The Catholic Church has no ethical objection to any Vaccine that is safe and effective. The Archdiocese of Port of Spain is aware of the January 2007 Position Paper by the Catholic Medical Association of America and Canada (CMA) on the implementation of the Gardasil vaccine for Human Papilloma Virus (HPV) which was approved by the Food and Drug Administration, USA, on 8 June 2006 and which is meant to protect girls and young women between the ages of 9 and 26 against four of the most common high risk HPV subtypes/strains: HPV 16 and HPV 18, that cause 70 per cent of cervical cancers, and HPV 6 and HPV 11, that cause 90 per cent of genital warts.
A statement by the CMA quotes John Brehany, Executive Director of the CMA, as stating that “the fact that HPV is spread primarily by sexual contact does not render vaccination against it unethical. Healing and preventing diseases, no matter what their source, are acts of mercy and a moral good.”
The Church teaches a consistent ethic of life and is committed to promoting and defending life at all stages and in all circumstances. Indeed, the dignity of the human person and the sanctity of life form the foundation of the social doctrine of the Church.
All children are a precious gift from God and whatever we do must be in their best interest. While one accepts that the Ministry of Health in Trinidad and Tobago (MOH) would have conducted its own research on the safety and efficacy of the Gardasil HPV Vaccine, the Archdiocese has a duty of care to appraise itself of the latest information on this Vaccine before recommending to parents that they should consent to their daughters receiving it in RC Schools, and to express any concerns regarding the administering of the Vaccine to students in ALL schools – not only Catholic schools. We are concerned about the welfare of all the nation’s children.
It is for this reason that Catholic Education Board of Management (CEBM), in a release dated Monday 28th January, 2013, recommended that “parents of children attending RC schools should desist from allowing their children to be vaccinated with Gardasil, pending further advice from CEBM.” Due to communication difficulties, CEBM was unable to participate in the MOH’s consultation relating to this Programme.
The Archdiocese welcomed the opportunity to discuss issues relating to the HPV Vaccine at a meeting held with representatives of the MOH and the Pan American Health Organization (PAHO). The meeting, which was held at Archbishop’s House on Friday 1st February, 2013, and was organised by Msgr Robert Llanos, Vicar-General, who was at that time in charge of the Archdiocese in Archbishop Joseph Harris’ absence.
Present at this meeting were Dr Krishna Kumar Sundaraneedi Medical Director Health Programmes and Technical Support Services, MOH, and some members of his team at the MOH, including the Manager of the HPV Vaccine MOH Programme, and Dr Yitades Gebre, (PAHO) representative. Also present was Dr. Sherene Kalloo, Obstetrician/Gynaecologist who was instrumental in bringing the Human Papillomavirus (HPV) vaccinations into T&T.
Representatives from the Archdiocese of Port of Spain included: Msgr Robert Llanos, Vicar-General, the 5 Vicars of the Archdiocese, the Chair and the CEO of CEBM and some members of CEBM, the Chair of the Social Justice Commission and a parent who supports the Commission, and a representative from the Catholic Media Services Ltd.
The MOH and PAHO representatives presented information about HPV, about the HPV Vaccine, Gardasil, and outlined the aims of the MOH Programme to offer the HPV Vaccine to a targeted age group of girls in TT schools. They sought to reassure representatives of the Archdiocese that the HPV Vaccine is safe and effective, stating that reports of negative side effects are carefully investigated through surveillance systems such as the U.S. Vaccine Adverse Event Reporting System (VAERS). They stated that to date, there has been no proof that associated severe adverse reactions, have been caused by the vaccine. They reiterated the fact that the programme is voluntary and not mandatory.
Dr Sherene Kalloo, testified that she has been administering the vaccine in her private practice since it became available in Trinidad and has had no reports of severe adverse effects.
The Archdiocese’s team expressed concerns about the safety and efficacy of Gardasil, in light of information in the international media which have queried this, and about certain aspects of the MOH’s Programme to administer this HPV Vaccine to some students in targeted schools.
Information shared by the team included:
- concerns expressed by Dr Diane M. Harper, an independent lead researcher in the development of Gardasil, who says she is: “an international expert in HPV science, its vaccines, its clinical disease and treatment.” Admittedly, she is one person, but her concerns, quoted in many articles and directly by her in video-clips about the lack of efficacy and safety of the Vaccine for girls under 15 years of age need to be addressed;
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- statements by the National Vaccine Information Center, a U.S. non-profit agency, which is petitioning President Barack Obama and Congress in the USA on behalf of families to investigate what NVIC says are “Gardasil vaccine deaths and serious injuries” (see www.nvic.org – Investigate Gardasil Vaccine Risks NOW!);
- an open letter to Hon. Kathleen Sebelius, Secretary of Health and Human Services, USA, dated 31 January 2012 by Ms Norma Erickson, President, S.A.N.E. VAX, INC (Safe, Affordable, Necessary and Effective Vaccines and Vaccination Practices) (http://sanevax.org/sanevax-open-letter-to-kathleen-sebelius-secretary-of-health-and-human-services/ ) , asking her to “rescind approval of Gardasil due to lack of efficacy during post-licensure monitoring.” Mrs Erickson states that Gardasil was “approved…under the fast track drug development programme despite the fact that the proposed vaccine did not qualify to use this programme under FDA regulations.” The letter referred to statistics and issues outlined in “a recently published (2012), industry-sponsored study (ATHENA) conducted on 12,852 young women.” The entire letter is worth reading;
- numerous reports of negative side-effects of varying degrees of intensity but including death – including a video-clip of concerns raised by Jenny Thompson, the Director of the Health Sciences Institute, USA (HSI) (HSI Alert- Urgent Warning about Gardasil – hsionline.com/search_gardasil.htm) ;
- a report by the Alliance for natural health (http://anh-europe.org) which states that Gardasil HPV Vaccine is the “first ever Genetically Modified (GM) virus” and that it “is not only genetically engineered, it is also trans-species.” Writers from this organization state: “We agree with Herb Newborg, a researcher and journalist, ‘The long term results of introducing into the human body genetically engineered, recombinant human, insect, and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body’s natural defenses against outside pathogens (skin, saliva, mucus, etc).’”
