May 21, 2010 (CIDRAP News) – In the wake of a pandemic vaccine that came too little and too late to blunt the second wave of pandemic flu infections last fall, President Barack Obama's science advisory group today presented a set of recommendations on how to more quickly produce a vaccine in the face of another novel flu outbreak or other public health emergency.
In a report to the President's Council of Advisors on Science and Technology (PCAST), the group's cochair, Dr Harold Varmus, a virologist who is president and chief executive officer at Memorial Sloan-Kettering Cancer Center in New York, presented the findings of a working group that was tasked in February with studying how to speed influenza vaccine production. In November, Dr John Holdren, Obama's science and technology advisor, and John Brennan, homeland security advisor, proposed that PCAST study the issue, Varmus said today.
Varmus said the task force briefed Obama on its findings in March, and after today's provisional approval from the PCAST group will submit the final report to the president soon.
In the early stages of the pandemic, the Obama Administration called on PCAST to assess the new virus's threat to the nation, and in late August the group weighed in on recommendations that the federal government accelerate pandemic H1N1 vaccine production and appoint a White House pandemic preparedness point person. Their report also made waves when its illness and death projections came in higher than what federal health officials had projected earlier.
Though the group's task was narrowly focused on influenza vaccines, the findings have broad implications that touch on basic science, public policy, regulatory systems, and manufacturing, Varmus said. "The group had a number of important conundrums to assess." He added that applicability to other biological threats could help build momentum for making the host of research and technology improvements needed to speed the production of flu vaccines.
He said in August when PCAST delivered its first pandemic-related report, it was already clear that the vaccine wouldn't be as timely and as plentiful as originally thought. "The bulk of the vaccine didn't arrive until the end of the year," he said. No one group bears responsibility for the vaccine delays, much of which Varmus attributed to the "antiquated" egg-based production system.
"Flu is different than other biothreats. We have tremendous experience with seasonal flu, which is a useful test bed," he said. "But it's hard to make changes in a large established industry that has commodity status."
When group members reviewed the pandemic vaccine production timeline, they found that some steps occurred on schedule, while others didn't.
The working group's short-term recommendations for speeding up influenza vaccine production include quicker and better identification of pandemic viruses, a shift from egg-based to cell culture production, better seed strains, improved methods to speed sterility testing, modernized and more reliable potency test reagents, and larger and more modern fill-and-finish facilities.
Longer-term recommendations include:
- Studying obstacles and incentives that affect cell culture production facilities
- Exploring the wider use of live attenuated influenza virus (LAIV) vaccines
- Developing and testing at least three recombinant influenza vaccines
- Creating an investment strategy for improved methods and vaccines
- Supporting clinical trials of adjuvanted vaccines
- Aiming for a universal flu vaccine
- Implementing a new management in federal departments in overseeing long-term strategies to speed vaccine production
Another measure that could streamline vaccine production is guidance from the US Food and Drug Administration for the pharmaceutical industry on what it takes to have a new flu vaccine approved.
Varmus told the group that the world dodged a bullet, because the virus was less virulent than originally though. "Getting this right is important, and vaccines aren't perfect," he said. "But producing the vaccine in 3 or 4 months rather than 6 to 8 months would have a dramatic effect."
PCAST Web site
Aug 24, 2009, CIDRAP News story "Presidential panel calls for planning czar, faster vaccine"