World Health Organization Cover Up Over Four MMR Vaccine Deaths In SAMOA Exposed
NEW YORK TO REQUIRE FLU SHOTS FOR PRESCHOOLERS; CALIFORNIA MOVES TO ELIMINATE VACCINE EXEMPTIONS FOR THE POOR ON WELFARE
BY JOSEPH MERCOLA, DO
SEE: https://thevaccinereaction.org/2018/07/new-york-to-require-flu-shots-for-preschoolers-california-moves-to-eliminate-vaccine-exemptions-for-the-poor/; republished below in full unedited for informational, educational and research purposes:
Recent events again highlight the need for Americans to stand up for their right to know, and freedom to choose when it comes to medical risk-taking. The New York Court of Appeals not only has given the nod of approval to New York City’s health department requirement that all preschoolers must get annual flu shots, but the California legislature is also moving toward eliminating the personal belief vaccine exemption for families on welfare.
Aside from the loss of the human right to informed consent to medical risk-taking, these decisions are all the more incomprehensible considering the lack of scientific evidence supporting the safety and effectiveness of annual flu vaccination from cradle to grave and one-size-fits-all vaccination policies and laws. Again and again, we see vaccine policy built on lobbying dollars without real concern for human health and welfare.
Informed Consent to Medical Risk Taking Is a Basic Human Right
As noted by National Vaccine Information Center (NVIC) president Barbara Loe Fisher in her Independence Day commentary on zero tolerance vaccine laws,1 “Today, we are witnessing the erosion of core values that our constitutional democracy was founded upon. One example is a public campaign led by the medical establishment to demonize and discriminate against anyone opposing zero tolerance vaccine laws that violate human rights in the name of public health.”
Informed consent is a basic human right in which a person has the ability to voluntarily accept or reject a treatment or medical procedure, including use of pharmaceutical products, after being fully informed of all possible risks and benefits. According to the University of Washington School of Medicine,2 “The most important goal of informed consent is that the patient has an opportunity to be an informed participant in her health care decisions.”
It’s a simple enough premise, but throughout history we’ve seen cases where informed consent was not only challenged but completely ignored, and this trend not only exists to this day, it has flourished in recent years, with cities, states and federal government pushing for mandatory vaccine laws with no ability to opt out. As noted by Fisher:3
There are only two laws that require American citizens to risk their lives. The first is a federal law, the military draft, which requires all healthy male adults to risk their lives in a war declared by the government to protect national security. The second is a state law requiring all healthy children to risk their lives in a war that doctors declared on microbes two centuries ago.
However, unlike adults who are NOT punished for following their conscience and refusing to fight in a war to protect national security, parents CAN be punished for following their conscience and refusing to risk their children’s lives in a war to theoretically protect the public health.
State sanctions include segregation and loss of the unvaccinated child’s right to a school education or permitting pediatricians to deny medical care to children if their parents refuse one or more government recommended vaccinations.
Two different laws that require healthy Americans to risk injury or death: one conscripting adults in what government clearly defines as an emergency military action; and the other conscripting children in a mandatory vaccination program that is not defined as an emergency military action but is operated like one.
New York City Gets Green Light to Require Annual Flu Vaccinations for Preschoolers
Case in point, June 28, 2018, the New York Court of Appeals unanimously ruled the New York City health department has the right to require flu vaccination for preschoolers. The requirement was initiated in 2013 by city public health officials.
Five families sued the health department in 2015 to have the requirement overturned and two lower court rulings agreed the city had overstepped its legal authority. This final decision by the Court of Appeals now cements the city’s legal right to require flu shots for children aged 6 to 59 months before they’re permitted to attend child care or preschool. In the decision, Judge Leslie Stein wrote:4
Undisputedly, there is a very direct connection between the flu vaccine rules and the preservation of health and safety. The rules challenged here do not relate merely to a personal choice about an individual’s own health but, rather, seek to ensure increased public safety and health for the citizenry by reducing the prevalence and spread of a contagious infectious disease within a particularly vulnerable population.
In response to the decision, New York City health commissioner Mary Bassett said:5
Vaccines save lives and are an effective public health tool to prevent the spread of disease. The severity of this past influenza season reminds us of how deadly influenza can be. The influenza vaccine is the best protection against seasonal influenza for everyone.
