The vaccine for swine flu won't be tested adequately before it is administered this fall in the first wave of tens of millions of vaccinations, which will go to the most vulnerable: children, infants, and pregnant women.
That fact about the disease, formally named H1N1 because of the scary nature of its casual title of swine flu, became apparent after the National Biodefense Science Board met in an emergency session to review issues surrounding the pandemic.
During the meeting Friday, the board members reviewed their working group's report on the swine flu before it is sent to the Advisory Committee on Immunization Practices, who makes final recommendations to Kathleen Sebelius.
The group is working off of several key assumptions:
Novel H1N1 viruses will continue to circulate.
A second wave is likely to occur, as soon as this fall. Best estimates suggest that infection rates will be two to three times higher than expected with seasonal influenza. The second wave could peak in October, but we must anticipate onset as early as September.
Attack rates will continue to be highest in children and young adults.
Hospitalizations and deaths will continue to be concentrated among children and younger adults with underlying medical conditions.
Children will continue to act as an amplifier to community spread of the virus.
Severity will continue to be similar to or somewhat greater than this wave, but the number of cases will be substantially larger.
Catastrophic disruption of societal function, as anticipated in some planning scenarios for a severe pandemic, is unlikely.
Waiting for a full characterization of the immunologic properties of candidate vaccines with extensive studies, and doing studies in series, would result in the H1N1 vaccine's not being available until late fall.
Having a vaccine only after the peak may be worse than having no vaccine at all: It incurs all of the risk and cost with no potential benefit. Licensed vaccines, or vaccines similar to licensed products, will be most acceptable at the beginning of the next epidemic wave.
Safety of the vaccines, both real and perceived, will shape risk/benefit calculations and acceptance. This will be true for both public health officials applying a collective perspective, and for individuals deciding whether to be vaccinated.
Decisions about vaccine formulation must be made rapidly on the basis of available data. Strategies can and should be changed as more data become available, but we cannot wait beyond mid-August if vaccine is to be in supply by mid-September.
The Biomedical Advanced Research & Development Authority's strategic goal of being able to produce vaccine for all 300 million Americans within six months of declaration of a pandemic is appropriate for capacity. However, it is not the same as the strategic goal for dealing with a specific pandemic.
Much of board's probable agenda has been discussed publicly, but here is a list of the board's current stance on vaccine issues, from page 5 of the report:
Goals and Principles:
A critical goal is to have some monovalent novel H1N1 vaccine available by mid-September 2009, should it be needed. This goal can take advantage of the decades of experience with other H1N1 subunit vaccines, typically at a 15mcg dose.
Begin with the goal of targeting a small amount of the vaccine to a small group where it will do the most good. To the extent possible, this should be driven by sound epidemiologic data.
This likely means focusing on infants, toddlers, school-age children, pregnant women, and adults with risk factors applicable to novel H1N1 virus. Manufacturing of vaccine for additional cohorts of the US population and the world should proceed, but without interfering with the goals listed above.
Safety monitoring must be in place before novel H1N1 vaccination begins, and have the sensitivity, power, and speed to detect signals and determine causal relations in a timely manner to aid policy and communication.
HHS should remind States and local health departments that durable record-keeping of who receives the vaccine (preferably in electronic format) is an essential component of local implementation plans.
HHS should consider recommending school-based immunization delivery for children for logistical simplicity.
Decision-making should remain flexible, based on clearly articulated principles and scientific evidence, and should be transparent.
Of the greatest concern to me was this portion of the paper:
If the government wants to have novel H1N1 vaccine available in September 2009, it should pursue a simplified testing program to achieve that goal. Additional studies may be appropriate for additional supplies in subsequent months, but time of availability seems to be the dominant criterion for vaccine decision making.
If the U.S. goal is vaccine availability in September 2009, 15-mcg unadjuvanted subunit vaccine and live attenuated intranasal vaccine for children may be a rational approach.
If the second wave is delayed or production is slower than expected, mix-and-match studies of vaccine plus separate adjuvant may yield information that may stretch the available vaccine supply.
During the discussion, members decided that they would recommend not only having the first doses of the vaccine ready by Sept. 15 but also shooting for Sept. 1.
However, since the clinical trials of the vaccines will begin just this week, the studies will not be completed by the time manufacturing decisions must be made in order to meet the September deadline.
So it was decided to recommend that the first few tens of millions of doses be formulated and produced BEFORE the results of the clinical trials are in. After the trials are completed, they will then have the option to go back and make changes to the vaccine. It sounded like the second round of vaccine would be expected at the end of October, but they were not completely clear on that.
This means that members of the public who are vaccinated with the H1N1 flu shot in September and probably in October will be receiving an untested vaccine. (Note that these most likely will be children, infants, and pregnant women).
This seems contrary to the statement that Sebelius made on the "Meet The Press" this week when she said: "We're on track to have a vaccine ready by mid-October. We need to make sure it's safe, and so clinical trials will begin. And we need to make sure it's, it's effective against this new novel strain. So that's what's happening in the meantime. And if the scientists say it's a go, by mid-October we will have a vaccine available and start with the priority communities."
Scientists are already saying "go" and the people will have no such assurances that it will work, or be safe, when it is first administered.
Ginger Taylor is a former marriage and family therapist, having received her master's degree in clinical counseling from Johns Hopkins University. She is raising her 7-year-old son Chandler, who lapsed into autism following his 18-month vaccinations. She blogs at AdventuresInAutism.com
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