AstraZeneca/MedImmune Effort To Resurrect FluMist Gets Good Government PR Boost as Well as Contract Dollars 

MedImmune is poised to be the first manufacturer to collect on government contracts with finished doses of the pandemic flu vaccines. The Centers for Disease Control reported in an update on the pandemic on Sept. 18 that the first deliveries of vaccine at the beginning of October would be the nasal, attenuated live-virus version FluMist.

The AstraZeneca subsidiary received commitments this year from the department of Health & Human Services for about 13% ($151 million) of the total ($1.12 billion) dollars committed by the government for the manufacture of bulk antigen. The first 3.4 million doses of an estimated 40 million doses of FluMist for the U.S. market in the 2009-2010 pandemic effort are now on track for release at the beginning of October, about two weeks ahead of the target date for the first shipments the injectable versions.

Being first is good PR for the product that was once a notable commercial flop when introduced for one flu season as a co-marketed product by Wyeth in 2003. MedImmune has been marketing the product alone. Under AstraZeneca the product recovered to $104 million annual sales in 2008. The pandemic bulk contract alone is more than 45% greater than the previous full year sales.

The product is also getting some good exposure from government officials within the vaccine community and on Capitol Hill.

During a September 21 press briefing on early immunogenicity findings in ongoing trials of the trials of the injectable vaccine formulation in children 10-17 years of age, FDA’s Deputy Commissioner for Science & Public Health Jesse Goodman, MD, digressed to report that “the live attenuated vaccine does not appear to work typically just through inducing an antibody response.”

Broader Response Possible; But Not for Patients With Complications

“One of the reasons” that the intranasal vaccine “has been particularly effective in some instances,” Goodman said, “is that it induces a broader immune response, involving cellular immunity and other factors.” FluMist is recommended for use in children down to age 2 but is not recommended for children with asthma or wheezing.

National Institute for Allergy & Infectious Diseases Director Anthony Fauci, MD, added that “when you look at data from the live attenuated vaccine, you don’t necessarily look at the classic serocon version or levels of titers. It is a different kind of immunological response.”

Fauci and Goodman were reporting on the preliminary childhood vaccination findings from the NIAID tests to suggest that the one-dose regimen of 15 mg of injectable antigen should suffice to create immunity in children above 10 years of age. Fauci reported from the early results of trials started in August “it seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age.”

FluMist also got a qualified endorsement during an update on the pandemic response on Sept. 15 by HHS Secretary Kathleen Sebelius to the House Energy &Commerce Committee. Sebelius was pressed by California Democrat Anna Eshoo for information on FluMist and the preferred patient group for use of the product. Noting that MedImmune has a facility in her congressional district, Eshoo asked whether the nasal spray would be “better used for children” and “how might it affect the voluntary compliance” to the pandemic vaccination effort.

Sebelius noted that the limitation against use in young children and individuals with health complications. She added, however, “it certainly is a viable alternative for a lot of the population.”