the United States Jeffrey T. Vietri, PhD Oct 20 12:15 – 1:30 PM US ET Virtual 393 - Healthcare and Out-of-Pocket Costs Associated With Clostridioides difficile Infection Among US Adults 18-64 Years of Age Holly Yu, MSPH Oct 20 12:15 – 1:30 PM US ET Hall B + C 396 - Incidence and Attributable Mortality of Clostridioides difficile Infection Among US Adults 18-64 Years of Age Jennifer Judy, MS, PhD Oct 20 12:15 – 1:30 PM US ET Hall B + C 387 - Differences in frequency of C. difficile infection testing of inpatients with diarrhea at selected acute care hospitals in NY and GA, 2020 Scott Fridkin, MD Oct 20 12:15 – 1:30 PM US ET Hall B + C 394 - Impact of Misdiagnosis of Clostridioides difficile Infection (CDI) by Standard-of-care Specimen Collection and Testing on Estimates of Hospitalized CDI Incidence Among Adults in Louisville, Kentucky, 2019-2020 Frederick Angulo, DVM PhD Oct 20 12:15 – 1:30 PM US ET Hall B + C Pneumococcal Disease 576 - Burden of Pneumococcal Disease Due to Serotypes Covered by the 13-Valent and New Higher-Valent Pneumococcal Conjugate Vaccines in All Children and Children at Risk in the United States Liping Huang, MD, MA, MS Oct 20 12:15 – 1:30 PM US ET Hall B + C 586 - Systematic Literature Review of the 13-valent Pneumococcal Conjugate Vaccine (PCV13) Effectiveness Against Invasive Pneumococcal Disease in Children Globally Johnna Perdrizet, MPH Oct 20 12:15 – 1:30 PM US ET Hall B + C Lyme Disease 1351 - A Retrospective Database Study of Lyme Borreliosis Incidence and Distribution in Poland from 2015 to 2019 James Stark, Ph.D. Oct 21 12:15 – 1:30 PM US ET Hall B + C 1352 - Exploring spatial and temporal trends in the incidence of Lyme borreliosis in Finland using surveillance data, 2015-2020 James Stark, Ph.D. Oct 21 12:15 – 1:30 PM US ET Hall B + C 1353 - Incidence of Lyme Borreliosis in Germany: Exploring Observed Trends Over Time Using Public Surveillance Data, 2016-2020 James Stark, Ph.D. Oct 21 12:15 – 1:30 PM US ET Hall B + C 1354 - Incidence, time trends and geographic distribution of Lyme neuroborreliosis in Denmark using public surveillance data, 2015-2019 James Stark, Ph.D. Oct 21 12:15 – 1:30 PM US ET Hall B + C 1361 - Lyme Borreliosis (LB) is a Significant Disease Burden in Germany: Estimated LB Incidence after Adjusting for Under-ascertainment by Public Health Surveillance, 2021 Frederick Angulo, DVM PhD Oct 21 12:15 – 1:30 PM US ET Hall B + C 1462 - Validating a claims-based algorithm for Lyme Disease in Massachusetts Sarah J. Pugh, PhD, MPH Oct 21 12:15 – 1:30 PM US ET Hall B + C Antimicrobial Surveillance 659 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents against Enterobacterales Collected from Patients with Bloodstream Infections (BSI) as Part of the ATLAS (India) Surveillance Program, 2019-2020 Abhisek Routray, PhD Oct 20 12:15 – 1:30 PM US ET Virtual Other 2134 - A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Booster Dose of a Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6) Babalwa Jongihlati, MD, MBA Oct 22 12:15 – 1:30 PM US ET Hall B + C 2207 - Rates of Lower Respiratory Tract Infections Among US Adults Aged ≥18 Years With and Without Chronic Medical Conditions Kari Yacisin, M.D. Oct 22 12:15 – 1:30 PM US ET Hall B + C 2208 - Rates of Medically-Attended RSV among US Adults: A Systematic Review and Meta-Analysis Farid L. Khan, MPH Oct 22 12:15 – 1:30 PM US ET Hall B + C 106 - High Maternal Tdap Vaccine Uptake During Early Part of Vaccination Window: Implications for Future Maternal Vaccines Amy W. Law, PharmD Oct 20 12:15 – 1:30 PM US ET Hall B + C POSTERS - PFIZER CO-AUTHORS COVID-19 1068 - Prior SARS-CoV-2 Infection And Risk of Subsequent COVID-19-Related Hospitalization: A Test Negative Design Khalel De Castro Oct 21 12:15 – 1:30 PM US ET Hall B + C 1908 - Social Risk Factors for COVID-19-Related Hospitalizations in Adults Olivia D. Reese, BA Oct 22 12:15 – 1:30 PM US ET Hall B + C 1934 - Association between Receipt of COVID-19, Influenza, and Pneumococcal Vaccination Chris Choi, BA Oct 22 12:15 – 1:30 PM US ET Hall B + C RSV 371 - Adding sputum and saliva to nasopharyngeal swab samples for PCR detection of Respiratory Syncytial Virus in adults hospitalized with acute respiratory illness may double case detection Julio A. Ramirez, MD, FACP Oct 20 12:15 – 1:30 PM US ET Hall B + C Antimicrobial Surveillance 1717 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated from Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2017-2020 Mark Estabrook, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1719 - In Vitro Activity of Ceftazidime-avibactam and Comparator Agents against Enterobacterales and Pseudomonas aeruginosa Collected from Patients with Bloodstream Infections as Part of the ATLAS Global Surveillance Program, 2017-2020 Mark Estabrook, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1720 - In Vitro Activity of Aztreonam-Avibactam and Comparator Agents Against Enterobacterales from Patients with Urinary Tract Infections Collected During the ATLAS Global Surveillance Program, 2017-2020 Mark Estabrook, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1673 - In vitro Activities of Ceftaroline and Comparator Agents against Bacterial Pathogens Frequently Causing Community-Acquired Respiratory Tract Infections in