Data from More Than 50 Clinical and
Epidemiological Abstracts Across Vaccines, HIV, Antibiotics and
Antimicrobials Show the Breadth of the Company’s Commitment to
Addressing the Threat of Infectious Diseases
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that new clinical and epidemiological data
from its broad infectious diseases and vaccines program will be
presented at IDWeek 2020 from Oct. 21 – 25, 2020. Clinical data to
be presented include new subgroup analyses from the Phase 3
RESTORE-IMI 2 trial evaluating the safety and efficacy of
RECARBRIO™ (imipenem, cilastatin, and relebactam) in adults with
hospital-acquired or ventilator-associated bacterial pneumonia
(HABP/VABP), and a new pooled analysis of the safety and efficacy
of PIFELTRO™ (doravirine) or DELSTRIGO™
(doravirine/lamivudine/tenofovir disoproxil fumarate) in adults 50
years of age and older living with HIV-1 who are treatment-naïve.
As part of Merck’s commitment to greater understanding of
infectious diseases, Merck researchers will present epidemiological
data including two multicenter evaluations of bacterial infections
and antimicrobial use among COVID-19 tested patients, and 12
studies evaluating disease burden and vaccination strategies. Merck
will also be sharing updates from SMART (Study for Monitoring
Antimicrobial Resistance Trends) surveillance program-related
abstracts accepted by the congress.
“This year, we’ve all witnessed the devastating impact
infectious diseases can have on patients and society. The pandemic
reinforces the compelling need for Merck to continue our
unwavering, decades-long commitment to addressing the threat of
infectious diseases through research,” said Dr. Nicholas Kartsonis,
senior vice president, infectious diseases and vaccines, Merck
Research Laboratories. “The breadth of our portfolio in infectious
diseases will be on display at IDWeek as we share new research in
vaccines, HIV and antibacterials.”
Select abstracts in the IDWeek program include:
Pediatric Infectious Diseases
- Evaluation of the Impact of a Single-dose Hepatitis A
Vaccination in Brazil: a time-series analysis. Poster: 1392.
Bierrenbach AL, et al.
- Current practices in the diagnosis and treatment of varicella
infections in the United States. Poster: 1387. Fergie J, et
al.
- Effectiveness of M-M-R® II in outbreaks - a systematic
literature review of real-world observational studies. Poster:
1390. Li S, et al.
- Factors Associated with Co-administration of Pentavalent
DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United
States (US). Poster: 1393. Petigara T, et al.
- Caregiver Burden related to Rotavirus Gastroenteritis: a
systematic literature review. Poster: 1379. Carias C, et al.
- Current status of the legal landscape regarding Rotavirus
Vaccination in the United States. Poster: 1380. Bhatti A, et
al.
- Rotavirus Gastroenteritis among older adults: discussion based
on a systematic literature review. Poster: 1381. Carias C, et
al.
Pneumococcal Disease
- Incidence of Acute Otitis Media in Children in the United
States before and after the introduction of Pneumococcal Conjugate
Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1479. Hu T, et
al.
- Incidence of Non-Invasive Pneumococcal Pneumonia in Children in
the United States before and after Introduction Pneumococcal
Conjugate Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1480.
Hu T, et al.
Certain HPV-Related Cancers and Disease
- Observational Study of Routine Use of 9-Valent Human
Papillomavirus Vaccine: Safe in More Than 140,000 Individuals.
Poster: 5. Hansen J, et al.
HABP/VABP & Antibiotics
- Imipenem/Cilastatin (IMI)/Relebactam (REL) in Hospital
Acquired/Ventilator-Associated Bacterial Pneumonia (HABP/VABP):
Subgroup Analyses of Critically Ill Patients in the RESTORE-IMI 2
Trial. Poster: 1460. Chen L, et al.
- Clinical and Microbiologic Outcomes by Causative Pathogen in
Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
(HABP/VABP) Treated with Imipenem/Cilastatin (IMI)/Relebactam (REL)
Versus Piperacillin/Tazobactam (PIP/TAZ). Poster: 1230. Losada M,
et al.
- Multivariate Regression Analysis to Determine Independent
Predictors of Treatment Outcomes in the RESTORE-IMI 2 Trial.
Poster: 1574. Tipping R, et al.
