WASHINGTON, D.C.--The federal government should take anactive role in ensuring the development and supply of vaccinesfor new infectious diseases such as AIDS, as well as forresurgent diseases such as multidrug-resistant tuberculosis,according to a report released here on Thursday by theNational Academy of Sciences (NAS).

The biotechnology industry will play a critical role in thedevelopment of such new vaccines, as well as adjuvants, anti-microbial drugs, pesticides and diagnostic materials needed fordisease surveillance, noted the report, "Emerging Infections:Microbial Threats to Health in the United States."

"We think there should be stockpiles of selected vaccines, a'surge capacity' to expand production quickly, new incentivesfor manufacturers to undertake vaccine development, andexpedited procedures for licensing pesticides needed to controloutbreaks of vector-borne diseases," said Robert E. Shope ofYale University School of Medicine, co-chair of the study panelwith Nobel laureate Joshua Lederburg of RockefellerUniversity, at a press briefing on the 18-month-long study.

The report comes in response to concerns that the public healthcommunity has become complacent about acute infectiousdiseases since the 1950s.

"We acted as though we had won the war on infectiousdisease," said Lederberg. "But the fact is, infectious microbeshave been around all along and will continue to pose threats topublic health."

Rather than dealing with recommendations for the AIDSepidemic or other currently recognized infectious diseaseproblems, the study presents, according to Lederberg, a"philosophical foundation" for dealing with emerging microbialthreats.

Several conferences in recent years have dealt with the scienceof emerging infections, but not the policies needed to confrontthem. The NAS's Institute of Medicine decided to initiate thestudy, drawing support from the National Institutes of Health,the U.S. Army, the Rockefeller Foundation, the Lucille B.Markey Charitable Trust and Lederle-Praxis Laboratories.

Specifically, the report calls for a centrally coordinatedprogram "to take maximal advantage of the capabilities of thepublic and private sectors and ensures the continued existenceof a competitive, efficient, reliable vaccine manufacturingindustry within the United States."

To achieve this the committee recommended two options:

-- Create an integrated vaccine management structure withinthe federal government to ensure the cooperation of vaccinemanufacturers through purchase guarantees. These agreementswould assure the long-term purchase of minimum amounts ofvaccine at a price allowing return on investment in itsdevelopment and production, much as farm commodity loanssupport the production of specific crops.

-- Build "government-supported vaccine research, developmentand production facilities analogous to those for the NationalCancer Institute's cancer therapeutics program and the federalspace, energy and defense laboratories."

These options are not exclusive, but the committee preferredthe incentive approach for most situations, Shope, a leadingarbovirus researcher, told BioWorld.

Government-owned production facilities, comparable to the U.S.nuclear weapons program facilities, would be useful in meetingthe needs for vaccines against rare and tropical diseases thatmight not prove profitable for private companies to produce.

In addition to strengthening the nation's vaccine infrastructureand developing an arsenal of new anti-microbial drugs andpesticides to treat, prevent and control the spread of newinfectious diseases, the study committee called for an improvedinfectious disease surveillance system (coordinated by theCenters for Disease Control in Atlanta), and better training ofphysicians.

The study committee acknowledged the difficulty of proposingnew initiatives in the face of the federal budget deficit. "This isnot a megaprogram," Lederberg said. "Tens of millions ofdollars will make a large difference in disease surveillanceprograms, and in vaccine development, we're talking about[only] hundreds of millions."

Copies of the report are available for $34.95 plus shipping andhandling from the National Academy Press, 202-334-3313 or1-800-624-6242.

-- David I Lewin Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.

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