Patients from a Global Population: ATLAS Surveillance Program 2017-2020 Meredith Hackel, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1707 - In vitro Activities of Ceftazidime-Avibactam and Comparator Agents against Enterobacterales and Pseudomonas aeruginosa Collected < 48 Hours and ≥48 Hours Post-Admission from Hospitalized Adult Patients, ATLAS Global Surveillance Program 2017-2020 Mark Wise, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1708 - In vitro Activities of Ceftazidime-Avibactam and Comparator Agents against Enterobacterales and Pseudomonas aeruginosa Collected < 48 Hours and ≥48 Hours Post-Admission from Hospitalized Pediatric Patients, ATLAS Global Surveillance Program 2017-2020 Mark Wise, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 1709 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against MDR Enterobacterales and Pseudomonas aeruginosa Collected in Latin America, ATLAS Global Surveillance Program 2018-2020 Mark Wise, PhD Oct 22 12:15 – 1:30 PM US ET Hall B + C 2043 - In Vitro Activity of Manogepix Against 2,810 Fungal Isolates from the SENTRY Surveillance Program (2020-2021) Stratified by Infection Type Michael D. Huband, BS Oct 22 12:15 – 1:30 PM US ET Hall B + C Pfizer Conference Call Pfizer Inc. invites Pfizer investors and the general public to view and listen to “RSV Data and COVID Vaccine Commercial Update,” a webcast of a live conference call with investment analysts at 4:30 p.m. ET on October 20. To view and listen to the webcast visit Pfizer’s web site at or directly at . Information on accessing and pre-registering for the webcast will be available at beginning today. Participants are advised to pre-register in advance of the conference call. You can listen to the conference call by dialing either 800-456-4352 in the United States or Canada or 785-424-1086 outside of the United States and Canada. The passcode is “48062.” Please join the call five minutes prior to the start time to avoid operator hold times. The transcript and webcast replay of the call will be made available on Pfizer’s web site at within 24 hours after the end of the live conference call and will be accessible for at least 90 days. INDICATIONS FOR PREVNAR 13® IN THE U.S. PREVNAR 13® is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) PREVNAR 13® is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae. It is also approved for children 6 weeks through 5 years for the prevention of otitis media (ear infection) caused by 7 of the 13 strains PREVNAR 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine PREVNAR 13® IMPORTANT SAFETY INFORMATION PREVNAR 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine Children with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response A temporary pause of breathing following vaccination has been observed in some infants born prematurely The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%) In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever Adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response In adults, the most common side effects (>5%) were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash Ask your healthcare provider about the risks and benefits of PREVNAR 13®. Only a healthcare provider can decide if PREVNAR 13® is right for your child Please see full prescribing information for PREVNAR 13® PAXLOVID™ 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-19 PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19 PAXLOVID 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 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: alfuzosin Antianginal: ranolazine Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine Anti-gout: colchicine Antipsychotics: lurasidone, pimozide Benign prostatic hyperplasia agents: silodosin Cardiovascular agents: eplerenone, ivabradine Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine HMG-CoA reductase inhibitors: lovastatin, simvastatin Immunosuppressants: voclosporin Microsomal triglyceride transfer protein inhibitor: lomitapide Migraine medications: eletriptan, ubrogepant Mineralocorticoid receptor antagonists: finerenone Opioid antagonists: naloxegol PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension Sedative/hypnotics: triazolam, oral midazolam Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin Vasopressin 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: apalutamide Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor Antimycobacterials: rifampin Herbal 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 medications Clinically significant adverse reactions from greater exposures of PAXLOVID Loss 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 <1%, respectively), diarrhea (3% and 2%), hypertension (1% and <1%), and myalgia (1% and <1%). The proportions of subjects who discontinued treatment due to an adverse event were 2% in the PAXLOVID group and 4% in the placebo group. The following adverse reactions have been identified during post-authorization use of PAXLOVID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis, hypersensitivity reactions Gastrointestinal Disorders: Abdominal pain, nausea General Disorders and Administration Site Conditions: Malaise Required Reporting for Serious Adverse Events and Medication Errors: The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider’s awareness of the event. Submit adverse event and medication error reports to FDA MedWatch using one of the following methods: Online: Complete and submit a postage-paid FDA Form 3500 and returning by mail/fax Call 1-800-FDA-1088 to request a reporting form In addition, please provide a copy of all FDA MedWatch forms to: , or by fax (1-866-635-8337) or phone (1-800-438-1985). PAXLOVID is a strong inhibitor of CYP3A and may increase plasma concentrations of drugs that are primarily metabolized by CYP3A. