- Submission seeks approval for the treatment of COVID-19 in both
vaccinated and unvaccinated individuals at high risk for
progression to severe illness from COVID-19; consistent with
current emergency use authorization
- Final results from EPIC-HR study showed an 86% reduction in
relative risk of hospitalizations or death from any cause; no
deaths were observed in patients treated with PAXLOVID™
(nirmatrelvir [PF-07321332] tablets and ritonavir tablets) through
Week 24, compared to 15 deaths observed with placebo
- 50-60% of the U.S. population is estimated to have at least one
risk factor for progressing to severe COVID-19 illness
- Available safety data generally consistent in more than 3,500
PAXLOVID-treated participants across EPIC clinical development
program
Pfizer Inc. (NYSE: PFE) today announced the submission of a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for approval of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets
and ritonavir tablets) for patients who are at high risk for
progression to severe illness from COVID-19. PAXLOVID is currently
authorized for emergency use 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 [88 lbs]) 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 submission provides the longer-term follow-up data necessary
for acceptance and potential approval.
According to the U.S. Centers for Disease Control and Prevention
(CDC), 50-60% of the U.S. population is estimated to have one or
more risk factors for progressing to severe COVID-19 illness.1
These risk factors include any of the following: being aged 65 and
older, obesity, diabetes, hypertension, smoking, physical
inactivity, chronic kidney or liver disease, and immunocompromised
conditions such as cancer, among others.2
“As the COVID-19 pandemic continues to evolve and be highly
unpredictable, we must remain vigilant in protecting those who are
at greatest risk of getting very sick from COVID-19, as they remain
vulnerable to potential hospitalization or even death,” said Albert
Bourla, Chairman and Chief Executive Officer, Pfizer. “Data from
our clinical development program, coupled with the more than 1.7
million patients around the world who have been prescribed our oral
treatment to date, reinforce PAXLOVID as an important treatment
option for mild-to-moderate COVID-19 in patients at greater risk of
progression to severe symptoms, regardless of vaccination status.
We look forward to working with the FDA toward full regulatory
approval for PAXLOVID.”
The NDA submission is supported by non-clinical and clinical
data for PAXLOVID. It includes results from the Phase 2/3 EPIC-HR
study (Evaluation of
Protease Inhibition for COVID-19 in High-Risk
Patients), which found that, compared to placebo, treatment with
PAXLOVID reduced the risk of hospitalization or death from any
cause by 88% in non-hospitalized, high-risk adult patients treated
within five days of symptom onset; results from the final Clinical
Study Report showed an 86% reduction in relative risk. The
submission is also comprised of the most recent analyses from the
Phase 2/3 EPIC-SR study (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), which included data from both
vaccinated patients with, and unvaccinated patients without, risk
factors for severe COVID-19. While the novel primary endpoint of
self-reported, sustained alleviation of all symptoms for four
consecutive days was not met, the data were supportive of the
efficacy and safety data observed in EPIC-HR for use in patients at
increased risk of progression to severe COVID-19 illness. The NDA
submission also includes:
- An integrated analysis of data across the EPIC-HR and EPIC-SR
studies, which showed an 84% reduction (p<0.0001) in
hospitalizations or death, compared to placebo and regardless of
vaccination status, in patients with at least one risk factor for
progression to severe COVID-19 illness who were treated with
PAXLOVID (12/1,400 [0.857%] PAXLOVID-treated patients versus
73/1,406 [5.192%] placebo recipients) within five days of symptom
onset.
- In EPIC-HR, there was an 86% relative risk reduction in
hospitalizations or death through Day 28 in PAXLOVID-treated
patients [9/1,039] with no deaths, compared to placebo [66/1,046]
which included twelve deaths.
- In EPIC-SR, there was a 57% relative risk reduction in
hospitalizations or death through Day 28 in PAXLOVID-treated
patients [3/361] with no deaths, compared to placebo [7/360] which
included one death.
- Available safety data for PAXLOVID, which have been generally
consistent in more than 3,500 PAXLOVID-treated participants across
the EPIC clinical development program, including EPIC-HR, EPIC-SR,
and EPIC-PEP3 studies, as well as in reported post-authorization
safety experience.
- Data from the EPIC-HR, EPIC-SR and EPIC-PEP studies which
showed a consistent reduction in viral load with PAXLOVID,
including across both the Delta and Omicron variants.
