By Theresa Wrangham
(VacTRUTH Author’s Note: See this article for all documents handed out at the meeting.)
Ã‚Â As the Centers for Disease Control (CDC) holds the first round in a series of public engagement sessions designed to promote public discussion on how pandemic swine flu vaccine will be made available to the public, many questions remain unanswered in terms of the safety of the vaccine being developed.
Dr. Roger Bernier and Capt. Raymond Strikas were present at the Denver public engagement session held on August 8th, which I attended to get answers to questions that remain as a result of July meetings held by the FDA Vaccine and Related Biologic Products Advisory Committee (VRBPAC) and the Advisory Committee on Immunization Practices (ACIP). Imagine my amazement as Dr. Bernier opened the meeting by stating that we Ã¢â‚¬Å“canÃ¢â‚¬â„¢t pick the right answer based on science and dataÃ¢â‚¬Â and I was pleasantly surprised that I was not alone in my questions around safety. It seemed as though roughly half of those attending had many of the same questions I did Ã¢â‚¬” it did not bode well for CDC. However, as the meeting progressed it was clear that the public engagement session was not going to be centered on answers to our questions; rather attendees were being asked to make policy decisions based on incomplete assumptions furnished to them by the CDC. The purpose of the endeavor as far as I could ascertain was to take the pulse of the public in determining the level of response the public felt was necessary in pursuing a vaccination program for the new swine flu vaccine under development.
What were the assumptions and scenarios in the discussion guideÃ¢â‚¬Â¦in a nutshell the scenarios were Ã¢â‚¬Å“Go EasyÃ¢â‚¬Â which was defined by providing a few extra sites for vaccination for expected low public demand for swine flu vaccine and providing time to gather data on severity and safety/effectiveness of the new vaccine; Ã¢â‚¬Å“ModerateÃ¢â‚¬Â to promote vaccination to target groups identified by the last ACIP meeting with a media/communication effort to promote uptake Ã¢â‚¬” given low demand, while acknowledging that safety/effectiveness of the vaccine would be unknown; and Ã¢â‚¬Å“Full ThrottleÃ¢â‚¬Â meaning that significant monies on all levels would be expended to create as many vaccination sites as possible no matter the severity of the virus with extensive communication efforts to stimulate uptake.
Assumptions on which to base program efforts were incomplete in that they did not clearly acknowledged severity of the swine flu as mild and stable. The vaccine’s safety profile was based on the current seasonal flu shot without distinguishing that the antigen for the swine flu was new and education given to the public on what a Class C drug classification (has never been evaluated for carcinogenic or mutagenic potential and that animal studies have never been conducted to investigate possible fetal harm) meant as it applies to safety data on the seasonal and swine flu shot.
Acknowledgments made and questions answered at the meeting were that there would not be enough vaccine for everyone until February 2010, two doses of vaccine administered 21 days apart is needed for protection, Ã¢â‚¬Å“ampleÃ¢â‚¬Â thimerosal-free vaccine would be available; thimerosal content for thimerosal-containing swine flu vaccine would be the same as the seasonal flu vaccine (25 mcg/dose); the swine flu vaccine program would be voluntary unless state/local jurisdictions otherwise stated mandatory requirements; over a million military personnel would be used for clinical trials and some of that data would be available in mid-September; squalene adjuvants could only be used under Emergency Use Authorization; the federal government would provide the vaccine free of charge and any charge for vaccine would be associated with administration of the vaccine, and enhancements to existing mechanisms and infrastructure to track adverse events is underway.
Attendees broke to mull over the scenarios and assumptions we were given in order to drive our policy decisions and when the session reconvened themes of consensus were apparent. The top two concerns were safety and choice/informed consent. The majority of attendees favored a moderate effort, but I have to wonder if this would remain true had participants been aware of previous statements on safety made at the FDA VRBPAC and ACIP meetings, which were not truly addressed during public engagement, as well as clear statements on the swine fluÃ¢â‚¬â„¢s virulence to date. However, what was very apparent from this process was that the public expected accurate information on which to base their choice and choice was a primary concern held by individuals regardless of vaccine beliefs.