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring. Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect. Pregnancy: There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drugassociated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Breastfeeding individuals with COVID19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID19. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pediatrics: PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. The authorized adult dosing regimen is expected to result in comparable serum exposures of nirmatrelvir and ritonavir in patients 12 years of age and older and weighing at least 40 kg as observed in adults, and adults with similar body weight were included in the trial EPIC-HR. Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment (eGFR ≥30 to <60 mL/min), reduce the dose of PAXLOVID to 150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions. PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min based on CKD-EPI formula) until more data are available; the appropriate dosage for patients with severe renal impairment has not been determined. No dosage adjustment of PAXLOVID is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of nirmatrelvir or ritonavir in subjects with severe hepatic impairment (Child-Pugh Class C); therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of October 18, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease portfolio, and licensed and investigational products, including Prevnar 13, Paxlovid, its respiratory syncytial virus vaccine candidate (RSVpreF), its C. difficile infection vaccine candidate its Lyme disease vaccine candidate, and its Group B Streptococcus vaccine candidate, GBS6, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed in any jurisdictions for any infectious disease products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such infectious disease products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such infectious disease products; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding any such infectious disease products and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Tag: Research and Pipeline

Forget Covid-19, monkeypox, and other viruses for the moment and consider another threat troubling infectious disease specialists: common urinary tract infections, or UTIs, that lead to emergency room visits and even hospitalizations because of the failure of oral antibiotics. There’s no Operation Warp Speed charging to rescue us from the germs that cause these infections, which expanded their range during the first year of the pandemic, according to a new Centers for Disease Control and Prevention report. In the past year, the FDA declined to approve two promising oral drugs — sulopenem and tebipenem — to treat drug-resistant UTIs, saying it needed more evidence they work as well as current drugs. In the meantime, some UTI patients “have to get admitted and get an IV treatment for a bladder infection that typically would be treated with oral antibiotics,” said Sarah Doernberg , an infectious disease specialist at the University of California-San Francisco Medical Center. Rebecca Clausen, an office worker in Durham, North Carolina, was prescribed several courses of a cheap oral antibiotic for a persistent UTI earlier this year, but it “just seemed to keep coming back,” she said. Doctors considered a six-week treatment with an intravenous drug, ertapenem, that would have cost her about $2,000 out-of-pocket, but decided it probably wouldn’t help. For now, she’s simply hoping the infection won’t worsen. While specialists say they are seeing more urinary tract infections that oral antibiotics can’t eliminate, the problem is still thought to be relatively rare (federal health officials don’t directly track the issue). However, it’s emblematic of a failure in the antibiotics industry that experts and even US senators say can be fixed only with government intervention. The CDC report, released July 12, showed that after mostly declining during the previous decade, the incidence rates of seven deadly antimicrobial-resistant organisms surged by an average of 15% in hospitals in 2020 because of overuse in Covid patients. Some of the sharpest growth occurred in bugs that cause hard-to-treat UTIs. Although nearly 50,000 Americans — and about 1.3 million people worldwide — die of resistant bacterial infections each year, the FDA has not approved a new antibiotic since 2019. Big Pharma has mostly abandoned antibiotics development, and seven of the 12 companies that successfully brought a drug to market in the past decade went bankrupt or left the antibiotics business because of poor sales. That’s because of