- The target Prescription Drug User Fee Act (PDUFA) action date
for a decision by the FDA is May 2023
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and
Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee
(AMDAC) voted 16 to 1 that available data support the safety and
effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir
tablets) for the treatment of mild-to-moderate COVID-19 in adult
patients who are at high risk for progression to severe illness.
The AMDAC's vote, while not binding, will be considered by the FDA
when making its decision regarding the potential approval of
PAXLOVID.
“We believe it is critical for adults who are at high risk of
progression to severe COVID-19 to have access to safe and effective
treatment options, like PAXLOVID, to help prevent avoidable
hospitalizations and deaths,” said James Rusnak, Senior Vice
President and Chief Development Officer, Internal Medicine,
Anti-infectives and Hospital, Pfizer. “We are encouraged by the
AMDAC’s positive vote today. The outcome is well supported by the
strong safety and efficacy data seen both in our clinical trials
and in a growing base of real-world evidence, showing that PAXLOVID
helps to reduce the risk of hospitalization or death for high-risk
adult patients regardless of vaccination status.”
The AMDAC based its vote on the totality of scientific and
real-world evidence shared by Pfizer, including safety and efficacy
data from the EPIC (Evaluation
of Protease Inhibition for COVID-19) clinical development program. This
included results from the Phase 2/3 EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk
Patients), which enrolled unvaccinated, non-hospitalized adults,
aged 18 years and older, with confirmed COVID-19 who are at
increased risk of progressing to severe disease. The data showed an
86% reduction in risk of COVID-19-related hospitalization or death
from any cause through Day 28 in patients treated with PAXLOVID
within 5 days of symptoms onset, compared to placebo. The vote was
further supported by results from a secondary endpoint of the Phase
2/3 EPIC-SR study (Evaluation
of Protease Inhibition for COVID-19 in Standard-Risk Patients) which showed the effectiveness
of Paxlovid in a sub-group of non-hospitalized adults, aged 18
years and older, with confirmed COVID-19 who had at least one risk
factor for progression to severe disease and who were fully
vaccinated.
In addition, real-world evidence presented to the AMDAC showed
that PAXLOVID’s clinical profile in the post-authorization setting
is consistent with the safety and efficacy conclusions from the
EPIC clinical program, including observations made when the Omicron
variant and its lineages were the predominant forms of SARS-CoV-2
in circulation. This real-world evidence also shows the
effectiveness of PAXLOVID among vaccinated patients and patients
who developed natural immunity.1,2,3
COVID-19 continues to cause significant burden in the U.S. as
case rates fluctuate and new variants and sub-variants emerge,
regardless of virulence. Approximately 4,000‒5,000 hospital
admissions and 500‒600 deaths are caused by the virus each day in
the U.S., as of January 2023.4 With more than 200 million adults in
the U.S. at high risk of severe COVID-19, there is a critical need
for treatment options in this population.5 According to the U.S.
Centers for Disease Control and Prevention (CDC), factors which
could put someone at high risk of severe COVID-19 include any of
the following: being aged 50 and older, obesity, diabetes (type 1
and type 2), heart conditions, smoking (current or former),
physical inactivity, chronic kidney or liver disease, and cancer,
among others.6
If approved by the FDA, PAXLOVID could be the first U.S.
FDA-approved oral treatment for COVID-19. The target Prescription
Drug User Fee Act (PDUFA) action date for a decision by the FDA is
May 2023. Under the FDA emergency use authorization (EUA), PAXLOVID
is currently authorized for use in, and remains available to,
adults and pediatric patients (12 years of age and older weighing
at least 40 kg) at high risk of progression to severe COVID-19. In
the U.S., more than 10 million treatment courses of PAXLOVID have
been prescribed to date.7
Pfizer continues to gather pediatric data from the ongoing
clinical trial EPIC-Peds (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) and intends to submit a supplemental New
Drug Application (NDA) to support the FDA approval of PAXLOVID in
children at a future date. In February 2023, the European
Commission (EC) granted standard Marketing Authorization (MA) of
PAXLOVID for the treatment of COVID-19 in adults who do not require
supplemental oxygen and who are at increased risk of the disease
becoming severe.
About PAXLOVID™ (nirmatrelvir 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, 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 variants
Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2,
BA.2.12.1, BA.4, BA.4.6, BA.5, BF.7, BQ.1.11, BQ.1 and XBB.1.5.
