THE CHURCH MILITANT
Ephesians 5:11-"And have no fellowship with the unfruitful works of darkness, but rather expose them". This Christian News Blog maintains a one stop resource of current news and reports of its own related to church, moral, spiritual, and related political issues, plus articles, and postings from other online discernment ministries, and media which share the aims to obey the biblical commands to shed light on and refute error, heresy, apostasy, cults, and spiritual abuse.
Robert discussed The Torture of Tommy Robinson, shedding disturbing light on how British jailers abused a courageous whistleblower on Muslim rape gangs.
Earlier this year, Clare Lopez, vice president for research and analysis at the Center for Security Policy, reported that Gulftainer seeks to acquire cargo container terminal leases for dozens of other ports in the United States. Her alarming statement is holding true.
In a unanimous vote, the board of directors of Diamond State Port Corporation moved forward with preparations for a 50-year lease of the Port of Wilmington (Delaware) to GT USA Wilmington, a subsidiary of Gulftainer, on April 6, 2018. Gulftainer has already acquired a 35-year lease in Port Canaveral, Florida, as reported by investigative journalists Mary Fanning and Alan Jones.
In their first occasional paper, Gulftainer’s co-ownership between the Emir of Sharjah, United Arab Emirates (UAE), and the brother of Jafar Dhia Jafar, Saddam Hussein’s top nuclear scientist, is revealed. In their second report, they expose a joint venture between Gulftainer and a Russian company that produces a cruise missile launch system called the Club-K – which appears identical to a standard 40-foot shipping container on the exterior. This is immensely disturbing, as “we are only able to scan less than one percent of the incoming containers,” according to Van Hipp in The New Terrorism and How to Defeat It.
Inside any one of the 3,000 containers a ship could transport into our country, is there potential for a Trojan horse operation? The answer is yes. There’s always a chance one could find four or more cruise missiles armed with biological, chemical, electromagnetic pulse (EMP), nuclear, or conventional payloads. Lopez asserts that “you would never know the difference between the Russian Club-K container cruise missile launch system and an ordinary standard ocean container. They look exactly alike.”
With a new lease on the way in a Delaware port, Gulftainer is said to have gone through a vetting process performed by multiple federal Cabinet departments and federal agencies. The corporation’s CEO, Peter Richards, claims that the deal is not a threat to national security, nor does it have any ties to Russia.
Similarly, the trepidation of Gulftainer’s ties to the United Arab Emirates were addressed by Richards. He said, “I object to people lying about us. I can’t believe people can be so simple-minded to believe the trash out there.”
Dr. Joseph King, a former U.S. Customs special agent and supervisor for 33 years, believes otherwise. “To imply that it’s not a national security threat is not the least bit believable,” says King. “If you’ve been to the ports, the operators are the ones who control everything. It’s a myth to believe the government is there to enforce or control anything. It’s ridiculous.”
He goes on to say “It’s a fallacy to think Customs and the Coast Guard are shoulder to shoulder at the front line, stopping and checking everything coming into the country. It’s easily detectable. Look at the amount of illegal aliens that come into the country. Look at the amount of heroin and cocaine that comes into this country.” He notes how the U.S. has spent billions of dollars trying to fight illegal immigration and drug-trafficking, yet we still haven’t been able to come even remotely close to preventing either problem.
If we can’t keep illegal immigrants and shipments of drugs from entering our country at rampant rates, are the American people supposed to believe we are capable of keeping out a 40-foot container housing hidden cruise missiles that can be deployed domestically or simply be held somewhere until one of our enemies decides to use it?
It makes sense that the person who does the hiring is the one who controls the port. One of his responsibilities is hiring the I.T. people, for example. This includes those who actually set up the I.T. system. King says a certain number of foreign workers can be “brought in on H-1 visas – and be put in control.” It raises the question: can we always trust this process?
King continues, “The fact of the matter is that you can bring in anything you want. It can be controlled however you want if you’re the operator. You can take a seal off the 40-foot container and replace it with another seal. You can take a document number and change it around. You can change a container from foreign to domestic. Customs wouldn’t even take a second look at it. This could include anything you want, whether it’s drugs, guns, people, or nuclear bombs. The supply chain is ultimately controlled by the operator of the port, not by a U.S. government official or an American corporation.”