- Data which show that the frequency of return of detectable
nasal viral RNA following PAXLOVID treatment was low and generally
similar among PAXLOVID and placebo recipients.
PAXLOVID is currently approved or authorized for conditional or
emergency use in more than 65 countries across the globe to treat
COVID-19 patients who are at increased risk for progressing to
severe illness. As of the end of May 2022, Pfizer had shipped more
than 12 million treatment courses of PAXLOVID to nearly 40
countries around the world.
Please see Full Emergency Use Authorization (EUA) Prescribing
Information available at www.fda.gov and www.PAXLOVID.com
About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and
ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also
known as SARS-CoV-2 3CL protease inhibitor) therapy. It was
developed to be administered orally so that it can be prescribed
early after infection, potentially helping patients avoid severe
illness (which can lead to hospitalization and death). Nirmatrelvir
[PF-07321332], which originated in Pfizer laboratories, is designed
to block the activity of the Mpro, an enzyme that the coronavirus
needs to replicate. Co-administration with a low dose of ritonavir
helps slow the metabolism, or breakdown, of nirmatrelvir in order
for it to remain active in the body for longer periods of time at
higher concentrations to help combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage
known as proteolysis, which occurs before viral RNA replication. In
preclinical studies, nirmatrelvir did not demonstrate evidence of
mutagenic DNA interactions.
Current variants of concern can be resistant to treatments that
work by binding to the spike protein found on the surface of the
SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by
binding to the highly conserved Mpro (3CL protease) of the
SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has
shown consistent in vitro antiviral activity against the following
variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1
and BA.2.
PAXLOVID is generally administered at a dose of 300 mg (two 150
mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir,
given twice-daily for five days. One carton contains five blister
packs of PAXLOVID, as co-packaged nirmatrelvir tablets with
ritonavir tablets, providing all required doses for a full five-day
treatment course.
Our Commitment to Access
Pfizer is committed to working toward equitable access to our
oral COVID-19 treatment, PAXLOVID, for high-risk patients in need,
aiming to deliver safe and effective oral treatment as soon as
possible and at an affordable price. If authorized or approved,
during the pandemic, Pfizer will offer its oral therapy through a
tiered pricing approach based on the income level of each country
to promote equity of access across the globe; high and upper-middle
income countries will pay more than lower-income countries. To
date, Pfizer has shipped more than 12 million treatment courses of
PAXLOVID to nearly 40 countries around the world.
Pfizer has established a comprehensive strategy in close
partnership with worldwide governments, international global health
leaders, including WHO’s Access to COVID-19 Tools Accelerator
(ACT-A), and global manufacturers to optimize supply and access of
PAXLOVID all around the world. This includes:
- Multilateral Supply Agreements: Signed agreement with
UNICEF to supply up to 4 million treatment courses of
PAXLOVID to low- and middle-income countries in 2022; Signed letter
of intent with Global Fund for up to 6 million PAXLOVID
treatment courses for supply to 130 Global-Fund eligible countries
in 2022 and 2023, subject to the signing of a definitive agreement
and regulatory approval or authorization.
- Expanding Access to Patent-Protected Medicines in
Lower-Income Countries: Launched An Accord for a Healthier
World, a first-of-its-kind initiative to enable sustained,
equitable access to high-quality medicines and vaccines for 1.2
billion people living in lower-income countries. Pfizer has
committed to provide its patent-protected medicines and vaccines
available in the U.S. or European Union, including PAXLOVID, on a
not-for-profit basis to 45 lower-income countries around the world
and will collaborate with government and global health leaders to
address barriers that limit access beyond supply, like diagnosis,
education, infrastructure, storage and more.
- Accelerating Testing and Treatment: Signed a letter of
intent to join COVID Global Accountability Platform (COVID
GAP), a joint initiative of COVID Collaborative and Duke
University, along with Open Society Foundations and the Clinton
Health Access Initiative (CHAI). Subject to a definitive agreement,
the company will provide treatment courses of PAXLOVID, as well as
funding and expert resources, to support the consortium’s efforts
aimed at accelerating testing and improving access to treatment in
under-resourced parts of the world.
- Treatment Donation: As part of its humanitarian
response, Pfizer donated 200K treatment courses of PAXLOVID to
Ukraine.
