And $487 million contract awarded to build first U.S. facility to produce cell-based flu vaccine – more of it, and faster.
Most states have done a pretty good job coming up with plans for dealing with a widespread influenza outbreak, but there is one major shortcoming.
According to a statement released today by the U.S. Dept. of Health & Human Services, state plans don’t do a good job of making sure that enough state workers make it to work – and keep the state running.
Local plans are required under the National Strategy for Pandemic Influenza. U.S. Health & Human Services Science Advisor Dr. William Raub said a survey of states shows that, “on the whole, states and territories have accomplished a tremendous amount in a short time. The results also indicate that much remains to be done to become prepared as a nation.”
State operating plans scored best when it comes to protecting the general population, Dr. Raub said. There are few, if any, major gaps when it comes to dealing with mass vaccinations operations, laboratory capability, keeping records, getting necessary supplies, or communication capability.
All state plans, though, have major gaps – or do not even address, “supporting and protecting state government workers so that the state government could continue to function during an influenza pandemic,” the report states.
Worse than a terrorist attack…
Without this part of the puzzle, a flu outbreak could severely cripple state services. “Even the best plans can fail, if managers cannot accommodate the significant absenteeism and disruptions in support services and supplies that an influenza pandemic is almost certain to produce,” the report states.
An influenza pandemic,”could have a significant impact on the social and economic health of the nation, and produce a public health emergency more daunting than any other type of naturally occurring, accidental, or terrorist event.”
*[See an overview of Connecticut's rating at the end of this story]
New technology promises more vaccine…
In related news, the U.S. Health & Human Services Dept. also announced today that it has a $487 million, multiple-year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu.
Cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, and the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25 percent.
Cell-based vaccine production could more easily meet what the CDC calls “surge capacity needs,” because cells can be frozen and stored in advance of an epidemic, or developed rapidly in response to an epidemic.
Cell-based vaccine production also dramatically reduces the potential for contamination and promises to be more reliable, flexible, and “expandable” than current egg-based methods, according to the CDC statement.
Good news for those allergic to eggs…
Currently, influenza vaccines licensed by the U.S. Food and Drug Administration (FDA) are made in specialized chicken eggs, using a process that hasn’t changed much in the last 50 years.
Cell-based vaccine production uses laboratory-grown cells and the virus is injected into these cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks.
“Today we are taking an important step in our ongoing commitment to pandemic preparedness,” said Dr. Robin Robinson, director of the H&HS Biomedical Advanced Research and Development Authority (BARDA), which will oversee the contract.
“In a pandemic, we would need [surge capacity levels of ] vaccine ready within six months… That goal could not be accomplished using the traditional egg-based method of producing flu vaccine,” Dr. Robinson said.
New cell-based influenza vaccines also provides an option for people who are allergic to eggs, and the technology can be used to make vaccines for seasonal influenza and other major emerging infectious diseases.
Licensing by the FDA…
Under the contract, Novartis and H&HS share the cost of the new cell-based influenza vaccine manufacturing facility in Holly Springs, N.C. – 40 percent H&HS and 60 percent Novartis.
The contract also requires Novartis to provide two new flu vaccines for seasonal flu or for pre-pandemic use.
The contract builds on a previous H&HS contract award to Novartis to accelerate development of cell-based influenza vaccine.
The new contract also will fund studies that will compare existing Novartis vaccines to new ones, including those developed in the new facility, to ensure that these new ones are also safe and effective – and to provide information quickly to the FDA to request licenses for the new vaccines.
If licensed by the FDA, the new cell-based vaccines made in the United States could be purchased by the federal government for vaccine stockpiles.
More information about the contract is available by clicking on this link
*How Connecticut’s plan rated:
“The United States Government Departments rated the Operating Objectives in their respective mission areas for comprehensiveness. That is, reviewers considered the information submitted for each associated Supporting Activity and assessed the degree to which the response described a) a definitive implementation strategy and b) unequivocal specification as to which organizations or individuals are responsible for which elements.”
Connecticut was given a rating of “inadequate preparedness” (indicated in red) for these areas:
Sustain Operations of State Agencies & Support and Protect Government Workers
Manage Mass Fatalities
Mitigate the Impact of an Influenza Pandemic on Workers in the State
Integrate EMS and 9-1-1 into Pandemic Preparedness
Integrate Public Safety Answering Points into Pandemic Preparedness
Public Safety and Law Enforcement
And found to have “many major gaps” (indicated in orange) for these areas:
Ensure Public Health COOP During Each Phase of a Pandemic
Enhance State Plans to Enable Community Mitigation through Student Dismissal and School Closure
And found to have “a few major gaps” (indiated in yellow) for these areas:
Ensure Integration of Uniformed Military Services Needs & Assets
Sustain Transportation Systems
The full report is available online by clicking this link
For more information on pandemic flu, visit www.pandemicflu.gov.