Children who receive the influenza vaccine are less likely to get sick, less likely to need medical attention and less likely to die from influenza. This decision will help us protect more than 150,000 children in city-regulated day cares and preschools across the city.
‘Vaccine-Before-Welfare’ Bill Moves Forward in California
Meanwhile, the California state Senate Committee on Human Services passed AB 19926 June 26—a controversial bill that eliminates the personal belief vaccine exemption for families on welfare. Already, welfare recipients are required by state law to be up to date on all government mandated vaccines or lose a portion of their welfare benefits.
AB 1992, authored by Assemblyman Kansen Chu, improves access to the California Work Opportunity and Responsibility to Kids (CalWORKS) program — a public assistance program that provides financial aid and services — for families whose children are not fully vaccinated or have difficulty proving that their children have received the required vaccinations.
Estimates suggest 4,000 families in California are not meeting the vaccine requirement for public assistance, and this bill would give families who want to vaccinate their children greater access to vaccination services.
The bill also lowers the monthly penalty for not being fully vaccinated from $130 to $50, extends the time that families have to produce vaccination records from 45 days to six months, and grants county welfare workers access to medical databases to determine whether the child has received the required vaccines in cases where parents cannot produce the records.
However, the bill also eliminates the personal belief exemption, which means welfare recipients would no longer have the legal right or ability to opt out of vaccine requirements. Candace Connelly testified before the committee, saying “her choice not to vaccinate her children shouldn’t preclude her from receiving benefits.”
According to a report by GV Wire,7 Connelly “objected to the 72 doses required in a child’s lifetime, noting the potential for vaccine injury. ‘Surely if parents have rights, one of them is to decide what gets injected into their children … I don’t believe I should have money taken out of my benefits because I don’t think that is a safe thing for my child.'”
AB 1992 Moves to Senate Appropriations Committee
Chu’s reasoning for including this provision in his bill is that the personal belief exemption from vaccines to attend public and private school was already removed by SB 277 in 2015.8 According to Chu, removing the personal belief vaccine exemption for welfare recipients simply makes the bill “comply with current law.”9 Sen. Janet Nguyen objected to the removal of the personal belief exemption.10
Sen. Connie Leyva also objected, saying “I believe requiring proof of vaccinations in order for someone to receive their benefits is unfair and unnecessary. We should not be basing it off their need, and not off of vaccinations.” Stefanie Fetzer, an advocate with Parents United 4 Kids, also commented:11
This is NOT a public health issue. Vaccination rates are high. There is no crisis mitigating such a heavy handed, totalitarian piece of legislation. Our legislators are testing the water. How far can they go? Can they withhold a parents’ ability to feed their children if the parents are unwilling to ignore their religious or personal convictions? Why are our legislators targeting this poor, minority community?
Fisher, on behalf of the NVIC, has also spoken out against the bill, saying,12 “It is cruel to withhold welfare benefits from families in need. NVIC opposes AB 1992 and any legislation that threatens Americans with punishment for making voluntary vaccine decisions for themselves or their children.”
Despite objections, the bill passed 4-0 out of the Senate Committee on Human Services. Leyva did not vote and Nguyen was not present during the voting; the remaining committee members, Scott Wiener, Steven Glazer, Mike McGuire and Anthony Portantino, voted in favor. A seventh member, Tom Berryhill also was not present. Next, AB 1992 will be reviewed by the Assembly Appropriations Committee.
Why the Lack of Concern for Vaccine Safety?
In a series of articles, the World Mercury Project questions the apparent disinterest of the American Academy of Pediatrics (AAP) and the Immunization Action Coalition (IAC) in improving vaccine safety, choosing instead to engage in smear campaigns against anyone who questions the conventional dogma and who counters false vaccine safety claims with scientific facts:13
“In the face of snowballing vaccine scandals—from fudged safety trials that use other vaccines as placebos, to persistent use of neurotoxic aluminum adjuvants, to the accelerated rollout of unproven vaccines that may be causing more problems than they solve—these and other vaccine advocacy organizations are not only turning a blind eye but are … beefing up public relations (PR) intended to stifle discussion …
Due to the well-funded medical-pharmaceutical-media apparatus that endlessly repeat the mantra that ALL vaccines are safe for ALL people ALL the time, it is nearly impossible to get a fair hearing for common-sense questions about vaccine safety, no matter how urgent such questions may be.”
