CDCExecSec (CDC) CDCExecSec@cdc.gov
Thank you for your letter to Dr. Brenda Fitzgerald, Director of the Centers for Disease Control and Prevention (CDC), regarding your concerns about vaccine research and safety. Your letter was forwarded to my office for a response.
CDC places a high priority on vaccine safety, is committed to the integrity and credibility of our vaccine safety monitoring and research, and devotes extensive effort to this field. Before the Food and Drug Administration (FDA) licenses a vaccine for use by the public, FDA studies it extensively to determine its safety and effectiveness, and we have several systems in place to monitor vaccine safety after licensure. One of these systems, the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by CDC and FDA, serves as an early warning system for adverse events (possible side effects) that people may experience following vaccinations. Anyone can report an adverse event to VAERS. In addition, healthcare professionals are required to report certain adverse events, such as shoulder injury related to vaccine administration, in VAERS, and vaccine manufacturers are required to report all adverse events that come to their attention. CDC and FDA scientists regularly analyze VAERS reports to detect new, unusual, or rare health events that might indicate possible safety problems. VAERS data are publicly available at www.vaers.hhs.gov/data.html.
In addition to VAERS, CDC has other safety monitoring systems in place. These include the Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) project. The VSD uses large electronic health record databases from integrated healthcare organizations to conduct near real-time safety monitoring and research studies. Guidelines for accessing VSD data are available at www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/ data-sharing-guidelines.html. The CISA project conducts clinical research and clinical case reviews. You will find information about the VSD and the CISA project atwww.cdc.gov/vaccinesafety/ ensuringsafety/monitoring/ index.html.
Additional information about the vaccine safety activities at CDC can be found at
www.cdc.gov/vaccinesafety/Activities/Activities_index. html.
The National Academy of Medicine [formerly known as the Institute of Medicine (IOM)], a non-governmental, nonprofit organization, has also conducted many reviews of vaccine safety. These thorough reviews of medical and scientific evidence on vaccines and vaccine adverse events indicate that vaccines are safe and that serious adverse reactions are rare. You can find the most recent IOM report at www.cdc.gov/vaccinesafety/research/iomreports/index.html .
In your letter, you asked that members of the Vaccine Risk Aware community be invited to meetings of the Advisory Committee on Immunization Practices (ACIP), a federal advisory committee. ACIP meetings occur three times per year to consider new scientific evidence regarding current or possible new vaccine recommendations, and the meetings are open to the public. The next ACIP meeting is October 25-26. A public comment period is held during every meeting. We invite you to register to attend at www.cdc.gov/vaccines/acipand provide your input during these meetings. You can find requirements for presenting comments atwww.cdc.gov/vaccines/acip/meetings/downloads/public- comment-instructions.pdf. CDC posts draft ACIP agendas at www.cdc.gov/vaccines/acip six weeks prior to the meeting.
The ACIP reviews many factors when considering potential vaccine recommendations. These factors include disease burden in the general population and in specific risk groups; available scientific information on the safety, immunologic response, efficacy, effectiveness, and acceptability of each vaccine; economic data; clinical trial results and use information provided in the manufacturer's labeling or package insert; recommendations of other professional liaison organizations; and the feasibility of incorporating the vaccine into existing domestic immunization programs. Based on its comprehensive analysis of the available evidence, it is possible that ACIP might not recommend an FDA-licensed vaccine for routine use. However, a physician or other healthcare provider would still be able to administer the FDA- licensed vaccine according to the labeled indications.
Thank you, again, for your letter and your interest in CDC’s public health efforts. We hope this information is helpful to you.
Sincerely,
Sandra Cashman, MS
Executive Secretary,
Office of the Chief of Staff, CDC
However gracious and professional/polished the response I am disappointed that several important issues I raised were never addressed - namely the serious and credible allegations of on-going fraud in vaccine research in which the CDC is complicit.
If the CDC places such a high priority on vaccine safety they would not be using VAERS as a way to monitor for sentinel events as it is widely (and credibly) believed to capture 10% (at most!) of vaccine related adverse events.
Also not addressed is the fact that vaccine "safety" studies lack two components necessary for "gold standard" research - genuine placebos and non-vaccinated control groups.
Why are parents who (in the thousands) are reporting to pediatricians the loss of previously gained skills and onset of chronic health conditions following vaccination not being mined for data?
She relates the types of factors that influence ACIP's decision-making regarding their recommendations about vaccines - one of which is economic ... but conveniently ignores the issue of conflict of interest - how many on this committee advocating for vaccination have ties to the manufacturers and will benefit from their decision to recommend adding yet another vaccine to the bloated schedule.
She does not say if my letter was ever read by the intended recipient.
She does not state if Dr. Bill Thompson will be released to testify to Congress, nor does she mention if Dr. Fitzgerald is reaching out to the members of CDC SPIDER to learn more about their concerns.
My offer to have Dr. Fitzgerald in my home for dinner and a screening of Vaxxed still stands - and I hope she will take me up on it.
Ignoring the issues I raised will not change them or make them go away. This deflection is deceptive, at best.
I am indeed, very interested in public health - but this information was not especially helpful. As a concerned citizen I think we all deserve better from the officials who are our employees - and I am convinced they can do better. We are in this situation not from a lack of expertise but because of a willful refusal to do actual science.
