Jul 27, 2007 (CIDRAP News) – The Health Industry Distributors Association (HIDA), a group that includes 600 companies that distribute half of the United States' flu vaccine supply, released a report yesterday to help shed light on the some of the supply chain obstacles have delayed vaccine shipments to doctors' offices.
During the 2006-07 season, influenza vaccine producers made a record 120.9 million flu vaccine doses, but 18.4 million of them went unsold amid complaints from many physicians that they received their supplies too late.
Earlier this year, public health officials said the vaccine glut was caused by a combination of record production, distribution delays, and a mild flu season. Sanofi, the largest producer of flu vaccines for the US market, had attributed some of the delay to a slow-growing influenza (H3N2) strain. Two other companies—GlaxoSmithKline and Novartis—also said they had problems growing the strain.
"The supply came later than expected or arrived in several staggered and/or partial shipments during peak periods of demand," the HIDA report says. Last season manufacturers shipped 50% of the flu vaccine supply to customers; distributors delivered the other half, which was up from the 35% they supplied the 2005-06 season, the report states.
Curtis Allen, a spokesperson for the National Immunization Program at the US Centers for Disease Control and Prevention (CDC) said in a previous CIDRAP report that in 2006 no vaccine doses shipped in August, compared with the previous 7 years when millions of flu vaccine doses began shipping in August.
The vaccine manufacturing process is a 5- to 8-month process that incorporates at least 15 weeks of lot testing by the US Food and Drug Administration (FDA), the HIDA report says. Scientists must test the safety and potency of each lot of vaccine, both at the monovalent and trivalent stages.
Over the course of the most recent influenza season, the FDA's lot-release process ranged from 21 lots for MedImmune to 85 lots for Sanofi, the group says.
This season, vaccine manufacturers have projected they will make 127 million to 132 million doses for the US market for the 2007-08 flu season, another record, according to the Centers for Disease Control and Prevention (CDC).
Production for 2007-08 could be even higher if the FDA approves a seasonal flu vaccine from a fifth manufacturer, CSL Biotherapies, the US branch of an Australian company. CSL announced Apr 3 it had applied for FDA approval for its vaccine.
The CDC and other healthcare experts have pushed for later flu vaccination clinics to help providers and their patients better adjust when vaccine supplies are delayed. Though many flu vaccination efforts focus on early autumn, the CDC says administering the flu vaccine in November, December, January, and beyond is consistent with the recommendations from the federal Advisory Committee on Immunization Practices.
Jul 27 HIDA press release
HIDA vaccine production and distribution report
Jan 30 CIDRAP News story "Winter glut of flu vaccine worries officials"
Apr 24 CIDRAP News story "Record flu vaccine expected for next season"
Nov 13, 2006, CIDRAP News story "CDC launches late-season immunization push"