Bahaya Vaksin

Perang pemikiran antara kelompok pro-imunisasi dan anti imunisasi menjadi hal yang sering terjadi di dunia maya, baik di situs pribadi, organisasi maupun media social. Jika diamati dan ditelusuri, kelompok yang kontra imunisasi kurang paham secara mendetail mengenai kandungan vaksin dan hanya mengambil sebagian penelitian yang tidak sahih dan dianggap sama untuk kelompok vaksin.

Seperti contohnya ada penelitian yang mengemukakan bahwa penggunaan aluminium secara banyak, dapat membuat kerusakan otak karena akan adanya deposit aluminium di otak. Dan memang ada alumunium dalam beberapa vaksin. Kemudian mereka menyimpulkan bahwa penggunaan vaksin membuat anak kelebihan aluminium dan merusak otaknya sehingga disimpulkan oleh golongan anti vaksin bahwa vaksin merusak otak.

Hal ini adalah cara pengambilan kesimpulan yang salah, karena jika kita lihat lebih dalam, jumlah vaksin yang terdapat dalam obat sakit lambung (maag) jauh lebih banyak dibandingkan dengan penggunaannya dalam vaksin. Selama ini jika Anda tidak pernah takut menggunakan obat maag, ya tidak perlu takut dengan kandungan Aluminium pada vaksin.

ALUMINIUM

Aluminium adalah elemen ketiga terbanyak di bumi setelah oksigen dan silikon, dan Aluminium adalah logam terbanyak, hampir 9 persen dari kerak bumi. Aluminium ditemukan dalam tanaman, tanah, air dan udara. Pada umumnya, tanaman megandung sedikit saja aluminium, namun ada tanaman yang mengandung banyak aluminium di dalamnya, yaitu teh, rumput dan anggrek.

Alumunium banyak sekali terdapat di dalam kehidupan kita:

  • Alumunium dapat ditemukan dalam wadah makanan, seperti di wajan, Teflon, kaleng makanan dan Alumunium foil.
  • Aluminium pun ditemukan dalam beberapa makanan dan snack termasuk buah dan sayuran, bird an wine (anggur), bumbu, tepung, sereal, kcang- kacangan, produk hewani, susu formula bayi dan madu. Pada umumnya, orang dewasa mengkonsumsi 7 sampai 9 milligram per hari.
  • Aluminium digunakan dalam industry pesawat terbang, bahan pembuat cat, isi dari rokok dan juga bahan bakar.
  • Aluminium ditemukan dalam produk kesehatan seperti obat sakit lambung (antasida), aspirin (obat sakit kepala), antiperspirants dan beberapa vaksin.

Penggunaan Aluminium dalam kehidupan sehari – hari :

Bahan Makanan Kandungan Aluminium
Air Susu Ibu 0.04 milligrams per liter (mg/L)
Susu formula bayi 0.225 mg/L
Susu formula bayi bahan kedelai 0.46 to 0.93 mg/L
Obat Aspirin 10 to 20 mg/tablet
Antasida (obat maag/ sakit lambung 104-208 mg/tablet

Vaksin hanya mengandung sedikit Aluminium di dalamnya, jadi jika Anda membaca efek samping yang ditimbukan oleh aluminium, sebetulnya Anda seharusnya lebih takut jika mengkonsumsi obats akit lambung (seperti antasida) dibandingkan dengan vaksin yang hanya sedikit sekali mengandung aluminium.

THIMEROSAL

Apa itu thimerosal ? Apakah sama dengan merkuri ?

Thimerosal adalah senyawa organik yang mengandung merkuri dan telah digunakan selama beberapa dekade di Amerika Serikat dan negara lainnya. Thimerosal digunakan sebagai pengawet dalam sejumlah produk biologi dan obat-obatan, termasuk banyak vaksin, untuk membantu mencegah pencemaran dari bakteri berbahaya. Jadi thimerosal melindungi vaksin dari bakteri berbahaya. Sementara mercuri adalah logam yang secara natural ditemukan di lingkungan berbahaya untuk tubuh. Merkuri berbeda dengan thimerosal.

Efek thimerosal akan muncul apabila seseorang mendapat dosis thimerosal yang tinggi, misalnya melalui suntikan berkali- kali sehingga terjadi akumulasi. Anggapan bahwa vaksinasi MMR memicu terjadinya autisme tidaklah rasional. Penetian menunjukkan bahwa tidak ada bukti yang menunjukkan MMR berhubungan dengan autism. Anak autism sudah memiliki bakat kelainan dalam susunan sarafnya sejak dalam kandungan.