In addition to the AAP and IAC, the World Mercury Project also singles out three organizations that are closely allied with AAP, all of which “frame their aims in terms of cementing vaccine infrastructure and funding,” according to the featured article:
- The 317 Coalition, whose members include vaccine manufacturers. The coalition’s focus is to increase funding to Section 317 of the Public Health Service Act, the law that governs federal purchases of vaccines. Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and co-inventor of a rotavirus vaccine, is on the steering committee, as are the executive director and chief strategy officer of the IAC
- Every Child by Two (ECBT), which promotes the mandatory use of vaccines to state and federal legislators, supports the elimination of all personal belief vaccine exemptions and generates “vaccine safety talking points.” Here, Offit is on the board of directors
- The Adult Vaccine Access Coalition, the focus of which is to lobby for “necessary federal policy changes” to boost adult vaccination rates
According to the World Mercury Project,14 ” … [T]he AAP, IAC and … ECBT are among the leading actors propagating misleading assertions about vaccine safety. All three are also actively lobbying legislators to effectively jettison informed consent in favor of mandatory vaccines.”
Leading Vaccine Educators Are Bound by Conflicts of Interest
The AAP, IAC and ECBT were also the focus of an investigative report into the partnerships between the CDC and non-profits promoting vaccines15 published in the British Medical Journallate last year. In the paper, “The Unofficial Vaccine Educators: Are CDC Funded Non-Profits Sufficiently Independent?” BMJ associate editor Peter Doshi wrote:
[S]urvey data have documented that parental concerns over vaccination safety and timing are common, even among those whose children receive all recommended vaccines.
In 2015, a U.S. federal advisory committee warned that public confidence in vaccines cannot be taken for granted, and some prominent vaccine advocacy organizations are pushing for greater compulsion. But are these groups—which present themselves as reliable sources of information — providing the public with independent information?
The AAP, IAC and ECBT all receive funding from the U.S. Centers for Disease Control and Prevention (CDC) and vaccine manufacturers. AAP is also on the CDC’s Advisory Committee on Immunization Practices, which determines which vaccines should be added to the childhood and adult vaccine schedules.
At the same time, these three nonprofits are also actively lobbying for legislation aimed at removing religious and conscientious belief vaccine exemptions from state vaccine laws, which has been successful in some states like California.
This, despite the fact that federal law prohibits nonprofit organizations from using CDC or other federal agency money for lobbying efforts. According to Doshi, it’s unclear whether the CDC’s relationship with these three organizations has crossed into illegal territory, as he could not determine exactly how much money was received from the CDC and vaccine makers respectively.
But, as noted by World Mercury Project, “It is clear that when these … nonprofits receive grant money from CDC, those grants free up other monies for lobbying purposes.”
Doshi also notes that “These groups are so strongly pro-vaccination that the public is getting a one-sided message that all vaccines are created equal … regardless of the circumstances.” What’s more, their inherent bias and financial ties with the CDC and vaccine manufacturers completely undermine their ability to appraise CDC vaccine recommendations.
As it stands, there’s no one to counter and cross-check those recommendations because everyone involved is on the same pro-vaccine team. The drug companies manufacturing and selling vaccines have no incentive to look at safety issues either, as this would merely cut into profits and undermine the partial product liability shield given to them by the U.S. Congress in 1986 and the total immunity from vaccine injury lawsuits handed to them by the U.S. Supreme Court in 2011.
Besides, 9 out of 10 of the world’s leading drug companies spend far more money on marketing their drugs and vaccines than they do on research and development.16
Note: This article, which is excerpted from an article written by Dr. Mercola and originally published on www.mercola.com, was reprinted with the author’s permission.
