Merck Releases Healthcare Professional Letter

In a letter, dated May 16, 2011 (See Letter), Merck & Co., Incorporated, alerted all Healthcare Professionals about findings of particulate matter in some Merck product vials.  In rare cases (a reported rate of less than 1 in 6 million overall vials), vials of vaccine and ANTIVENIN™ products containing brown particles have been reported.  These particles are derived from the plastic packaging used to cover empty vials during shipment to Merck.  This issue is specific to vials, so prefilled syringes and oral dosing tubes are not impacted.  A list of all injectable vaccines and ANTIVENIN™ manufactured by Merck that may be affected by this issue is included in the letter.

Merck & Co. urges all Healthcare Professionals to continue the practice of examining all vaccines and injectables for particulate matter and discoloration prior to use.

As the letter describes, there is no impact expected to the sterility or the potency of the vaccines from this particulate matter.  However, vaccines containing small quantities of particulate matter may potentially lead to injection-site reactions if the material is not noticed prior to injection.  If you receive a vial of a Merck vaccine or ANTIVENIN™ containing particles, please set the vial aside and contact the Merck National Service Center at (800) 444-2080.

Suspected adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) at (800) 822-7967 (www.vaers.hhs.gov), with a copy of the VAERS report sent by FAX to the VAERS coordinator at the Bureau of Immunization at (850) 922-4195.

Please distribute this important update to colleagues, members, coalitions, and partners who provide immunizations or who have an interest in the promotion of vaccines. Please place this information prominently on your website.  Contact Laura Rutledge, RN, of my staff for questions regarding vaccine recommendations and adverse event reporting at (850) 245-4342.