a central paradox: The more an antibiotic is administered, the quicker bacteria will mutate to get around it. So practitioners are aggressively curbing use of the drugs, with 90% of US hospitals setting up stewardship programs to limit the use of antibiotics, including new ones. That, in turn, has caused investors to lose interest in the antibiotics industry. A pipeline of new drugs is vital, given the implacable capacity of bacteria to mutate and adapt. But while resistance is an ever-present danger, some 90%-95% of fatal infections involve microbes that are not multidrug-resistant but difficult to treat for other reasons, such as the delicate condition of the patient, said Sameer Kadri , head of clinical epidemiology at the National Institutes of Health Clinical Center’s Critical Care Medicine Department. “As bad as antibiotic resistance is, it’s bad against a minority of people,” said Jason Gallagher , a professor and infectious diseases pharmacist at Temple University Hospital in Philadelphia. Since clinicians usually can’t quickly determine a bug’s resistance level, they start with the old drug most of the time. “That makes anti-infectives a pretty tough investment from a drug company perspective,” he added. “You’re going to develop your drug and people are going to do their best to not use it.” As antibiotics companies disappear, so does their scientific expertise, said David Shlaes , a retired pharmaceutical industry scientist. Should a particularly deadly pattern of resistance develop with no drug pipeline, it could cause destruction on a hair-raising scale, he said. “Antibiotics are an essential part of civilization,” said Kevin Outterson, a Boston University law professor who leads a public-private fund that helps companies develop antimicrobials. “They must be renewed every generation or we will slip back into the pre-antibiotic era.” The roadblocks to approval of the UTI drugs tebipenem and sulopenem illustrate the complexity and regulatory challenges of the antibiotics arena. In a big clinical trial completed last year, Iterum Therapeutics’ sulopenem was far better than an older drug, ciprofloxacin, at reducing UTI symptoms, but it didn’t seem as adept at killing bacteria, which the FDA considered to be an equally important measure of success. At a June 3 workshop, FDA officials indicated they might be willing to change their standard in future trials. Another company, Spero Therapeutics, published what looked like a successful trial for oral tebipenem in the New England Journal of Medicine in April. But FDA officials rejected Spero’s application for licensure because a species of bacteria included in the analysis was deemed irrelevant to the drug’s efficacy. Though new oral drugs against UTIs are sorely needed , IV drugs can still conquer most routine UTIs. But the broader threat of a future without new antibiotics is particularly frightening to patients with serious chronic diseases, who are permanently engaged in struggles with bacteria. Two or three times a day, Molly Pam, a 33-year-old chef and patient advocate in San Francisco, inhales nebulized blasts of colistin or aztreonam. These are antibiotics that the typical person stays away from, but for the 30,000 US cystic fibrosis patients like Pam, deadly bugs and powerful drugs are a fixture of life. Several times a year, when fever or exhaustion signals that the bugs colonizing her damaged, mucus-clogged lungs are getting overly procreative, Pam heads to a clinic or hospital for IV treatment. In 2019, just as she was approaching resistance to all antibiotics, the drug Zerbaxa received FDA approval. Pseudomonas and MRSA bacteria have colonized Pam’s lungs since she was a child, their mutations requiring frequent antibiotic updates. In 2018, she was struck down with a drug-resistant, tuberculosis-like bacteria that required a year of three-times-a-day IV drug treatments on top of her other drugs. Last year, she was airlifted to Stanford Medical Center after she began coughing up blood from a damaged lung. Doctors test Pam’s sputum four times a year to determine which bugs she’s harboring and which antibiotics will work against them. She’s always only a few mutations from disaster. “I absolutely depend on new drugs,” Pam said. The development and testing of these new molecules is hardscrabble terrain, featuring frequent conflicts between the FDA and industry over how to measure an antibiotic’s effectiveness — is it patient survival? Symptom improvement? Bacteria count? And over how long a period? Meanwhile, Congress has aided the industry with patent extensions, and federal agencies have poured in hundreds of millions in grants and partnerships . The World Health Organization and the drug industry in 2020 created a $1 billion venture capital fund to support worthy antibiotics companies. Still, stewardship of antibiotics arguably has had the biggest influence in reducing the threat of resistance. A 2019 CDC report found an 18% reduction since 2013 in deaths caused by drug-resistant organisms, and a 21% decline in infections of MRSA, or methicillin-resistant Staphylococcus aureus , once a leading medical bogeyman. But progress can make it harder to test new drugs. With highly resistant bacterial infections still relatively unusual, clinical