Vaccines, Blood & Biologics

CBER-Regulated Products: Current Shortages

The following table identifies current shortages of CBER-regulated products. The information contained in this table is generally provided to CBER by the manufacturer of the CBER-regulated product that is in shortage. CBER is committed to ensuring that the information in the table is current, and works closely with the manufacturer to obtain accurate information.

Please refer to the Resources for You box to the left for a complete listing of all CBER approved, licensed, and cleared products, as well as CDC's recommended immunization schedules for adult and children.

Additional information regarding possible causes for CBER-regulated product shortages is provided on CBER-Regulated Products: Possible Causes of Shortages Page.

Product Manufacturer and Manufacturer Contact Information Product Availability and Estimated Shortage Duration (when known) Shortage Reason (per FDASIA)* Additional Information Date
Yellow Fever Vaccine
YF-VAX®

NDC Number: 49281-915-01

Vial, 1 Dose (5 per package)

NDC Number:
49281-915-05

Vial, 5 Dose with 3mL vial of diluent
Sanofi Pasteur Inc.
For questions, please call Sanofi Pasteur customer service at: 1-800-VACCINE (1-800-822-2463)

Sanofi Pasteur Inc. has a limited supply of Yellow Fever Vaccine YF-VAX®.

Currently, YF-VAX® is only being provided to customers that have patients who are traveling within 30 days to an area where yellow fever vaccine is required or recommended.

This measure is necessary to responsibly manage the limited supply of YF-VAX® in the United States.

Other

How to obtain products for patients:

Health care providers may no longer place orders for Yellow Fever Vaccine online. Health care providers must call Sanofi Pasteur at 1-800-VACCINE (1-800-822-2463), and speak to a customer service representative. Yellow Fever Vaccine doses will be prioritized to patients who are traveling within 30 days to an area where Yellow Fever Vaccine is required or recommended.

Additional information from Sanofi Pasteur can be found at:

https://www.vaccineshoppe.comdisclaimer icon

Onset: April 2016

Ongoing

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel®

NDC Number:
49281-0510-05

Vial, 1 Dose (5 per package)
Sanofi Pasteur Limited
For questions, please call customer service at: 1-800-VACCINE (1-800-822-2463)

Currently Sanofi Pasteur is experiencing a manufacturing delay for Pentacel® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.

As a result, Pentacel vaccine is available under supply limitations into the second half of 2016.

However, to address the anticipated gap in Pentacel supply Sanofi Pasteur has sufficient supplies of the relevant separately administered vaccines:

  • DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed Vaccine [DTaP])
  • IPOL® Poliovirus Vaccine Inactivated
  • ActHIB® Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Other

For guidance to healthcare providers please refer to the
Centers for Disease Control and Prevention (CDC)
Current Vaccine Shortages & Delays
page.

Additional information from Sanofi Pasteur can be found at:

https://www.vaccineshoppe.com/disclaimer icon

https://www.vaccineshoppe.com/
mailing/VSH/2015/12allo30341/index.html
disclaimer icon

You may also contact Sanofi Pasteur directly at: 1-800-VACCINE
(1-800-822-2463)

Onset: December 2015

Updated: June 2016

Ongoing

BCG Live (Intravesical)
TheraCys®

NDC Number:
49281-0880-03

81 mg lyophilized powder
Sanofi Pasteur, Ltd.
For questions, please call Sanofi customer service at:
1-800-VACCINE
(1-800-822-2463)
TheraCys® BCG is currently unavailable. Requirements related to complying with good manufacturing practices  

Onset:
May 2012

Ongoing

Immune Globulin Intravenous (Human) Multiple manufacturers Not applicable Other (No evidence of shortages, but CBER monitors for possible fluidity in product supply/demand) 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 (240) 402-8380.

Onset: Not applicable

Updated: June 2012

Being monitored

* FDASIA added several new, drug-shortage related sections to the FD&C Act, including section 506E. Section 506E of the FD&C Act further requires FDA to include on the shortages list the reason for the shortage, choosing from the following categories:

  • Requirements relating to complying with current good manufacturing practices (CGMP);
  • Regulatory delay;
  • Shortage of an active ingredient;
  • Shortage of an inactive ingredient component;
  • Discontinuation of the manufacture of the drug or biological product;
  • Delay in shipping of the drug or biological product;
  • Demand increase in the drug or biological product; or
  • Other.

 

Contact FDA

Biological Product Shortages

Page Last Updated: 06/13/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.