Novartis Vaccines and Diagnostics, Inc. of Rosia, Italy, recalled one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. The recall followed observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial in the lot noted above. This residual moisture content is not expected to impact product quality, but constitutes a deviation to registered specifications. All other aspects of this lot have met the required quality standards.
Menveo (meningococcal conjugate vaccine) is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria. Menveo works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes your body to develop immunity to the disease. Menveo will not treat an active infection that has already developed in the body.
Meningococcal disease is a serious infection caused by bacteria. Meningococcal bacteria can infect the blood, spinal cord, and brain. Meningitis can be fatal. Meningococcal disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.
Menveo is for use in children and adults between the ages of 2 years and 55 years old. No action is required for patients previously vaccinated with a dose from this lot.
See the Recall
See also Medical Law Perspectives, January 2013 Report: Vaccines: An Ounce of Prevention May Lead to a Pound of Injury