BRIDGEWATER, N.J. and KENILWORTH, N.J. – October 20, 2020 - The MSP Vaccine Company, a joint venture between Sanofi Pasteur, the global vaccines unit of Sanofi and Merck, known as MSD outside the United States and Canada, will present new results from three U.S.-based studies at IDWeek 2020, taking place virtually from October 21 to 25. These studies explore combination pediatric vaccines and highlight: parents’ perceptions of the vaccination schedule and combination vaccines, physicians’ attitudes towards combination vaccines, and variations in co-administration of combination and monovalent vaccines.
“These studies provide important insights into perceptions of physicians and parents on the current use of combination vaccines for infants and children and will hopefully help lead to timely and improved vaccination rates. This is important for now, and in the future, as achieving this goal is challenging given the current pandemic,” says Monica Mercer, M.D., Senior Director Scientific and Medical Affairs at Sanofi Pasteur.
“By exploring healthcare professional and parental attitudes toward combination vaccines, we are hoping to better understand the potential utilization of combination vaccinations as well as the barriers that may prevent timeliness and completion of the recommended immunization schedule in infants. We believe the healthcare community will find these studies and their results to be very interesting,” says Michelle Goveia, M.D., Executive Director Medical Affairs at Merck.
The following abstracts are currently available for meeting attendees viewing, and the full presentations (including audio and/or poster PDFs) will become available on October 21, 2020:
About the MSP Vaccine Company
The MSP Vaccine Company is a U.S.-based joint-partnership between Merck and Sanofi Pasteur, the vaccines unit of Sanofi, and draws upon both companies’ experience for the development, manufacturing and marketing of Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).
About Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
Vaxelis, the first and only hexavalent vaccine in the U.S., was approved by the Food and Drug Administration in December 2018 and includes antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi Pasteur and antigens for H. influenzae type b and hepatitis B from Merck. The vaccine is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Merck and Sanofi are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated U.S. demand. Vaxelis product availability is expected mid-2021.
Important Safety Information
Do not administer VAXELIS to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.
Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause.
Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
If any of the following events occur after administration of a pertussis vaccine, the decision to administer VAXELIS should be based on careful consideration of potential benefits and possible risks.
• Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.
• Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
• Persistent, inconsolable crying lasting ≥3 hours within 48 hours.
• Seizures with or without fever within 3 days.
A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.
If VAXELIS is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on consideration of the infant’s medical status and the potential benefits and possible risks of vaccination.
Vaccination with VAXELIS may not protect all individuals.
Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease following vaccination with VAXELIS.
Rates of adverse reactions varied by number of doses of VAXELIS received. The solicited adverse reactions following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
Please see the full Prescribing Information for VAXELIS.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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