Comments Due Monday on Designing a Vaccine Safety System
Comments Due Monday on Designing a Vaccine Safety System
Report Reveals Vaccine Safety System in Crisis
Vaccine Safety Working Group Website: http://www.hhs.gov/nvpo/nvac/subgroups/vaccinesafety.html
Due: June 6 at 5:00
Federal Register: http://www.federalregister.gov/articles/2011/05/10/2011-11401/solicitation-of-written-comments-on-the-draft-report-and-draft-recommendations-of-the-vaccine-safety
Draft Report: http://www.hhs.gov/nvpo/nvac/subgroups/vswg_draftreportv2_publiccomment.pdf
Electronic Submission: [email protected]
Contact: Kristin Goddard, telephone (202) 205-5317; fax 202-260-1165; e-mail [email protected].Show citation box
Reading through the bureaucratese in the draft white paper, the report reveals a vaccine safety “system” in shambles. Uptake of the basic childhood vaccines has dropped to 70%, exemptions are rising rapidly, and polls show a majority doubt the safety of vaccines, believe they do cause autism, and are deeply concerned over vaccine safety as an essential element of public health policy. Outbreaks of preventable infectious diseases are recurring.
The Government is obsessed with preventing every last case of even mild infections with an unproven and bloated one-size-fits all vaccine schedule, but has no serious commitment to even know the extent of, much less prevent, chronic vaccine adverse events. The obsession has inevitably lead to pressure to ignore, trivialize, or accept as unavoidable and acceptable “collateral damage” any adverse effects by public health and medical practitioners, basically ignoring or “disappearing” the “vaccine veterans” in the war against disease. We have no idea how much chronic illness is being caused by vaccines because the Government has refused to fund a comprehensive program of research comparing the health of unvaccinated children and animals to those fully vaccinated, and to conduct adequate research on the mechanisms of injury. A leaked document from CDC (See AofA HERE)] conceded they don’t have the basic science to support safety claims so instead they’ve embarked on a broad campaign of propaganda and fear. A just-released SafeMinds Report as well as www.fourteenstudies.com debunk the poorly designed and in the case of the Verstraeten paper, fraudulent, junk science supposedly exonerating vaccines of causing autism. Thanks to EBCALA and their team of intrepid investigators [www.ebcala.org], we now have more proof that vaccines cause an unknown portion of the autism epidemic in the form of at least 83 cases, and this is probably a dramatic undercount, in which the Government has secretly paid hundreds of millions to victims of vaccine-caused autism. 
The recommendations in the report (e.g. better coordination, stronger oversight, better science, more funding, and data transparency) should have been implemented 25 years ago when the Vaccine Act was first passed. The Executive Branch has too long ignored Congress’s Mandate for Safer Childhood Vaccines. Although infections are reported down to the last case of measles, there is no serious follow-up of voluntary VAERS reports and no ongoing study of children compensated by VICA. The “safety net” in the form of generous compensation for ALL victims of vaccine injury so necessary as a moral and legal duty in support of a universal vaccination policy is virtually non-existent.
Comments should address from the point of view of the individual or organization what is “broken” with the vaccine safety “system,” from design, funding, trials, licensure, administration, surveillance, governance, and compensation. Safeminds filed comments describing A Roadmap to a Safety First Agenda [HERE] which can be used as a guide to your comments. An adequate vaccine safety system should at least have the following characteristics:
1. A fully independent Vaccine Safety Commission, insulated from all vaccine “cheerleading,” e.g. like NTSB or CPSC.
2. Sound science: beginning with a comprehensive and ongoing programs comparing health of vaccinated with unvaccinated humans and animals as the only way to adequately detect and evaluate acute and chronic adverse events, as well as research on mechanisms of and treatments for vaccine injury.
3. An express “safety first” commitment to preventing adverse events, especially necessary since the risk of AE’s is now much greater than the risk of infection, putting at grave risk the benefits of universal vaccination.
4. Transparent: all safety-related data pre-and post-licensure and relating to injuries must be public.
5. Informed choice: absolute protection must be afforded the “civil right” to refuse any or all vaccines for any reason.
6. Consumer-driven and conflict-free: Governance should not be influenced by industry, providers, or public health advocates whose commitments primarily lay with full vaccination.
7. A “safety net” committed to treatment of and generous compensation for all injured “vaccine veterans.” Any “alternative” or “no fault” system offered must be backstopped by ordinary tort liability for producers and providers.
Mail:
NVAC VSWG Report Comments
c/o Kristin Goddard
National Vaccine Program Office
200 Independence Avenue, SW
Room 715-H
Washington, DC 20201
Stakeholder Meeting:
Date: June 13, 2011
Time: 8:30-5:00
Location: Hubert Humphrey Building, Room 800, 200 Independence Ave. SW, Washington, DC.