Antimicrobial Epidemiology/Surveillance
- Comparison of the Epidemiology and Pathogens Cultured from
Patients Hospitalized with SARS-CoV-2 Positive versus SARS-CoV-2
Negative in the US: A Multicenter Evaluation. Poster: 373. Puzniak
L, et al.
- Epidemiology of Antimicrobial Use Among SARS-CoV-2 Positive and
Negative Admissions in the US: A Multicenter Evaluation. Poster:
379. Puzniak L, et al.
- Comparison of Ceftolozane/Tazobactam, Ceftazidime/Avibactam,
and Meropenem/Vaborbactam Activity Against P. aeruginosa: A
Multicenter Evaluation. Poster: 1603. Moise P, et al.
- Frequency of Carbapenem-resistant Pseudomonas aeruginosa Among
Respiratory Pathogens Impacts First-Line Beta-Lactam
Susceptibility: Potential Role for Ceftolozane/Tazobactam (C/T)
and/or Imipenem/Relebactam (I/R). Poster: 1450. Klinker K, et
al.
- Activity of Ceftolozane/Tazobactam Against Gram-Negative
Isolates From Lower Respiratory Tract Infections – SMART United
States 2018. Poster: 1587. Lob S, et al.
- Epidemiology and Susceptibility to Imipenem/Relebactam of
Gram-Negative Pathogens From Patients With Lower Respiratory Tract
Infections – SMART United States 2017-2018. Poster: 1609. Lob S, et
al.
HIV
- Efficacy and Safety of Doravirine in Treatment-Naïve Adults ≥50
Years Old With HIV-1. Poster: 1011. Mills A, et al.
For more information and access to IDWeek’s virtual program,
please visit the IDWeek 2020 website.
About RECARBRIOTM (imipenem, cilastatin, and relebactam) for
injection 1.25 g
RECARBRIO is indicated for the treatment of patients 18 years of
age and older with hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia, caused by the following
susceptible Gram-negative microorganisms: Acinetobacter
calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia
coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella
oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia
marcescens.
RECARBRIO is also indicated in patients 18 years of age and
older who have limited or no alternative treatment options, for the
treatment of complicated urinary tract infections (cUTI), including
pyelonephritis, caused by the following susceptible Gram-negative
microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella
aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa.
RECARBRIO is also indicated in patients 18 years of age and
older who have limited or no alternative treatment options, for the
treatment of complicated intra-abdominal infections (cIAI) caused
by the following susceptible gram-negative microorganisms:
Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus,
Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides
uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter
cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella
aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae,
Parabacteroides distasonis and Pseudomonas aeruginosa.
Approval of the cUTI and cIAI indications is based on limited
clinical safety and efficacy data for RECARBRIO.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of RECARBRIO and other antibacterial
drugs, RECARBRIO should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
Selected Safety Information for RECARBRIO
Hypersensitivity Reactions: RECARBRIO is contraindicated
in patients with a history of known severe hypersensitivity (severe
systemic allergic reaction such as anaphylaxis) to any component of
RECARBRIO. Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions have been reported in patients receiving
therapy with beta-lactams. Before initiating therapy with
RECARBRIO, careful inquiry should be made concerning previous
hypersensitivity reactions to carbapenems, penicillins,
cephalosporins, other beta-lactams, and other allergens. If a
hypersensitivity reaction to RECARBRIO occurs, discontinue the
therapy immediately.
Seizures and Other Central Nervous System (CNS) Adverse
Reactions: CNS adverse reactions, such as seizures, confusional
states, and myoclonic activity, have been reported during treatment
with imipenem/cilastatin, a component of RECARBRIO, especially when
recommended dosages of imipenem were exceeded. These have been
reported most commonly in patients with CNS disorders (e.g., brain
lesions or history of seizures) and/or compromised renal function.
Anticonvulsant therapy should be continued in patients with known
seizure disorders. If CNS adverse reactions including seizures
occur, patients should undergo a neurological evaluation to
determine whether RECARBRIO should be discontinued.
Increased Seizure Potential Due to Interaction with Valproic
Acid: Concomitant use of RECARBRIO, with valproic acid or
divalproex sodium may increase the risk of breakthrough seizures.
Avoid concomitant use of RECARBRIO with valproic acid or divalproex
sodium or consider alternative antibacterial drugs other than
carbapenems.