- Voluntary Licensing: Signed a voluntary license
agreement with Medicines Patent Pool (MPP) to enable the
development and distribution of generic versions of Pfizer’s oral
treatment to further expand long-term global supply and access. MPP
has signed sublicense agreements with 38 manufacturers, who will
supply the generic versions in 95 low- and lower-middle-income
countries.
Risk Factors for Severe Illness Due to COVID-19
People with certain risk factors or medical conditions are more
likely to become severely ill with COVID-19.2 According to the U.S.
Centers for Disease Control and Prevention, people more likely to
get very sick with COVID-19 include those aged 65 and older and
people with certain underlying conditions or risk factors such as
cancer, chronic kidney, lung, or liver disease, cystic fibrosis,
dementia or other neurological conditions, diabetes (type 1 or 2),
disabilities, heart conditions, HIV infection, an immunocompromised
condition or weakened immune system, mental health conditions,
being overweight or obese, physical inactivity, pregnancy, sickle
cell disease or thalassemia, smoking (current or former),
recipients of a solid organ or blood stem cell transplant, stroke
or cerebrovascular disease, substance use disorders, and
tuberculosis.2 Similarly, according to the World Health
Organization, COVID-19 is often more severe in people aged 60 and
older or with health conditions like lung or heart disease,
diabetes, or conditions that affect their immune system.2
About the EPIC-HR Final Results
In the final analysis of the primary endpoint from all patients
enrolled in EPIC-HR, an 89% reduction in COVID-19-related
hospitalization or death from any cause compared to placebo in
patients treated within three days of symptom onset was observed,
consistent with the interim analysis. In addition, a consistent
safety profile was observed.
0.7% of patients who received PAXLOVID were hospitalized through
Day 28 following randomization (5/697 hospitalized with no deaths),
compared to 6.5% of patients who received placebo and were
hospitalized or died (44/682 hospitalized with 9 subsequent
deaths). The statistical significance of these results was high
(p<0.0001). In a secondary endpoint, PAXLOVID reduced the risk
of hospitalization or death from any cause by 88% compared to
placebo in patients treated within five days of symptom onset; 0.8%
of patients who received PAXLOVID were hospitalized or died through
Day 28 following randomization (8/1039 hospitalized with no
deaths), compared to 6.3% of patients who received placebo (66/1046
hospitalized with 12 subsequent deaths), with high statistical
significance (p<0.0001). In the overall study population through
Day 34, no deaths were reported in patients who received PAXLOVID
as compared to 13 deaths in patients who received placebo.
Results from the final Clinical Study Report showed an 86%
reduction in risk of COVID-19 related hospitalization or death from
any cause through Day 28 in PAXLOVID-treated patients, relative to
placebo. For the pre-specified endpoint of all-cause mortality at
Week 24, no deaths were reported in patients who received PAXLOVID
as compared to 15 deaths in patients who received placebo,
representing a 100% relative risk reduction (p<0.0001).
In the EPIC-HR trial, in a secondary endpoint, SARS-CoV-2 viral
load at baseline and Day 5 have been evaluated for 1,574 patients.
After accounting for baseline viral load, geographic region, and
serology status, PAXLOVID reduced viral load by approximately
10-fold relative to placebo when treatment was initiated within
three days of symptom onset, indicating robust activity against
SARS-CoV-2.
Treatment-emergent adverse events were comparable between
PAXLOVID (23%) and placebo (24%), most of which were mild in
intensity. Fewer serious adverse events (1.6% vs. 6.6%) and
discontinuation of study drug due to adverse events (2.1% vs. 4.2%)
were observed in patients dosed with PAXLOVID, compared to placebo,
respectively.
All other secondary endpoints for this study, which are
available on clinicaltrials.gov (NCT04960202) and EudraCT
(2021-002895-38), were not yet available for this review.
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 only 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 in the therapeutic class to which PAXLOVID belongs
(i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the
treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use of PAXLOVID under 564(b)(1) of the Food Drug and
Cosmetic Act unless the authorization is terminated or revoked
sooner.
IMPORTANT SAFETY INFORMATION
PAXLOVID is contraindicated in patients with a history of
clinically significant hypersensitivity reactions (eg, toxic
epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its
active ingredients (nirmatrelvir or ritonavir) or any other
components of the product.
