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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 (HABPVABP), and a new pooled analysis of the safety and efficacy of PIFELTRO™ (doravirine) or DELSTRIGO™ (doravirinelamivudinetenofovir 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 RECARBRIO TM (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 PIFELTRO TM (doravirine, 100 mg) and DELSTRIGO TM (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
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and
Patient Information for GARDASIL 9 at
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf
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