U.S. public health emergency plan calls for better vaccine production

The Dept. of Health and Human Services has established a $1.9 billion plan to speed how quickly the nation responds with new medications and treatments to combat bioterrorist attacks, infectious disease outbreaks and other public health threats.

The plan targets both the known and the unknown, HHS Secretary Kathleen Sebelius said at an Aug. 19 news conference. "Increasingly, the range of dangers we face is widening to include biological, chemical, nuclear and radiological hazards," she said. "Today, we really don't know where our next public health crisis can come from."

An HHS report outlines initiatives to streamline research and development of medical countermeasures and allows for expedited Food and Drug Administration approval. Medical countermeasures include vaccines, antivirals, antibiotics, diagnostics and medical equipment needed in a public health emergency.

"Our nation must have the nimble, flexible capacity to produce [medical countermeasures] rapidly in the face of any attack or threat," the report states.

The report was partly a response to the 2009 influenza A(H1N1) outbreak that placed new demands on the nation's public health system and highlighted issues that needed to be addressed, such as the nation's reliance on an outdated and slow egg-based vaccine production process, Sebelius said in a statement.

HHS will encourage new production methods and expand the country's capacity to manufacture the flu vaccine, eliminating U.S. reliance on foreign manufacturers. The report recommends that the agency support development of at least three flu vaccines that can be manufactured from viruses that aren't grown in eggs or cells.

Most of the plan's funding will come from preparedness funds already allocated to HHS. About $822 million will go toward flu response.

If Congress approves the proposal, the agency would invest an additional $200 million to provide incentives for private companies to produce medical countermeasures.

The initiatives are "badly needed" and ultimately will enable physicians to respond more effectively to public health emergencies, said Maj. Gen. Philip K. Russell, MD, founding president of the Sabin Vaccine Institute, a Washington, D.C.-based nonprofit that develops and helps distribute vaccines to fight global health threats.

But the success of the initiatives depends on how they are executed, he said.

"I am concerned about the emphasis on coordination and multiagency participation without designating responsibility, timelines and objectives," Dr. Russell said. "Dynamic leadership is needed."

Multiagency approach

The report calls for the FDA to identify promising research early on and lessen regulatory barriers to ensure that new discoveries are translated quickly into new medicines or other medical countermeasures.

HHS will work with research partners such as the National Institutes of Health, private biotech companies and large pharmaceutical manufacturers to provide strategic guidance to researchers. On the manufacturing side, the agency will establish the Centers for Innovation in Advanced Development and Manufacturing to create manufacturing technologies and promote research collaborations.

Fostering public-private partnerships is key to developing new antibiotics, said Brad Spellberg, MD, associate professor at the David Geffen School of Medicine at the University of California, Los Angeles.

The Infectious Diseases Society of America has urged Congress for years to remove regulatory barriers to research, development and FDA approval of new antibiotics. The approval process can take up to 10 years, said Dr. Spellberg, an IDSA member.

Drug manufacturers have moved steadily away from making new antibiotics, leaving the public unprotected against a growing number of antibiotic-resistant strains of bacteria such as Klebsiella and Acinetobacter, he said.

"This is actually a small piece of the puzzle of what needs to be done," Dr. Spellberg said. "This is the first salvo in a multipronged approach."