Vaccine Recalls

comvax
Two lots of Comvax were recalled in 2007 because of contamination concerns.

Vaccines aren’t often recalled. There have been about 18 recalls of vaccines since 2006.

While that might seem like a lot, remember that at least 2.5 billion doses of vaccines have been given in that time .

When vaccines are recalled, it is typically because:

  • there is a loss of potency over time (typically flu vaccines near the middle or end of flu season)
  • there are minor production or manufacturing issues

Fortunately, these recalls don’t usually seem to involve major problems.

They are also a testament to just how closely vaccines are inspected after they are manufactured.

Vaccine Recalls

Recent vaccine recalls include:

  • Fluzone Quadrivalent – 3 lots had declined below the stability specification limit for 2 strains (2015)
  • Flulaval Quadrivalent – 13 lots of thimerosal-free pre-filled syringes were recalled because of loss of potency (2015)
  • Gardasil – one lot was recalled “due to the potential for a limited number of vials to contain glass particles” (2013)
  • Menveo – two lots were recalled “following observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial” (2013)
  • Recombivax HB – one lot was recalled “due to the potential for a limited number of cracked vials to be present in the lot.” (2013)
  • Typhim Vi – two lots of prefilled syringes and 20-dose vials because the “lots are at risk for lower antigen content” (2012)
  • MMR-II – one lot was recalled because it had not been shipped before being released. (2012)
  • Prevnar 13 – one lot was recalled because “the lot was formulated and filled with expired serotype 3 conjugate material.” (2012)
  • Fluvirin – one lot was recalled because “for a small number of vials, cracked vial necks leading to broken vials have been detected” (2010)
  • RabAvert Rabies Vaccine Kits – one lot was recalled because “as the stopper and the metal crimp dislodge from the vial completely when removing the protective cap.” (2010)
  • Prevnar 7 – 4 lots were recalled because “a potential exists for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar.” (2010)
  • 2009 H1N1 intranasal vaccine – 13 lots were recalled because of a “slight decrease in the potency of the H1N1 component of the vaccine” (2009)
  • 2009 H1N1 vaccine – 4 lots were recalled because they were “intended for children 6 through 35 months of age” (2009)
  • Prevnar 7 – 1 lot was recalled because some of pre-filled syringes were “not intended for commercial use” (2009)
  • Fluvirin – 5 lots was recalled because of “a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine” (2009)
  • PedvaxHib and Comvax – 13 lots were recalled because of a “lack of assurance of product sterility” (2007)
  • Fluvirin – 2 lots were recalled because they were shipped “in either a frozen state and/or below the required storage temperature” (2006)
  • Decavac – one carton (about 3000 Td shots) was recalled because it ” exceeded labeled temperature requirements during shipment” (2006)

These vaccine recalls shouldn’t scare you away from getting your kids vaccinated.

None led to “serious adverse events,” as some folks try to scare parents.

If anything, they should reassure you just how safe vaccines are. After all, from these vaccine recalls, you now know that ‘they’ are:

  • monitoring the potency of vaccines after they are manufactured
  • monitoring the temperatures of the vaccines while they are being shipped and stored
  • continuing to do quality testing, even after the vaccine is released

Remember, according to the CDC:

There have been only a few vaccine recalls or withdrawals due to concerns about either how well the vaccine was working or about its safety.  Several vaccine lots have been recalled in recent years because of a possible safety concern before anyone reported any injury.  Rather, the manufacturer’s quality testing noticed some irregularity in some vaccine vials.  In these cases, the safety of these vaccines was monitored continuously before and after they were in use.

Of these recalls, one of the largest was the 2007 recall of PedvaxHib and Comvax by Merck over concerns “about potential contamination with bacteria called B. cereus.” Fortunately, “no evidence of B. cereus infection was found in recipients of recalled Hib vaccines.”

If one of your child’s vaccines have been recalled, you will likely be notified by your pediatrician, who would have been notified by the manufacturer of the vaccine.

For More Information on Vaccine Recalls:

One thought on “Vaccine Recalls

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