White House, Congress propose steps to encourage industry investment in AIDS, malaria and TB vaccines

by Victor Zonana

Pharmaceutical and biotech industry leaders pledged increased support for the development and deployment of affordable vaccines at a White House summit on vaccine development hosted by U.S. President Bill Clinton on 2 March 2000. The purpose of the unprecedented gathering was to build momentum in the private sector and to forge new partnerships among the participants, who included heads of United Nations organizations, foundations, leaders of the world's major vaccine producers, U.S. government officials, and vaccine and biotech experts.

Several of the CEOs used the occasion to describe new company initiatives on developing the most urgent vaccines, and most also announced donations of existing vaccines and medications for use in developing countries. These included one million doses of Hepatitis B vaccine from Merck, 10 million doses of Haemophilus influenza type-B vaccine from American Home Products, 50 million doses of polio vaccine from Aventis Pasteur and a US$1 billion donation from SmithKline Beecham to eliminate elephantiasis.

Raymond V. Gilmartin, chairman, president and CEO of Merck & Co., said that "given recent scientific advances in understanding the biology and immunology of HIV infection," Merck has increased its efforts to develop an AIDS vaccine. "Our objective is to develop a vaccine that would be effective against multiple strains of the virus, thereby increasing the vaccine's global utility," Gilmartin said. Merck recently began a Phase I trial of an HIV-DNA vaccine.

Aventis Pharma's CEO, Richard Markham, called upon world leaders to begin addressing the "enormous ethical, political, economic and social issues" surrounding AIDS vaccine development. "We must deal with these hard issues now or else we could wind up with a scientific achievement and a public failure - an AIDS vaccine that people will be afraid to take, be unable to pay for or be available only to a privileged few," Markham said. Aventis Pasteur is developing a number of different candidate HIV vaccines, including the canarypox-based vectors.

IAVI, which was represented at the summit by its president, Seth Berkley, was praised by President Clinton as "a model public private partnership" for its role in accelerating the development of affordable AIDS vaccines. Berkley announced at the meeting that IAVI intends to triple, to six, the number of new AIDS vaccine candidates it will sponsor this year.

Other corporate leaders at the summit included Donald Francis, president of VaxGen, Sean Lance, chairman and CEO of Chiron, Jean-Pierre Garnier, CEO of SmithKline Beecham, and John Stafford, president and CEO of American Home Products Inc. Foundation officials at the summit included William Gates Sr., co-president of the Bill and Melinda Gates Foundation, Gordon Conway, president of the Rockefeller Foundation, Timothy Wirth, president of the United Nations Foundation and Herbert Brown, president of Rotary International.

The assembled leaders expressed broad support for President Clinton's Millennium Vaccine Initiative, a comprehensive plan to increase global usage of existing vaccines and create new incentives for the development of new vaccines against the world's major infectious killers ñ AIDS, tuberculosis, and malaria.

The Millennium Vaccine Initiative includes the following elements:

• A US$50 million contribution to the vaccine purchase fund of the Global Alliance for Vaccines and Immunization;
• U.S. support for the World Bank to increase low-interest loans for health services by as much as US$900 million annually;
• Significant increases in federally-funded basic research on diseases that affect developing countries;
• A US$1 billion tax credit on sales to developing countries of vaccines against malaria, TB and AIDS; and
• A call to G-7 partners to ensure a future market for these vaccines.

SmithKline Beecham's Garnier, for example, commented: "The President's Millennium Vaccine Initiative - to provide tax credits to companies for sales of eligible vaccines - will now provide industry with an important new incentive to launch research and development efforts into tropical disease areas," a field which he said "has always been challenging because of the complexity of the scientific research and difficult local economic conditions."

Don Francis of VaxGen, which is now running two Phase III trials of an HIV vaccine, said: "The majority of HIV infections occur in less developed countries, many of which will need financial assistance to purchase vaccines. The Administration's Initiative, and multimillion-dollar contributions from private foundations and the World Bank - all of which were discussed at the meeting - would make tremendous contributions toward helping these countries acquire life-saving vaccines sooner and in larger quantities."

"President Clinton has put forward a balanced and forward-looking plan that should energize vaccine development at every level, from the university lab bench to the pharmaceutical industry board room," IAVI's Berkley said.

Clinton's plan for tax credits appears to be gaining support. In a 14 March editorial, The New York Times noted that, "With any luck, the benefits for mankind (from the vaccine tax credits) could be spectacular."

Separately, legislation was introduced in the Congress that would both codify the President's initiative and enact other measures aimed at spurring vaccine development. The bill, known as the Vaccines for the New Millennium Act of 2000, was introduced by Senators John Kerry (D-Mass.) and Bill Frist (R-Tenn.) and Representative Nancy Pelosi (D-Calif.).

In addition to incorporating the President's initiative, the measure would provide a tax credit for industry research and development expenses for AIDS, malaria and TB vaccines, authorize a US$10 million government contribution to IAVI, and create a Lifesaving Vaccine Purchase Fund administered by the Treasury Secretary. It also authorizes an advance appropriation of US$100 million a year over ten years, to the Lifesaving Vaccine Purchase Fund, to be used for the purchase and distribution of vaccines for malaria, tuberculosis, HIV, or any infectious disease which kills more than one million people.

The legislation was endorsed by the AIDS Vaccine Advocacy Coalition, VaxGen, the Gates Foundation and IAVI.