Commonground
Senior Moderator
Bulletin
Influenza Virus Vaccine
15 October 2009
Products Affected - Description
Fluarix, pre-filled syringes, GlaxoSmithKline
Fluzone, multi-dose vials and pre-filled syringes, Sanofi Pasteur
Fluvirin, multi-dose vials and pre-filled syringes, Novartis
FluMist, Intranasal spray, MedImmune
Reason for the Shortage
* In September 2009, GlaxoSmithKline (GSK) revised production estimates of Fluarix from 8 million doses to 6.5 million due to variability in influenza manufacturing.1,2
* GSK?s production of 12 million doses of FluLaval was not affected.1,2
* In late September 2009, 500,000 doses of Fluarix did not pass GSK internal inspection bringing the total production of Fluarix to 6 million doses.1,2
* Most doses of Fluarix were allocated to hospitals and health-systems and many customers have had orders cancelled. Supplies of FluLaval were not allocated or made available to customers whose Fluarix orders were cancelled.1,2
* Sanofi Pasteur has not cancelled any orders for influenza vaccine, however some shipments are delayed.3
* Novartis has revised production estimates of Fluvirin from 30 million doses to 27 million doses.4
* MedImmune has not cancelled any orders for influenza vaccine, however some shipments are delayed.5
Estimated Resupply Dates
* GSK has distributed 17.5 million doses and expects to distribute the last 500,000 doses by mid-October, 2009.1,2
* Sanofi Pasteur is shipping Fluzone as product becomes available.3
* Novartis will complete all shipments of Fluvirin by mid-October, 2009.4
* MedImmune is shipping FluMist as product becomes available.5
Alternative Agents & Management
* Influenza vaccine is ordered in advance each year and typically most supplies are allocated in advance to customers.
* No supplier is able to meet the increased demand for vaccine created by cancelled orders.
* Additional doses of influenza vaccine are unlikely to be available in sufficient amounts for customers who have had a substantial number of doses cancelled by GSK. Hospitals and other customers who ordered Fluarix are disproportionately affected by the cancellation of 25% of all Fluarix doses. The National Influenza Vaccine Summit posts vaccine availability. Small amounts of vaccine may be available for purchase.
* The Centers for Disease Control and Prevention state the total production of influenza vaccine is approximately 97% of earlier estimates.6
* The CDC has published guidelines for prioritizing influenza vaccine during a shortage.7 These guidelines recommend prioritizing influenza virus vaccine for the following groups of patients who are at higher risk of complications due to influenza. There are no specific priorities within each tier.
o Tier 1
+ Persons aged 65 years or older
+ Children 6 to 23 months of age
+ Residents of long-term care facilities and nursing homes
+ Persons 2 to 64 years of age with chronic medical conditions (eg, cardiovascular or pulmonary disorders, diabetes or metabolic diseases, sickle cell anemia, kidney diseases, or weakened immune systems including HIV/AIDS)
+ Health care personnel
+ Household contacts and out-of-home caregivers of children less than 6 months of age
+ Women who will be pregnant during the flu season
o Tier 2
+ Adults aged 50 years or older
+ Household contacts or caregivers of persons with increased risk of developing influenza-related complications such as children less than 2 years of age, anyone over the age of 65 years, anyone with chronic medical conditions or weakened immune systems.
o Tier 3
+ Any person age 2 to 49 years without high-risk conditions.
References
hat-tip Eccles
http://www.ashp.org/Import/PRACTICE...Started/CurrentShortages/Bulletin.aspx?id=571
Influenza Virus Vaccine
15 October 2009
Products Affected - Description
Fluarix, pre-filled syringes, GlaxoSmithKline
Fluzone, multi-dose vials and pre-filled syringes, Sanofi Pasteur
Fluvirin, multi-dose vials and pre-filled syringes, Novartis
FluMist, Intranasal spray, MedImmune
Reason for the Shortage
* In September 2009, GlaxoSmithKline (GSK) revised production estimates of Fluarix from 8 million doses to 6.5 million due to variability in influenza manufacturing.1,2
* GSK?s production of 12 million doses of FluLaval was not affected.1,2
* In late September 2009, 500,000 doses of Fluarix did not pass GSK internal inspection bringing the total production of Fluarix to 6 million doses.1,2
* Most doses of Fluarix were allocated to hospitals and health-systems and many customers have had orders cancelled. Supplies of FluLaval were not allocated or made available to customers whose Fluarix orders were cancelled.1,2
* Sanofi Pasteur has not cancelled any orders for influenza vaccine, however some shipments are delayed.3
* Novartis has revised production estimates of Fluvirin from 30 million doses to 27 million doses.4
* MedImmune has not cancelled any orders for influenza vaccine, however some shipments are delayed.5
Estimated Resupply Dates
* GSK has distributed 17.5 million doses and expects to distribute the last 500,000 doses by mid-October, 2009.1,2
* Sanofi Pasteur is shipping Fluzone as product becomes available.3
* Novartis will complete all shipments of Fluvirin by mid-October, 2009.4
* MedImmune is shipping FluMist as product becomes available.5
Alternative Agents & Management
* Influenza vaccine is ordered in advance each year and typically most supplies are allocated in advance to customers.
* No supplier is able to meet the increased demand for vaccine created by cancelled orders.
* Additional doses of influenza vaccine are unlikely to be available in sufficient amounts for customers who have had a substantial number of doses cancelled by GSK. Hospitals and other customers who ordered Fluarix are disproportionately affected by the cancellation of 25% of all Fluarix doses. The National Influenza Vaccine Summit posts vaccine availability. Small amounts of vaccine may be available for purchase.
* The Centers for Disease Control and Prevention state the total production of influenza vaccine is approximately 97% of earlier estimates.6
* The CDC has published guidelines for prioritizing influenza vaccine during a shortage.7 These guidelines recommend prioritizing influenza virus vaccine for the following groups of patients who are at higher risk of complications due to influenza. There are no specific priorities within each tier.
o Tier 1
+ Persons aged 65 years or older
+ Children 6 to 23 months of age
+ Residents of long-term care facilities and nursing homes
+ Persons 2 to 64 years of age with chronic medical conditions (eg, cardiovascular or pulmonary disorders, diabetes or metabolic diseases, sickle cell anemia, kidney diseases, or weakened immune systems including HIV/AIDS)
+ Health care personnel
+ Household contacts and out-of-home caregivers of children less than 6 months of age
+ Women who will be pregnant during the flu season
o Tier 2
+ Adults aged 50 years or older
+ Household contacts or caregivers of persons with increased risk of developing influenza-related complications such as children less than 2 years of age, anyone over the age of 65 years, anyone with chronic medical conditions or weakened immune systems.
o Tier 3
+ Any person age 2 to 49 years without high-risk conditions.
References
- GlaxoSmithKline. Dear Customer Letter. October 6, 2009.
- GlaxoSmithKline. Personal communication. October 13, 2009.
- Sanofi-Pasteur. Personal communication. October 1, 2009.
- Novartis. Dear Customer Letter. September 18, 2009.
- MedImmune. Personal communication. October 9, 2009.
- Centers for Disease Control and Prevention. 2009 Seasonal Influenza Vaccination Update. October 14, 2009.
- Centers for Disease Control and Prevention. Tiered Use of Inactivated Influenza Vaccine in the Event of a Vaccine Shortage. MMWR. 54(30):749-250.
hat-tip Eccles
http://www.ashp.org/Import/PRACTICE...Started/CurrentShortages/Bulletin.aspx?id=571