Report on Vaccine Related Federal Advisory Committee Activities
By Theresa Wrangham
After the U.S. Food and Drug Administration’s (FDA) approved Merck’s HPV-9 Gardasil vaccine for use in adults age 27 to 45 in 2018, the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) of the Department of Health and Human Services (HHS) is evaluating whether to expand their current HPV vaccine recommendation to include this new age group.
ACIP’s current recommendation is that boys and girls ages 9 through 15 should get two-doses of HPV-9. The “catch-up” vaccine schedule is a three- dose series for females above age 15 through age 27 and males above 15 years of age to 21 years of age, if not previously vaccinated with HPV vaccine.1
CDC to Step Up HPV Vaccine Marketing Strategies
Should ACIP expand their recommendations for use of HPV-9 vaccine in the newly approved age group, the CDC won’t be alone in the push to increase the use of the HPV vaccine by children and adults in the U.S. During the September meeting of the National Vaccine Advisory Committee (NVAC), a federal advisory committee that makes recommendations to the National Vaccine Program Office (NVPO), the HHS Assistant Secretary ADM Brett Giroir M.D. emphasized that HHS supported the NVAC’s HPV vaccine recommendations 2 published in June 2018. Dr. Giroir stated that increasing HPV vaccination in America would be a focus for HHS in 2019.
The federal government’s focus on increasing the use recommendations for the HPV vaccine may result in a renewed effort by state legislators to introduce legislation in many states to mandate HPV vaccine for school entry.
HPV-9 Use in Older Adults Considered by ACIP
During the October 2018 ACIP meeting, the HPV workgroup presented preliminary information for discussion purposes. Cost data, though incomplete, showed that increasing use recommendations of the HPV-9 vaccine is not likely to be cost effective. In addition, preliminary data showed that receiving the vaccine would not likely have a significant positive impact on those who may have chronic HPV infections that go on to become HPV associated cancers.3
As this discussion unfolds and finalized data is presented to ACIP during 2019, reportedly a permissive use recommendation is more likely than a routine use recommendation.4 A permissive use recommendation would mean that consumers would be advised of the vaccine’s approval for use in 27 to 45 year olds, while a routine use recommendation would mean that vaccine providers would more strongly recommend use of the vaccine in this older age group.
Any recommendation by ACIP to expand the use recommendation of the HPV vaccine in this age group will result in providing a liability shield to vaccine providers and require anyone in this age group who is injured by this vaccine to petition the federal vaccine injury compensation program (VICP) for injury compensation.
ACIP may vote on this issue as early as their next meeting in February 2019. However, ACIP’s February agenda has not yet been published. Notably, during the February 2018 ACIP meeting, the CDC presented data indicating that it may be decades before it is known whether HPV vaccine has impact on HPV associated cancers.5
ACIP Recommends Routine Hepatitis A Vaccination for the Homeless
Votes carried out during October’s ACIP meeting included the passage of a routine recommendation of Hepatitis A vaccine for the homeless to prevent outbreaks in this at risk group;6 and formatting and language clean up of the CDC recommended childhood7 and adult8 vaccine schedules (routine, catch-up and medical indication tables). The CDC’s website will be updated with these vaccine schedules with the goal of making the new schedules clearer to vaccine administrators and the public.
Vaccine Access A Key Factor in Rise in Unvaccinated Children
At the October ACIP meeting, the CDC set forth the latest MMWR reports on childhood vaccine coverage. Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases (NCIRD) commented on the slight increase in the number of unvaccinated children. Dr. Messonnier stated,
“Parental choice may play some role, but CDC’s data really suggests that many of these parents do want to vaccinate their children, but they may not be able to get vaccines for them. They may face hurdles like not having a health care professional near by, not having time to get their children to a doctor, and thinking that they cannot afford vaccines.”9
New Anthrax Vaccine Likely to be Stockpiled
A presentation was made on the new anthrax vaccine AV7909, which is manufactured by Emergent Biosolutions, and uses the novel CpG 7909 adjuvant. The new adjuvant CpG oligodeoxynucleotide (CpG ODN) is a synthetic oligodeoxynucleotide derived from bacterial DNA that accelerates the pro-inflammatory response of the immune system to stimulate immunity.10 11 This vaccine, once approved, will be stockpiled in the Strategic National Stockpile, to be used in the event of a bioterrorism attack.12 13
Pneumococcal Vaccine May Provide Little Benefit To Seniors
ACIP is also conducting a routine review of their use recommendation for PVC 13 pneumococcal vaccine in adults. Data was presented suggesting that the vaccine has little direct benefit to seniors. Additional data will be presented during February’s ACIP meeting with a possible vote in February or June that may result in a change to the routine use recommendation of the PCV 13 vaccine in 65+ adults.14
Change in Tetanus Revaccination Considered
Data was presented on the use of Tdap in place of Td vaccine for the 10-year booster vaccination recommended by the CDC.15 It appears a key reason behind this possible substitution has to do with vaccine providers opting to keep little to no Td vaccine supplies on hand. ACIP has formed a workgroup to evaluate a possible change in this policy and will present data and recommendations to ACIP for additional consideration.
