Avian Flu Plan From Administration Places Vaccines First, Antivirals Second

The Bush Administration's pandemic flu preparedness plans call for a dramatic expansion in the stockpiling of antivirals, an increase expected to be largely paid for by the states.

According to the HHS plan which was announced Nov. 2, "quantities of antiviral drugs sufficient to treat 25% of the U.S. population should be stockpiled."

This translates to enough doses for approximately 74 mil. people, up from the 4.3 mil. doses the federal government has presently contracted.

While the prospect of a significant increase in stockpile sales may initially seem appealing to antiviral manufacturers, the Administration's plan could create a situation in which firms are required to go through multiple negotiations with individual states, which could focus more attention on product pricing.

Individual states will shoulder 75% of the cost of antivirals for their residents in the case of a pandemic avian flu outbreak, with the federal government contributing the remainder of the costs, according to the HHS plan.

Part of the administration's $7.1 bil. strategy is a request for $1 bil. in antiviral stockpiles "so that we have enough on hand to help treat first responders and those on the front lines, as well as populations most at risk in the first stages," President Bush said during a Nov. 1 event at the National Institutes of Health.

However, "antiviral drugs cannot prevent people from contracting the flu." Therefore, as "the foundation of our pandemic response," the President is also asking Congress for $1.2 bil. for HHS to purchase 40 mil. doses of avian flu vaccine, which would be sufficient to inoculate 20 mil. people.

At a Nov. 2 Senate Appropriations/Labor-HHS Subcommittee hearing, Sen. Tom Harkin (D-Iowa) said that the plans released by the White House and HHS fail to adequately fund states' stockpiling and preparedness needs.

The plans allocate $100 mil. for state and local preparedness efforts.

Harkin attached an $8 bil. amendment to the HHS appropriations bill which placed a larger emphasis on state and local preparedness (¹ ).

Harkin said that he fears state preparedness efforts could suffer in light of a financial burden. "It seems that the money will be allocated based on states' ability to pay."

"How are you going to ask Louisiana right now to come up with this money?" he asked HHS Secretary Michael Leavitt.

Leavitt responded: "We want to make sure [states are] buying into pandemic preparation and not just looking for a check from the federal government to put into the federal stockpile."

He added that the preparedness plans permit the federal government to assist state preparation efforts, but that "public health is a state and local function."

"We want them to have a plan, and we want them to have access to those antivirals and to be able to do it in a way that's consistent with their other preparation."

Leavitt also said that the states will be solely responsible for dissemination of antivirals. "We expect we'll be placing the bulk of the entire stockpile of federally purchased antivirals in the states."

However, "there is a view that antivirals [such as Roche's Tamiflu ] are synonymous with preparation; that just isn't the case. It is an important part of a comprehensive plan, but there are limits to it."

Roche and GlaxoSmithKline (which markets Relenza ) have seen considerable demand growth as governments and private entities make plans for a potential outbreak. Both firms have been emphasizing a willingness to partner with outside manufacturers to meet demand, but the firms want to maintain control over the production process.

Roche's production of Tamiflu (oseltamivir) was recently boosted by FDA approval of an additional specialized Tamiflu manufacturing site.

The approval allows Roche to manufacture Tamiflu in the U.S. for the first time. "By mid-2006, global production capacity for Tamiflu will have increased eight to 10-fold over 2003," the firm said Nov. 1.

The firm also announced that it has established an "internal high-level team...that is dedicated to assessing the ability of other companies and partners to either produce or provide capabilities in Tamiflu production."

The Administration's plan also includes efforts to "develop new technologies that will allow us to produce new vaccines rapidly."

To that end, the plan would earmark $2.8 bil. for development of cell culture-based vaccines, which HHS has said could allow for faster vaccine manufacturing (² (Also see "Unused Flu Vaccine Would Be Purchased By HHS Under Draft “BioShield II”" - Pink Sheet, 4 Apr, 2005.), p. 29).

Another aspect of the plan would be to provide liability protections for vaccine manufacturers. The request is noteworthy because the existing Vaccine Injury Compensation Program is often held up by industry as a good model for how to handle other kinds of medical liability cases (³ (Also see "Pfizer CEO Proposes Specialized Medical Courts; Not Worried About Bextra" - Pink Sheet, 30 May, 2005.), p. 10).

Also under the HHS plan, FDA would assume additional activities beyond its current regulatory scope.

For instance, the agency would evaluate "long-term stability of stockpiled antiviral drugs for purposes of shelf life extension."

The plan also highlights some mandates that FDA currently performs that would be more important during a pandemic, such as monitoring "to protect against the distribution of counterfeit antiviral drugs and pandemic vaccines."

The National Institutes of Health, meanwhile, would develop and evaluate "novel influenza vaccines and vaccination strategies (e.g., adjuvants, delivery systems)" and evaluate "the molecular and/or environmental factors that influence the transmission of influenza viruses, including drug-resistant strains."

NIH is also tasked with maintaining "close communication with drug and vaccine manufacturers."

The Centers for Disease Control & Prevention will coordinate antiviral delivery from the National Strategic Stockpile and monitor "antiviral drug use, effectiveness, safety and resistance" as well as vaccine effectiveness.