Safety and transparency again were concerns held by all individuals regardless of individual vaccine beliefschoices. At the end of the day what CDC should have come away with is that gone are the days of Ã¢â‚¬Å“trust me and roll up your sleeveÃ¢â‚¬Â. The rise in distrust and desire for choice, safety and transparency are values held by the general public. In fact, enthusiastic cheers from the majority of attendees went up when one attendee stated that the Ã¢â‚¬Å“CDC and pharmaceutical companies must have some skin in the gameÃ¢â‚¬Â to gain the publicÃ¢â‚¬â„¢s trust and be accountable for liabilities and injuries resulting from vaccines.
It will not surprise me if all ten public engagement meetings reveal the same themes. What would surprise me is if CDC really listens and pulls their head out of the sand and pursues a different tact in communications that is more honestly based on the actual risk/benefit of any vaccine inclusive of gaps and limitations of what is known and what remains unknown. It would also be nice to think that gaps in vaccine safety research will be closedÃ¢â‚¬Â¦one can dream. However, Dr. BernierÃ¢â‚¬â„¢s statement that science has no place in the current swine flu vaccination effort is less than encouraging. We are 10 years into the promise of thimerosalÃ¢â‚¬â„¢s removal from vaccines Ã¢â‚¬” something that is possible but not made a reality; and 30 years into application of lessons learned from a swine flu pandemic that never materialized Ã¢â‚¬” many lessons from which have not been integrated into this current effort.
Questions that remain, or clarifications that are needed, continue and below is a brief list. We hope that our community will turn out at the public engagement sessions yet to transpire and continue asking them.
- In Denver Capt. Strikas stated that squalene adjuvants could only be used under Emergency Use Authorization. What studies are currently being conducted for the swine flu vaccine antigen to be used with squalene and thimerosal that demonstrate safety and efficacy and what are the gaps and limitations of this data?
- We keep hearing reassurance that the safety of H1N1 swine flu vaccine is assumed because it will be formulated in the same manner as seasonal flu vaccine. Yet the NVAC H1N1 subgroup draft recommendation specifically states, Ã¢â‚¬Å“The need to actively monitor vaccine recipients for vaccine adverse events is critical given that the vaccine candidates will all contain a new antigen and may be combined with adjuvants that are not part of licensed vaccines in the US.Ã¢â‚¬Â Please explain the inconsistency between what the public is being told about safety vs. the concern cited by this HHS scientific advisory panel?
- How will warnings on possible side effects be identified to the public, and injuries compensated, with no safety data available prior to vaccination?
- During the Denver public engagement session Capt. Strikas stated that he believed that separate administration of the swine flu vaccine was not necessary, but that ACIP had not ruled on administration of this vaccine separately or simultaneously with other vaccines. The National Vaccine Advisory Committee (NVAC) has already cited a lack of safety data on simultaneous administration of multiple vaccines for existing vaccines and ACIP does not meet again until October Ã¢â‚¬” how will administration of the swine flu vaccine in this sense be decided with roll-out to begin in October?
- In response to vaccine safety infrastructure deficits cited by NVAC H1N1 Subgroup, Capt. Strikas also stated in Denver that additional HMO databases and other measures were being added to existing monitoring and tracking infrastructure. What other enhancements are underway and where is this information available to the public?
- Capt. Strikas stated he could not answer how long-term health outcomes would be tracked given that monitoring of adverse events will only be for 6 months and focus immune response. How will this be accomplished and where is that information available to the public?
- Will preference be stated for thimerosal-free vaccine for special populations such as pregnant women, young children and premies, given that the thimerosal-containing vaccine will exceed IOM recognized EPA safety standards on mercury exposure from vaccines?
- Per the NVAC H1N1 Subgroup recommendations, will a transparent and independent panel of outside experts with no stake in vaccines be assembled to review accumulated data, assess risks and advise on implications of possible side effects of this vaccine be assembled?
The next round of public engagement sessions are being held August 15th. Below are links to register for these meetings and registration is a requirement to attend. Additional information is available here.Ã‚Â
Vincennes, Indiana, Saturday, August 15
Birmingham, Alabama, Saturday, August 15
Sacramento, California, Saturday, August 15
El Paso, Texas, Saturday, August 22
Spokane, Washington, Saturday, August, 29
Additional meetings are being planned in the following cities. Please check back frequently for registration information.
Bucks County, Pennsylvania, Saturday, August 22
New York, New York, Saturday, August 22
Somerville, Massachusetts, Saturday, August 29
The public must keep pressing for answers to these important safety questions. Please consider going to these meetings!
Continue to check the SafeMinds Swine Flu Information Page for updates on meetings and unanswered questions.