Overview of SafeMinds Swine Flu Concerns

In light of the many unknowns concerning the possible Swine Flu Pandemic, SafeMinds is providing the following updates for informational purposes and to raise awareness regarding possible vaccine safety issues, policy decisions and facts regarding the production and possible use of the novel H1N1 vaccine currently being developed.

Our primary goal in raising these concerns it is to promote the production of the safest vaccine possible as our nation develops its strategy with regard to a possible pandemic.  Given past safety failures and vaccine injuries resulting from the 1976 Swine Flu Immunization Program, we believe that lessons from those failures, as documented by Institute of Medicine President Harvey Fineberg, MD, PhD, as well as the draft recommendations made by the National Vaccine Advisory Committee, H1N1 Vaccine Safety Subgroup, must be integrated into the current effort to improve protection for all individuals.  Life is precious and safety a priority in assuring the health of every man, woman and child.   Additional information on Swine Flu is also available from our friends at National Vaccine Information Center.  Please visit often for updates and subscribe to our newsletter for current information.

August 9th Update - CDC Sponsored Public Meeting on Swine Flu Leaves Questions Unanswered

The first in a series of public engagement meetings on the Swine Flu Vaccine Program sponsored by the Centers for Disease Control (CDC) took place in Denver, Colorado and Lincoln Nebraska on took place August 8th.  SafeMinds President, Theresa Wrangham attended the Denver meeting and raised concerns with regard to vaccine safety, the use of thimerosal in this vaccine and the possible introduction of currently unlicensed adjuvants. 

Dr. Roger Bernier and Capt. Raymond Strikas of the CDC were present during the Denver meeting, which opened with Dr. Bernier stating that we “can’t pick the right answer based on science and data”.   Questions SafeMinds had for this meeting were 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) and roughly half of those attending had many of the same questions. 

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, “ample” 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.


The top two concerns of attendees at Denver’s meeting were safety and choice/informed consent.  Also apparent 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.  These themes strongly suggest that the rise in distrust and desire for choice, safety and transparency are values held by the general public and are similar to concerns expressed to the National Vaccine Advisory Committee during their public engagement process in connection with the review of the CDC's Immunization Safety Office Draft Research Agenda. There were also many criticisms of the government’s actions in shielding vaccine makers from liability claims, with one attendee stating that the “CDC and pharmaceutical companies must have some skin in the game” to gain the public’s trust and be accountable for liabilities and injuries resulting from vaccines.

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, “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.” 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 – 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?

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. 

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 updated information.

Bucks County, Pennsylvania, Saturday, August 22
New York, New York, Saturday, August 22
Somerville, Massachusetts, Saturday, August 29

 

August 5th Update - Parents Await Answers as CDC Sponsors Public Engagement on Pandemic H1N1 Vaccine

As the Centers for Disease Control (CDC) prepares for the first 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.

The first public engagement sessions are scheduled to take place in Denver, Colorado and Lincoln, Nebraska on August 8th, with additional meetings planned in the coming weeks.  Information and registration for these meetings is available at keystone.org/H1N1.  Below are cities meetings will be held in with links for registration provided:

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

Questions that remain as a result of the most recent ACIP and FDA VRBPAC meetings, as well as the draft recommendations by the National Vaccine Advisory Committee, H1N1 Vaccine Safety Subgroup are as follows – the public awaits answers!

  • As ACIP recommendations have been predicated on non-adjuvanted vaccine scenarios, how will recommendations for use of the currently unlicensed adjuvants under consideration be determined prior to their use? 

  • How will warnings on possible side effects be identified to the public, and injuries compensated, with no safety data available prior to vaccination?

  • Currently, the majority of seasonal flu vaccine exceeds the EPA’s safe exposure standard for mercury established in 2000 by the Institute of Medicine (IOM).  Will pandemic H1N1 vaccine also exceed this guideline for any target population identified?  

  • What safety studies are being carried out, particularly on the currently unlicensed adjuvants under consideration and their effects when combined with thimerosal, and what are their gaps and limitations?

  • Two manufacturers (CSL and Sanofi-Pasteur) can make pandemic mercury-free vaccine.  Will there be a preference for mercury-free vaccine to be administered for pregnant women, young children and vulnerable and special populations such as premies?

  • What mechanism has been created to properly monitor adverse events on this vaccine’s new antigen and the possible use of unlicensed adjuvants, given the NVAC’s H1N1 Subgroup’s statement that the current vaccine safety infrastructure is unlikely to be sufficient and may need to be enhanced?