Clostridioides difficile-Associated Diarrhea (CDAD) has
been reported with use of nearly all antibacterial agents,
including RECARBRIO, and may range in severity from mild diarrhea
to fatal colitis. Careful medical history is necessary since CDAD
has been reported to occur over two months after the administration
of antibacterial agents. If CDAD is suspected or confirmed, ongoing
antibacterial drug use not directed against C difficile may need to
be discontinued.
Development of Drug-Resistant Bacteria: Prescribing
RECARBRIO in the absence of a proven or strongly suspected
bacterial infection or prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
Adverse Reactions: The most frequently reported adverse
reactions occurring in ≥2% of cUTI and cIAI patients treated with
RECARBRIO were diarrhea (6%), nausea (6%), headache (4%), vomiting
(3%), alanine aminotransferase increased (3%), aspartate
aminotransferase increased (3%), phlebitis/infusion site reactions
(2%), pyrexia (2%), and hypertension (2%). The most frequently
reported adverse reactions occurring in ≥5% of HABP/VABP patients
treated with RECARBRIO were aspartate aminotransferase increased
(11.7%), anemia (10.5%), alanine aminotransferase increased (9.8%),
diarrhea (7.9%), hypokalemia (7.9%), and hyponatremia (6.4%).
About ZERBAXA® (ceftolozane and tazobactam) for injection
(1.5g)
ZERBAXA is indicated for the treatment of patients 18 years and
older with hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP), caused by
the following susceptible Gram-negative microorganisms:
Enterobacter cloacae, Escherichia coli, Haemophilus influenzae,
Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis,
Pseudomonas aeruginosa, and Serratia marcescens.
ZERBAXA is indicated for the treatment of patients 18 years and
older with complicated urinary tract infections (cUTI), including
pyelonephritis, caused by the following susceptible Gram-negative
microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, and Pseudomonas aeruginosa.
ZERBAXA used in combination with metronidazole is indicated for
the treatment of patients 18 years and older with complicated
intra-abdominal infections (cIAI) caused by the following
susceptible Gram-negative and Gram-positive microorganisms:
Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa,
Bacteroides fragilis, Streptococcus anginosus, Streptococcus
constellatus, and Streptococcus salivarius.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of ZERBAXA and other antibacterial
drugs, ZERBAXA should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
Selected Safety Information for ZERBAXA
Patients with renal impairment: Decreased efficacy of
ZERBAXA has been observed in patients with baseline CrCl of 30 to
<50 mL/min. In a clinical trial,
patients with cIAIs with CrCl >50 mL/min had a clinical cure
rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9%
when treated with meropenem. In the same trial, patients with CrCl
30 to <50 mL/min had a clinical
cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs
69.2% when treated with meropenem. A similar trend was also seen in
the cUTI trial. Dose adjustment is required for patients with CrCl
50 mL/min or less. All doses of ZERBAXA are administered over 1
hour. Monitor CrCl at least daily in patients with changing renal
function and adjust the dose of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients
with known serious hypersensitivity to the components of ZERBAXA
(ceftolozane/tazobactam), piperacillin/tazobactam, or other members
of the beta-lactam class. Serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported in
patients receiving beta-lactam antibacterials. Before initiating
therapy with ZERBAXA, make careful inquiry about previous
hypersensitivity reactions to cephalosporins, penicillins, or other
beta-lactams. If an anaphylactic reaction to ZERBAXA occurs,
discontinue use and institute appropriate therapy.
Clostridioides difficile-associated diarrhea (CDAD),
ranging from mild diarrhea to fatal colitis has been reported with
nearly all systemic antibacterial agents, including ZERBAXA.
Careful medical history is necessary because CDAD has been reported
to occur more than 2 months after the administration of
antibacterial agents. If CDAD is confirmed, antibacterial use not
directed against C. difficile should be discontinued, if
possible.
Development of drug-resistant bacteria: Prescribing
ZERBAXA in the absence of a proven or strongly suspected bacterial
infection or a prophylactic indication is unlikely to provide
benefit to the patient and risks the development of drug-resistant
bacteria.
Adverse reactions: The most common adverse reactions
occurring in ≥5% of patients in the HABP/VABP trial were hepatic
transaminase increased (11.9%), renal impairment/renal failure
(8.9%), and diarrhea (6.4%). The most common adverse reactions
occurring in ≥5% of patients in the cUTI and cIAI trials were
headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea
(6.2%), and pyrexia (5.6%) in the cIAI trial.
