US Plans Fund for Vaccine Trials, Manufacturing
Thu December 5, 2002 05:27 PM ET
By Alicia Ault
WASHINGTON (Reuters Health) - The US government is planning a
fund for biotech companies to use to pay for late-stage clinical
trials and manufacturing of vaccines, the head of the National
Institute of Allergy and Infectious Diseases said Thursday.
At first, the fund would be for vaccines against bioterrorism
agents, but it would eventually be expanded to cover other
infectious diseases, Dr. Anthony Fauci said at the Partnership for
Global Health Forum, sponsored by the Biotechnology Industry
Organization (BIO) and the Bill & Melinda Gates Foundation.
"If we're going to get vaccines off the ground, we need to meet
industry halfway," Fauci said, noting that he is working with Health
and Human Services (HHS) Secretary Tommy Thompson to get the fund in
place.
Small biotech companies developing new therapies and vaccines for
diseases that primarily affect developing nations have complained
they can't get financing for late-stage development because of
uncertain demand.
"Lots of good medications and vaccines are in the pipeline, but
they are stuck," said Una Ryan, president and CEO of Avant
Immunotherapeutics. The problem comes to a head with phase III
(late-stage) clinical trials and manufacturing--a low-risk, but
expensive juncture, she said.
Fauci said the government understands the problem, but that it is
"cost-prohibitive" for the National Institutes of Health (NIH) to
finance late-stage trials out of its own budget.
So Fauci has been discussing with Thompson a separate fund that
could provide for phase III studies and manufacturing. The proposal
"is in very active negotiations right now," he said.
The fund amount would be based partly on what price the
government could be expected to pay for the vaccine. But the
government would not set the price, Fauci said.
It is one of many new government approaches, he noted, adding
that it will also pursue more partnerships with manufacturers, as
mentioned by NIH director Elias Zerhouni at the same meeting on
Wednesday.
HHS and the White House have become much more interested in
infectious diseases that are undermining stability in developing
nations, according to Fauci. The economic impact of AIDS, malaria
and tuberculosis is "galvanizing everyone," he said. |