Vaccines, Blood & Biologics
Biologic Product Shortages
A biological product shortage occurs when a biological product is not commercially available in sufficient quantity to meet the demand.
A biological product is considered medically necessary when it is used to treat, cure, mitigate, prevent, or diagnose a serious or life-threatening disease or medical condition and there is no other available source or alternative therapy. A shortage situation occurs when the total supply of all licensed or approved product available at the market level will not meet the current demand and there is no adequate alternative therapy available that is judged by appropriate medical staff to be a suitable alternative. CBER's goal is to help prevent or alleviate shortages of biological products, and to work with all parties involved to make certain medically necessary products are available within the United States.
Manufacturing problems are the most common cause of biological product shortages. Manufacturing issues may be brought to FDA's attention by the manufacturer or as a result of an FDA inspection. Other activities that may cause product shortages include corporate decisions to discontinue the product, distribution disruptions, regulatory actions, or natural disasters.
Current Biological Product Shortages
| Product | Reason for Shortage | Status |
|---|---|---|
Tuberculin, Purified Protein Derivative Sanofi Pasteur LimitedTubersol® | Sanofi Pasteur is experiencing a temporary delay in the availability of 50-test vials of Tuberculin, Purified Protein Derivative Tubersol®. Currently – the 10-test vials of Tuberculin, Purified Protein Derivative Tubersol® are available to be ordered on VaccineShoppe.com® or by contacting Sanofi Pasteur directly at: 1-800-VACCINE (1-800-822-2463). Tuberculin, Purified Protein Derivative Tubersol® 10-test vials will also be available soon through wholesalers and distributors as inventories are replenished. At the present time, only 50-test vials are unavailable. It is anticipated that 50-test vials will become available late-May 2013. For questions, please call customer service at: 1-800-VACCINE (1-800-822-2463). | Onset: March 2013 Updated: April 2013 Ongoing |
Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel® Sanofi Pasteur, Ltd. | Pentacel®vaccine is temporarily unavailable. Pentacel® vaccine supply is expected to return in June 2013 under supply limitations. Sanofi Pasteur’s single antigen diphtheria, tetanus, and acellular pertussis (DTaP) DAPTACEL®, inactivated polio IPOL®, and Haemophilus influenza type b (Hib) ActHIB®, vaccines are in sufficient supply to address historic usage of Pentacel® vaccine as well as the historic demand for these single antigen vaccines. For guidance to healthcare providers please refer to the Centers for Disease Control and Prevention (CDC) Current Vaccine Shortages & Delays page. Information concerning supply can be found at: You may also contact Sanofi Pasteur directly at: 1-800-VACCINE (1-800-822-2463) | Onset: April 2012 Updated: April 2013 Ongoing |
Tuberculin, Purified Protein Derivative | Tuberculin, Purified Protein Derivative product Aplisol® is on allocation and is available in restricted quantity. There is an increased demand for this product. Please check with your physician, wholesaler, or call JHP Pharmaceuticals, LLC directly for product availability. 1-877-547-4547 | Onset: |
| Rabies Immune Globulin (Human) Imogam® Sanofi Pasteur SA | Sanofi Pasteur SA currently has a limited supply of Rabies Immune Globulin (Human) Imogam® Currently, Imogam® is only being shipped directly to customers as needed for use with patients that have documented exposure to rabies which require post-exposure prophylaxis. This measure is necessary to responsibly manage the limited supply of rabies immune globulin in the United States. How to obtain products for patients with urgent need: Access post-exposure information via link on www.vaccineshoppe.com home page. Please fill out a post exposure use form and fax it to Sanofi Pasteur at 1-877-287-9391 (Attn: Sanofi Pasteur Customer Service) For questions, please call customer service at: 1-800-VACCINE (1-800-822-2463). | Onset: March 2013 Ongoing |
