This page was updated March 29, 2010
IMPORTANT: Wyeth Recalls 4 Lots of Privately Sold Prevnar® Pneumococcal 7-Valent Conjugate Vaccine
The Bureau of Immunization, as part of our commitment to our partners, brings to your attention the following Centers for Disease Control and Prevention (CDC) information distributed on March 23, 2010, regarding Wyeth's voluntary recall of 4 lots of privately sold Prevnar® Pneumococcal 7-Valent Conjugate Vaccine. This recall does not involve vaccines distributed through the Vaccines for Children (VFC) Program.
During a routine physical inspection of Prevnar® pre-filled syringes, Wyeth determined that 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®. Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients. Further, there would be no expected loss of potency and there is no need to revaccinate children who may have received a dose of Prevnar® from an affected syringe.
There is no safety concern with the lots that are being recalled and therefore no need to revaccinate anyone who had been immunized with vaccines from these specific lot numbers:
E25197 (EXP 10/13)
E28211 (EXP 10/13)
E37556 (EXP 10/13)
E38749 (EXP 11/13)
These lots were distributed January 9 - March 3, 2010.
If you have any product from the above lots, please remove it immediately from use. Contact Stericycle Inc. at 1-800-668-4391 and request a Return Kit from the Customer Service agent. Stericycle Inc. will subsequently send you a Return Kit with preprinted return address label(s), packing slip and instructions for returning the recalled product. You will receive credit for the returned merchandise.
IMPORTANT: FDA Recommends Suspension of Rotarix Vaccine
The Food and Drug Administration (FDA) recommends that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
Routine testing of Rotarix vaccine by an independent U.S. academic research team detected PCV1 genetic material (Porcine Circovirus 1) in the vaccine. PCV1 is not known to cause illness in humans or other animals. Rotarix has been studied extensively and found to have an excellent safety record. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.
This temporary suspension will enable further evaluation of the vaccine by the FDA and CDC while not losing its efficacy.
Vaccine Storage and Handling:
Isolate the Rotarix vaccine while maintaining the proper cold chain in anticipation of the cancellation of the suspension.
Do not return or discard the vaccine.
It is important to note:
- The vaccine is effective.
- Children who completed the 2 dose series are considered protected.
- There is no need to re-administer any Rotarix doses.
- If the Rotarix vaccine series has not been completed, complete the series with 2 doses of RotaTeq at the appropriate intervals.
- There is no need to test children who received the vaccine.
The FDA press release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm. The FDA has established a website with information regarding the rotavirus vaccine at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm205585.htm#hcpFDA. This website will provide updates as more information becomes available from the FDA.
Other Vaccine News:
Vaccines and Autism
U.S. Court of Federal Claims Special Masters that
thimerosal-containing vaccines do not cause autism