President Bush Meets With Flu Vaccine Manufacturers To Discuss Production Problems
President Bush on Friday met with the CEOs of six vaccine manufacturers to discuss strategies to increase global production of flu vaccines and the importance of preparedness for a potential pandemic, the Washington Post reports. The companies -- Chiron, GlaxoSmithKline, Merck, Sanofi-Aventis, Wyeth and MedImmune -- could not discuss their strategies to increase vaccine product because of antitrust laws, but each company will provide additional details of their plans in one-on-one meetings with federal officials, according the HHS Secretary Mike Leavitt (Weiss, Washington Post, 10/8).
Leavitt said on Friday, "We received expressions of vigorous support from the vaccine industry, their willingness to aggressively help us prepare. We talked about the need for short-term and long-term preparations, talked about the importance of a vigorous domestic vaccine market and the need for us to be planning" for avian flu and a potential flu pandemic.
Leavitt added that vaccine manufacturers must "have a sense of certainty" that a market will exist, possibly through the expansion of other federal vaccine programs. "By creating an ethic of vaccinations, for example, for the ordinary flu, it increases not only the health of our country, but the certainty of the capacity that we need in time of crisis," Leavitt said (Douglas/Landay, Philadelphia Inquirer, 10/8). In addition, Leavitt said that the federal government will "have to deal with the indemnity issue" and "create a streamlined regulatory process for the development of new facilities" (AP/Washington Times, 10/8).
Leavitt, who traveled to several Asian nations on Saturday to meet with local leaders, said that, in addition to increased vaccine production, nations must stockpile antiviral medications, increase animal health surveillance and implement public health measures to prepare for a potential flu pandemic (Washington Post, 10/8). On Monday, Leavitt said that the likelihood of a flu pandemic is "very high, some say even certain." He added, "Whether or not H5N1 is the virus that will ultimately trigger such a pandemic is unknown to us. The probability is uncertain. But the warning signs are troubling. Hence we are responding in a robust way" (Peck, AP/Las Vegas Sun, 10/10).
GSK CEO Jean-Pierre Garnier on Friday said that the company will triple flu vaccine production capacity in North America over the next two years, as well as increase production of Relenza, an antiviral medication.
GSK also has begun to develop an avian flu vaccine that has proven effective against the avian flu, as well as derivatives, Garnier said. The avian flu vaccine requires at least one year of additional tests to prove safety and effectiveness, according the Garnier (Cortez/Burnett, Bloomberg/Philadelphia Inquirer, 10/8).
David Williams -- CEO of Sanofi-Pasteur, a division of Sanofi-Aventis -- said, "We're very encouraged. We think a national plan is going to come into place."
Several Democratic senators on Friday criticized the Bush administration for delays in the release of a national flu pandemic plan (Washington Post, 10/8). Sen. Barack Obama (D-Ill.) said, "This is not one of those situations where I think you can just jawbone industry into making the investment. This is not something that the markets alone will correct. We will have to use the government as the market maker" (Philadelphia Inquirer, 10/8).
Senate Democrats on Thursday introduced a bill that would commit the federal government to bulk purchases of vaccines and antiviral medications but would not include restrictions on lawsuits -- a major concern of vaccine manufacturers. Rebecca Kirszner, a spokesperson for Senate Minority Leader Harry Reid (D-Nev.), said, "We don't need to throw out important consumer protections to address problems in our vaccine supply" (Mondics, Philadelphia Inquirer, 10/9).
Sen. Tom Harkin (D-Iowa) said, "Having a plan on paper does nothing to protect us. ... The United States is woefully unprepared for this, and we must get started immediately" (Neergaard, AP/Las Vegas Sun, 10/9).
Christopher-Paul Milne, assistant director of the Tufts Center for the Study of Drug Development, said, "It's just too high-risk for a potentially low return on investment."
Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said, "You have this thing boiling, the virus is mutating and mutating and mutating, and we don't have an infrastructure to make a flu vaccine. That's probably the most striking example of what's wrong with the system, of how the system has failed."
Charles Helms, chair of the National Vaccine Advisory Committee, said, "We should take advantage of this issue. Even if we do not have an epidemic strain, we should use it to strengthen the basic infrastructure" (Bishop, Baltimore Sun, 10/9).
Philip Russell, former senior consultant to the HHS Office of Public Health Emergency Preparedness, said that "the real reason that we are not ready relates to the vaccine industry and the lack of aggressive vaccine development, domestic manufacturing and deployment capacity," adding, "Maybe this will generate the resources to fix the problem" (Brown/Weiss, Washington Post, 10/9).
The New York Times on Saturday reported that the newspaper had received a draft of the Pandemic Influenza Strategy Plan, which federal health officials developed over the past several years. According to the draft, a flu outbreak in Asia likely would reach the U.S. within "a few months or even weeks," with a worst-case scenario in which more than 1.9 million individuals would die and 8.5 million would require hospitalization. The draft estimates that costs under the scenario would exceed $450 billion.
Under the scenario, hospitals would exceed capacity and "social unrest" would occur, according to the draft. The draft calls for quarantine and travel restrictions but states that such steps "are unlikely to delay introduction of pandemic disease into the U.S. by more than a month or two" (Harris, New York Times, 10/8). The draft does not provide details on quarantine enforcement or punishments for violators (Kennedy, New York Daily News, 10/9).
In addition, the draft outlines a triage distribution network for vaccines and antiviral medications, which health officials would first distribute to workers who produce them and medical personnel who administer them, followed by elderly and severely ill individuals, pregnant women, transplant and AIDS patients, and parents of infants. Police, firefighters and government leaders later would receive vaccines and antiviral medications, according to the draft.
The draft calls for a stockpile of 133 million courses of antiviral medication; the Bush administration to date has purchased 4.3 million courses. The draft also calls for domestic vaccine production capacity of 600 million doses within six months, more than 10 times the current capacity. The Bush administration likely will release the plan later this month, the New York Times reports.
Leavitt said that preparations for a potential flu pandemic will "require school districts to have a plan on how they will deal with school opening and closing," adding, "It will require the major to have a plan on whether or not they're going to ask the theaters not to have a movie. Over the next couple of months, you will see a great deal of activity asking metropolitan areas, 'Are you ready?' If not, here is what must be done."
According to health officials who released the draft of the plan to the New York Times, "The real shortcoming of the plan is that it doesn't say who's in charge. We don't want to have a FEMA-like response, where it's not clear who's running what" (New York Times, 10/8).
Michael Osterholm, a government adviser familiar with the draft, on Saturday said that the plan "is a much more comprehensive view than has previously been detailed" (Neergaard, AP/Las Vegas Sun, 10/9).