About PIFELTROTM (doravirine, 100 mg) and DELSTRIGOTM
(doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate
300 mg)
PIFELTRO is indicated in combination with other antiretroviral
(ARV) agents for the treatment of HIV-1 infection in adult patients
with no prior ARV treatment history or to replace the current ARV
regimen in those who are virologically suppressed (HIV-1 RNA less
than 50 copies per mL) on a stable ARV regimen with no history of
treatment failure and no known substitutions associated with
resistance to doravirine.
DELSTRIGO is indicated as a complete regimen for the treatment
of HIV-1 infection in adult patients with no prior ARV treatment
history or to replace the current ARV regimen in those who are
virologically suppressed (HIV-1 RNA less than 50 copies per mL) on
a stable ARV regimen with no history of treatment failure and no
known substitutions associated with resistance to the individual
components of DELSTRIGO. DELSTRIGO contains a boxed warning
regarding posttreatment acute exacerbations of hepatitis B (HBV)
infection. See Selected Safety Information below.
Selected Safety Information for PIFELTRO and
DELSTRIGO
Warning: Posttreatment Acute Exacerbation of Hepatitis B
(HBV)
All patients with HIV-1 should be tested for the presence of HBV
before initiating ARV therapy. Severe acute exacerbations of HBV
have been reported in patients who are coinfected with HIV-1 and
HBV and have discontinued products containing lamivudine or
tenofovir disoproxil fumarate (TDF), which are components of
DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue
DELSTRIGO should be monitored with both clinical and laboratory
follow-up for at least several months after stopping DELSTRIGO. If
appropriate, initiation of anti-HBV therapy may be warranted.
PIFELTRO and DELSTRIGO are contraindicated when co-administered
with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers
(including the anticonvulsants carbamazepine, oxcarbazepine,
phenobarbital, and phenytoin; the androgen receptor inhibitor
enzalutamide; the antimycobacterials rifampin and rifapentine; the
cytotoxic agent mitotane; and the herbal product St. John’s wort
(Hypericum perforatum)), as significant decreases in doravirine
plasma concentrations may occur, which may decrease the
effectiveness of DELSTRIGO and PIFELTRO.
DELSTRIGO is contraindicated in patients with a previous
hypersensitivity reaction to lamivudine.
Renal impairment, including cases of acute renal failure and
Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO
should be avoided with concurrent or recent use of a nephrotoxic
agent (eg, high-dose or multiple NSAIDs). Cases of acute renal
failure after initiation of high-dose or multiple NSAIDs have been
reported in patients with risk factors for renal dysfunction who
appeared stable on TDF.
Prior to or when initiating DELSTRIGO, and during treatment,
assess serum creatinine, estimated creatinine clearance, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, also assess serum phosphorus. Discontinue
DELSTRIGO in patients who develop clinically significant decreases
in renal function or evidence of Fanconi syndrome. Discontinue
DELSTRIGO if estimated creatinine clearance declines below 50
mL/min.
In clinical trials in HIV-1 infected adults, TDF was associated
with slightly greater decreases in bone mineral density (BMD) and
increases in biochemical markers of bone metabolism. Serum
parathyroid hormone levels and 1,25 Vitamin D levels were also
higher. Cases of osteomalacia associated with proximal renal
tubulopathy have been reported with the use of TDF.
Immune reconstitution syndrome can occur, including the
occurrence of autoimmune disorders with variable time to onset,
which may necessitate further evaluation and treatment.
Because DELSTRIGO is a complete regimen, co-administration with
other antiretroviral medications for the treatment of HIV-1
infection is not recommended.
Co-administration of PIFELTRO with efavirenz, etravirine, or
nevirapine is not recommended.
If DELSTRIGO is co-administered with rifabutin, take one tablet
of DELSTRIGO once daily, followed by one tablet of doravirine
(PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.
If PIFELTRO is co-administered with rifabutin, increase PIFELTRO
dosage to one tablet twice daily (approximately 12 hours
apart).
Consult the full Prescribing Information prior to and during
treatment for more information on potential drug-drug
interactions.
Because DELSTRIGO is a fixed-dose combination tablet and the
dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not
recommended in patients with estimated creatinine clearance less
than 50 mL/min.