Infant Dose of Influenza Vaccine May Change
Sanofi Pasteur presented data on the initial use of a full dose (.5-ml) of the Fluzone Quadrivalent vaccine in infants six months of age compared to the current half dose recommended for this age group.16 Additional information will be presented at future ACIP meetings as the committee considers a possible change in recommendations.
CDC Removes Many Pertussis Vaccine Contraindications
The CDC removed four DTaP precautions to receipt of pertussis containing vaccines, including
- Fever over 105 F within 48 hours following DTaP;
- Persistent, inconsolable crying lasting more than 3 hours within 48 hours following a dose of DTaP;
- Collapse or shock-like state within 48 hours following a dose of DTaP;
- Seizure within 72 hours following a dose of DTaP.
from their Best Practice Guidelines webpage.17 18 The reason provided for this change was that these precautions were associated with the DTP vaccine, which is no longer licensed for use in the U.S. due to its higher reactivity and risk for vaccine injury, and not the DTaP vaccine.
Parents Describe Vaccine Injury and Death During ACIP Public Comment Period
During ACIP’s public comment session, the majority of comments were made by individuals reporting vaccine injuries and deaths and those concerned about lack of informed consent protections in vaccine policies and laws. Health care professionals provided public comments that were critical of data presented to ACIP and of current ACIP vaccine recommendations. Many parents echoed these concerns and shared their heart breaking stories of vaccine injury and death.19 20
Destiny Maynard tearfully shared with the committee the story of her son, Christopher, who died in the summer of 2018 following complications from Acute Disseminated Encephalomyelitis (ADEM) shortly after receiving an HPV vaccination. She read a statement from her son’s neurologist explaining that cases of ADEM can be triggered by vaccines and that the HPV vaccine, specifically, has been implicated in cases of ADEM within one month of vaccination. The statement concluded that strong consideration must be given to the HPV vaccine causing ADEM, which resulted in the death of Christopher.21
ACCV Requests Funding for More Special Masters But Ignores Vaccine Safety Gaps
On December 6, 2018, The Advisory Committee on Childhood Vaccines (ACCV) met and passed a resolution to request that the Secretary of Health provide additional funding to hire more special masters for the U.S. Court of Federal Claims to adjudicate vaccine injury claims in the federal vaccine injury compensation program (VICP). When the Secretary of HHS opposes awarding compensation, the special masters make determinations about whether plaintiffs will or will not receive an award from the federal vaccine injury compensation program (VICP). Noting a serious backlog in pending compensation claims, ACCV expressed hope that providing funding for hiring more special masters will accelerate to processing of claims.
The Government Accountability Office published a report in 2014 critical of the length of time it takes to process VICP claims, 22 one of many criticisms of the implementation of the VICP created by Congress in the 1986 National Childhood Vaccine Injury Act.23 The Secretary of Health still has not fulfilled NVIC’s long-standing request for funding of research to address acknowledged vaccine safety science gaps identified in over 25 years of reports issued by the National Academy of Medicine (NAM), formerly the Institute of Medicine (IOM).
Vaccine Administrators Get Liability Shield for Causing Shoulder Injuries
According to reports by federal officials during ACCV’s meeting, the leading injury claim in the VICP by adults is shoulder injury (SIRVA) from improperly administered vaccines, followed by Guillian-Barre Syndrome (GBS) caused by from influenza vaccine. Notably, during the June 4, 2015 meeting of ACCV, HRSA noted that SIRVA was not an adverse reaction to the vaccine itself, rather it was an injury resulting from incorrect administration of the vaccine too high in the shoulder muscle causing shoulder injury. NVIC provided public comment opposing the addition of SIRVA to the Vaccine Injury Table (VIT) due to the fact that this injury is not a vaccine adverse event, rather it is the result of a lack of professional training and/or misadministration by the vaccine provider.24
Despite these comments, ACCV recommended adding SIRVA to the VIT to provide healthcare professionals with a liability shield if they incorrectly administer any routinely recommended childhood vaccine in the shoulder and cause a shoulder injury. SIRVA injuries can range from mild to severe, can cause temporary or permanent injury that limits movement and results in pain from bursitis and tendinitis.25 26
ACCV Considers Survey to Assess VICP Experience and Awareness
ACCV’s process workgroup presented initial discussion results on their review of a survey of petitioners rating their experience with VICP, the outcome of their claim, and how they found out about the VICP. This survey is, in part, the result of the acknowledged lack of public awareness of the VICP and how it might be improved. NVIC has requested that ACCV amend the survey to include questions relating to the satisfaction and adequacy of awards from VICP based on recommendations from federally commissioned reports on VICP.
Upcoming Federal Advisory Committee Meetings.