Apa bedanya Etil- Merkuri dan Metil- Merkuri?

  • Ketika belajar mengenai thimerosal dan merkuri, sangatlah penting untuk memehami perbedaan antara METIL MERKURI dan ETIL MERKURI.
  • METIL- MERKURI dibentuk dalam lingkungan ketika adanya logam merkuri. Jika bahan ini ditemukan dalam tubuh, biasanya disebabkan karena memakan beberapa jenis ikan atau makanan lain. Jumlah metil merkuri yang tinggi dapat membahayakan sistem saraf. Ini telah ditemukan dalam studi dari beberapa populasi yang telah lama terpapar metil merkuri.
  • ETIL – MERKURI dibentuk sebagai hasil pemecahan thimerosal oleh tubuh. Tubuh menggunakan etil merkuri, berbeda dengan metil merkuri yang meracuni tubuh. Etil merkuri dipecah tubuh dan disekresikan dari darah dengan cepat. Pajanan etil merkuri yang sangat kecil dari vaksinasi sangat berbeda dengan efek samping dari metil merkuri yang berbahaya untuk tubuh.

Bahan Adjuvant (tambahan) vaksin yang telah diteliti di manusia

Adjuvant / Formulasi Manfaat Keterangan Keamanan/ Imunogenisitas
Garam Mineral

 

Garam Aluminium (Alumunium hidroksida/ Alumunium fosfat)

§ 80 % vaksin yang ada menggunakan adjuvan Alum.

§ Menginduksi respon antibodi yang kuat, memberikan signal TLR

§ Secara langsung mengaktivasi DCs untuk mensekresikan IL-1β dan IL-18

 

§ Alum has been used for years in vaccines for billions of people of all ages.

§ Poor CD8 T-cell induction

§ May cause mild local reactions at the site of injections, occasional granulomas.

 

 

Calcium phosphate

§ Has been used as an adjuvant in vaccine formulations against diphtheria, tetanus, pertussis and poliomyelitis;

§ More efficient than aluminum hydroxide when tested as a booster with DT as an antigen;

§ Has also been used for absorption of extracts for hyposensitization of allergic patients.

 

§ Potential alternative to aluminum salts.

 

§ Calcium phosphate adjuvant contains no components that are not natural constituents of the body, and vaccines containing it are well tolerated.
Emulsions

 

MF59

(Microfluidized detergent stabilized squalene oil-in-water emulsion)

 

§ Increased flu vaccine immunogenicity in young adults and in elderly as evaluated with HAI titers; broadens response against heterovariant strains.

§ Improved immunogenicity over Alum when tested with HBV vaccine, HSV, HIV1 gp120, and CMV gB.

§ IM injection in combination with a variety of subunit antigens results in elevated antibody response, increased T-cell proliferation and induction of cytotoxic lymphocytes.

 

§ Induces chemokines to increase recruitment of immune cells, enhances ag uptake by monocytes and differentiation to DCs.

§ MF59 is a component of Fluad®, a licensed subunit influenza vaccine in Europe with >30 million doses distributed.

§ Combination of MF59 with MTP-PE enhanced systemic reactogenicity, without improving immunogenicity in Ph1 flu vaccine study.

§ Mild local reactions;

§ Minor reactogenicity upon intramuscular injections of humans in combination with various antigens.

 

Incomplete Freund’s adjuvant (IFA,

stabilized water/Drakeol oil)

 

§ Increased anti-p24 titers and DTH responses when used with gp120-depleted inactivated HIV1.

§ In seropositive subjects, increased lymphoproliferation and – chemokine production following p24 stimulation.

§ Induction of T-cell responses against gp100 HLA A2 restricted epitopes in melanoma patients.

 

§ May cause granulomas and abscesses at the site of injection.

 

Adjuvant / Formulasi Manfaat Keterangan Keamanan/ Imunogenisitas
 

Montanide ISA-51 (Stabilized water-in-oil emulsion) and ISA-720 (stabilized water/squalene)

 

§ Induction of anti-Tat antibodies in 100% of vaccines;

§ Strong T cell lymphoproliferative response;

§ DTH and lymphoproliferative response to Tat was observed in 50% of vaccines.