The most common adverse reactions with DELSTRIGO (incidence ≥5%,
all intensities) were dizziness (7%), nausea (5%), and abnormal
dreams (5%). The most common adverse reactions with PIFELTRO
(incidence ≥5%, all intensities) were nausea (7%), dizziness (7%),
headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%),
and abnormal dreams (5%).
By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the
PIFELTRO group and 3% in the DRV+r group had adverse events leading
to discontinuation of study medication.
By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO
(doravirine/3TC/TDF) group and 7% in the EFV/FTC/TDF group had
adverse events leading to discontinuation of study medication.
In DRIVE-FORWARD, mean changes from baseline at Week 48 in
LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were
pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL
in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs
13.7 mg/dL in the DRV+r group. The clinical benefits of these
findings have not been demonstrated.
In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-C
and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the
DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C:
-4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF
group. The clinical benefits of these findings have not been
demonstrated.
In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-C
and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the
DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group.
Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI +
ritonavir group. The clinical benefits of these findings have not
been demonstrated.
In DRIVE-AHEAD, neuropsychiatric adverse events were reported in
the three pre-specified categories of sleep disorders and
disturbances, dizziness, and altered sensorium. Twelve percent of
adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF
group reported neuropsychiatric adverse events of sleep disorders
and disturbances; 9% in the DELSTRIGO group and 37% in the
EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group
and 8% in the EFV/FTC/TDF group reported altered sensorium.
The safety of DELSTRIGO in virologically-suppressed adults was
based on Week 48 data from subjects in the DRIVE-SHIFT trial.
Overall, the safety profile in virologically-suppressed adult
subjects was similar to that in subjects with no ARV treatment
history.
Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and
16% of subjects in the immediate switch group experienced ALT and
AST elevations greater than 1.25 X ULN, respectively, through 48
weeks on DELSTRIGO. For these ALT and AST elevations, no apparent
patterns with regard to time to onset relative to switch were
observed. One percent of subjects had ALT or AST elevations greater
than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST
elevations were generally asymptomatic, and not associated with
bilirubin elevations. In comparison, 4% and 4% of subjects in the
delayed switch group experienced ALT and AST elevations of greater
than 1.25 X ULN through 24 weeks on their baseline regimen.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in individuals exposed to PIFELTRO or DELSTRIGO during
pregnancy. Healthcare providers are encouraged to register patients
by calling the Antiretroviral Pregnancy Registry (APR) at
1-800-258-4263.
Mothers infected with HIV-1 should be instructed not to
breastfeed if they are receiving PIFELTRO or DELSTRIGO due to the
potential for HIV-1 transmission.
About VAQTA® (Hepatitis A Vaccine, Inactivated)
Indication
VAQTA is indicated for the prevention of disease caused by
hepatitis A virus (HAV) in persons 12 months of age and older. The
primary dose should be given at least 2 weeks prior to expected
exposure to HAV.
Dosage and Administration
Children/Adolescents (12 months through 18 years of age): The
vaccination schedule consists of a primary 0.5 mL dose administered
intramuscularly and a 0.5 mL booster dose administered
intramuscularly 6 to 18 months later. Booster Immunization
Following Another Manufacturer’s Hepatitis A Vaccine: A booster
dose of VAQTA may be given at 6 to 12 months following a primary
dose of Havrix.*
Select Safety Information for VAQTA (Hepatitis A Vaccine,
Inactivated)
Do not administer VAQTA to individuals with a history of
immediate and/or severe allergic or hypersensitivity reactions
(e.g., anaphylaxis) after a previous dose of any hepatitis A
vaccine, or to individuals who have had an anaphylactic reaction to
any component of VAQTA, including neomycin.
The vial stopper and the syringe plunger stopper and tip cap
contain dry natural latex rubber that may cause allergic reactions
in latex-sensitive individuals.
The most common local adverse reactions and systemic adverse
events (≥15%) reported in different clinical trials across
different age groups when VAQTA was administered alone or
concomitantly were:
- Children 12 through 23 months of age: injection-site
pain/tenderness (37.0%), injection-site erythema (21.2%), and fever
(16.4% when administered alone, and 27.0% when administered
concomitantly).
- Children/Adolescents 2 through 18 years of age: injection-site
pain (18.7%).
Safety and effectiveness in infants below 12 months of age have
not been established.
Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished immune response to
VAQTA and may not be protected against HAV infection after
vaccination.
