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FDA Announces New Guidance for Cell-Based Vaccine Production

March 5, 2010

beaker A Long Time in the Making

On Tuesday, Health and Human Services Secretary Kathleen Sebelius announced new guidance to help speed the development of cell-based vaccine production methods. The announcement is timely in the wake of the recent H1N1 pandemic that shed light on a flawed current system of vaccine production.

“The development of safe and effective vaccines is critical toward protecting Americans against an influenza pandemic,” said Sebelius. “This final guidance recognizes that a new generation of medical products using innovative methods is needed to ensure we are better prepared today than we were yesterday.”

Developments towards this guidance, intended to “safely expand the types of cells used,” were under way well before the first H1N1 outbreaks occurred in Mexico last year. The draft HHS guidance document was first released in 2006 after a decade of research, testing, and consultation. And cell-based vaccine production has already been used for polio and smallpox immunization.

Back in 2005, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), called for the ramping up of cell-based vaccine technologies in response to the threat of Avian Flu.

The H1N1 pandemic again forced a 50-year-old process of vaccine production with fertilized eggs directly into the public spotlight. The method requires a fertilized egg to be injected with the virus (in the fluid cushioning the embryo), and the virus produced by the infected embryo is then collected. Millions of eggs are required in order to make enough vaccine for all Americans.

Lesson Learned about Gaps in Technology

At the Public Health Preparedness Summit this past February in Atlanta, Sebelius also mentioned the importance of updating vaccine production technology.

“Perhaps the biggest lesson we learned was about the limits of our vaccine technology,” said Sebelius during the opening plenary session at the summit. “We could hurry to develop a vaccine candidate, verify its safety, and clear production facilities, but there was nothing we could do to make the vaccine grow faster in eggs….It was like an old car we had tuned up but still couldn’t accelerate the way we needed it to.”

To compare the current vaccine production technology to an old station wagon that’s hard to maneuver is a pretty accurate analogy. Once manufacturers run into bumps in the road it can be impossible to get the vaccine required for the job. This was seen in the delays in manufacturing and delivering H1N1 vaccine that occurred last fall.

In the 2003–2004 flu season, a new strain of flu was discovered once seasonal influenza vaccine production was already under way. Because it was too late to turn around, the vaccine produced that year offered only partial protection against the Fujian flu strain.

Sebelius announced at the summit that the government would continue to make long-term investments in developing more reliable countermeasures—including more advanced vaccine development.

The HHS recently invested 487 million dollars in the opening of a new Novartis, Inc. manufacturing plant—fronting 40 percent of the costs in exchange for the production of two influenza vaccines, including a “pre-pandemic” influenza vaccine available in stockpiles. The plant will be the first in the U.S. to produce influenza vaccines using the cell-based technology.

Continued investments in new vaccine technology will help put an improved, more robust infrastructure in place and will speed the government’s response to an outbreak of a new strain of virus.

Related News

InPharma: FDA Encourages Cell-Based Vaccine Production
March 3, 2010

ABC News: Novavex Presents Swine Flu Vaccine Data
Feb. 19, 2010

InPharma Sanofi Breaks Ground in Cell Culture-Based Vaccine Production
Sept. 28, 2006


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