 

§ ISA-51 has been used in vaccines for >1000 people and has slow release properties like IFA;

§ ISA-720 has been used in vaccines for approximately 1,000 people, >250 in malaria including some children;

§ When used with a malaria subunit antigen (MSP1, MSP2, Resa AMA1), antibody responses equivalent to Alum were obtained in humans.

 

§ ISA-720 t – Minor local effects such as local tenderness, swelling and discomfort).

Microbial (natural and synthetic) derivatives

 

Monophosphoryl lipid A (MPL)

 

§ When combined with polysaccharide-conjugate vaccine, enhanced Th1 responses to the carrier protein, but no impact on antibody responses in humans, despite superior antibody responses observed in animals.

§ Reduced toxicity vs. LPS

§ Detoxified derivative of LPS from Salmonella minnesota

§ TLR-4 agonist

§ Component of a melanoma vaccine approved in Canada;

§ MPL has been used in vaccines for >20,000 people.

§ Possible effects on autoimmune and neuroinflammatory disorders being evaluated.

§ Strong activator of pro-inflammatory cytokines

 

Detox (MPL + CWS)

 

§ Induction of cellular and humoral responses against melanoma associated antigens.

§ Increase in survival in patients with metastatic melanoma.

§ Detox has been approved for use in Canada as a component of Melacine – a melanoma vaccine

§ Has been used in vaccines for >5,000 people.

 

OM-174 (Lipid A derivative, E. coli), OM-triacyl

§ OM-triacyl adjuvants are synthetic analogs based ona common triacyl motif, which induce maturation of human dendritic cells in vitro. § IM route studied in cancer patients.
 

Modified LT, CT (Genetically modified bacterial toxins [heat-labile enterotoxin, cholera toxin] to provide non-toxic adjuvant effect)

 

§ Enhancement of seric and mucosal IgA production; LT activates Langerhans’ cells, causing migration from skin to draining LNs

§ Ongoing evaluation of CT and LT as adjuvants in patch-based transcutaneous immunization; LT induces more balanced Th1/Th2 response than CT

 

§ Potential for oral and intranasal adjuvant use.

§ LT has been used in human clinical trials, with modest adjuvant effect by oral route and promising results as an antigen in a traveller’s vaccine given as a patch.

§ Prototypic mucosal adjuvants, efficient in numerous animal models, but toxic in humans;

§ A flu vaccine formulation with LT was withdrawn in Switzerland because of potential safety issues (Bell’s palsy).

§ Local rashes with patch

 

 

Adjuvant / Formulasi Manfaat Keterangan Keamanan/ Imunogenisitas
 

CpG ODN (synthetic oligonucleotides containing immunostimulatory CpG motifs)

 

§ Phase 1 trials conducted in humans (in association with Alum) have shown enhanced antibody responses against HBsAg.

§ At least 3 classes of oligonucleotides are now defined, with respect to their distinct capacity to activate either: human B, NK or dendritic cells in vitro.

§ Act as potent Th1 adjuvants in mice, chimpanzees and orangutans.

§ Act as TLR-9 agonists, bias response to Th1 immunity with CD8 T cell induction

§ Responses greater with conjugation than with mixture of CPG and ag

§ Mild increase in frequency but not severity of AEs with marked improvements in immunogenicity in HBV trials.

 

Combination Adjuvants

 

AS04

(Alum + MPL)

§ When compared with Alum, increased antibody titers, seroconversion rates and lymphoproliferative responses.

 

§ Administered to >30,000 subjects

§ Tested in combination with proteins (HBsAg, HSV gD, EBV gp350) and HPV16/18 L1 VLP

§ Component of Fendrix™ and Cervarix™, approved HBV and HPV vaccines in Europe.

§ Mild-moderate local pain redness and swelling at injection site with HSV-2

§ Occ. malaise with pneumo conj. vaccine

 

 

AS02

(Oil-in-water emulsion + MPL + QS-21)

 

§ With a candidate malaria vaccine, induced high anti-plasmodium CSP lymphoproliferative and antibody responses but no induction of CD8 T cells, leading to short-lived protection (<6 months) against challenge. § AS02 (SBAS2) has been used in vaccine candidates in >1,000 people.

§ Used with malaria, TB, HBV, HIV and MAGE-A3 antigens.

§ Significant local (swelling and pain) and systemic reactogenicity in malaria CSP and MSP-1 antigen trials, but not with RTS,S antigen in Ph1.

§ Local and systemic reactogenicity more common in children than adults.

