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 | |
|---|---|---|---|
| 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 2013Ongoing | |
Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel® Sanofi Pasteur, Ltd. Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed Vaccine (DTaP) DAPTACEL® Sanofi Pasteur, Ltd. | There is currently a manufacturing delay related to Pentacel®vaccine that will result in the need for order limitations for this product. Pentacel® remains available, but order limitations are necessary because the manufacturing delay will temporarily reduce supply below the level needed to fully satisfy market demand. Due to the Pentacel® manufacturing delay, order limitations will also be placed on DAPTACEL® to ensure that healthcare providers have access to single entity DTaP vaccine for their patient needs. For information on supply and guidance to healthcare providers who experience supply interruptions, please see: Additional information can be found at: https://www.vaccineshoppe.com/index.cfm?fa=anon.catalog#category=1§ion=1 and www.vaccineshoppe.com/assets/pdf/Important%20Supply%20Information_MKT24949.pdf You may also contact Sanofi Pasteur, Inc. at: 1-800-VACCINE (1-800-822-2463). | Onset: April 2012 Updated: October 2012 Ongoing | |
| Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) Ortho-Clinical Diagnostics, Inc | Ortho Clinical Diagnostics, the distributor of CHIRON® RIBA® HCV 3.0 SIA, has been informed by Novartis Diagnostics, the legal manufacturer of this immunoblot assay, that the product is currently out of stock and is unavailable. Laboratories may contact Ortho Clinical Diagnostics Customer Technical Services directly at 1-800-421-3311 (Options 2, 4) 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.
| Onset: October 2012 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: | 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
| 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: | 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 | 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 Merck & Co., Inc.PedvaxHIB® | 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 |
| Yellow Fever Vaccine YF-VAX® Sanofi Pasteur | There is no shortage of Yellow Fever vaccine, but there is a temporary supply problem with single dose vials. Multi-dose (5 dose) vials are available. Sanofi Pasteur expects to have single dose vials back in stock in March 2008. Additional information can be found at the CDC's Traveler's Health site. | Onset: January 2008 Resolved: March 2008 |
Discontinued Biological Products
| Product | Comments | Date |
|---|---|---|
| Rubella Virus Vaccine Live Meruvax II® Merck & Co., Inc.
| MERUVAX® II (Rubella Virus Vaccine Live) has been discontinued. | 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 |
