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2017-2018 Influenza Quadrivalent Virus Vaccine Ordering Procedures

April 28, 2017

Program Support Center (PSC) is now taking orders for the 2017-2018 influenza quadrivalent virus vaccine. We recommend consolidating your requirements (i.e., number and type of vaccines and safety needles needed) for the 2017-2018 flu season and placing your orders as soon as possible. This helps us better plan to meet all our customers’ flu vaccine needs for the upcoming season.

Manufacturer Information

Sequirus is the manufacturer of the 2017-2018 influenza quadrivalent virus vaccine multi-dose vials and pre-filled syringes. The following vaccines are available for the 2017–2018 season:

National Stock Number Product Description U/I Price
6505-00-000-8553 Pre-filled Syringes, 10s FLUCELVAX® QUADRIVALENT, Preservative-Free and Latex-Free, 0.5 ml Syringes $167.58
6505-00-000-8551 Multiple-Dose Vial (10 doses), FLUCELVAX® QUADRIVALENT, 5 ml Vial $153.86
 

Safety needles recommended for use with the flu vaccine are:

  • 6515-00-000-0082 (23G x 1 in.), 50s Safety Glide
  • 6515-00-000-0081 (25G x 1 in.), 50s Safety Glide

Vaccine Composition

Please note that FLUCELVAX multiple-dose vial is for ages four years and older and contains a small amount of preservative. The FLUCELVAX pre-filled syringes is for four years and older and is preservative-free and the stopper is latex-free. Please notify us if you have patients younger than four years old that require vaccination.

The composition for the quadrivalent U.S. 2017–2018 influenza vaccine season contains the following:

  • A/Michigan/45/2015 (H1N1)pdm09-like virus
  • A/Hong Kong/4801/2014 (H3N2)-like virus
  • B/Brisbane/60/2008-like (B/Victoria lineage) virus
  • B/Phuket/3073/2013-like (B/Yamagata lineage) virus

Vaccine Orders

Please submit a purchase order and fax your orders to (410) 642-1392. You may also contact our customer service department at (800) 642-0263 or (410) 642-2244 with you order.

We request that your requirements for this vaccine be submitted as a separate purchase order since orders will not be processed until stock is available. Additionally, no orders will be processed unless appropriate purchase information is submitted with the purchase order. Be sure to notify us of changes in address or hours of operation before your order is shipped.

At this time, delivery to PSC is expected to come in multiple shipments before September 30, 2017. Orders will be processed on a first-come, first served basis. Please note, this delivery schedule is subject to change and is at the discretion of the manufacturer. We will advise our customers of any change in the delivery schedule.

 

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URGENT DRUG RECALL

April 17, 2017

Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, is conducting a voluntary worldwide recall of the EpiPen® Auto-Injector.

Meridian Medical Technologies is recalling those lots and expiration dates described in the table stated below, due to failure of activation caused by a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life threatening allergic reaction (anaphylaxis).

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The recall impacts the 0.3mg and 0.15mg strengths of EpiPen Auto-Injector.

EpiPen® Auto-Injector

Lot

NDC

Product Description

Exp. Date

5GN767

49502-501-02

EpiPen Jr 2-Pak®Auto-Injectors, 0.15mg

April 2017

5GN773

49502-501-02

EpiPen Jr 2-Pak®Auto-Injectors, 0.15mg

April 2017

5GM631

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

April 2017

5GM640

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

May 2017

6GN215

49502-501-02

EpiPen Jr 2-Pak®Auto-Injectors, 0.15mg

September 2017

6GM082

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

September 2017

6GM072

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

September 2017

6GM081

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

6GM088

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

6GM199

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

6GM091

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

6GM198

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

6GM087

49502-500-02

EpiPen 2-Pak®Auto-Injectors, 0.3mg

October 2017

 

An assessment of our inventory shows that SCMS stocks this product (EPI AUTO INJ) under NSN 6505-01-599-0353 for the 0.3mg and 6505-01-599-1871 for the 0.15mg. We ask for your cooperation in taking the following action:

  • Please examine your inventory and if you have the recalled product in question immediately cease distribution / use.
  • If you have purchased the product from Supply Chain Management Services, fill out the “Return Response Form” and send with recall product.
  • Mark the returned product purchase from SCMS “Recall Materials Enclosed” and return to:
    ATTN: Leslie Ridgeway
    HHS Supply Chain Management Services
    Building 14
    Perry Point, MD 21902
  • Used product is not accepted for credit.
  • Please return the affected product before May 15, 2017 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product.

Contact

Please note customers must reorder the EpiPen® Auto-Injector if desired. If you have any questions about this recall please contact Heather Ward, Quality Assurance Specialist at (410) 642-2244 ext. 1132. We apologize for any inconvenience and appreciate your prompt response to this recall.

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Update on Menomune

February 9, 2017

Sanofi has just informed us of the discontinuation of their meningococcal polysaccharide vaccine (MPSV4, Menomune®), the only vaccine available to vaccinate people 56 years and older.

With the limited number of remaining doses of Menomune-A/C/Y/W-135 vaccine, Sanofi anticipates being able to supply the vaccine into mid-2017. In addition, all Menomune-A/C/Y/W-135 vaccine currently available for purchase will have the following expiration dates:

  • Lot UI037AA will expire June 24, 2017
  • Lot UI038AA will expire June 24, 2017
  • Lot UI039AA will expire June 25, 2017
  • Lot UI040AA will expire September 10, 2017
  • Lot UI041AA will expire September 10, 2017

This decision to discontinue the production of Menomune-A/C/Y/W-135 vaccine is not based on any quality, safety, or efficacy issues. With increasing interest in quadrivalent meningococcal conjugate vaccines and other alternatives being available to help address public health needs, Sanofi has decided to focus its resources on quadrivalent meningococcal conjugate vaccines.

According to ACIP recommended previously only the quadrivalent meningococcal polysaccharide vaccine (MPSV4; Menomune, Sanofi) for use in adults age 56 years and older. The most recent consolidation of recommendations, published in March 2013, recommend the use of quadrivalent meningococcal conjugate vaccine (MCV4; Menactra, Sanofi; Menveo, Novartis) in adults age 56 years and older who (1) were vaccinated previously with MCV4 and now need revaccination or (2) are recommended to receive multiple doses (for example, adults with asplenia or microbiologists working with Neisseria meningitides). Both MCV4 vaccine products are licensed for use in people through age 55 years, which means that the use of these vaccines in people age 56 and older is off-label but ACIP-recommended. It is also acceptable to use MCV4 if MPSV4 is not available (www.immunize.org/askexperts/experts_men.asp )

Contact

If you have any questions or concerns please feel free to contact Annette Quinones at (410) 642-1386 or annette.quinones@psc.hhs.gov.

 

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