  • How will long-term health outcomes be determined given that they may not manifest until many years later, as is the case with schizophrenia linked to viral illness during pregnancy, when current monitoring is only planned for 6 months after the second dose of pandemic H1N1 vaccine?

  • Given National Vaccine Advisory Committee identified a gap in data on simultaneous administration of multiple vaccines, will pandemic H1N1 vaccine be administered separately to permit identifying, tracking and analyzing and if necessary, removal of this vaccine from the market as was the case in 1976? 

  • Will the NVAC’s H1N1 Subgroup’s recommendation for a transparent and independent panel of outside experts with no professional or commercial stake in vaccines be assembled to review accumulated data, assess risks and advise on implications of possible side effects be implemented?   

 

Swine Flu Update - July 29th

During the July 29th meeting of the Advisory Committee on Immunization Practices (ACIP) made their recommendations on use of experimental novel H1N1 vaccine. Target populations for the pandemic vaccine have been established, though it was generally acknowledged that there will not be enough vaccine for all Americans and thus, the program is expected to be voluntary. Additionally, no assurances were made regarding whether or not sufficient amounts of thimerosal-free vaccine would be available for vulnerable populations. Below are sequential targets for the vaccine, of which over 50% of all Americans fall within these categories.

• pregnant women;
• household contacts with children less than 6 months of age;
• health care workers;
• children 6 months to 24 years;
• and adults with certain risk factors who were 25 to 64 years of age.

These recommendations were made, though CDC staff presenting at the meeting confirmed that H1N1 pandemic was mild with no apparent increased virulence, as well as efficacy and safety data from clinical trials would not be available until mid-September at the earliest. Dr. Cody Meissner, a Professor of Pediatrics at Tufts Medical Center in Boston and an ACIP member, raised a concern that the current H1N1 pandemic is related to past H1N1 pandemics and as a result is causing milder disease due to decreased virulence and transmissibility and access to better health care. As such, Dr. Meissner voiced concern, regarding the potential hazards of administering a vaccine based on limited safety and efficacy data, which could result in federal agency credibility issues.

SafeMinds Vice-President, Lyn Redwood RN, MSN attended this meeting and reminded ACIP of the public’s on-going concerns regarding gaps in vaccine safety research and the continued use of thimerosal in influenza vaccines and its use planned use in pandemic vaccine formulations. Ms. Redwood also voiced great concern over the fact the pandemic vaccine will be rolled out for use prior to completion of clinical trial data in sufficient numbers of subjects to identify adverse events and subgroups for whom contraindications to vaccination are needed – concerns shared by other ACIP members during the meeting. A key concern raised by SafeMinds is also shared by the National Vaccine Advisory Committee (NVAC) in their report reviewing the Centers for Disease Control’s Immunization Safety Office Draft Research agenda, which identified critical gaps in vaccine safety research and made sweeping recommendations for improvement. Specifically, one area identified by NVAC related to lack of safety data on simultaneous administration of multiple vaccines. It is unclear if the pandemic H1N1 vaccine will be given with other vaccines, or separately, as well as how much thimerosal will be in pandemic H1N1 shots, or if a thimerosal-free formulation would be available for special populations (pregnant women, premies, individuals with mitochondrial dysfunction, etc.)

Of particular concern to SafeMinds is that ACIP identified pregnant women as one of the most important groups to receive experimental H1N1 vaccine. Given that the pandemic H1N1 vaccine will be a Class C drug – meaning that the vaccine has never been evaluated for carcinogenic or mutagenic potential and that animal studies have never been conducted to investigate possible fetal harm. The 2004 Black et al study findings on over 48,000 pregnant women followed for five flu seasons demonstrated that there was no difference in rates for flu-related illness and hospitalization between pregnant women who got seasonal flu shots and who didn’t get flu shots. With public acknowledgement by federal agencies that efficacy and safety data will not be available for the pandemic H1N1 vaccine, it is equally unclear if it will perform any better than the seasonal influenza vaccine for pregnant women.

ACIP committee members and meeting presentations acknowledged that information on pregnant women was “scanty” and that adverse events will be tracked and recorded for only 6 months after the second dose of pandemic flu vaccine is given. However, a recent issue of Scientific American MIND reported that when a pregnant mother’s immune system becomes activated, as happens with vaccine administration, it can influence fetal brain development and neuronal growth. SafeMinds supports long-term tracking of adverse neurological outcomes following pandemic H1N1 vaccination to identify the adverse neurological outcomes that can take years to manifest, as is the case with schizophrenia which has been linked to viral illness during pregnancy.