| Rabies Vaccine IMOVAX® Sanofi Pasteur SA | Sanofi Pasteur SA currently has a limited supply of Rabies Vaccine IMOVAX® Currently, IMOVAX® is only being shipped directly to customers as needed for use with patients that have documented exposure to rabies which require post-exposure prophylaxis. This measure is necessary to responsibly manage the limited supply of rabies vaccine in the United States. How to obtain products for patients with urgent need: Access post-exposure information via link on www.vaccineshoppe.com home page. Please fill out a post exposure use form and fax it to Sanofi Pasteur at 1-877-287-9391 (Attn: Sanofi Pasteur Customer Service) For questions, please call customer service at: 1-800-VACCINE (1-800-822-2463). | Onset: March 2013 Ongoing |
| Antivenin (Latrodectus Mactans) Black Widow Spider Antivenin (Equine Origin) Merck & Co., Inc. | Merck & Co., Inc. is temporarily limiting distribution of Antivenin (Latrodectus Mactans) to cases of confirmed black widow spider bites. How to obtain products for patients with confirmed black widow spider bites: Healthcare providers may contact Merck & Co., Inc., directly at 1-800-NSC-MERCK (1-800-672-6372) | Onset: January 2009 Updated: February 2013 Ongoing |
| BCG Live (Intravesical) TheraCys® Sanofi Pasteur, Ltd. | Theracys-BCG is currently unavailable due to a manufacturing issue. You may contact Sanofi Pasteur, Inc. at: 1-800-VACCINE (1-800-822-2463). | May 9, 2012 |
| BCG Live (Intravesical)TICE®BCG Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc. | There is an increased demand for this product. BCG Live product is available. Product may go on allocation if demand exceeds increased production plans and available inventory. Please check with your physician, wholesaler, or call Merck directly for product availability. 1-800-NSC-MERCK (1-800-672-6372)
| May 9, 2012 |
| Rabies Vaccine RabAvert® Novartis Vaccines and Diagnostics, Inc. | Novartis Vaccines and Diagnostics, Inc. currently has a limited supply of Rabies Vaccine RabAvert®
| Onset: September 2011 Ongoing |
| Immune Globulin (Human) GamaSTAN® S/D Talecris Biotherapeutics, Inc. | 10-ml vials of GamaSTAN® S/D are in temporary short supply. 2-ml vials of GamaSTAN® S/D are available on a limited basis. Talecris Biotherapeutics, Inc. expects to release new lots of 10-ml vials and 2-ml vials of GamaSTAN® S/D in the near future. How to obtain products for patients with urgent need: Healthcare providers may contact Talecris Biotherapeutics, Inc., directly at 800-243-4153. | Onset: July 2011 |
Immune Globulin Intravenous (Human) | Since the 1990’s, the FDA, along with other HHS agencies, has periodically received reports from stakeholders, patients, and health care providers regarding difficulty in obtaining Immune Globulin Intravenous (IGIV) products. From discussions with manufacturers, distributors, providers, and consumers, it is clear that availability and treatment patterns have shifted; but we have not found clear evidence that there is a shortage. This is a multi-faceted and fluid situation. If you have any difficulty in obtaining IGIV and/or have additional information concerning the availability of IGIV please contact CBER at: CBERshortage@fda.hhs.gov or (301) 827-4239. | Onset: Not applicable |
Resolved Biological Product Shortages
| Product | Reason for Shortage | Status |
|---|---|---|
| Hepatitis A Vaccine VAQTA® Merck & Co., Inc. | Merck & Co., Inc. is reporting that: VAQTA® (Hepatitis A Vaccine, Inactivated) Adult Formulation 1ml vials are currently unavailable But VAQTA® (Hepatitis A Vaccine, Inactivated) Adult Formulation 1ml prefilled syringes are available Additional information can be found at: or at: | Onset: February 2008 Updated: November 2012 Resolved: February 2013 |
| Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad® Merck & Co., Inc. | Merck & Co., Inc. is reporting that ProQuad® is unavailable. Please see CDC recommendations for alternate vaccine usage at CDC's Notice to Readers: Update on Supply of Vaccines Containing Varicella-Zoster Virus Additional information can be found at: or at: | Onset: June 2007 Updated: March 2012 Resolved: October 2012 |
| Zoster Vaccine Live Zostavax® Merck & Co., Inc. | Merck & Co., Inc. is reporting shipping delays for Zostavax® (Zoster Vaccine Live) with backorders of 3 to 5 weeks. Information on supply and availability can be found on the CDC's Current Vaccine Shortages and Delays web page. Additional information can be found at: or at: | Onset: July 2008 |
| Hepatitis B Vaccine Recombivax HB® Merck & Co., Inc. | Merck & Co., Inc. anticipates a supply interruption in the Additional information can be found at: or at: | Onset: January 2009 Resolved: August 2011 |