For more than three decades, NVIC has monitored and reported on federal vaccine advisory committee meetings that shape federal vaccine policy and influence state vaccine laws. These meetings are open to the public and most are streamed live. All meetings allow for public comment and have different requirements on registering to make a public comment. A selection of NVIC’s previous public comments can be read here. We encourage our supporters to make their voice heard and to voice their concerns to these federal committees. Upcoming committee meetings in 2019 are:
ACIP - February 27-28, 2019, learn more and register here.
ACCV – March 7-8, 2019, learn more and register here.
NVAC – March 25, 2019, learn more and register here.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
1 CDC. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR. Dec. 16, 2016. Vol 65. No. 49.
2 NVAC. Strengthening the Effectiveness of National, State, and Local Efforts to Improve HPV Vaccination Coverage in the United States. ASPPH Public Health Reports. Aug. 9, 2018.
3 CDC . ACIP Meeting Presentation - Impact and economic analysis – Summary of three models of 9-valent HPV vaccination among adults up to age 45 years in the United States. Chesson, H., CDC. Oct. 25, 2018.
4 CDC. ACIP Meeting Presentation – Expanded age range for 9-valent HPV vaccine: Work Group plans and policy considerations. Markowitz, L. Oct. 25, 2018.
5 CDC. ACIP Meeting Presentation – Trends in HPV-associated cancers in the United States. Dr. Elizabeth VanDyne, CDC/NCIRD. Feb. 12, 2018.
6 CDC. ACIP Presentations – Hepatitis A Vaccines. Oct. 24, 2018.
7 CDC. ACIP Presentations – 2019 Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. Bernstein, H. Robinson, C. Oct. 24, 2018.
8 CDC. ACIP Presentation – Recommended Adult Immunization Schedule, 2018. Hunter, P. Kim, D. Oct. 24, 2018.
9 CDC. ACIP Video Recording – October 2018 ACIP Meeting – Agency Updates & HPV. Nov. 14, 2018.
10 Hopkins RJ, Daczkowski NF et al. Randomized, Double Blind, Placebo Controlled, Safety and Immunogenicity Study of 4 Formulations of Anthrax Vaccine Adsorbed Plus CPG7909 (AV7909) in Health Adult Volunteers. Vaccine 2013; 31(30): 3051-3058.
11 Coherent Market Insights. CpG Oliogodeoxynucleotide Market. January 2019.
12 CDC. ACIP Meeting Presentations – Anthrax. Oct. 24, 2018.
13 Hackett DW. Anthrax Vaccine Stockpile is Reloading. Precision Vaccines Dec. 28, 2017.
14 CDC. ACIP Meeting Presentation – Preliminary Evidence to Recommendations for the ongoing review of the PCV 13 recommendation for adults >65 years old. Matanock, A. Oct 24, 2018.
15 CDC. ACIP Meeting Presentation – Background: Repeat Tdap vaccination. Havers, F. Oct. 25, 2018.
16 Sanofi Pasteur. ACIP Meeting Presentation - Study GRC88, Safety and Immunogenicity of Fluzone Quadrivalent Vaccine 0.5-mL Dose for Children 6 through 35 Months of Age. Mercer, M. Oct. 25, 2018.
17 CDC. Recommendations and Guidelines of the ACIP – General Best Practice Guidelines. Table 4.2. Sep. 14, 2018.
18 CDC. ACIP Video Recording – October 2018 ACIP Meeting – General Recommendations; Influenza; Rabies; Meningococcal; Pertussis. Nov. 14, 2018.
19 CDC. ACIP Video Recording – Japanese Encephalitis. Nov. 14, 2018.
20 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.
21 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.
22 Government Accountability Office (GAO). Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled Through Negotiation. U.S. Government Accountability Office Nov. 21, 2014.
23 Fisher BL, Williams K, Wrangham TK. NVIC response to an inquiry from the Government Accountability Office (GAO) on the implementation of the federal vaccine injury compensation program (VICP) after passage of the 1986 National Childhood Vaccine Injury Act. National Vaccine Information Center July 11, 2014.
