FDA Approves a New Vaccine for Infants

by Sam Malone

The Food and Drug Administration (FDA) - an agency that works within the US Department of Health and Human Services recently approved a new combination vaccine that protects infants against two deadly infections. These infections can cause fatal diseases such as meningitis, meningococcal disease and Hib disease. As part of the FDA's responsibility to protect and improve public health by testing human drugs and vaccines for safety and effectiveness, the new vaccine was approved for children between the ages of 6 weeks to 18 months of age. The first dose of the vaccine can be given as early as 6 weeks though ideally it should be given as a series at two, four, six, and twelve through fifteen months of age. Manufactured by GlaxoSmithKlein Biologicals, based in Rixensart, Belgium, the new vaccine is known as Menhibrix.

Before the approval of the vaccine, children below the age of two were especially vulnerable to these serious illnesses. Meningococcal disease is the reason for nearly a thousand infant deaths every year. Caused by the bacteria Neisseria meningitides, the infection results in meningitis - an often fatal disease that affects infants, children and young adults. Meningitis is an infection of the covering of the spinal cord and brain and leads to symptoms such as irritability and slowness in infants, vomiting and feeding difficulties. If not diagnosed and treated in time, meningitis can lead to death.

The Haemophilus influenzae type b bacteria are responsible for Hib disease and the infection is spread easily through coughing and sneezing. An infected infant may develop meningitis or other life-threatening conditions such as epiglottis (an infection of the throat) and pneumonia (an infection of the lungs), that makes it difficult to breathe. The Hib bacterium is also responsible for infections that affect a child's bones, joints, and blood. Approximately 12,000 children in the US suffer from Hib disease each year. Both Meningococcal and Hib disease can lead to long-term health complications such as blindness, amputations, and mental disabilities.

The FDA approved the vaccine on the basis of the immune responses of thousands of infants who were given Menhibrix. Around 7,500 infants and toddlers from the US, Mexico, and Australia were also evaluated with regards to the safety of the vaccine. On the basis of these observations, it was noted that the possible side effects of the Menhibrix vaccine include pain and swelling at the site of the vaccination, irritability, redness, and fever. With the approval of the Menhibrix vaccine, the FDA aims to bring about a reduction in the number of children suffering from these deadly infections and prevent possible fatalities as a result of the diseases.

In addition to the Menhibrix vaccination, the FDA also announced that it has approved the 2012-2013 vaccine formulation for licensed manufacturers to produce and distribute the influenza vaccine in the US. Every year the FDA in collaboration with WHO (World Health Organisation) and CDC (Centers for Disease Control and Prevention) study influenza virus samples from all over the world in order to predict which ones are most likely to cause illnesses in the flu season to come. In this way, influenza vaccines for the year are produced so that people are protected against specific viruses. This year, the H1N1 virus used to make the 2011-2012 influenza vaccines remains the same along with the new strains of H3N2 and B vaccine viruses to be used for 2012-2013 vaccines in the US. The FDA urges children and adults to protect themselves against influenza and follows the CDC's Advisory Committee on Immunization Practices (ACIP) recommendations to get vaccinated.




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