| Immune Globulin (Human) GamaSTAN® S/D Talecris Biotherapeutics, Inc. | 2-ml vials of GamaSTAN® S/D are in temporary short supply. 10-ml vials of GamaSTAN® S/D are available and are not in short supply. Talecris Biotherapeutics, Inc. expects to release a new lot of 2-ml vials of GamaSTAN® S/D in the near future. How to obtain products for patients with urgent need: Healthcare providers may contact Talecris Biotherapeutics, Inc., directly at 800-243-4153. | Onset: January 2010 Resolved: July 2011 |
| Haemophilus influenza Type b (Hib) Conjugate Comvax® Merck & Co., Inc. | Merck is working to restore availability Comvax®. More information is available on the CDC's Current Vaccine Shortages and Delays web page. | Onset: December 13, 2007 Resolved: August 2010 |
| Haemophilus influenza Type b (Hib) Conjugate PedvaxHIB® &Co., Inc. | Merck is working to restore availability of PedvaxHiB®. More information is available on the CDC's Current Vaccine Shortages and Delays web page. | Onset: December 13, 2007 Resolved: January 2010 |
| Immune Globulin (Human) GamaSTAN® S/D Talecris Biotherapeutics, Inc. | 10-ml vials of GamaSTAN® S/D are in temporary short supply. 2-ml vials of GamaSTAN® S/D are available and are not in short supply. Talecris Biotherapeutics, Inc. expects to release a new lot of 10-ml vials of GamaSTAN® S/D in the near future. How to obtain products for patients with urgent need: Healthcare providers may contact Talecris Biotherapeutics, Inc., directly at 800-243-4153. | Onset: April 2009 Resolved: March 2010 |
| Digoxin Immune Fab (Ovine) Digibind® GlaxoSmithKline (GSK) | The current short supply situation is due to increased order volumes in the latter part of 2007, and should improve within weeks. FDA and the manufacturer have not received reports of specific shortages at this time. Although industry inventories are currently limited, it is possible that sufficient supplies exist at the distributor and pharmacy level. How to obtain products for patients with urgent need: Digibind®: Patients and healthcare providers may contact GlaxoSmithKline directly at 800-877-1158. Your Regional Poison Control Centers may also be able to assist in locating regional supplies of Digoxin Immune Fab products (1-800-222-1222) | Onset: February 2008 Resolved: May 2, 2008 |
Discontinued Biological Products
| Product | Comments | Date |
|---|---|---|
| Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA) Manufactured by: Novartis Diagnostics Distributed by:
| Novartis Diagnostics, the legal manufacturer of this immunoblot assay, has informed the FDA that the production of the CHIRON® RIBA® HCV 3.0 Strip Immunoblot Assay (SIA) has been discontinued. FDA regulations provide procedures for licensed and unlicensed blood establishments wishing to obtain an exception or alternative procedure to the requirements in Parts 600-680. Additional information concerning this product and instructions for obtaining an exception or alternative procedure can be found at: CBER Safety and Availability webpage and Information for Blood Establishments: DISCONTINUATION of CHIRON® RIBA® HCV 3.0 SIA (RIBA) and Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001) | Discontinued: February 18, 2013
|
| Rubella Virus Vaccine Live Meruvax II® Merck & Co., Inc.
| MERUVAX® II (Rubella Virus Vaccine Live) has been discontinued. The Advisory Committee on Immunization Practices (ACIP) has recommended the use of combined measles-mumps-rubella vaccine (M-M-R® II - Measles, Mumps, and Rubella Virus Vaccine Live) for appropriate individuals to help protect against measles, mumps, and rubella. | 5/24/2011 |
Varicella Zoster Immune Globulin (Human) VZIG | MPHBL has discontinued manufacture of VZIG and a limited supply of VZIG remains. Investigational (not licensed) VZIG product is available under an investigational new drug application (IND) protocol. FFF Enterprises (Temecula, CA) the sole authorized distributor of the product, will assist in determining patient eligibility and in shipping investigational VZIG. | 2/10/2006 |
| HIVAG-1 Monoclonal Assay (Catalog # 2A81) Abbott Laboratories 1-800-323-9100 | Letter sent to US customers 8/18/2003: Abbott will cease shipping the test effective 12/31/2003. Decision based on industry's use of Nucleic Acid Testing (NAT) as a substitute for HIV antigen testing. | 12/31/2003 |