24 HRSA. ACCV Certified Minutes. Pg 5. Jun. 4, 2015.
25 CDC. Intramuscular Influenza (Flu) Vaccination Infographic. Jun. 4, 2018.
26 Llamas, M. Shoulder Injury Related to Vaccine Administration: SIRVA. Drugwatch.
by Barbara Loe Fisher
On Jan. 16, 2019 the World Health Organization (WHO) issued a report ranking “vaccine hesitancy” as one of the top “Ten Threats to Global Health in 2019”, alongside air pollution and climate change; noncommunicable diseases; global influenza pandemic; antimicrobial resistance; and infectious diseases such as ebola, dengue fever and HIV.1 Throughout history, the greatest contributors to disease and early death in human populations have been poverty, poor sanitation and poor nutrition, 2 3 4 yet infectious diseases with pharmaceutical solutions dominated this list. And there was no mention of the major opioid addiction crisis crippling and killing tens of thousands of people in the U.S. and Europe, 5 6 or the iatrogenic medical error epidemic that every year claims more than 750,000 lives in Europe 7 and 250,000 lives in the U.S., where it is the third leading cause of death. 8
The immediate mainstream media response to the WHO’s announcement was to focus on “vaccine hesitancy.” On Jan. 19, the Editorial Board of the New York Times declared that “anti-vaxxers” are “the enemy” and called on the U.S. government to “get tough” by waging a “bold and aggressive” pro-vaccine campaign that includes “tightening restrictions around how much leeway states can grant families that want to skip essential vaccines.” 9 By Jan. 23, The Hill announced that Washington state had declared a state of emergency because of 23 cases of measles reported in an “anti-vaccination community” near Portland, Oregon,10 and there was a public call in the UK for social media platforms to “clamp down on fake news” and censor “misleading information and negative messaging around vaccination.” 11 12
The New York Times editorial headline “How to Inoculate Against Anti-Vaxxers” was a theme repeated in articles reacting to the WHO’s suggestion that people wanting to make informed, voluntary decisions about vaccination are a global menace. One doctor suggested that parents who don’t vaccinate their children are selfish: ”… it’s a matter of 'I don’t care about other people in the community, I only care about the health and welfare of my own child.’” 13
There was no discussion about institutionally acknowledged gaps in vaccine safety science 14 15 or the fact that most parents dutifully follow the advice of pediatricians and public health officials and only became vaccine safety critics after the risks of vaccination for their children turned out to be 100 percent.16 17 No discussion about the fact that since 2011, pharmaceutical companies have no liability for injuries and deaths caused by government recommended and mandated vaccines they sell in the U.S. 18 Instead, parents of vaccine injured children and others concerned about vaccine safety, who for decades have been asking government and industry to produce better quality vaccine science and more humane vaccine policies that respect genetic and biological diversity, were stereotyped as “anti-vaxxers” and demonized as a “threat” to public health.
The Editorial Board of The New York Times explained, “It’s no mystery how we got here. On the internet, anti-vaccine propaganda has outpaced pro-vaccine public health information.” Authoritatively, “the Board, its editor and the publisher” of The New York Times stated that, “Scientists, especially, are uncomfortable with black and white statements, because science is all about nuance. But, in the case of vaccines, there are some hard truths that deserve to be trumpeted. Vaccines are not toxic, and they do not cause autism. Full stop.”
There was no discussion about why people are legitimately concerned about vaccine ingredients 19 and Pharma paying the Food and Drug Administration (FDA) to fast track new vaccines to licensure without adequate testing. 20 No discussion about the fact that doctors are giving children 69 doses of 16 vaccines starting on the day of birth 21 – three times as many vaccinations as they got in 1983 - 22 and cannot explain why so many highly vaccinated children in the U.S. are sicker, not healthier today: 1 child in 6 learning disabled 23 and 1 in 40 with autism 24 and millions more suffering with asthma, diabetes, severe allergies, epilepsy, cancer, schizophrenia, depression and other chronic disease marked by chronic inflammation in the body. The CDC states that, “90 percent of the $3.3 trillion in annual health care expenditures are for people with chronic and mental health conditions.” 25 The largely unexplained chronic disease and disability epidemic in the U.S. is bankrupting the U.S. health care system and there is no research being funded to investigate the role that ever increasing numbers of vaccines given to infants, children and adults may be playing.
Multi-national pharmaceutical corporations 26 27 in command of a global 34 billion dollar vaccine market 28 29 are holding billion dollar contracts with mass communication companies 30 and public-private partnerships with governments to purchase vaccines and create vaccine marketing campaigns 31 32 33 34 that dwarf the relatively small number of websites and blogs labeled “anti-vax” simply for criticizing vaccine science and government policy. 35 Yet, there is no recognition by mainstream media articles of the fact that wealthy corporations and philanthropic foundations with political agendas, 36 37 well paid medical doctors, 38 39 40 and government health officials in charge of operating the vaccine system 41 are in privileged positions of power with a distinct advantage over ordinary people subjected to vaccine laws that place an unequal risk burden on individuals with genetic and biological susceptibility to suffering harm from vaccination. 42 43
“Bio-Populism” Blamed for Vaccine Hesitancy in Europe
In the UK, The Economist published an article entitled “The campaign against vaccination,” in which an anonymous author declared, “Across Europe, the rise of populism is damaging public health. A common feature is skepticism of vaccines.” 44 Pointing to Italy, Austria and France as hotbeds of political support for “parental choice” about vaccination, the author attempted to politically tie growing public support for vaccine choice to a fear of migrants and coined a new term: “bio-populism:”
“It is increasingly clear that Europe’s populists want for the body what they want for the nation: purity, unity and self-governance. Populist health policies mean citizens being free from outside influences – whether vaccines devised by doctors, regulations invented by politicians or diseases supposedly carried by migrants – and in control of their own epidemiology.”
He (or she?) went on to explain that bio-populism is a “combination of me-first libertarianism and anti-expertise herd mentality.” Quoting Italian medical professor Dr. Roberto Burioni, who has stated authoritatively that ”Vaccines are not an Opinion” and offered an explanation for “Why Science Can’t be Democratic,” The Economist article ended with a warning that, “At least one pandemic will probably sweep the interconnected world in the next decade. Viruses, after all, know no borders.”
