New Combination Vaccine Licensed for Young Children

In late March, Sanofi Pasteur Inc. and the FDA announced a newly licensed vaccination safe for use in children ages four to six. This combination vaccine will complete the diphtheria, tetanus, and pertussis (DTaP) vaccination series, as well as provide an inactivated poliovirus vaccination series.

The labeling for the vaccine indicates it is meant for children who have already received four doses of the company’s DTaP vaccine, or the company’s diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine.

This vaccine is known by the brand name Quadracel. It is a new diphtheria and tetanus toxoids and acellular pertussis, combined with inactivated poliovirus. A company spokesperson said the vaccine will be made available at some point during the second quarter of 2015, but did not release any more specific information with regards to availability.

The vaccine will be available in single-dose vials, each containing 0.5mL of a suspension comprised of toxoids, antigens, and inactivated virus.

The product labeling states that each dose needs to be prepared right before being administered into the deltoid. Before taking the dose from the vial, healthcare professionals are advised to shake the vial until its contents look like a white, cloudy suspension that is uniform in appearance.

Any patients who have experienced a severe allergic reaction after receiving any diphtheria or tetanus toxoid, any vaccine that contains pertussis, or any inactivated poliovirus vaccine should not use this product. The combination vaccine is not safe for anyone who had encephalopathy within the first week after receiving a pertussis containing vaccine, or in anyone who has a progressive neurologic disorder that has yet to stabilize.

A clinical study showed patients who received the combination vaccination commonly experienced: pain and erythema at the injection site, increased arm circumference, and muscle pain. These reactions each occurred in more than 50% of patients.

The new combination vaccination will be supplied in packages containing 10 vials. They should be stored between 2 and 8°C (35.6 and 46.4°F), and never frozen. If the vials have been frozen at any point in time, they should not be used.

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