Hepatitis A virus has a relatively long incubation period
(approximately 20 to 50 days). VAQTA may not prevent hepatitis A
infection in individuals who have an unrecognized hepatitis A
infection at the time of vaccination.
In clinical trials in children, VAQTA was concomitantly
administered with one or more of the following US-licensed
vaccines: Measles, Mumps, and Rubella Virus Vaccine, Live;
Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and
Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and
Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine;
and Haemophilus b Conjugate Vaccine (Meningococcal Protein
Conjugate). Safety and immunogenicity were similar for
concomitantly administered vaccines compared to separately
administered vaccines.
The total duration of the protective effect of VAQTA in healthy
vaccinees is unknown at present.
Vaccination with VAQTA may not result in a protective response
in all susceptible vaccinees.
* Havrix is a registered trademark of
GlaxoSmithKline.
About M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine
Live)
M-M-R®II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months
of age or older.
The first dose of M-M-R®II is administered at 12 to 15 months of
age and the second dose of M-M-R®II is administered at 4 to 6 years
of age.
Selected Safety Information for M-M-R®II
M-M-R®II is contraindicated in certain individuals, including
those with: a history of hypersensitivity to any component of the
vaccine, including gelatin; a history of anaphylactic reaction to
neomycin; individuals who are immunodeficient or immunosuppressed
due to disease or medical therapy; family history of congenital or
hereditary immunodeficiency; an active febrile illness; active
untreated tuberculosis; or those who are pregnant or are planning
to become pregnant within the next month.
Due caution should be employed in administration of M-M-R®II to
persons with: a history of febrile seizure or family history of
febrile seizures; immediate-type hypersensitivity reactions to
eggs; thrombocytopenia.
Immune globulins (IG) and other blood products should not be
given concurrently with M-M-R®II. The ACIP has specific
recommendations for intervals between administration of
antibody-containing products and live virus vaccines.
The following adverse reactions have been identified during
clinical trials or reported during post-approval use of M-M-R®II or
its components: fever, headache, dizziness, rash, injection-site
reactions, febrile convulsions, anaphylaxis and anaphylactoid
reactions, arthritis, thrombocytopenia, encephalitis and
encephalopathy.
Dosage and Administration for M-M-R®II
FOR SUBCUTANEOUS USE ONLY.
M-M-R®II vaccine can be administered concurrently with other
live viral vaccines. If not given concurrently, M-M-R®II vaccine
should be given one month before or one month after administration
of other live viral vaccines to avoid potential for immune
interference.
About RotaTeq® (Rotavirus Vaccine, Live, Oral,
Pentavalent)
RotaTeq is indicated for the prevention of rotavirus
gastroenteritis in infants and children caused by Types G1, G2, G3,
G4, and G9 when administered as a 3-dose series to infants between
the ages of 6 to 32 weeks. The first dose of RotaTeq should be
administered between 6 and 12 weeks of age.
The vaccination series consists of 3 ready-to-use liquid doses
of RotaTeq administered orally starting at 6 to 12 weeks of age,
with the subsequent doses administered at 4- to 10-week intervals.
The third dose should not be given after 32 weeks of age.
Selected Safety Information for RotaTeq
RotaTeq should not be administered to infants with a
demonstrated history of hypersensitivity to the vaccine or any
component of the vaccine.
Infants with Severe Combined Immunodeficiency Disease (SCID)
should not receive RotaTeq. Post-marketing reports of
gastroenteritis, including severe diarrhea and prolonged shedding
of vaccine virus, have been reported in infants who were
administered RotaTeq and later identified as having SCID.
Infants with a history of intussusception should not receive
RotaTeq.
No safety or efficacy data are available from clinical trials
regarding the administration of RotaTeq to infants who are
potentially immunocompromised.
In a post-marketing observational study in the US, cases of
intussusception were observed in temporal association within 21
days following the first dose of RotaTeq, with a clustering of
cases in the first 7 days.
No safety or efficacy data are available for administration of
RotaTeq to infants with a history of gastrointestinal
disorders.
Vaccine virus transmission from vaccine recipient to
nonvaccinated contacts has been reported. Caution is advised when
considering whether to administer RotaTeq to individuals with
immunodeficient contacts.
In clinical trials, the most common adverse events included
diarrhea, vomiting, irritability, otitis media, nasopharyngitis,
and bronchospasm.
In post-marketing experience, intussusception (including death)
and Kawasaki disease have been reported in infants who have
received RotaTeq.