There was no discussion of the fact that most parents and physicians calling for better quality vaccine science and informed consent protections in vaccine laws are ideologically diverse and do not all identify with one particular political party. In fact, a 2015 Pew Research Center survey revealed that age and parenthood had more to do with vaccine hesitancy, with young adults and parents with children under age 18 being less supportive of mandatory vaccination. 45
Vaccines, Autism, Erosion of Trust in Drug Companies & Doctors
In the U.S., Live Science trumpeted: “Anti-Vaccine Movement Joins Ebola, Drug Resistance on List of Top Global Threats.” 46 A doctor at Johns Hopkins Center for Health Security was quoted as saying the reason that noncommunicable diseases and not infectious diseases made the WHO’s top ten global threat list is “a testament to how powerful vaccines are.” Pointing to the jubilant public response to the release of polio vaccine in the 1950s, he commented, “We need to get back to that era when vaccines were celebrated the way a new iPhone is.”
The headline People Magazine chose was “World Health Organization Names Anti-Vaxxers As a Top Threat to Global Health in 2019.” 47 At the beginning of the article, the following statement appeared: “There is no scientific link between vaccines and autism, according to the Centers for Disease Control.” It ended with the statement “To tackle the rising levels of vaccine hesitancy, WHO plans to push forward with the goal of eliminating cervical cancer with greater application of HPV vaccine…”
U.S. News & World Report ran this headline: “WHO: Anti-Vaccine Movement a Top Threat in 2019.” 48 That author stated, “So-called anti-vaxxers refuse the required shots for their children on religious or philosophical grounds. An increase in unvaccinated children has, in part, been tied to the medically discredited belief that vaccines cause autism spectrum disorder.” Pointing out that a recent U.S. survey found that public trust in vaccination is on the decline, she added, “The heightened mistrust, researchers said, was especially prevalent in small pockets of people in insular communities or like-minded communities online.”
Pacific Standard asked “Are Anti-Vaxxers A Major Health Threat? The World Health Organization Says Yes.“ 49 This article included a quote from a pediatrician:
“The ongoing erosion of trust in the medical establishment as a whole is also to blame, as frequent reports of dubious financial relationships between physicians, professional medical societies, and the pharmaceutical industry leave many questioning whether or not physicians can be trusted. Unsure of what to do and whom to listen to, many seek answers to their questions elsewhere, or simply rely on their gut feeling…”
Salon created the most sensational headline that asked the foreboding question, “The anti-vaxxocalypse” What happens to humanity if vaccine hesitancy continues?” 50 The author explained to readers, “In other words, the anti-vaccination movement, which has inspired many in first-world countries to refuse or hesitate vaccination for easily-preventable diseases, is now a threat to global health and, ergo, stability.”
The exaggerated response to the WHO announcement by corporations owning mainstream media outlets has been curiously uniform. Often using identical talking points, perspective from parents and physicians in the U.S. and Europe rationally calling for reform of the vaccine policies and laws is left out. 51
The politics of vaccination is in full swing, but where is the money coming from to fund these vaccine marketing campaigns using name calling, threats, shaming and misinformation to demonize and call for discrimination against those who criticize vaccine science and government policy?
The World Health Organization (WHO) Marketing Vaccines
Immediately after World War II in 1945, the United Nations (UN) voted to establish a new international health organization. In 1948, the World Health Organization WHO) was founded by the UN after ratification by 26 members states and given a budget of $5M. WHO is a specialized agency of the UN headquartered in Geneva, Switzerland and is composed of six regional offices operating in different parts of the world, including the Pan American Health Organization (PAHO) located in Washington, D.C. Today, 194 members states of the United Nations are impacted by the activities of the WHO, which has a broad mandate to “act as the directing and coordinating authority on international health work.” 52
The WHO Constitution, revised in 2006, states that its objective “is the attainment by all peoples of the highest possible level of health” and health is defined as “a state of complete physical, mental and social well being and not merely the absence of disease or infirmity.” 53 The WHO Constitution also states that, “Informed opinion and active co-operation on the part of the public are of the utmost importance in the improvement of the health of the people.”
The top priorities of the WHO when it was founded seventy years ago were malaria, tuberculosis, venereal diseases, maternal and child health; sanitary engineering and nutrition. During the first 30 years of WHO’s operation, the UN agency spearheaded a global smallpox eradication campaign (1958-1980); prevention and control of yaws, endemic syphilis, leprosy, trachoma, cholera and yellow fever (1960s); fertility regulation and birth control (1970s) childhood vaccination programs (initiated 1974) and the institution of primary health care of all national health systems (initiated 1978). 54
Today, the WHO is the world’s largest and most influential public health agency with an annual budget for 2018-2019 of $4421.5M ($4.4 billion). 55 About 20 percent ($956.9M) of the WHO budget is funded by assessments on member states and the remaining 80 percent funded by “voluntary contributions.” The biggest individual programs funded by WHO are for polio eradication vaccine campaigns ($903M); vaccine campaigns for other communicable diseases ($805M); and corporate services/enabling functions ($715.5M).