trials for new drugs generally measure their effectiveness against all bacteria in the relevant class, rather than the most resistant bugs. And since new drugs often gain approval simply by showing they are roughly as effective as existing drugs, infectious disease doctors generally shun them, at least initially, skeptical of their relatively high prices and questionable superiority. “There aren’t that many people with antibiotic resistance,” said Emily Spivak , who leads stewardship programs at the University of Utah and VA Salt Lake City hospitals. “When people get these infections, it’s horrible. But there aren’t enough to make the kind of profits the companies want.” For example, hospitalized patients with MRSA-related pneumonia often can be treated with vancomycin (starting at about $15 per day ), said Spivak, who chairs the Infectious Diseases Society of America’s antimicrobial resistance committee. She sometimes turns to a newer alternative, ceftaroline ($400 a day), which can have fewer side effects. “But even so, we are not cranking through these drugs, and we never will, because luckily we can do other things to prevent MRSA, such as cleaning skin before surgery and keeping catheters clean.” In the early days of Covid, many hospitals desperately threw antimicrobials at the mysterious virus, and the pandemic crisis strained stewardship teams, Spivak said. The new CDC data showed that clinicians gave antibiotics to 80% of hospitalized Covid patients in the first eight months of the pandemic, although such drugs have no impact on Covid infection. But the uptake of new antibiotics has been slow. A report on 17 new antibiotics marketed in the United States over the past five years showed only three with sales over $100 million per year. The 17 averaged sales of about $44 million for the 12 months ending in June 2020. A few of the new drugs, such as a combination antibiotic marketed in the US as Avycaz, have gradually replaced colistin, a highly toxic 1950s compound that was brought back in 2000 because of its efficacy against certain resistant bacteria. Yet even that transition, recommended by infectious disease specialists, was gradual. That’s not surprising since colistin costs about $140 for a 10-day treatment, while a course of Avycaz might set a hospital back $14,000 to $28,000, noted Dominic Chan , chief of pharmacy services at Legacy Health in Oregon. Medicare reimbursement for treating hospital infections is low, Chan said, “so there’s no incentive for the hospitals to invest that type of capital into bringing these agents in — other than doing the right thing.” In most cases, hospitals do appear to be doing the right thing, however. Recent CDC data shows that 90% of US hospitals have stopped using colistin, said agency spokesperson Martha Sharan. Executives from the dwindling number of antibiotics makers complain that stewardship programs are too stingy, to the detriment of patients. In part, they blame Medicare programs that pay hospitals a lump sum for treatment of a given condition. A congressional bill filed in 2019 and resubmitted last year would require Medicare to pay for new antibiotics separately. Democrats blocked the bill, but antibiotics producers argue it would incentivize hospitals to use their drugs. Holding back on the new antibiotics allows resistance to old drugs to grow worse, and “that makes it harder and harder for a new antibiotic to do its job,” said Ted Schroeder, CEO of antibiotics maker Nabriva and leader of an industry interest group. But the bottom line is that most patients don’t need the newest drugs, Kadri said. In a 2020 NIH study that the FDA helped fund, Kadri and his colleagues reviewed records from 134 hospitals from 2009 to 2015 to find examples of difficult-to-treat, highly resistant bacteria of the gram-negative type — a key area of concern. Of about 139,000 gram-negative infections, only 1,352 fell into the difficult-to-treat category — roughly 1%. “There are just not enough cases” to create an adequate market for new antibiotics, Kadri said. Extrapolating from the study, the market for new antibiotics against highly resistant gram-negative bacteria would range from $120 million to $430 million a year, compared with the average $1 billion needed to develop a single drug, wrote Neil Clancy and Minh-Hong Nguyen of the Veterans Affairs Pittsburgh Healthcare System. In the absence of a viable market, infectious disease experts, drug companies, and patient groups have rallied behind the PASTEUR Act, introduced by Sens. Michael Bennet (D-Colo.) and Todd Young (R-Ind.) last year. The bill would create a fund of up to $11 billion over 10 years to award promising antimicrobials that were close to or had received FDA approval. The government would guarantee payments of up to $3 billion for each drug, removing the incentive for overuse. PASTEUR has 40 co-sponsors in the Senate. Experts think its passage is crucial. “Even though, on a population basis, the need for new drugs is small, you don’t want to be that patient” who might need them, Kadri said. “If you are, you want to have an array of drugs that are safe and effective.” By Arthur Allen First published at KHN ( Kaiser Health News ) — a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.