2009 H1N1 Influenza Vaccine with Long-Dated Expiration Questions and Answers

Learn about the 2009 H1N1 Central Vaccine Recovery Program

July 23, 2010, 12:00 PM EDT

Background

Unlike seasonal influenza vaccine which typically expires on June 30th, the 2009 H1N1 monovalent influenza vaccine expiration dates range from February 2010 to early 2011.  Sanofi Pasteur multi-dose vials (MDV), specifically, have expiration dates in 2011. Additional 2009 H1N1 influenza activity (i.e. "third wave") is possible through spring and summer of 2010, or in early fall 2010 when the 2010-11 trivalent influenza vaccine is not yet available.  Although the 2010-11 seasonal trivalent influenza vaccine will contain a 2009 H1N1-like influenza A strain, the timing of its production and availability is not yet known.

The purpose of this document is to address questions raised by the long-expiry vaccine.

How should grantees handle Sanofi Pasteur 2009 H1N1 vaccine that expires next year?

Viable 2009 H1N1 Sanofi Pasteur MDV should not be destroyed until 2010-11 seasonal vaccine (which will contain 2009 H1N1 strain) is widely available. It should be stored in the event there is a resurgence of disease before the 2010-2011 vaccine is available.

Should the long-dated 2009 H1N1 influenza vaccine be used instead of 2010-2011 seasonal influenza vaccine?

The 2010-2011 seasonal vaccine will contain two other strains in addition to the 2009 H1N1 strain. For this reason the 2009 H1N1monovalent vaccine will not be considered a substitute for the seasonal  trivalent vaccine. It would only be used in the event of  a resurgence in disease before the 2010-2011 seasonal vaccine is widely available.

What should grantees do with excess viable 2009 H1N1 monovalent vaccine?

Grantees should identify a way of storing viable vaccine in the event of a resurgence of 2009 H1N1 disease before the 2010-2011 trivalent vaccine is widely available. Because providers may want to free up their refrigerator storage, states may choose to accept vaccine back from providers if vaccine viability and cold chain integrity can be assured.  States must review provider temperature logs for vaccine while in their possession to ensure that the vaccine has been properly stored before accepting this vaccine back from providers.

Can unused or expired 2009 H1N1 monovalent vaccine be sent back to McKesson?

Unused or expired vaccine should not be sent back to McKesson.

How long should grantees plan to store the long-dated 2009 H1N1 influenza vaccine?

At a minimum, grantees should plan to store such vaccine until seasonal vaccine distribution is well underway. The time at which sufficient supply can be assured is difficult to predict given year to year variations. Distribution of seasonal influenza vaccine by manufacturers will be monitored by CDC and CDC expects to issue a recommendation that stored vaccine no longer needs to be kept once available information indicates a robust supply, in order to minimize confusion about which flu vaccine (2010-11 trivalent vaccine versus 2009 H1N1 monovalent vaccine) should be administered

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What should grantees say to providers about current vaccination efforts?

CDC recommends direct communication with health care providers and retailers to continue to encourage vaccination of people with high risk conditions. As part of this communication, CDC recommends that state health departments request that retailers, pharmacies, and healthcare providers retain their unexpired 2009 H1N1 vaccine supplies as a reserve, should demand for vaccination increase before seasonal vaccine becomes available

Can PHER funds be used to cover vaccine storage?

PHER funds can be used for storage until July 30, 2010, but at this time there is no carry over authority for PHER funds past July 30, 2010. Grantees will be kept informed of any changes to this policy.