Emerge Health announced a worldwide recall of all unexpired doses of Meningitec, a meningococcal serogroup C conjugate vaccine, according to the Medical Observer. The vaccine is labeled as being used to prevent meningococcal disease caused by meningococcal C bacteria. The Inquisitr readers in the United States should note this vaccine is not marketed to the U.S., according to information on the Neuron Biotech website and the CDC website.
A review of batches of Meningitec that have been manufactured since October 2012 discovered that a small number of syringes were contaminated with iron oxide (rust) and oxidized stainless steel, which originated from manufacturing equipment, according to First Word Pharma.
Emerge Health said the chances that individuals have received a contaminated Meningitec vaccine is very low. Per batch, only a small number of doses of Meningitec were contaminated. Emerge Health stated that contamination within doses would be visible during a pre-vaccination visual inspection, which healthcare workers are required to do prior to vaccination.
“If contamination was identified, the vaccine would not be administered,” according to First Word Pharma, which also stated that the contamination of Meningitec would not have interfered with the sterility or efficacy of the vaccines.
Consumers and healthcare providers should note that no other meningococcal serogroup C conjugate vaccines besides Meningitec are affected by this recall.
Healthcare workers have been instructed by Emerge Health to quarantine all stocks of Meningitec and to then contact Emerge Health to coordinate their return. Alternative meningococcal C conjugate vaccines from other producers are available to substitute during the worldwide Meningitec recall.
According to the sponsor, estimates of the maximum amount of contamination per syringe would have been up to 105 mg, with an estimated elemental iron amount of about 70 percent of the 105 mg.
If a syringe were administered and it had been contaminated, it could have resulted in localized injection site reactions such as redness, swelling, pain, or discoloration of the skin. An allergic reaction might also have been possible.
According to the vaccine manufacturer’s statement, if an affected syringe of Meningitec were given to a baby weighing less than seven kilograms (15.4 pounds), there may have been a potential risk of iron toxicity. Other vaccines are generally given to babies this small in some countries, according to information obtained by Pulse Today from NHS England, but the vaccine’s pamphlet states that Meningitec has been given to babies as young as 2-months-old. Past news reports indicate that the reported consequences of infants given Meningitec were lessened efficacy rather than safety concerns.
“NHS England area teams are writing to affected practices that may have vaccinated three-month-old babies with the Meningitec vaccine, instead of either of the two recommended meningitis C vaccines, NeisVac-C or Menjugate,” Pulse Today reported April 2014.
“Meningitec is also included in a number of national pediatric immunization programs, including Cyprus, France, Germany, Greece, Italy and Switzerland. To date, more than 50 million doses of Meningitec have been distributed worldwide since launch,” Nuron Biotech’s website states. The website has an easily accessed webpage for adverse reaction reporting categorized by country of distribution. Press releases about the Meningitec recall in countries where the vaccine is used have stated that there have been no reports of adverse events stemming from the contamination.