Aug 19, 2010 (CIDRAP News) – In light of vaccine production problems that delayed the delivery of the pandemic H1N1 vaccine, a report by President Barack Obama's science advisers released today said targeted investments in five specific areas could trim the time needed to quickly produce enough to protect the nation by weeks or months.
The President's Council of Advisors on Science and Technology (PCAST) said if federal officials follow the roadmap, within 1 to 3 years the country will be in a better position to more quickly speed production of a pandemic vaccine as well as medical countermeasures against other diseases or bioterrorism attacks. The five key areas, as well as longer-term goals, are included in an 87-page report that appears on the PCAST Web site.
Some of the pandemic flu vaccine recommendations are echoed in a federal public health countermeasure review, also released today, that explores the way officials procure vaccines, equipment, and supplies needed for response to bioterror attacks and other medical emergencies.
Pharmaceutical companies produced the first doses of the vaccine about 6 months after the new flu virus emerged, a timeline that was consistent with what experts had predicted in previous pandemic planning reports. However, early projections that supplies of pandemic H1N1 vaccine would be ready in time to blunt a second wave of pandemic infections in the fall of 2009 fell well short of expectations.
Federal officials and vaccine industry executives were called before Congress to answer for the pandemic vaccine delays, which prompted the Obama Administration to ask PCAST advisers to review current production processes and suggest ways the government could speed production to prepare the nation for the next influenza pandemic.
Harold Varmus, MD, who until recently co-chaired PCAST, said in a press release today that the delays have raised awareness of the limitations of current flu vaccine production processes. The 50-year-old technology and laborious egg-based production system has been adequate for producing seasonal flu vaccine but fell short during the pandemic.
"Production of a new vaccine, our most important defense, was not fast enough to afford optimal protection," he said today at a media briefing to unveil the countermeasure report. "Sufficient vaccine to protect the majority of people was not available until well after the second wave had peaked in the middle of fall."
In a serious pandemic, cutting even a few weeks off the vaccine production process could translate into saving thousands of lives, he said in the press release.
The five key steps that could streamline flu vaccine production are:
- Boost surveillance so the Centers for Disease Control and Prevention (CDC) can more quickly identify emerging pandemic viruses, allowing vaccine production to start sooner.
- Develop a collection of seed viruses that can serve as "backbones" for producing specific vaccine strains, an initiative that could be accomplished by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Slow-growing seed viruses were a bottleneck during production of the pandemic H1N1 vaccine.
- Devise better and faster tests to assure sterility during vaccine production, which currently takes 2 weeks, a task the group envisions could be taken on by BARDA and the Food and Drug Administration (FDA).
- Produce faster and more reliable tests for vaccine potency, which currently can take 8 to 12 weeks to produce, a task that could be spearheaded by BARDA and the FDA.
- Expand and modernize fill-and-finish capacity for use in the final stages of vaccine production, goals that might be accomplished by federal agencies and vaccine manufacturers.
Each of the measures can be accomplished in 1 to 3 years, the advisors said in their report. The options each have the potential to speed pandemic vaccine delivery by a few weeks or more, except for improved sterility testing, which would only reduce production time by about 1 week.
Longer-term goals that could streamline pandemic vaccine production even more require federal investments in a broad range of research, the report said. The group suggested that federal health officials phase out egg-based technology and move toward more modern cell-culture and recombinant vaccines that can be produced more quickly. They suggested expanding the use of live attenuated viruses rather than killed viruses during vaccine production as a way of squeezing more vaccine doses out of live virus material. Exploring the use of adjuvants, ingredients that can boost immune response, could also stretch the use of virus material to allow the production of more doses.
PCAST members advised the Obama Administration to develop a new management system to achieve the vaccine production goals. They suggested that the US Department of Health and Human Services (HHS) have its Assistant Secretary for Preparedness Response (ASPR) coordinate the tasks among the various department agencies and appoint a small advisory group to guide federal engagement with the vaccine industry, with the group made up of representatives from biotechnology, pharmaceutical, and investment groups. A presidential executive-level office, such as the National Security Council, should have overall responsibility for the vaccine initiative, the group wrote.
The price tag for the improvements would roughly be $1 billion a year over the next several years, the advisors estimated. They said the investment in speeding pandemic vaccine response could be leveraged to help support the development and production of other medical countermeasures. The group added that relatively inexpensive tweaks in current methods could save large numbers of lives.
Aug 19 PCAST press release
Aug 19 PCAST report
Aug 19 HHS Public Health Emergency Countermeasures Enterprise Review