References:
2 Washington School of Medicine, Informed Consent.
3 See Footnote 1.
4 Daily News June 28, 2018.
5 Ibid.
6 AB 1992 Fact Sheet February 13, 2013 (PDF).
7 GVwire.com June 28, 2018.
8 SB-277 Public Health: Vaccinations.
9 See Footnote 7.
10 Ibid.
11 GVwire.com June 25, 2018.
12 Ibid.
13 World Mercury Project December 20, 2017
14 World Mercury Project December 27, 2017.
15 BMJ 2017;359:j5104.
16 Washington Post February 11, 2015.
3 See Footnote 1.
4 Daily News June 28, 2018.
5 Ibid.
6 AB 1992 Fact Sheet February 13, 2013 (PDF).
7 GVwire.com June 28, 2018.
8 SB-277 Public Health: Vaccinations.
9 See Footnote 7.
10 Ibid.
11 GVwire.com June 25, 2018.
12 Ibid.
13 World Mercury Project December 20, 2017
14 World Mercury Project December 27, 2017.
15 BMJ 2017;359:j5104.
16 Washington Post February 11, 2015.
_____________________________________________________
FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns
BY Rishma Parpia
SEE: https://thevaccinereaction.org/2018/08/fda-licenses-new-hepatitis-b-vaccine-despite-big-safety-concerns/; republished below in full unedited for informational, educational and research purposes:
In February 2018, the Advisory Committee on Immunizations Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) approved the recommendation for a new hepatitis B vaccine, Heplisav-B (HepB-CpG) targeting for adults over the age of 18.1 Heplisav-B is manufactured by Dynavax Technologies Corp. and the new vaccine is given in a two-dose series versus the three dose recommendation for Merck’s Recombivax hepatitis B vaccine licensed in 1986 and Glaxo Smith Kline’s Engerix-B vaccine licensed in 1989.
The U.S. Food and Drug Administration (FDA) had twice rejected Dynavax’s application for licensure for Heplisav-B in the past four years because of safety signals.2 In Dynavax’s third attempt, the FDA granted the license in November 2017, despite unresolved safety concerns. Below is the sequence of events leading to licensure of Heplisav-B.
In 2013, the FDA rejected Dynavax’s license application for Heplisav-B for the first time due to the regulatory agency’s concern that the experimental vaccine’s new adjuvant, which was designed to boost immunogenicity, could lead to development of autoimmune disorders.3
Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules.4
Hepatitis B vaccines previously licensed in the U.S contain alum adjuvants (aluminum salts), which stimulate a general inflammatory response.3 CpG 1018 is believed to stimulate a more specific inflammatory response by producing hepatitis B surface antigen-specific antibodies against the hepatitis B virus.3
According to an article published in Medscape, the first application by Dynavax Technologies for licensure of Heplisav-B vaccine was rejected by the FDA for the following reason:
Although safety analyses showed no statistically significant differences between Heplisav and the currently licensed hepatitis B vaccine Engerix-B (GlaxoSmithKline) in local and systemic solicited adverse events or deaths, there were numerically greater numbers of patients receiving Heplisav who had evidence of autoimmunity disorders, including thyroid disorders. The increases were not statistically significant, but advisory panel members said the safety database was too small to detect rare adverse events.3
At the time, Melinda Wharton, Deputy Director of the National Center for Immunization and Respiratory Diseases at the CDC stated, “I don’t think the safety database is sufficiently large to support a recommendation for use in the general adult population, given that this vaccine contains a new adjuvant.”3
In 2016, the FDA rejected a second application by Dynavax for licensure for Heplisav-B vaccine. That time the agency was concerned about an increased rate of cardiovascular events and deaths in people who had been given Heplisav-B vaccine versus Engerix-B.5
In a randomized clinical trial involving approximately 8,400 subjects, 5,600 study participants received Heplisav-B and 2,800 participants received Engerix-B.6 7 During the trial, approximately 14 subjects in the Heplisav-B group had heart attacks in comparison to one subject in the Engerix-B group.6 7 Taking into account that the Heplisav-B group was twice as large as the Engerix-B group, the risk for heart attacks was seven times higher for people who had been given the experimental vaccine.6
In an attempt to minimize the significance of the increased rate of serious heart complications, Dynavax argued that the higher number heart attacks recorded in the Heplisav-B group was due to the “fewer than expected” instances that occurred with the Engerix-B group.8
According to a press release by Dynavax in 2016:
The FDA’s Complete Response Letter (CRL) seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.9