Apart from the Trojan horse possibilities that could wreak havoc in our country, the other end of the spectrum deals with intelligence-gathering. Both the port in Florida and the port in Delaware are ideal places for intelligence-gathering, human and electronic, according to King. “Regardless of whether it’s being used to bring in humans or nuclear weapons,” King concludes, “both are great places to be used as bases for intelligence operations.”
Before it’s too late, it’s time for our congressmen and our federal Cabinet departments and agencies to seriously consider and address all the possibilities. The facts are beyond dispute. There is an association among Gulftainer, Russia, and the potential for nuclear weapons entering the country unbeknownst to the American people. Undoubtedly, there are many around the world who would love to bring America to her knees by taking advantage of the smallest crack in the system, so let’s sure up our ports and not give them an avenue to do so.
“Human life begins at conception and to destroy a human embryo means impeding the birth of a human being”, Argentinian Academy of Medicine says in a statement. AUTHOR Evangelical Focus BUENOS AIRES 03 AUGUST 2018 16:55 h GMT+1
Argentinian doctors in one of the protests.
Hundreds of Argentinian doctors recently took the streets to protest against the abortion Bill that passed the lower house in June and will be debated on August 8. During the protests, many doctors held signs with the message, “I’m a doctor, not a murderer”. Some said they would rather go to jail than kill unborn babies in abortions. “How far are we willing to go to? Jail”, said Ernesto Beruti, chief of obstetrics at the Austral University Hospital. Even if the law is passed, “I’m not going to eliminate the life of a human being. The most important right is the right to live”, he added.
LEGAL ABORTION AT 14 WEEKS
Abortion is forbidden in Argentina, except in cases of rape, severe disabilities or threats to the mother’s life. However, the Bill proposes to legalize abortions for any reason up to 14 weeks of pregnancy, arguing that the measure will reduce women’s deaths. About 300 private and public hospitals across the country have shown their opposition to the legislation. Private hospitals denounce that the law would not allow them to opt out of performing abortions. Although individual doctors might be able to opt out, other confusing aspects of the law could make them vulnerable to prosecution and persecution for their beliefs. “Doctors can't work under the threat of prison time”, said Maria de los Angeles Carmona, Head of gynecology at the Eva Peron public Hospital.
MEDICAL INSTITUTIONS AGAINST THE BILL
Argentina's Federation of Gynecology and Obstetrics Societies issued a statement, expressing concern that “doctors who refuse to perform abortions on moral grounds might suffer professional discrimination”. Additionally, objectors would have to register, and they are worried that could be used to “blacklist” them at hospitals. The highly respected Argentinian Academy of Medicine is also against the Bill: “human life begins at conception and to destroy a human embryo means impeding the birth of a human being”, the pointed out in a statement. “Nothing good can come when society chooses death as a solution”, the Academy said.
LATE TERM ABORTIONS
Opponents also warn it could open the way to widespread late term abortions, because it waives the 14-week limit in cases of rape or when a woman's health is at stake. If the Bill is approved, Argentina will be the first nation to legalize abortion since a historic vote in Ireland to overturn its Eighth Amendment, which provided legal protections for unborn children. It would be one of the only nations in South America with legalized abortion on demand. ______________________________________________________________ UPDATE AUGUST 9, 2018:
There was anguish among many activists when the result was announced Supporters say dangerous abortions have killed thousands in the country - but politicians have voted against changing the law.
Protesters have lit fires and thrown bottles at police after Argentina's senate rejected a bill to legalize abortion in the first 14 weeks of pregnancy.
Thousands of pro and anti-abortion protesters in rival colors gathered in heavy rain outside Congress in Buenos Aires as politicians debated the proposal for 15 hours.
Officers fired tear gas as some protesters reacted angrily to the result, setting up flaming barricades and throwing bottles at police in riot gear.
Image:Violence broke out outside the country's congress
Image:Police arrested some pro-life demonstrators as violence broke out
Meanwhile, at the city's Metropolitan Cathedral, a "mass for life" was held in support of keeping laws unchanged.
President Mauricio Macri, who is against abortion, had already said he would sign the bill after the country's lower house chose to support it - but senators voted it down 38 to 31.
Abortion is illegal in the South American country except in cases of rape or risks to a woman's health.
Image:Pro-choice protesters held their green banners aloft as politicians voted
Many women, most of them poor, have dangerous and degrading abortions every year - and activists estimate 3,000 have died since 1983.
Some resort to using a clothes hanger wire or knitting needle to break the amniotic sac inside the womb, others take toxic mixtures or herbs that can prove fatal.