Currently, the top 10 UN member state annual funders of WHO are the governments of United States of America ($125M); Japan ($49M); China ($40M); Germany ($33M); France ($27M); United Kingdom of Great Britain and Northern Ireland ($23M); Brazil ($19.5M); Italy ($19M); Canada ($15M); Australia ($12M). 56
The Bill & Melinda Gates Foundation is the largest non-state funder of the WHO, having donated more than $2B in earmarked grants to the international health agency since 1998, and is the second largest WHO funder overall (after the U.S. government). Because Gates Foundation grant money is earmarked for specific programs, such as vaccine purchase, delivery and promotion, the Gates Foundation significantly influences the setting of WHO’s program priorities. 57
In 2010, after a joint investigation by the British Medical Journal (BMJ) in collaboration with the London-based Bureau of Investigative Journalism, an article was published in the BMJ revealing that three key scientists, who influenced the WHO’s decision to declare a swine flu (H1N1) influenza pandemic in 2009 and recommend that all countries use and stockpile vaccines and pandemic flu drugs, had financial ties to pharmaceutical companies profiting from the WHO recommendations (GlaxoSmithKline and Roche). WHO was also criticized for lack of transparency for refusing to release the identities of the 16 members of an Emergency Committee formed in 2009 to guide pandemic policy. 58
The 2009 pandemic H1N1 vaccine, which was rushed to market to address a WHO declared pandemic that did not happen, triggered an autoimmune reaction in more than 1,300 people in Europe who got GSK’s Pandemrix vaccine and left them with narcolepsy, an incurable immune mediated neurological disorder. 59
Gavi, the Vaccine Alliance Marketing Vaccines
The WHO and the U.S. government are founding partners of Gavi, the Vaccine Alliance. In 2000, the Bill and Melinda Gates Foundation provided $750M in seed money to spearhead the creation of Gavi, a public-private partnership and multilateral funding mechanism involving the WHO, governments, the vaccine industry, the World Bank, philanthropic foundations and civil society groups to “improve access to new and underused vaccines for children living in the world’s poorest countries.” 60
Of the more than $15B raised by Gavi since 2000 to vaccinate the world’s children, U.S. government contributions have totaled $1.9B or 12 percent of all contributions received by Gavi. The United Kingdom has contributed $2.2B or 14 percent of Gavi’s total contributions. The single biggest funding source for Gavi is the Gates Foundation, which has donated more than $3B or 20 percent of Gavi’s total income. 61 Between 2000 and 2013, only about 10 percent of total funding provided by Gavi ($862M) was used to strengthen health systems in developing countries, such as improving sanitation and nutrition, while nearly 80 percent was used to purchase, deliver and promote vaccines. 62
Gavi is headquartered in Geneva with an office in Washington, D.C. that carries out day-to-day operations and one of Gavi’s core goals is to “shape markets for vaccines and other immunization products.”
In 2008, Gavi announced that five countries - Italy, Norway, Canada, the UK and Russia - had joined the Gates Foundation to pledge $1.5B in the Advance Market Commitments (AMC) to accelerate access to pneumococcal vaccines with donors providing up front funding commitments to support vaccine purchase and speed the introduction and use of vaccines in countries partnering with Gavi. Currently, the AMC incentivizes vaccine manufacturers to sign contracts to provide pneumococcal vaccine to developing countries at lower per dose prices and be reimbursed by Gavi funds. By March 2015, Pfizer and GlaxoSmithKline had received more than $1B from Gavi’s AMC funds. 63
CDC officials provide Gavi with technical support and guidance. In 2015, the U.S. Congress pledged to appropriate $1B to Gavi that was spread over four years (2015-2018). 64
On Oct. 16, 2018 at the World Health Summit in Berlin, Gavi CEO Dr. Seth Berkley announced that 11 heads of the world’s leading health and development organizations had signed a “landmark commitment” to find new ways to accelerate achieving goals of the United Nation’s Sustainable Development Goals created in 2015. The new Global Action Plan vaccine marketing initiative is being coordinated by the WHO. 65 Relating Sustainable Development Goals to vaccination of all the people in the world, Gavi states that: 66
- “immunization protects people from being forced into poverty by high out-of-pocket expenses;”
- “vaccines protect child health and support cognitive development, allowing children to perform better at school and have more opportunities;”
- “vaccinated healthy children grow into a productive workforce and become strong contributors to the economy, and healthy children free up parents’ time so they are able to work;”
- “vaccines are critical to building people’s resilience to and mitigating the risk of disease outbreaks tied to climate change…;” and
- “good health is a critical determinant of peace and well being in a society. People-centered health systems are core social institutions in every country, and immunisation is often the first point of contact between these systems and the population.”
