Vaccines, Blood & Biologics
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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 |
|---|---|---|
| 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.
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Onset: April 2009
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| Antivenin (Latrodectus Mactans) Antivenin (Black Widow Spider Antivenin) (Merck) Merck & Co., Inc. |
Merck is temporarily limiting distribution of this product to cases of confirmed spider bites. | Onset: January 2009 Ongoing |
| Hepatitis B Vaccine Recombivax HB® Merck & Co., Inc. |
Beginning in January 2009, Merck anticipates a supply interruption in the US of the adult formulation for hepatitis B vaccine, Recombivax HB®. This includes vials, syringes and dialysis formulations. Merck states that pediatric formulations are not affected and will be sufficient to meet anticipated demand. For additional information on supply and availability, please see CDC's Current Vaccine Shortages & Delays web page. | Onset: January 2009 Ongoing |
| Pediatric and Adult Hepatitis A Vaccine VAQTA® Merck & Co., Inc. |
Merck & Co., Inc. is reporting that VAQTA® (Hepatitis A Vaccine, Inactivated) Pediatric/Adolescent will be available in the future. VAQTA® (Hepatitis A vaccine, inactivated) Adult is still unavailable. CDC expects the overall U.S. hepatitis A vaccine supply to be adequate to vaccinate all persons who fall within recommendations to receive hepatitis A vaccine. More information is available at the CDC's Current Vaccine Shortage and Delays web page. |
Onset: February 2008 Being Monitored |
| Haemophilus influenza Type b (Hib) Conjugate PedvaxHIB® and Comvax® Merck & Co., Inc. |
Merck is working to restore availability of PedvaxHiB® and Comvax®. More information is available on the CDC's Current Vaccine Shortages and Delays web page. | Onset: December 13, 2007 Projected to continue until mid-2009 |
| Rubella Virus Vaccine Live Meruvax II® Merck & Co., Inc. |
According to Merck’s web page, MERUVAX® II (Rubella Virus Vaccine Live) is no longer available for order. 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. | Onset: Fall 2008 Ongoing |
| Zoster Vaccine Live Zostavax® Merck & Co., Inc. |
Beginning in July of 2008 Merck reported shipping delays for Zostavax® (Zoster Vaccine Live). As of mid-November 2008 the product availability is unchanged with backorders of 3 to 5 weeks. More information is available on the CDC's Current Vaccine Shortages and Delays web page. | Onset: July 2008 Ongoing |
| Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad® Merck & Co., Inc. |
Merck's Supply of the Varicella Virus Vaccine component of ProQuad® will be available until June 15, 2007. Merck & Co. is requesting that customers begin transitioning from ProQuad® to M-M-R®II and VARIVAX® at their earliest convenience. For additional information, see CDC recommendations for alternate vaccine usage at CDC's Notice to Readers: Update on Supply of Vaccines Containing Varicella-Zoster Virus | Onset: June 2007 Being monitored |
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Immune Globulin Intravenous (Human) Multiple manufacturers: |
Along with other HHS agencies, the FDA has 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 did not find clear evidence that there is currently a shortage. This is a multi-faceted and fluid situation. We are seeking additional information on the current availability of IGIV (see contact information). For more information about the status of IGIV products, read the announcement on the HHS web site. | Onset: Not applicable Being monitored |
Resolved Biological Product Shortages
| Product | Reason for Shortage | Status |
|---|---|---|
| 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 |
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Tetravalent meningococcal conjugate vaccine Menactra |
Due to supply shortages, Menactra® (tetravalent meningococcal conjugate vaccine) availability will likely be limited through the fall of 2006. Menactra® is indicated for active immunization of individuals 11-55 years of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Until supply can adequately meet demand, providers are being asked by the Center for Disease Control (CDC) to modify vaccination practices. During the current shortage, CDC recommends that providers defer vaccination for persons 11 to 12 years old, and give priority to adolescents entering high school and college freshmen living in dorms. Vaccination is also recommended for other high risk groups including military recruits, people traveling to meningitis endemic areas, immune deficient, and asplenic individuals. According to CDC, Menomune® (meningococcal polysaccharide vaccine, groups A, C, Y and W-135), also manufactured by Sanofi Pasteur Inc., may be an acceptable alternative to Menactra® in certain situations (e.g., travelers to endemic areas). However, the availability of Menomune® is also limited. For additional information, go to CDC's Notice to Readers: Limited Supply of Meningococcal Conjugate Vaccine, Recommendation to Defer Vaccination of Persons Aged 11--12 Years | Onset: May 2006 Resolved: November 2006 |
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Cytomegalovirus Immune Globulin Intravenous (Human) CytoGam |
CytoGam (cytomegalovirus immune globulin intravenous (human)) is an intravenous immune globulin enriched in antibodies against cytomegalovirus (CMV), and is indicated for prophylaxis against CMV disease associated with transplantation of kidney, lung, liver, heart, and pancreas. Recently, MedImmune has experienced supply shortages. In order to provide product to post-operative transplant patients, MedImmune has provided ordering instructions for physicians and healthcare professionals to obtain product through designated wholesalers. For more information, call MedImmune Customer Support Network at (877) 633-4411 or look on the MedImmune web page under "Products" and click on "CytoGam®." |
Onset: Not applicable Resolved: August 2006 |
| Influenza Virus Vaccine Fluvirin Chiron Corp |
On October 5, 2004, HHS was notified by Chiron Corporation that its influenza vaccine (Fluvirin) would not be available for distribution in the United States for the 2004-05 influenza season. The company indicated that the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, where Chiron's Fluvirin vaccine is produced, has suspended the company's license to manufacture Fluvirin vaccine in its Liverpool facility, thereby preventing any release of this vaccine for this influenza season. This action will reduce by approximately one half the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004-05 influenza season. The CDC recommends vaccination priority be given to children aged 6-23 months, persons aged 2-64 years with underlying chronic medical conditions, all women who will be pregnant during the influenza season, and those over 65 years of age, as well as several other groups (see the CDC website for further information). |
Onset: October 5, 2004 Resolved: End of 2004 flu season |
| Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar Wyeth Laboratories, Inc |
In February, Wyeth Laboratories, Inc. informed its customers that it was experiencing supply limitations of Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), used in the prevention of invasive pneumococcal disease in infants and young children. Since February, it was recommended that the 4th dose and, subsequently, the 3rd dose of Prevnar should be temporarily suspended in healthy children until sufficient supply was available. Production problems now appear to be resolved. On July 9, 2004, CDC in conjunction with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics recommended that providers administer 3 doses of vaccine. The fourth dose should still be deferred for healthy children until production and supply data demonstrate that a 4-dose schedule can be sustained. Children at high risk for severe pneumococcal disease should continue to receive the 3rd and 4th doses. |
Onset: February 10, 2004 Resolved: September 17, 2004 Normal immunization schedule can be resumed |
Discontinued Biological Products
| Product | Comments | Date |
|---|---|---|
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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 |