There remains great concern regarding the possible use of squalene-based adjuvants ASO3 (GlaxoSmithKline) or MF-59 (Novartis). Neither of these adjuvants is currently licensed in the U.S. and multiple studies in animals have associated squalene with autoimmune problems. Additionally, a 2002 study linked use of squalene as an experimental vaccine adjuvant with the clinical signs of Gulf War Syndrome and suggests that the squalene-containing vaccines could be responsible for the Gulf War Syndrome symptoms observed in the study’s participants (Antibodies to Squalene in Recipients of Anthrax Vaccine; Experimental and Molecular Pathology 73, 19–27, 2002).


Compensation for injuries that occur following pandemic H1N1 vaccination, according to a representative from the Vaccine Injury Compensation Program present during the ACIP meeting, will be handled by a new program under development.   Injures have not been identified for this vaccine given that clinical trials will involve very few subjects, injuries may only be identified once the vaccine is given to the public in the Fall. Should the pandemic H1N1 vaccine be given at the same time with other vaccines, delineation o f injuries from vaccines administered will be difficult and complicated. Mechanisms to monitor and record injuries have not been clearly defined.

Swine Flu Update - July 23rd

During the FDA's Vaccine and Related Biologic Products Advisory Committee (VRBPAC) meeting of July 23rd convened to address the possible swine flu pandemic, it was revealed that some of the novel (pandemic) H1N1 inactivated vaccine would contain thimerosal (a vaccine preservative containing mercury) – ten years after the vaccine industry was asked by public health agencies and organizations to remove it (see statement at end of page). It was also reported that most manufacturers were having difficulty growing the novel H1N1 virus, suggesting that an adjuvant may be needed to “spare antigen” and to increase vaccine production.  Additionally, the CDC’s ferret studies suggest that the novel H1N1 virus is not as contagious as has been reported. 

Notably, the committee was not furnished with any preclinical trial data, or FDA safety analyses, for the novel H1N1 vaccine, or the proposed adjuvants. Of concern is that the proposed adjuvants (AS03 & MF59) are squalene (oil) based and studies suggest that exposure to squalene is associated with production of auto-antibodies and auto-immune disease. Nor were safety analyses on administration the novel H1N1 vaccine with other vaccines, or with mercury-containing vaccines, provided for the committee's review.

The disconnect between CDC media announcements and advisory meeting comments suggest a campaign of “fear mongering” reminiscent of the 1976 swine flu vaccine fiasco.

To date, the H1N1 pandemic appears to be mild and there’s no evidence of increased virulence. As such, it seems highly irresponsible to recommend use of potentially dangerous vaccines - especially those with adjuvants combined with thimerosal - which have not been shown to be safe, or effective, by the FDA. 

Information provided by manufacturers during the FDA VRBPAC meeting indicate that In order to get this vaccine to market by the fall, none of the safety studies will be completed. It also appears that pregnant women and young children will be among the first to receive the experimental novel H1N1 vaccine - the same population most vulnerable to vaccine side effects and injury.

Given these concerns, SafeMinds will raise the following questions during the upcoming July 29th meeting of the Advisory Committee on Immunization Practices (ACIP):

  • Should squalene-based adjuvants be used, what studies demonstrate that it’s safe to combine thimerosal (mercury) with squalene?

  • Both CSL and Sanofi-Pasteur have indicated they can make pandemic mercury-free vaccine. Will ACIP state a preference for mercury-free vaccine for pregnant women, young children and vulnerable and special populations such as premies and immunocompromised children?

  • How much mercury will be in multi-dose vials and what dose of mercury will be given to premies, infants, pregnant women and adults?

  • Given that the National Vaccine Advisory Committee identified a gap in data demonstrating the safety of simultaneous administration of multiple vaccines during a given office visit, will ACIP recommend administration of H1N1 vaccine separately as a precaution and to permit identifying, tracking and analyzing and if necessary, removing a vaccine from the market as was the case in 1976? 

_____________________

In 2000 “The AAFP (American Academy of Family Physicians), AAP (American Academy of Pediatrics), and the PHS (U.S. Public Health Service) in consultation with the ACIP (Advisory Committee on Immunization Practices) reaffirmed the goal set in July 1999 to remove or greatly reduce thimerosal from vaccines as soon as possible for the following reasons:

  1. the removal or substantial reduction of thimerosal from vaccines is feasible,

  2. the progress in removal which has been made to date is substantial,

  3. the discussions between the Food and Drug Administration and the vaccine manufacturers in removing thimerosal are ongoing, and

  4. the public concern about the use of mercury of any sort remains high.”

The 2006 url where this statement appeared is no longer active for reasons unknown -