In 2016, Dr. Berkley and other Gavi executives came under criticism in the UK in 2016 for taking excessively high salary packages. According to an investigative news report: 67 “Seth Berkley has taken home more than £2 million over the past four years as chief executive officer of Global Alliance for Vaccines and Immunisation (Gavi), which has been given £1.5 billion by Britain. Another official at the Geneva-based group collects a pay package of more than £500,000 a year. Incredibly, Dr. Berkley was given a housing allowance on top of his £623,370 pay package.”
In December 2018, Dr. Berkley told CNN that “while measles is one of the few diseases we could potentially eradicate, that will never happen if wealthy countries like the United States can't maintain herd immunity. Because a measles case anywhere is a threat everywhere.” He said parents in the U.S. are delaying their children’s vaccinations “perhaps because they believe in immunization but are worried by some of the anti-vaccine scaremongering. This needs to stop.” Echoing the idea that parents who don’t go along with the vaccine program are selfish, he added, “in countries like the United States we need to stop thinking about vaccination as something you only do to protect the ones you love, and instead view it also as a goodwill act for the benefit of others.” 68
According to the CDC, in 2017-2018 “vaccination coverage among kindergarteners remained high,” with 94 percent of children having received two doses of measles, mumps and rubella (MMR) vaccine; 4 or 5 doses of diphtheria, tetanus and pertussis (DTaP) vaccine and two doses of varicella zoster (chickenpox) vaccine (among many other vaccines required by states for school attendance). Two percent of kindergarteners had an exemption from one or more state required vaccines. 69
The Bill and Melinda Gates Foundation Marketing Vaccines
The Gates Foundation was established in 2000 by Microsoft Corporation founder Bill Gates and his wife, Melinda. 70 Headquartered in Seattle, Washington, the Gates Foundation is the largest philanthropic foundation in the world with a $43.5B trust that makes grant payments of more than $3B annually to advance the foundation’s goals for reforming education systems, such as institution of Common Core curriculum in all U.S. schools, 71 and funding public health initiatives, primarily global vaccination programs. 72 A major goal of the Gates Foundation is to make sure every child in the world is vaccinated. 73
Investor businessman Warren Buffet, who took control of textile manufacturer Berkshire Hathaway, Inc. in 1965 and went on to amass a personal fortune of more than $60B, pledged $31B and became a co-director of Gates Foundation in 2006. 74
In 1998, the same year that the U.S. Department of Justice filed an anti-trust lawsuit against Microsoft Corporation, 75 Bill and Melinda Gates committed $100M to create the Bill & Melinda Gates Children’s Vaccine Program. One purpose of that program was to establish an international consensus on vaccine use recommendations: “Efforts will be made to support international conferences and the development and dissemination of strong international consensus statements and recommendations for the use of the new vaccines.” 76
The homepage of the Gates Foundation proclaims ALL LIVES HAVE EQUAL VALUE and states:77
“We believe we can save lives by delivering the latest in science and technology to those with the greatest needs. We work with partners to provide effective vaccines, drugs and diagnostics and to develop innovative approaches to deliver health services to those who need it most. And we invest heavily in developing new vaccines to prevent infectious diseases that impose the greatest burden.”
In 2016, Global Justice Now published an investigative report, Gated Development: Is the Gates Foundation always a force for good? Authors were critical of the unchecked political power and influence on global health programs and agricultural policies of Bill Gates and the Bill and Melinda Gates Foundation (BMGF): 78
“To say that the BMGF has become an important actor in international development would be an understatement. When it comes to global health and agriculture policies, two of its key grant areas, the BMGF has become probably the most influential actor in the world. It is also likely that Bill Gates, who has regular access to world leaders and is in effect personally bankrolling hundreds of universities, international organisations, NGOs and media outlets, has become the single most influential voice in international development.”
“But the BMGF’s increasing global influence is not being subjected to democratic scrutiny. Unlike governments, which are formally accountable to their electorates, the BMGF is a private US foundation, and remains unaccountable to public bodies (except for tax reporting purposes). Even worse, the BMGF appears to have bought the silence of academics, NGOs and the media who might otherwise be expected to criticize aspects of the foundation’s work.”
Money Makes the World Go Around
Congress appropriated nearly $90B to the U.S. Department of Health and Human Services in 2018 and the biggest line item in the CDC’s $11B budget was the Vaccines for Children program (VFC) ($4.5B), which was created by Congress in 1993. 79 Under the VFC program, the federal government purchases CDC recommended vaccines from vaccine manufacturers to administer to children who are on Medicaid, are uninsured or whose health insurance plans do not fully cover CDC recommended vaccines. 80 81 Hundreds of millions of dollars are additionally allocated in the HHS budget for vaccination programs, including $700M for the National Center for Immunization and Respiratory Diseases.