- the number of adverse events listed on the U.S. HPV Vaccine Adverse Event Reporting System (VAERS) Reports as of Dec 2012 – 28,433 reports, including 128 reports of deaths. The Archdiocese is aware that while this US surveillance system collects raw data, “they do not in themselves establish causal connections between vaccines and adverse medial issues – such determinations cannot be made until the reports have been investigated, evaluated, and analyzed” (www.snopes.com).
Nevertheless, it is important to note that on the Food and Drug Administration website: www.fda.gov/BiologicsBloodVaccines/Safety/Availability/Vaccines under the section entitled: “Adverse Event Reports following Gardasil, it is stated:
“The Gardasil safety review assessed the following adverse events: local injection site reactions, syncope (fainting), dizziness, and nausea, headaches, hypersensitivity reactions, such as rashes, hives, itching, anaphylaxis, Guillain-Barré syndrome (GBS) (a disorder affecting the peripheral nervous system. It can cause life-threatening complications), transverse myelitis, motor neuron disease, venous thromboembolic events (VTEs) (bloodclots), pancreatitis, autoimmune disorders, pregnancy, and deaths. All of these events are included in Gardasil’s labelling.”
The National Vaccine Information Center (www.nvic.org/) states that “The thousands of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) since Gardasil has been licensed, including deaths and serious health problems involving emergency room visits, hospitalizations, and permanent injuries, have been written off by federal health agencies as a coincidence.”
In fact, the U.S. FDA states that “Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccination…”
- a report dated 12 January 2013 and published in: alignlife.com/news/indias-supreme-court-may-hear-gardasil-and-cervarix-violations , that “India’s Supreme Court has “accepted a writ of petition on the unethical trialing of HPV vaccines for cervical cancer, Gardasil and Cervarix.” Inter alia, “the petition also alleges that following vaccination, the girls and their families were abandoned without receiving any information on potential adverse reactions, the need to schedule follow-up exams, and the need for post-vaccine treatment.”
Dr Sundaraneedi undertook to investigate the reports outlined above. He apologized for the inaccurate information contained in the MOH’s website regarding the number of cases and deaths from cervical cancer in Latin America and the Caribbean. He said that in Latin America and the Caribbean there are 72,000 cases and 33,000 deaths and worldwide there are about 500,000 cases and about 260,000 deaths.
The Archdiocese accepts that 128 cases of cervical cancer per year in T&T and between 80 – 90 deaths per year here are too many and that we must strive to reduce this figure.
Once again, the MOH Team and the PAHO representative sought to reassure those present from the Archdiocese of Port of Spain that in spite of negative reports relating to Gardasil, the HPV Vaccine, TT’s MOH and Medical experts in many parts of the world continue to believe that Gardasil is safe and effective. The Vaccine is in use in 40 countries around the world and about 100 million doses have been administered to date.
The Archdiocese believes that the best interests of children are only served if parents and guardians are fully informed before granting consent for their daughters/wards to receive the HPV Vaccine. The Archdiocese’s representatives stated at the meeting that the information given to schools via a letter to Principals, and to parents, via a simple brochure regarding the HPV Vaccine was inadequate.
The Archdiocese is not satisfied that there has been full disclosure of the potential side-effects to parents to assist them in making an informed decision as to whether or not they wish to let their daughters/wards receive the HPV Vaccine.
In light of the discussions at this meeting, Dr Sundaraneedi has agreed to work with his team to review the brochure for parents. Amendments should include:
- the name of the drug (Gardasil is not named in the brochure currently);
- the HPV strains that the HPV Vaccine provides protection for, that is, Types 16 , 18, 6 and 11;
- the period for which it is effective. The brochure currently states: “The vaccine has long lasting protection.” The literature says protection lasts about 5 years;
- the full range of possible side effects;
- Contraindications, that is, specific situations in which Gardasil should NOT be used, because it may be harmful to the patient/student;
- the list provided on the Gardasil website of problems that recipients of the Vaccine could experience and which may be signs of an allergic reaction;
- information that will encourage cancer screening/pap smears in later life and where this can be obtained.
After this discussion, Msgr Llanos, on behalf of the Archdiocese, agreed to permit administration of the vaccine in its schools on condition that:
- full disclosure is made to parents about the vaccine to enable them to make an informed decision. Details will include the virus strains that are not covered by the vaccine, the period for which it is effective, contraindications, and the full range of possible side effects;
- a programme be effected for the systematic monitoring of students after they receive the vaccine.
The Archdiocese shares the concern of the MOH over the high incidence of cervical cancer in Trinidad and Tobago and supports the goal of reducing the incidence of this disease and preventing deaths that result from cervical cancer. It therefore encourages all students to take positive steps to avoid this disease. These include the following:
- Since HPV is sexually transmitted reserve sexual activity to within marriage as the best protection against risk of the disease.
- Young women should access recommended medical treatments which include where appropriate, regular PAP smear screening.
Finally, parents are urged to learn the medical facts concerning this vaccine and to consider the spiritual, emotional, moral, and physical health of their daughters in making their decision about it. – CEBM/CCSJ