 

AS01

(Liposomes + MPL + QS21)

§ Designed to improve CD8 T-cell responses

§ Data with malaria antigens indicate higher antibody and T-cell response with AS01 than with AS02

§ AS01 favors Th-1 responses, AS02 elicits more balanced Th-1/Th-2 responses.

§ Used with malaria and TB antigens.

§ Limited human safety data.
Immuno-adjuvants

 

Cytokines: (IL-2, IL-12, GM-CSF, Flt3)

§ Enhancement of antibody responses with GM-CSF. § Administration of Flt3 with HBV antigen resulted in the accumulation of immature DCs in peripheral blood, without enhancement of antibody response. § Utilization of cytokines as immunoadjuvants in cancer patients as recombinant proteins, with limitations including short biological half-life and some severe toxicity.
Accessory molecules (B7.1)

 

§ The accessory molecule B7.1 provides costimulatory signals to T lymphocytes, has been included in association with the CEA antigen within the canarypox vector ALVAC, thereby potentially enhancing cellular responses.

 

 

Adjuvant / Formulasi Manfaat Keterangan Keamanan/ Imunogenisitas
Particulate formulations

 

Liposomes (DNPC/Chol)

§ Lipd-bilayer membranes enclosing aqueous compartments.

§ Slight increase in CD8 + CTL response when combined with a flu vaccine.

§ Can be freeze-dried

 

§ Fuse with cell membrane to deliver proteins to MHC class I pathway

§ No increase in antibody titers (equivalent to vaccine alone).

§ Limited by manufacturing and cost issues.

 

DC Chol (Lipoidal immunomodulators able to self-organize into liposomes)

§ Some enhancement of cellular immune response in humans when tested with H. pylori urease (i.e. lymphoproliferation and balanced Th1/Th2 responses as evaluated by IFN-g/IL-5 production) § Parenteral and intranasal potential;

§ Enhanced antibody responses in animal models.

 

Virosomes™

(Unilamellar liposomal vehicles, immunostimulating reconstituted influenza virosomes [IRIV])

 

§ Rapid seroconversion leading to protective anti-HAV or anti-influenza virus antibody responses.

§ No block in immune response from pre-existing influenza immunity

§ IN route for influenza is immunogenic with good protection.

§ Component of licensed flu and Hep A vaccines in Europe.

§ >34 million doses of Inflexal V flu vaccine distributed in Europe since 1997.

 

§ Nasalflu®, with HLT from E. coli, withdrawn because associated with Bell’s palsy
 

ISCOMS® (structured complex of saponins and lipids)

§ Increase of influenza-specific CD8 + CTL response (when compared with flu vaccine alone).

§ Allows reduction in QS-21 dose.

§ Adjuvant activity from induction of cytokines (IFN-g and IL-12)

§ ISCOMS has been used in vaccines for >1,000 people; with flu, HPV, HCV and cancer antigens

§ Second generation (ISCOMATRIX) adjuvants based on purified saponins are currently being tested with HPV16 (E6/E7) fusion protein.

§ Some level of mild/mod local and systemic AEs over vaccine without adjuvant.
 

PLA (polylactic acid)

PLG (poly[lactide-co-glycolide]) microparticles

§ PLGA particles were shown to elicit Th1 (presentation of CTL epitopes) and Th2 responses in mice.

 

§ Microparticles function mainly as delivery system.

§ Clade B Gag DNA/PLG and Env DNA/PLG Microparticles Vaccine is in an ongoing Ph1 trial in HIV-negative adults.

§ Ongoing trial with the tetanus toxoid

§ Difficult to prepare GMP-grade PLGA particles

 

Proteosomes™

·    Developed for mucosal vaccination, no concerns about transmission of vaccine from person to person

·    Lacks known neurotropic components, does not bind to GM1 ganglioside

·    Hydrophobic, proteinaceous, nanoparticles comprised of purified N. meningitidis outer membrane proteins

§ TLR-2 agonist

§ Proteosome-S. flexneri 2a LPS vaccine given IN was safe, and well tolerated

§ Nasal congestion and HA with IN flu vaccine

 

Referensi :

DeStefano F, Price CS, Weintraub ES. Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism. J Pediatr. 2013 Aug;163(2):561-7. Epub 2013 Mar 30.

http://www.cdc.gov/vaccinesafety/Concerns/Thimerosal/thimerosal_faqs.html

 

 

 

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