Biological 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.
Reasons for Shortages
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.
Causes of Shortages
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.
How to Report Product Shortages
To report a biological product shortage by email, you may send an email to CBERProductshortages@cber.fda.gov . Also, during business hours, biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling (301) 827-6220.
Specific postings concerning product shortages will be added as questions about availability arise.
Shortage information for drug products handled by the Center for Drug Evaluation and Research (CDER) can be found on the CDER web site.
Current Biological Product Shortages
|Product Name /
|Manufacturer||Reason for Shortage||Date of Onset||Status|
|Haemophilus influenza Type b (Hib) Conjugate
PedvaxHIB® and Comvax®
|Merck & Co., Inc.||
Merck & Co., Inc. issued a voluntary recall of certain lots of Haemophilus influenza Type b products as a precautionary measure because the company cannot assure the sterility of these lots. Merck has suspended production of its Hib conjugate vaccines and does not expect to resume distribution of these vaccines until the fourth quarter of 2008. Additional information on the recall of affected lots is available online at http://www.fda.gov/consumer/updates/
Because of short-term reduction in available product, CDC in conjunction with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics has issued a temporary modification in vaccination schedules for Hib-containing vaccines. For further information on dose deferral, see the Morbidity and Mortality Weekly Report for December 19, 2007 at www.cdc.gov/mmwr
|December 13, 2007||Ongoing|
|Pediatric and Adult Hepatitis A Vaccine
|Merck & Co., Inc.||At the present time Merck reports temporary backorder and shipment delays for pediatric and adult hepatitis A vaccines (VAQTA®). Details regarding future availability of products ordered after September are not known. However, CDC expects the overall U.S. hepatitis A vaccine supply to be adequate to vaccinate all persons who fall within the recommendations to receive hepatitis A vaccine. Presently, GlaxoSmithKline (GSK) has plans to increase production of their pediatric and adult hepatitis A (HAVRIX®) and Adult hepatitis A/hepatitis B combination vaccine (TWINRIX®). More information is available on the CDC Current Vaccine Shortages and Delays web page.||August 1, 2007|
|Measles, Mumps, Rubella and Varicella Virus Vaccine Live
|Merck & Co., Inc.||Merck's Supply of the Varicella Virus Vaccine component of ProQuad® will be available until June 15, 2007. It will be unavailable from mid June through the remainder of 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||June 2007||Being monitored|
|Immune Globulin Intravenous (Human)||Multiple manufacturers:
Baxter Healthcare Corp
Grifols Biologicals Inc
Instituto Grifols, SA
Octapharma Pharmazeutika Produktionsges.mbH
Talecris Biotherapeutics, Inc
ZLB Behring AG
ZLB Behring LLC
|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. If you are experiencing difficulty in obtaining one of the IGIV products, you may tell us of your difficulties in an email to CBERProductshortages@cber.fda.gov. Those without email access may call (800) 835-4709. For more information about the status of IGIV products, read the announcement on the HHS web site.||Not applicable||Being monitored|
Resolved Biological Product Shortages
|Product Name /
|Manufacturer||Reason for Shortage||Date of Onset||Status||Date Resolved|
|Digoxin Immune Fab (Ovine)
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)
To report a biological product shortage, you may send an email to CBERProductshortages@cber.fda.gov. Also, during business hours, biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling (301) 827-6220.
|Yellow Fever Vaccine
|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 Traveler's Health site.||January 2008||Resolved||March 2008|
Tetravalent meningococcal conjugate vaccine
|Sanofi Pasteur, Inc.||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||May 2006||Resolved||November 2006|
(Cytomegalovirus Immune Globulin Intravenous (Human))
|Massachusetts Biological Public Health Laboratories
Distributed by MedImmune, Inc.
|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®."
|Not applicable||Resolved||August 2006|
|Influenza Virus Vaccine
1-800-244-7668, select #2
|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).
end of 2004 flu season
|Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
|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.
Normal immunization schedule can be resumed
|Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
|Wyeth Laboratories, Inc
|Wyeth is currently experiencing interruptions in shipment||11/5/2003||RESOLVED||11/14/2003|
|Pneumococcal Vaccine, Polyvalent
(single dose vial)
|Merck & Co, Inc
|Increased demand for single dose vials. Pneumovax 23 is still available in multidose vials. It will be a few weeks before single dose vials are available||10/29/2003||RESOLVED||11/10/2003|
Discontinued Biological Products
|Varicella Zoster Immune Globulin (Human) (VZIG)||Massachusetts Public Health Biologic Laboratories (MPHBL)
FFF Enterprises 1-800-843-7477
|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. (further information)||2/10/2006|
|HIVAG-1 Monoclonal Assay
(Catalog # 2A81)
|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|