Work is ongoing to evaluate activity against recently identified
variants as they become available for testing.
PAXLOVID is generally administered at a standard dose of 300 mg
(two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of
ritonavir, taken together 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. The dose for patients
with moderate renal impairment (eGFR ≥30 to <60 mL/min) should
be reduced to 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg
ritonavir (one 100 mg tablet), with both tablets taken together
twice daily for five days (PAXLOVID is not recommended in patients
with severe renal impairment [eGFR <30 mL/min]).
For more information, please visit www.PAXLOVID.com.
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 adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with a
current diagnosis of mild-to-moderate coronavirus disease 2019
(COVID-19) 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 adults and pediatric patients (12 years of age and older
weighing at least 40 kg) with a current diagnosis of
mild-to-moderate coronavirus disease 2019 (COVID-19) 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 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
- 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 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.
Please see Fact Sheet for Healthcare Providers
and Fact Sheet for Patients, Parents, and
Caregivers.
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 March 16,
2023. 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
efforts to combat COVID-19 and PAXLOVID (including a New Drug
Application pending with the FDA and a FDA Antimicrobial Drugs
Advisory Committee vote in favor of approval of PAXLOVID for adult
patients who are at high risk for progression to severe illness
from COVID-19, intention to submit a supplemental New Drug
Application to support the FDA approval of PAXLOVID in children at
a future date, the anticipated timing of data readouts, regulatory
submissions, regulatory approvals or authorizations, and
anticipated manufacturing, distribution and supply), 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
possibility of unfavorable new preclinical, clinical or safety data
and further analyses of existing preclinical, clinical or safety
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 or any of Pfizer’s other products or
product candidates 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 or any of Pfizer’s other products or
product candidates that may be pending or filed (including the New
Drug Application pending with the FDA), 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 or any of Pfizer’s other products
or product candidates, including the authorization or approval of
products or therapies developed by other companies; the risk that
other companies may produce superior or competitive products; risks
related to the availability of raw materials to manufacture or test
PAXLOVID; manufacturing capabilities or capacity; the risk that we
may not be able to maintain manufacturing capacity or 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 or existing
agreements will be completed or re-negotiated; the risk that demand
for any products may be reduced, no longer exist or not meet
expectations, which may lead to excess inventory on-hand and/or in
the channel or reduced revenues; 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, 2022 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 Lewnard JA, McLaughlin JM,
Malden D, et al. Effectiveness of nirmatrelvir-ritonavir against
hospital admission or death: a cohort study in a large US
healthcare system. Lancet ID:
https://doi.org/10.1016/S1473-3099(23)00118-4 2 Ganatra S, Dani SS,
Ahmad J, et al. Oral Nirmatrelvir and Ritonavir in Non-hospitalized
Vaccinated Patients with Covid-19 [published online ahead of print,
2022 Aug 20]. Clin Infect Dis. 2022;ciac673.
doi:10.1093/cid/ciac673 3 Aggarwal NR, Molina KC, Beaty LE, et al.
Real-world use of nirmatrelvir–ritonavir in outpatients with
COVID-19 during the era of omicron variants including BA.4 and BA.5
in Colorado, USA: a retrospective cohort study. The Lancet
Infectious Diseases 2023. DOI:
https://doi.org/10.1016/S1473-3099(23)00011-7. 4 Centers for
Disease Control and Prevention. COVID Data Tracker: Daily Update
for the United States. Available at:
https://covid.cdc.gov/covid-data-tracker/#datatracker-home. 5 Li,
H. L., & Cheung, B. M. (2020). The proportion of adult
Americans at risk of severe covid-19 illness. Journal of General
Internal Medicine, 36(1), 259–261.
https://doi.org/10.1007/s11606-020-06325-9 6 To learn more about
who may be at high risk of progression to severe COVID-19, visit
the Centers for Disease Control and Prevention 7 IQVIA National
Prescription Audit data through February 24, 2023, containing
retail pharmacy, mail order and long-term care channels; U.S.
Department of Health and Human Services data through February 2023,
for non-retail channels. Note: This information is an estimate
derived from the use of information under license from the
following IQVIA information service: National Prescription Audit,
for the period January 1, 2022-Feburary 24, 2023. IQVIA expressly
reserves all rights, including rights of copying, distribution and
republication.
View source
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