Image:A model of fetus was carried by anti-abortion protesters
Image:Anti-abortion activists celebrated the senate's decision
Supporters of the bill argued it would save lives, and the run-up to the vote sparked months of passionate debate and protest in the Catholic country.
Hundreds of doctors who opposed the bill had laid their white medical coats outside the presidential palace, while the pro-choice movement - in their signature green - held larger demonstrations and drew support from the likes of The Handmaid's Tale author Margaret Atwood and actress Susan Sarandon.
Amnesty International had told Argentinian politicians that "the world is watching", and Human Rights Watch said the country had a "historic opportunity" to protect women's rights.
This is just a courtesy public service announcement for pseudo-Christian celebrities who think that they can sue or intimidate their critics into silence…you can’t. It’s America. We can still criticize you (even if Facebook throttles us). Paula White just discovered that.
Several years ago, Ergun Caner – a Swedish-born, American-raised, English-only speaker who claimed to be a Turkish-born, Lebanon-raised, Arabic speaker – sued Jonathan Autry and Jason Smathers for copyright infringement when they took a video of his lies and posted them on Youtube. He lost in court and was ordered to pay their attorney fees. In similar fashion, Paula White sued Shirley Johnson for taking clips of White’s videos and posting them with accompanying criticism, which is acceptable under the Fair Use Doctrine. Unless someone takes another’s intellectual material in its entirety, for the purpose of profiting from it, devoid of commentary, criticism or education, it’s not an infringement of intellectual property rights. Almost everyone recognizes this when it comes to public officials, politicians, teachers, or celebrities of any type. A few evangelical celebrities, on the other hand, think they’re above the law.
Shirley Johnson used images and videos of White to criticize her prosperity-driven ministry. White sued Johnson, but the case was dismissed. Johnson counter-sued for emotional damages due to the impastor’s frivolous lawsuit and the judge ruled in favor of Johnson, granting her $13,707 in damages. Of that amount, $12,500 was for mental anguish and the rest was for her legal fees.
The legal trouble is not over for White, however, as Johnson filed a separate complaint against her for intentionally misrepresenting copyright law. That case is still pending, and it does not bode well for the prophetess.
The judge in the case that was decided said the following:
The Court now finds that the interests of justice require default judgment as the only effective remedy. Motion Defendants willfully failed to comply with the Court’s discovery orders. Lesser sanctions would be ineffective. Indeed, the Court balks at Motion Defendants’ suggestions to allow Johnson additional discovery, impose more monetary fines, or again push back the litigation calendar. (Doc. 171, p. 3.) Been there, done that—to no avail. Motion Defendants have made clear their refusal to comply with discovery orders, and they “richly deserve[] the sanction of a default judgment.” See Malautea, 987 F.2d at 1542. Their willful disregard of discovery orders has prejudiced Johnson and brought this action to a standstill for eighteen months. Motion Defendants’ obstreperous conduct warrants the sockdolager of default. See Nat’l Hockey League, 427 U.S. at 643 (“[T[he most severe in the spectrum of sanctions must be available to the district court in appropriate cases.”); Adolph Coors, 777 F.2d at 1543; (upholding default judgment when the defendants refused to turn over crucial documents from the get-go, claiming privilege, and the district judge “exhibited great sensitivity” to the defendants’ concerns)
As TechDirt points out, the judge actually said, “Been there, done that” in an official court ruling. And that’s funny, right there.
Pulpit & Pen would like to issue a word of encouragement to those who have been similarly threatened with a lawsuit over copyright infringement for criticizing false teachers (as we have been threatened many, many times). These people are all bark and no bite. When it eventually does go to court, as it did with Caner and White, the plaintiffs are usually penalized for not showing up, not providing discovery or making their case. Their hope is that you will simply give up and stop criticizing under threat of litigation. In our case, in spite of the multitude of threats (often from completely fake “legal departments” and law firms that don’t even exist), we have never actually been taken to court. Any decent attorney knows Fair Use law and their case can’t be won. And if a decent judge understands that what’s being attempted is suppression of free speech, like with the Caner-Smathers judge, they’ll dismiss it “with prejudice.”
Don’t give up. Protect your right to speak up and speak out.
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.
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.67 During the trial, approximately 14 subjects in the Heplisav-B group had heart attacks in comparison to one subject in the Engerix-B group.67 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.
