Drug Manufacturer Recalls Vaccine Due to Expired Ingredients

Pneumococcus CDC PHIL ID1003Pfizer, Inc., the giant pharmaceutical company known for famous drugs like Lipitor, Lyrica, and, of course, Viagra, recently announced a recall of a batch of its pneumococcal vaccine Prevnar 13. The vaccine is distributed as a pre-filled syringe. An announcement by the U.S. Food and Drug Administration stated that the syringes covered by the recall contained “expired serotype 3 conjugate material.” Pfizer is conducting the recall at the wholesale level and has stated that the defective vaccine doses went to a single wholesaler. The wholesaler reportedly did not distribute the recalled vaccine to any pharmacies or health care providers. Pfizer did not say how many syringes are covered by the recall.

The FDA had just given its approval to Pfizer to expand use of the vaccine in December. Prevnar 13 has been used in infants and children since 2010. The new approval allowed Pfizer to also market the vaccine to adults over the age of 50. The vaccine fights the Streptococcus pneumoniae bacteria. This is an invasive bacteria that can cause pneumonia, meningitis, cellulitis, sepsis, and numerous other diseases. According to the FDA, around 300,000 adults over the age of 50 are hospitalized every year in the United States for pneumococcal pneumonia. It is one of the leading causes of death for older people. People over the age of 50 contract pneumococcal pneumonia at a higher rate than others. Prevnar 13 sales brought revenues of $3.7 billion to Pfizer in 2011.

Vaccines work by introducing a neutralized form of a bacterium or virus, known as an antigen, to a person’s immune system. This triggers an immune response from the body, such as the production of antibodies that attack the antigen, without giving the person the actual disease. Prevnar 13 is a conjugate vaccine, a new type of vaccine that attaches the antigen to a protein that helps deliver the antigen in a way that prompts an immune response. It is commonly used for bacterial antigens. Use of a conjugate vaccine with expired conjugate material, as is the case with the Prevnar 13 batch, would seriously compromise the vaccine’s effectiveness and expose the patient receiving the vaccine to infection.

Medication errors involving expired vaccines can have dire consequences for patients. This Pharmacy Error Injury Lawyer Blog recently reported on the case of a tennager in Florida who lost all four limbs as an infant due to an expired vaccine. A hospital medical assistant gave the child, who had just had her spleen removed, a vaccine specifically formulated to guard against infection after spleen-removal surgery. The batch of vaccine the assistant used had expired five months earlier and had no effect. The girl developed an infection that had spread to all of her limbs by the time doctors identified it. All four limbs had to be amputated.

Patients who have suffered injury due to pharmacy errors have rights to compensation for their damages. If you or a loved one have suffered harm from a medication error, contact the Maryland pharmacy error attorneys at Lebowitz and Mzhen online or at (800) 654-1949 to schedule a free and confidential consultation.

More Blog Posts:

Voluntary Recall Announced for Certain Oral Contraceptives Due to Packaging Error, Pharmacy Error Injury Lawyer, March 15, 2012
Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements, Pharmacy Error Injury Lawyer, February 29, 2012
Risperdal Recalled by Manufacturer Due to Drug Contamination, Pharmacy Error Injury Lawyer, July 29, 2011
Photo credit: ‘Pneumococcus CDC PHIL ID1003’ by CDC/Dr. M.S. Mitchell [Public domain], via Wikimedia Commons

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