One of the most politically powerful public-private partnerships in the world today is the lucrative one that has been forged by the pharmaceutical industry with government, 82 83 84 85 86 mainstream media 87 and wealthy philanthropic foundations with political agendas. 88 89
In the past decade, these public private partnerships have come under scrutiny by public policy analysts. In 2015, authors of a special report published by the Global Policy Forum observed: 90
“However, it is not only “big business” but also “big philanthropy” that has an increasing influence in global development policy, particularly large philanthropic foundations. The scope of their influence in both past and present discourse and decision-making processes is fully equal, and in some cases goes beyond that of other private actors. Through the sheer size of their grant-making, personal networking and active advocacy, large global foundations, most notably the Rockefeller Foundation and the Bill & Melinda Gates Foundation have played an increasingly active role in shaping the agenda-setting and funding priorities of international organizations and governments.”
For example, the Gates Foundation has given Johns Hopkins more than $100M in research grants since 2015, including for vaccine development and promotion. 91 At the same time, Johns Hopkins University receives more than $2B per year in funding from U.S. government agencies, such as the National Institutes of Health (NIH) and the National Science Foundation (NSF), to conduct research, including for vaccine development and vaccine use promotion. 92
The National Institutes of Health (NIH) and other federal health agencies give millions of dollars in taxpayer dollars to academic institutions and vaccine manufacturers to improve vaccine technology, find new lucrative vaccine markets, and boost vaccine marketability. 93 The U.S. government also partners with the Gates Foundation to develop and promote vaccine use.
For example, in 2013, the CDC Foundation received three grants totaling $13.5M from the Gates Foundation to globally “advance the implementation” of meningitis and rotavirus vaccine programs. 94 The Centers for Disease Control and the CDC Foundation have received more than $167M from the Gates Foundation. 95 Vaccine manufacturers have also received millions of dollars in grants from the Gates Foundation, including GlaxoSmithKline (over $50M); 96 Merck $1.4M; 97 Pfizer $16.5M; 98 and Sanofi Pasteur $3.6M. 99
Big Media: Under the Influence
Mass media corporations are also under the influence of Big Pharma and Big Philanthropy money. For example, National Public Radio has received $20M in grants 100 and Solutions Journalism Network has received $4M 101 in grants from the Gates Foundation. Recently, Gates’ Microsoft Corporation partnered with NewsGuard Technologies, Inc.,102 103 a new corporation that is rating websites and online publications to “fight false news, misinformation and disinformation.” 104 105 106 The NewsGuard corporation is also collaborating with other corporations, such as Google, 107 108 which owns over 90 percent of the Internet search market.109
One of the biggest investors in NewsGuard is Publicis, the oldest advertising company in the world and the third largest mass communications company today. 110 Publicis is paid billions of dollars by pharmaceutical companies to market vaccines,111 including a $1.5B media contract with GlaxoSmithKline.112 PDI, a Publicis health company states: 113
“Vaccination coverage in the United State is high, but in the face of the resurgence of vaccine-preventable diseases such as pertussis and measles, the existing gaps in the vaccination coverage of the US population have become worrisome. Gaps exist because not every patient who needs a vaccination gets it at the recommended age. Moreover, the recommendations for new vaccines, including vaccines for influenza and human papillomavirus (HPV), have been expanded...
PDI’s field-based medical sales representatives and inside medical sales representatives from our healthcare contact center can increase adoption of vaccines by responding to questions and concerns...To increase immunization rates, we must build sustainable systems for vaccination within the context of a changing healthcare system. Here some recommended steps toward achieving this goal: assessment of the actual vaccination rate in a provider’s practice; consistently making recommendations for timely vaccinations to both the parents of pediatric patients and adult patients; standing orders for non-physician personnel to carry out vaccinations at the scheduled time without physician involvement; educating physicians on emerging research of vaccine risks, and on how to interact with parents who are concerned about the detrimental effects of the MMR and HPV vaccines; and educating physicians about state-sponsored and other programs that can help patients overcome financial barriers to vaccination.”
It is clear that mass media communications today is being controlled by corporations financially tied to pharmaceutical companies and influenced by powerful political institutions in society. It goes a long way to explaining why mainstream media outlets have been united in attacking parents and physicians who defend the ethical principle of informed consent, including informed consent to vaccination, and are calling for vaccine exemptions to be severely restricted or eliminated. 114
The five largest companies in the world today are Apple, Google, Microsoft, Amazon and Facebook. 115 These and other technology corporations dominate online communications and sales and are positioned to join together to aggressively market vaccines and promote “no exceptions” vaccine use policies endorsed by the WHO and governments. The threat to autonomy and freedom of thought and speech posed by these companies, especially in censoring online public conversations about vaccination and health, is considerable.116 117
The People are Not Represented
Today, everybody knows somebody who was healthy, got vaccinated and was never healthy again. The people, whose lives are being impacted by business deals between governments, Big Pharma and Big Philanthropy, increasingly are being marginalized in the top down public policymaking process by wealthy and powerful institutions in society financing the global multi-billion dollar vaccine industry.118 This is evident when the people raise their voices to ask for better vaccine science and more humane public health policies and are demonized, discriminated against and punished by those in control of those wealthy and powerful institutions.
A system that will not bend will break. The responsibility for the crisis of trust in the global vaccination system lies squarely at the feet of those who operate the system and refuse to acknowledge the suffering of the people harmed by vaccines. 119 120
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