Flu Vaccine Delay In 2001 Will Not Be As Extensive As Last Year - CDC

The influenza vaccine delay for the 2001 flu season is not expected to be as significant as the delay in 2000, CDC's National Immunization Program informed the Advisory Committee on Immunization Practices.

Projections for 2001 put the pace of flu vaccine distribution between 1999 and 2000 levels, with 1999 considered as the benchmark year, NIP told ACIP at its June 20 meeting in Atlanta.

Ninety-two percent of influenza vaccine supplies are predicted to be available by the end of November (versus 68% in 2000 and 100% in 1999), with all doses to be distributed by the end of December (as in previous years).

The cumulative vaccine supply - an anticipated 84 mil. total doses - should exceed the supply for the previous two years, NIP predicted. The total supply in 1999 was 77 mil. doses, while the total in 2000 was 70 mil. doses.

The largest influenza vaccine manufacturer, Aventis Pasteur, anticipates producing 40 mil. total doses of Fluzone, while Wyeth-Lederle plans to produce 24 mil.-27 mil. doses of Flushield. The third flu vaccine Fluvirin is manufactured by Powderject.

By the end of October, 54 mil. doses, or 64% of the cumulative total, are expected to be available, versus 27 mil. doses (38% of the total) available at the same time last year, NIP reported. Ninety-nine percent, or 76 mil. doses, were available by the end of October 1999.

Aventis Pasteur plans to ship all of its doses by the end of November. The company will not start shipments until September, when it will fill at least 25% of every customer's order (¹ (Also see "Flu Vaccine Distribution Guidance Needed For Suppliers, HIDA Says" - Pink Sheet, 23 Apr, 2001.)).

At the ACIP meeting, NIP cautioned that all 2001 flu vaccine projections are preliminary, and that factors such as unforeseen production difficulties, uneven vaccine distribution, early vaccination of healthy individuals, and "price speculation" could influence the actual supply.

The General Accounting Office reported in May that vaccine pre-order purchasers are reporting flu vaccine prices of about 50% to 100% higher than those for the previous flu season (² (Also see "Flu Vaccine Prices For Early Orders Up 50% To 100%, GAO Reports" - Pink Sheet, 21 May, 2001.)).

The shipping plan chosen by Aventis Pasteur is consistent with ACIP's updated guidelines for the 2001-2002 flu season.

The guidelines, issued June 21, urge manufacturers, distributors and vendors to "distribute some vaccine available early to all providers who have placed orders."

The guidelines also instruct manufacturers and distributors to delay vaccine distribution to worksites until November, and inform all providers of the expected quantity and date of deliveries.

The updated guidelines ask providers to target September and October vaccine supplies to high-risk patients and healthcare workers, and encourage the public to wait until November to get vaccinated unless an individual is at high risk, in which case vaccination should be sought in September and October.

Health departments and other organizations providing vaccination are urged to develop contingency plans in case of a vaccine distribution delay, and to put off mass immunization campaigns until late October or November.

The full text of ACIP's supplemental flu guidelines will be published in the Morbidity and Mortality Weekly Report on July 5. The original guidelines, released April 20, extend the recommended flu vaccination season until the end of November.

This year's updated guidelines, unlike last year's, do not encourage high-risk patients to seek pneumococcal vaccine early in the season as extra protection from flu complications.

The 2000 guidelines addressed the influenza vaccine delays caused by King's discontinuation of its Fluogen vaccine product, lower than expected yields of flu vaccine strains and compliance problems at Wyeth-Lederle facilities (³ (Also see "FDA Concerned By Shrinking Vaccine Supplier Pool, CBER's Zoon Says" - Pink Sheet, 9 Oct, 2000.)).

Wyeth said that the only remaining manufacturing difficulty for its influenza vaccine involves culturing, which should be resolved shortly.