Viruses, Vaccines and Mass Inoculations

Government to Overhaul Bioterror and Pandemic Flu Plans

Federal officials will use H1N1 funding to speed the process of discovering and developing drugs and vaccines in case of emergency.

August 20, 2010

Los Angeles Times — Acknowledging that the development of medical countermeasures against bioterrorism threats and pandemic flu is lagging, federal authorities Thursday announced a $1.9-billion makeover of the system for identifying and manufacturing drugs and vaccines for public health emergencies.

The overhaul includes refinements to manufacturing aimed at shaving weeks off the time it takes to produce pandemic flu vaccine, and a series of steps aimed at more quickly spotting promising scientific discoveries and getting them to market.

"We aren't generating enough new products," said Health and Human Services Secretary Kathleen Sebelius, citing "leaks, chokepoints and dead ends" in the medical development pipeline.

Money for the changes comes from funds initially allocated for the H1N1 flu pandemic.

Among other things, the effort would provide $822 million for upgrades to speed up production of pandemic flu vaccine. Another large block, $678 million, would be used to set up at least one private facility that would work under government contract with small companies to manufacture new products, develop new manufacturing processes and help produce vaccines during periods of peak demand.

The reforms were detailed in a Health and Human Services Department report commissioned in late 2009 and released Thursday along with a separate report by the President's Council of Advisors on Science and Technology.

Both reports were spurred by months-long delays in production of the H1N1 vaccine last year. The pandemic flu turned out to be relatively mild, but health authorities said the delay exposed flaws in response that could cost thousands of lives in future outbreaks if uncorrected.

The changes, particularly the additional money for drug development and improvement of the FDA's regulatory process, are important steps in the right direction, said Dr. Brad Spellberg of the Infectious Diseases Society of America.

"This is a sign that the federal government is starting to get it," said Spellberg, author of "Rising Plague," which describes that emergence of antibiotic-resistant "superbugs."

Although Sebelius did not address it directly, the changes are an implicit acknowledgement that Project BioShield, a $5.6-billion fund set up in 2004, has not led to the quick development of a stream of vaccines, drugs and equipment for the bioterrorism medicine chest.

Key congressional lawmakers last month proposed cutting $2 billion from BioShield.

White House spokesman Nick Shapiro said that BioShield and Health and Human Service's Biomedical Advanced Research and Development Authority, which manages it, remained important players in bioterrorism defense, but that "we are now finally creating conditions that will enable their success."

New U.S. Pandemic Plan Aims to Speed Products

August 19, 2010

Reuters – The U.S. government proposed major changes Thursday to the way it works with companies to fight new disease threats such as flu, including reform at the Food and Drug Administration and setting up centers to make vaccines quickly.

The report from the Health and Human Services Department said the U.S. ability to respond to new outbreaks is far too slow and it lays out a plan for helping academic researchers and biotechnology companies develop promising new drugs and vaccines.

"At a moment when the greatest danger we face may be a virus we have never seen before ... we don't have the flexibility to adapt," Health and Human Services Secretary Kathleen Sebelius said at a news briefing.

The report suggests providing clearer guidance to industry on what kinds of tests are needed for regulatory approval of new drugs and vaccines -- something industry has asked for -- and says new teams should be set up at FDA to help this.

HHS and the Department of Defense should set up Centers for Innovation in Advanced Development and Manufacturing, it said.

"These centers will provide assistance to industry and government by advancing state-of-the-art, disposable, modular manufacturing process technologies," the report said.

"Finally, in public health emergencies, these centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza."

Experts in industry and the government have long agreed that the U.S. system for producing drugs and vaccines to fight pandemics -- especially influenza -- is slow and unwieldy.

It takes months to make a vaccine against influenza using current processes. While companies are working to modernize their abilities, any big changes are still years away.

By the time companies were able to make a vaccine against the H1N1 swine flu pandemic virus last year, it was already spreading around the world.

SPEEDING RESPONSE

"Accelerated delivery of vaccines by even a few weeks can mean saving tens of thousands of lives," Dr. Harold Varmus, who helped write a separate report from the Presidential Council of Advisors on Science and Technology, told the news conference.

The report also calls for better surveillance to give a much quicker heads-up when new diseases emerge. Studies show H1N1 had been circulating for weeks or months before it was detected.

Companies have complained that U.S. federal regulations are confusing and do not help much. The report takes many of the concerns into account.

Sebelius said there had been little investment in "regulatory science" -- studying the best ways to test new products.

"Because of this under-investment we are often testing and producing cutting-edge products using science that is decades old," Sebelius said.

"We are also going to reach out to product developers earlier in the process so they know what to expect."

The report says new teams also will look for promising ideas for fighting disease or other threats and make sure they get developed.

"Some of these great ideas are going to come from very small companies that don't really have the capital and wherewithal to get a product from microscope to market," Sebelius said.

She said much of the $2 billion needed to make the first changes would come from money already allocated to fight H1N1.