Flu-Flop? Vaccine Shortage Becomes Presidential Campaign Issue

The emergence of the flu vaccine shortage as a Presidential campaign issue suggests that longstanding recommendations on providing incentives to manufacturers may receive serious attention in 2005.

Since the flu issue was raised during the third Presidential debate - and distressed seniors standing in long lines have attracted public attention - President Bush and Democratic challenger John Kerry have voiced some policy ideas on how future vaccine shortages could be avoided.

During the debate, Bush focused on the need for medical liability reform to quell potential vaccine manufacturers' fears of litigation (¹ (Also see "Rx Imports: President Bush Says Decision Could Come In December" - Pink Sheet, 18 Oct, 2004.), p. 17).

To that end, the Administration is pushing the Senate to pass the President's medical liability reform bill.

"The next giant step forward would be having the Untied States Senate passing what the House passed as far as the liability reform," HHS Secretary Thompson said during an Oct. 18 briefing.

"You've got to realize that liability has been a big concern of companies for the last 10 years," he said.

Thompson indicated the Administration also would support legislation to create market-based incentives for manufacturers to enter the vaccine market. When asked if he favors the federal government guaranteeing a market for a certain number of vaccine doses each year, Thompson replied, "Yes, I do."

Kerry is suggesting his approach to fixing vaccine shortages would also rely on market incentives for private sector development.

"To prevent future flu vaccine shortages, Kerry will...provide incentives to manufacturers to ensure that we have enough suppliers and enough vaccines to protect the American public. And Kerry will encourage more research to discover more efficient ways to produce better vaccines," an Oct. 18 campaign press release states.

Though Kerry and Bush differ on medical liability reforms, the general agreement on a need for private sector incentives may represent progress on the path to legislation.

One other potential solution to the vaccine problem - government-run production - is not being loudly championed by either party.

Among current Congressional proposals to address vaccine supply issues is a bill (S 2038) co-sponsored by Sens. Larry Craig (R-Idaho) and Evan Bayh (D-Ind.) that would create a government purchasing program for unused vaccine (² (Also see "Flu Vaccine Program Review Will Consider “Major Changes In Strategy”" - Pink Sheet, 9 Feb, 2004.), p. 41). Craig also supports the tort reform effort.

Sen. Patrick Leahy (D-Vt.) recently said the "concentration" of the pharmaceutical industry is to blame for vaccine shortages (³ (Also see "Flu Vaccine Shortage Shows Hazards Of Market Concentration – Sen. Leahy" - Pink Sheet, 11 Oct, 2004.), p. 31).

Any legislation to move through Congress might include plans for increased government oversight of vaccine distribution, as favored by some congressional Democrats.

In materials posted on the House Government Reform Committee minority website after the Presidential debate, Ranking Member Henry Waxman (D-Calif.) highlighted a series of reports by the Government Accountability Office that have pointed to the need for a better public strategy in the event of a shortage.

"Not one of these reports cites liability concerns as a reason why there are so few vaccine manufacturers in the United States," Waxman's statement maintains.

Meanwhile, the Bush Administration is highlighting steps it is taking to alleviate the current shortage. "No president or administration has invested more in the flu than this one," Thompson declared.

On an Oct. 21 call, acting FDA Commissioner Lester Crawford said the agency is in negotiations with several other countries worldwide, including Canada and France, on obtaining extra flu vaccine doses.

Those products would likely undergo some abbreviated approval process for U.S. licensure, Crawford said. Previously, the acting commissioner had said FDA's IND process could be used.

Despite that possibility, FDA is not changing its overall policy on importation. Unlike importation of other drugs, Crawford noted the flu vaccine acquired would have to meet all FDA approval standards and that shipments would go directly from manufacturers to the U.S. government, avoiding any possibility of adulteration.

HHS is also putting together a federal flu task force that will include representatives from NIH, FDA, the Centers for Disease Control & Prevention, the Justice Department, the Federal Trade Commission and Homeland Security.

"This will enhance our ongoing coordination of flu-related matters not only within our department but with our federal partners in health care, law enforcement, consumer protection and health security," Thompson said.

In addition, the Administration has stockpiled 7 mil. doses of flu treatments such as Roche's Tamiflu (oseltamivir) and rimantadine to help care for people who become infected. CDC released updated ⁴ flu treatment guidelines Oct. 18 that encourage the use of antivirals - amantadine, rimantadine, oseltamivir and zanamivir (GlaxoSmithKline's Relenza ) - particularly by persons at high risk for flu complications.

Crawford said FDA has been talking with manufacturers about ramping up production of the antivirals. All told, HHS estimates there will be enough doses to treat 40 mil. people this year.

HHS is also encouraging seniors to be treated with pneumococcal vaccine to help prevent the flu-related complication of pneumonia.

As for actual flu vaccine, the nation's supply is expected to be about 61 mil. total doses this year. Thompson said CDC will announce the week of Oct. 25 the next wave of a distribution plan that was implemented after Chiron announced the Fluvirin problem (⁵ (Also see "Aventis Fluzone Distribution Will Be Monitored In Partnership With CDC" - Pink Sheet, 11 Oct, 2004.), p. 28).

Thompson stressed there are still 21 mil. doses to be parceled out over the next several weeks, plus an additional 26 mil. doses of Aventis Pasteur's Fluzone in the first two weeks of January.

Aventis announced Oct. 19 that it is resuming production of Fluzone and will be able to provide the extra doses for use in the latter part of the flu season.

MedImmune also said it will provide 2 mil. more doses of FluMist than originally expected, for a total of about 3 mil. The extra supply will be ready for shipment in early November, CEO David Mott said Oct. 21.