RotaTeq—helping protect against RGE caused by five strains, including G2

CONSIDER STRAIN VARIABILITY – RotaTeq® (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) COVERS G2

RotaTeq—helping protect against RGE caused by five strains of rotavirus including G2

RotaTeq helps prevent RGE in infants and children caused by five common strains (types G1, G2, G3, G4, and G9).

RGE, rotavirus gastroenteritis.

MOST PEDIATRICIANS CHOSE RotaTeq to help protect their patients2

Based on Komodo claims data from January 2020 to March 2023 and defining the pediatrician as a RotaTeq user if they vaccinated at least 80% of their patients with RotaTeq annually.

Group@2x-2

Rotavirus Strain Coverage

Learn why broad coverage matters and how RotaTeq helps protect against RGE caused by 5 strains of rotavirus, including G2.1
Circle@2x-2

Dosing and Administration

Review the dosing schedule and administration of RotaTeq.
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Reference

  1. Staat MA, Payne DC, Halasa N, et al. Continued evidence of the impact of rotavirus vaccine in children less than 3 years of age from the United States New Vaccine Surveillance Network: a multisite active surveillance program, 2006-2016. Clin Infect Dis. 2020;71(9):e421-e429. doi:10.1093/cid/ciaa150
ref2rota

Reference

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-ROT-00704.
ref3rota

Reference

  1. Dennis AF, McDonald SM, Payne DC, et al. Molecular epidemiology of contemporary G2P[4] human rotaviruses cocirculating in a single U.S. community: footprints of a globally transitioning genotype. J Virol. 2014;88(7):3789-3801. doi:10.1128/JVI.03516-13
ref4rota

Reference

  1. Matthijnssens J, Van Ranst M. Genotype constellation and evolution of group A rotaviruses infecting humans. Curr Opin Virol. 2012;2(4):426-433. doi:10.1016/j.coviro.2012.04.007
ref5rota

Reference

  1. Centers for Disease Control and Prevention (CDC). Rotavirus, about the vaccine. Updated March 25, 2021. Accessed June 5, 2023. https://www.cdc.gov/vaccines/vpd/rotavirus/hcp/about-vaccine.html
ref6rota

Reference

  1. Centers for Disease Control and Prevention (CDC). Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2023. Updated April 21, 2023. Accessed June 30, 2023. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
ref7rota

Reference

  1. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices, Vaccines for Children program, Vaccines to prevent rotavirus gastroenteritis. Adopted and effective June 25, 2008. Accessed June 5, 2023. https://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0608-rotavirus.pdf
ref8rota

Reference

  1. Iwata S, Nakata S, Ukae S, et al. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013;9(8):1626-1633. doi:10.4161/hv.24846
ref9rota

Reference

  1. Vesikari T, Matson DO, Dennehy P, et al; Rotavirus Efficacy and Safety Trial (REST) study team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(7):23-33. doi:10.1056/NEJMoa052664
ref10rota

Reference

  1. Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006;354(1):75-77. doi:10.1056/NEJMe058285
ref11rota

Reference

  1. Dennehy PH, Goveia MG, Dallas MJ, et al. The integrated phase III safety profile of the pentavalent human-bovine (WC3) reassortant vaccine. Int J Infect Dis. 2007;11(suppl 2):S36-S42. doi:10.1016/S1201-9712(07)60020-4
ref12rota

Reference

  1. Committee on Infectious Diseases; American Academy of Pediatrics (AAP). Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009;123(5):1412-1420. doi:10.1542/peds.2009-0466
ref13rota

Reference

  1. Cortese MM, Parashar UD; Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009;58(RR-2):1-25.
ref14rota

Reference

  1. Hill HA, Chen M, Elam-Evans L, Yankey D, Singleton J. Centers for Disease Control and Prevention. Vaccination Coverage by Age 24 Months Among Children Born During 2018–2019 — National Immunization Survey–Child, United States, 2019–2021. MMWR Morb Mortal Wkly Rep. 2023;72:33–38. https://www.cdc.gov/mmwr/volumes/72/wr/mm7202a3.htm
ref15rota

Reference

  1. Mast CT, Heyman D, Dasbach E, et al. Planning for the introduction and effectiveness of new vaccines using real-world data and geospatial visualization: an example using rotavirus vaccines with potential application to SARS-CoV-2. Vaccine X. 2021;(7);100084. doi:10.1016/j.jvacx.2021.100084
ref16rota

Reference

  1. Centers for Disease Control and Prevention (CDC). Immunization Information Systems (IIS) – CPT Codes Mapped to CVX Codes. Updated May 17, 2023. Accessed June 5, 2023. https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cpt

Indications and Usage for RotaTeq

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® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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.

Before administering RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the accompanying Prescribing Information. The Patient Product Information also is available.

Indications and Usage for 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.

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children

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.

Selected Safety Information for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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.

Before administering RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the accompanying Prescribing Information. The Patient Product Information also is available.

RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity

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

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