Register: http://www.hhs.gov/nvpo/nvac/meetings/upcomingmeetings/index.html
http://www.digitaljournal.com/pr/331961
"Fourteen leading scientists and advocacy experts in vaccines and infectious diseases have announced the formation of a new international Foundation to advance and accelerate vaccine research and development against infectious diseases. The Foundation for Vaccine Research will be headquartered in Washington, DC. The Foundation's mission is to raise global awareness of the need for increased, long-term, flexible funding for vaccine research against HIV/AIDS, tuberculosis, malaria, and other infectious diseases, including neglected tropical diseases, as well as universal vaccines for influenza and a vaccine to avert pandemic influenza. The Foundation's activities will focus on persuading opinion leaders, policymakers inside and outside government, and other decision makers of the benefits and safety of vaccines and the merits of increased investment in vaccine research. The Foundation will seek to mobilize resources internationally and on a large scale to finance vaccine research globally, with a special focus on securing new assets and the development of innovative financing mechanisms. The Foundation will also conduct televised fundraising events and benefit concerts, with 100 percent of publicly donated funds going directly to teams of scientists and their institutions. The Foundation will also engage with the anti-vaccine movement to persuade them of the benefits of vaccines."
Posted by: Carol | June 08, 2011 at 02:52 PM
Over-vaccination may be the trigger for autism in those that have a genetic predisposition. It may have nothing to do with how "green" we make a vaccine.
What are we doing to the child with repeat vaccinations; the child who has already acquired immunity and not in need of a booster? What happens to a sensitive child's immune system, when we inject viruses into the body that wouldn't have got passed the front door (the nose and mouth) because the child had the ability to fight off the virus before it entered the body?
We are not all immune-compromised carbon copies of one another. Perhaps, the way to go would be to test blood titers to see if a child has acquired immunity instead of vaccinating every child over and over again.
Posted by: Rachael | June 06, 2011 at 11:57 AM
Here is the comment I submitted to the committee:
Vaccines have always been inherently unsafe in that it is known that side effects can occur. Sometimes these side effects are serious, and even death may be the outcome as a result of vaccination. Therefore we want to be sure that any vaccination that is required, even recommended, makes sense for and can be viewed as necessary for the target population. I have been a pediatrician since 1982. When the hepatitis B vaccine was introduced for routine use in children, and then for routine use in one day old babies, it never made sense to me. I have asked numerous clinicians, but not one has ever been able to give me a medical justification for giving hepatitis B vaccine as a routine to all newborns whether or not they have any risk factors. The time frame in which this has been the practice is the exact time frame in which the autism spike began to occur (1990-1991). One very simple step to making vaccination safer is to STOP GIVING ALL ONE DAY OLD BABIES HEPATITIS B VACCINE. It's really a no-brainer. They are not going to be having sex, sharing needles, or working with body fluids. With the possible exception of some freak occurrence, no routine medical procedure or event in daily life will transmit hepatitis B to a baby. The only possible medical justifications I can see for giving a newborn hepatitis B vaccine is if the birth mother has an active case of the disease or if the child is immediately going to live in an endemic area. If you do nothing else, please stop this practice. You will see autism begin to recede if you do.
Respectfully submitted,
Janet Levatin, MD
Posted by: Janet Levatin | June 05, 2011 at 08:10 PM
GREENING VACCINES will not convince me to vaccinate. If my kid had gotten e coli, we would have been compensated! Nothing short of reversing legal corporate welfare to the vaccine industry will secure the long term safety of the vaccine business.
Hey congress- eliminate the vaccine court and stay out of legal health protections!
STOP AUTISM NOW
Posted by: STOP AUTISM NOW | June 05, 2011 at 05:17 PM
Salinas, Ca June 4, 2011. Maria age 4 arrived in a clinic coughing, vomiting in moderate respiratory distress with retractions, wheezing, fever and a rash. Respiratory distress began following the onset of fever and a rash of her right upper arm. Maria's mother reported immunizations for measles, mumps, rubella, chickenpox, and pneumonia had been administered in her pediatrician's office on June 2, 2011.
Following aggressive respiratory therapy this child's pediatrician was contacted with the recommendation a VAERS be completed. Once again I heard the comment that it would not be necessary-there was a history of asthma.
Without an enforceable reporting requirement it has become apparent emergency and urgent care physicians universally do not comply with VAERS. Sadly most pediatricians do not appear interested in compliance requirements leaving parents, babies and children to fend for themselves.
A solution is available. Medical intake forms must ask "the last immunization date" rather "up to date." Symptoms occurring in any age group within 30 days of any immunization must automatically trigger a VAERS document. There can be No Safety System that continues to allow 95-99% of adverse events to continue to go unreported.
Posted by: David Denton Davis MD | June 05, 2011 at 03:28 PM
Since Congress’s Mandate for Safer Childhood Vaccines has been ignored, is there anyway we can get the schools and pediatricians to stop forcing vaccines? I know this will not stop as long as big pharma is lining their pockets. But is there a way to request they back off until we have a program in place?
parents feel the pressure, many don't know of religious exemptions (I didn't until it was too late). Many worry their kids will be kicked out of school or unwelcome back at the pediatricians office unless they fully vaccinate.
Forcing us to vaccinate when no safety program is in place seems criminal to me.
Posted by: Marie | June 05, 2011 at 11:24 AM