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Food and Drug Administration, Meningococcal Vaccine

FDA Approves New Meningococcal Vaccine, MenQuadfi, Manufactured by Sanofi Pasteur, Inc.

The U.S. Food and Drug Administration (FDA) has approved a new meningococcal vaccine for use in the United States. The new vaccine, MenQuadfi, is manufactured by pharmaceutical giant Sanofi Pasteur, Inc.

MenQuadfi joins five other meningococcal vaccines that are currently approved for use in the U.S.: Menveo, Menactra, BEXSERO, TRUMENBA and Menomune-A/C/Y/W-135. It is indicated for immunization against meningococcal serogroups A, C, Y and W, and is specifically approved for immunization of individuals two years of age and older. The U.S. Centers for Disease Control and Prevention (CDC) recommend vaccination against meningococcal serogroups A, C, Y and W at 11 to 12 years of age, although vaccination as early as two months of age may be recommended in some cases.

How is the MenQuadfi Meningococcal Vaccine Administered?

MenQuadfi is administered via intramuscular injection in a single 0.5 mL dose. In addition to an initial dose at age 11 to 12 (or earlier if recommended), the FDA indicates that a booster vaccination, “may be administered to individuals 15 years of age and older who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of meningococcal (Groups A, C, W, Y) conjugate vaccine.”

What are the Risks Associated with MenQuadfi?

Like all vaccines, MenQuadfi carries certain risks. For example, the FDA indicates that MenQuadfi should not be administered to anyone who has experienced a “[s]evere allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.” The risks associated with MenQuadfi include:

  • Anaphylaxis Anaphylaxis, or a severe allergic reaction, can potentially have serious effects if not treated promptly. If an individual who has been immunized with MenQuadfi exhibits symptoms of a severe allergic reaction, medical attention should be sought right away.
  • GuillainBarre Syndrome (GBS) – Immunization against meningococcal disease with MenQuadfi may pose a risk for Guillain-Barre Syndrome (GBS). According to the FDA, “Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.”
  • Shoulder injury related to vaccine administration (SIRVA) Shoulder injuries related to vaccine administration (SIRVA) are a concern with all intramuscular vaccines. Common symptoms include pain (which may lead to persistent crying in young children), shoulder stiffness and limited mobility.
  • Vasovagal syncope – Vasovagal syncope is a condition that results in loss of consciousness due to a sudden drop in heart rate and blood pressure. Additional symptoms may include pale skin, nausea, tunnel vision, blurred vision and lightheadedness prior to fainting.
Contact National Vaccine Lawyer Leah V. Durant

If you or your child experiences any of these conditions after receiving a MenQuadfi vaccination, your family may be entitled to financial compensation under the National Vaccine Injury Compensation Program (VICP). To learn more in a free and confidential consultation with national vaccine lawyer Leah V. Durant, call 202-800-1711 or tell us how you would like to be contacted online today.

Leah Durant Bio

Experienced litigation attorney Leah Durant focuses on representing clients in complex vaccine litigation matters. Leah Durant is the owner and principal attorney of the Law Offices of Leah V. Durant, PLLC, a litigation firm based in Washington, DC. Leah Durant and her staff represent clients and their families who suffer from vaccine-related injuries, adverse vaccine reactions and vaccine-related deaths. The Law Offices of Leah V. Durant, PLLC is dedicated to assisting individuals in recovering the highest level of compensation as quickly and efficiently as possible. To learn more, contact vaccine attorney Leah Durant today.

About Leah Durant

Leah Durant is a former U.S. Department of Justice trial attorney who specializes in vaccine injury claims covered by the National Vaccine Injury Compensation Program. These cases are filed before the U.S. Court of Federal Claims (more commonly known as the “vaccine court”) in Washington, DC, where she has been admitted to practice since 2008. Originally from the Pacific Northwest, Leah Durant is a graduate of the University of Maryland College Park and received her law degree from the University of Maryland School of Law. Leah Durant’s legal practice concentrates on litigating complex vaccine injury and medical related cases. She has an extensive legal background and has experience representing individuals with complex medical claims.

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