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.
Current Biological Product Shortages
Product Name /
Tradename |
Manufacturer |
Reason for Shortage |
Date of Onset |
Status |
Date Resolved |
Pneumococcal Vaccine, Polyvalent
Pneumovax 23
(single dose vial)
NDC #00006-4943-00 |
Merck & Co, Inc
1-800-672-6372 |
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 |
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
CRM197 Protein)
Prevnar |
Wyeth Laboratories, Inc
1-800-572-8221 |
Wyeth is currently experiencing interruptions in shipment |
11/5/2003 |
RESOLVED |
11/14/2003 |
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
CRM197 Protein)
Prevnar |
Wyeth Laboratories, Inc
1-800-572-8221 |
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. |
2/10/2004 |
RESOLVED
Normal immunization schedule can be resumed |
9/17/2004 |
Influenza Virus Vaccine
Fluvirin |
Chiron Corp
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 www.cdc.gov/flu/protect/whoshouldget.htm). |
10/5/2004 |
|
|
Discontinued Biological Products
Product Name/
Tradename |
Manufacturer |
Comments |
Date |
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 |
|
