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
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
www.pfizer.com/investors or directly at
https://pfizer.rev.vbrick.com/#/events/c5b674a0-5663-4030-a863-16ecfb0a0f9b.
Information on accessing and pre-registering for the webcast will
be available at www.pfizer.com/investors 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 www.pfizer.com/investors 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: https://www.fda.gov/medwatch/report.htm
- 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:
www.pfizersafetyreporting.com, 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 www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com 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 www.sec.gov and www.pfizer.com.
Tag: Research and Pipeline
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