In July 2017, the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) convened to re-evaluate the scientific evidence and make a decision on whether Heplisav B should or should not be approved for use in the U.S.6 A majority of the committee consisted of immunology and infectious disease professionals with only one cardiologist on the team, Milton Packer, MD, who is a Distinguished Scholar in Cardiovascular Science at the Baylor University Medical Center in Dallas, Texas.6
According to Dr. Packer, it was possible the strong inflammatory response induced by the Heplisav B vaccine’s novel adjuvant was causally related to the higher number of heart attacks in study participants who received the experimental vaccine. He said:
The advisory committee needed to consider whether it was biologically plausible for the new vaccine to cause heart attacks. The new adjuvant in the vaccine caused an inflammatory response of uncertain duration. We know that inflammation causes atherosclerotic plaques in coronary arteries to rupture—the event that triggers most heart attacks. So a causal link between the vaccine and heart attacks wasn’t out of the question. Most importantly, we needed to decide if the imbalance in heart attacks between the two groups could have been due to the play of chance. That was a great question, but one that was impossible to answer.6
Dr. Packer goes on to explain:
To know if the 7 -1 heart attack imbalance represented a real risk, we’d need comparative data in 50,000 people. The fastest way of obtaining that evidence would be through a post-marketing trial. But a post-marketing trial would be possible only if the vaccine was approved for public use.6
The FDA asked the committee to vote on whether there was reasonable evidence that Heplisav-B vaccine is safe. Twelve committee members voted in favor of the safety of the new vaccine, one voted against it and three abstained.6 Dr. Packer was one of those who abstained.6
Dr. Packer explains why he abstained:
Why did I abstain? Based on the available data, it was impossible for anyone to know if the increase in heart attack risk in the Dynavax group was real or spurious. So although the questions were fascinating and the discussions terrific, my vote wasn’t that complicated. There is a simple rule in life: if you don’t know, you should say you don’t know.6
Following the meeting, the FDA requested more information from Dynavax on its post-marketing study.6 Four months later, in November 2017, the FDA licensed Heplisav-B for use in the U.S, by adults over age 18. However, continued approval hinges on a post-marketing study that will compare health outcome results from people who have received Heplisav-B with those who have received Engerix-B.2
On the FDA website, the agency claims that “FDA regulations for the development of vaccines ensure their safety, purity, potency, and effectiveness.”10
However, the fact that Heplisav-B vaccine was approved for public use despite clear evidence in pre-licensure clinical trials that the new vaccine is associated with the development of autoimmunity, heart attacks and death calls into question the FDA’s commitment to adhering to its own regulations.
References:
1 Centers for Disease Control and Prevention. Heplisav-B (HepB-CpG). CDC.gov Apr. 28, 2018.
2 Lowes R. Heplisav-B Vaccine for Hep B Finally Wins FDA Approval. Medscape Nov. 10, 2017.3 Tucker M. FDA Rejects Novel Hepatitis B Vaccine. Medscape Feb. 23, 2013.4 Dynavax Technologies Corp. Heplisav-B. FDA.gov 2017.5 National Vaccine Support Group. Heplisav Hep B Vaccine Linked to Heart Attacks, Deaths.6 Packer M. Is the new Dynavax hepatitis vaccine safe? I couldn’t tell — and I was advising the FDA. StatNews Aug. 4, 2017.7 Food and Drug Administration. FDA Advisory Committee Briefing Document – Heplisav-B. FDA.gov July 28, 2017.8 Clarke T. Dynavax hepatitis B vaccine works; raises safety issues: FDA. Reuters July 26, 2017.9 Dynavax Innovative Immunology. Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B. Dynavax Nov. 14. 2016.10 FDA. Ensuring the Safety of Vaccines in the United States. July 2011.
2 Lowes R. Heplisav-B Vaccine for Hep B Finally Wins FDA Approval. Medscape Nov. 10, 2017.3 Tucker M. FDA Rejects Novel Hepatitis B Vaccine. Medscape Feb. 23, 2013.4 Dynavax Technologies Corp. Heplisav-B. FDA.gov 2017.5 National Vaccine Support Group. Heplisav Hep B Vaccine Linked to Heart Attacks, Deaths.6 Packer M. Is the new Dynavax hepatitis vaccine safe? I couldn’t tell — and I was advising the FDA. StatNews Aug. 4, 2017.7 Food and Drug Administration. FDA Advisory Committee Briefing Document – Heplisav-B. FDA.gov July 28, 2017.8 Clarke T. Dynavax hepatitis B vaccine works; raises safety issues: FDA. Reuters July 26, 2017.9 Dynavax Innovative Immunology. Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B. Dynavax Nov. 14. 2016.10 FDA. Ensuring the Safety of Vaccines in the United States. July 2011.