RotaTeq may not protect all vaccine recipients against
rotavirus.
About GARDASIL®9 (Human Papillomavirus 9-valent Vaccine,
Recombinant)
GARDASIL 9 is a vaccine indicated in females 9 through 45 years
of age for the prevention of cervical, vulvar, vaginal, anal,
oropharyngeal and other head and neck cancers caused by human
papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58;
cervical, vulvar, vaginal, and anal precancerous or dysplastic
lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for
the prevention of anal, oropharyngeal and other head and neck
cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal
precancerous or dysplastic lesions caused by HPV Types 6, 11, 16,
18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6
and 11.
The oropharyngeal and head and neck cancer indication is
approved under accelerated approval based on effectiveness in
preventing HPV-related anogenital disease. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in a confirmatory trial.
GARDASIL 9 does not eliminate the necessity for vaccine
recipients to undergo screening for cervical, vulvar, vaginal,
anal, oropharyngeal and other head and neck cancers as recommended
by a healthcare provider.
GARDASIL 9 has not been demonstrated to provide protection
against diseases caused by:
- HPV types not covered by the vaccine
- HPV types to which a person has previously been exposed through
sexual activity
Not all vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers are caused by HPV, and GARDASIL 9 protects only
against those vulvar, vaginal, anal, oropharyngeal and other head
and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and
58.
GARDASIL 9 is not a treatment for external genital lesions;
cervical, vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar
intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia
(VaIN), or anal intraepithelial neoplasia (AIN).
Vaccination with GARDASIL 9 may not result in protection in all
vaccine recipients.
Select Safety Information for GARDASIL 9
GARDASIL 9 is contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or
after a previous dose of GARDASIL 9 or GARDASIL® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant].
Because vaccinees may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after
administration is recommended. Syncope, sometimes associated with
tonic-clonic movements and other seizure-like activity, has been
reported following HPV vaccination. When syncope is associated with
tonic-clonic movements, the activity is usually transient and
typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established
in pregnant women.
The most common (≥10%) local and systemic adverse reactions in
females were injection-site pain, swelling, erythema, and headache.
The most common (≥10%) local and systemic reactions in males were
injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been
established.
Dosage and Administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid
or anterolateral area of the thigh.
- For individuals 9 through 14 years of age, GARDASIL 9 can be
administered using a 2-dose or 3-dose schedule. For the 2-dose
schedule, the second dose should be administered 6-12 months after
the first dose. If the second dose is administered less than 5
months after the first dose, a third dose should be given at least
4 months after the second dose. For the 3-dose schedule, GARDASIL 9
should be administered at 0, 2 months, and 6 months.
- For individuals 15 through 45 years of age, GARDASIL 9 is
administered using a 3-dose schedule at 0, 2 months, and 6
months.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
Forward-Looking Statement of Merck & Co., Inc., Kenilworth,
N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for RECARBRIO (imipenem,
cilastatin, and relebactam) at
https://www.merck.com/product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf
Please see Prescribing Information for ZERBAXA (ceftolozane
and tazobactam) at
https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf
Please see Prescribing Information for PIFELTRO (doravirine)
at
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf
and Patient Information for PIFELTRO at
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf
Please see Prescribing Information for DELSTRIGO (doravirine,
lamivudine, and tenofovir disoproxil fumarate)
https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf
and Patient Information for DELSTRIGO at
https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf
Please see Prescribing Information for VAQTA® (Hepatitis A
Vaccine, Inactivated) at
https://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf
Please see Prescribing Information for M-M-R®II (Measles,
Mumps, and Rubella Virus Vaccine Live) at
https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
and Patient Information for M-M-R®II at
https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_ppi.pdf
Please see Prescribing Information for RotaTeq® (Rotavirus
Vaccine, Live, Oral, Pentavalent) at
https://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf
and Patient Information for RotaTeq at
https://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_ppi.pdf
Please see the Prescribing Information for GARDASIL®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and Patient Information for GARDASIL 9 at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201021005316/en/
Media:
Pamela Eisele (267) 305-3558 Sarra S. Herzog (201) 669-6570
Investors:
Peter Dannenbaum (908) 740-1037 Raychel Kruper (908)
740-2107
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2024 to May 2024
Merck (NYSE:MRK)
Historical Stock Chart
From May 2023 to May 2024