Drugs listed in this section are a guide and not considered a
comprehensive list of all drugs that may be contraindicated with
PAXLOVID. The healthcare provider should consult other appropriate
resources such as the prescribing information for the interacting
drug for comprehensive information on dosing or monitoring with
concomitant use of a strong CYP3A inhibitor such as ritonavir.
PAXLOVID is contraindicated with drugs that are highly
dependent on CYP3A for clearance and for which elevated
concentrations are associated with serious and/or life-threatening
reactions:
- Alpha1-adrenoreceptor antagonist: alfuzosin
- Analgesics: pethidine, propoxyphene
- Antianginal: ranolazine
- Antiarrhythmic: amiodarone, dronedarone, flecainide,
propafenone, quinidine
- Anti-gout: colchicine
- Antipsychotics: lurasidone, pimozide, clozapine
- 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, primidone, phenytoin
- Cystic fibrosis transmembrane conductance regulator
potentiators: lumacaftor/ivacaftor
- 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.
Hypersensitivity reactions have been reported with
PAXLOVID including urticaria, angioedema, dyspnea, mild skin
eruptions, and pruritus. Cases of anaphylaxis, TEN, and
Stevens-Johnson syndrome have also been reported with components of
PAXLOVID (refer to NORVIR labeling). 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: 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:
http://www.pfizersafetyreporting.com/ or by fax (1-866-635-8337) or
phone (1-800-438-1985).
PAXLOVID is an 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 drug‑associated
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 drug‑associated 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 COVID‑19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID‑19.
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 June 30,
2022. Pfizer assumes no obligation to update forward-looking
statements contained in this statement as the result of new
information or future events or developments.
This release contains forward-looking information about Pfizer’s
efforts to combat COVID-19 and PAXLOVID (including qualitative
assessments of available data, potential benefits, expectations for
clinical trials, the anticipated timing of data readouts,
regulatory submissions, regulatory approvals or authorizations, a
new drug application submission in the U.S. for appropriate
individuals at high risk of progression to severe illness and
potential in high-risk COVID-19 patients, and efforts toward
equitable access), involving 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, the uncertainties inherent in research
and development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with preclinical
and clinical data (including the data discussed in this release),
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data, including the risk that final results from
EPIC-SR could differ from the interim data; the ability to produce
comparable clinical or other results including efficacy, safety and
tolerability profile observed to date, in additional studies or in
larger, more diverse populations following commercialization;
uncertainties regarding the commercial impact of the results of the
EPIC-SR and EPIC-PEP trials; the ability of PAXLOVID to maintain
efficacy against emerging virus variants; the risk that serious and
unexpected adverse events may occur that have not been previously
reported with PAXLOVID use; the risk that preclinical and clinical
trial data are subject to differing interpretations and
assessments, including during the peer review/publication process,
in the scientific community generally, and by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from these and any future preclinical and
clinical studies; whether and when any drug applications or
submissions to request emergency use or conditional marketing
authorization for any potential indications for PAXLOVID may be
filed in particular jurisdictions and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when regulatory authorities in any
jurisdictions may approve any applications or submissions for
PAXLOVID that may be pending or filed (including the new drug
application submission for PAXLOVID in the U.S. for appropriate
individuals at high risk of progression to severe illness and
submissions in other jurisdictions), 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 it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of PAXLOVID, including development of products
or therapies by other companies; risks related to the availability
of raw materials for PAXLOVID; the risk that we may not be able to
create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand, which would negatively impact our ability to supply
the estimated numbers of courses of PAXLOVID within the projected
time periods; whether and when additional purchase agreements will
be reached; the risk that demand for any products may be reduced or
no longer exist which may lead to reduced revenues or excess
inventory; uncertainties regarding the impact of COVID-19 on
Pfizer’s 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.
1 Percentage of 12+ population derived from a) Analysis
conducted flagging all diagnosed patients in claims data with
diagnosed conditions that CDC considers to be “high-risk” except
for “sedentary”, smoking and obesity March – April 2022 b) RWE From
July 2020-July 2021 2 To learn more about who may be at high risk
of progression to severe COVID-19, visit the Centers for Disease
Control and Prevention or World Health Organization 3 EPIC-PEP
(Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis)
View source
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Pfizer Contacts: Media Relations +1 (212) 733-1226
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