Pharma Controversy Presentation: Vaccination and Autism

When Was the Medication Introduced to the Public?

• Measles vaccine: first introduced in 1963 (Betáková, Svetlíková, & Gocník, 2013).
• Mumps vaccine: introduced in the late 1960s (Betáková et al., 2013).
• Rubella vaccine: introduced in 1969 and enhanced in 1979 (College of the Physicians of Philadelphia, 2017).
• Before, the incidence of the diseases among children was high.
• Immunization allowed dropping the rate of infection significantly.

Note: The introduction and widespread use of vaccination was a turning point in eliminating this serious healthcare burden.

What is the Indication for the Medication?

• Usually prescribed to children and teenagers.
• Adults: vaccinated if they have negative immunization history (Centers for Disease Control and Prevention [CDC], 2012);
• The average age of infection is 5–9 years (Lambert, Strebel, Orenstein, Icenogle, & Poland, 2015).
• Affected 90% of children (age <15) before 1963 (Betáková et al., 2013).
• MMR is endemic throughout the year in hot countries (Betáková et al., 2013).

Note: There is a strong indication for the use of medicine among children because the given population group is at the highest risk of infection.

What are the Pharmacokinetics for the Medication?

• MMR vaccines contain live attenuated viruses.
• They trigger immune system responses.
• Antibodies can be detected 2-3 weeks after injection.
• The estimated duration of effects: 12-23 years/lifelong.
• Vaccines are eliminated through the liver.

Note: The metabolic breakdown processes of the MMR vaccine occurs in the drug-metabolizing enzyme system of the liver. It fosters the immune resistance to viruses.

What is the Pharmacodynamics for the Medication?

• Early cellular immunity: marked by an immunosuppressive phenotype (Lambert et al., 2015).
• The observed increase in serum IL-10 and TNF-α
• A decrease in IFN-γ and proliferative properties of peripheral lymphocytes (Lambert et al., 2015).
• HLAs play the main role in immune responses (Lambert et al., 2015).
• HLA alleles bind to rubella-derived epitopes (Lambert et al., 2015, p. 11).

Note: “genetics; age; race; gender; antigenic exposure history,” etc. can individual responses to the vaccine (Lambert et al., 2015, p. 11).

How is the Medication Dosed?

• First dose: 12-15 months after birth (CDC, 2012).
• Second dose: between 4 and 6 years (CDC, 2012).
• Two doses of 0.5 ml for adults and children (“Vaccine,” n.d.).
• A suggested minimum interval between the dosages: 3 months.
• After exposure: injected within 72 hours of contact (“Vaccine,” n.d).

Note: Although at least 3 month-period between the dosages is required, it can be reduced to 1 month in case of urgency.

What Kind of Monitoring is Required with the Medication?

• Moderate and severe reactions should be identified in time.
• An injection can be made in the morning to facilitate monitoring (Taylor, Swerdfeger, & Eslick, 2014).
• Risk factors must be considered before the injection.
• They may be the reason to postpone or to not get the vaccination.
• Risk factors: blood disorder, use of steroids, HIV/AIDs, etc. (CDC, 2012).

Note: No specific monitoring is usually required, but some precautions must be considered to avoid adverse events (AE) and ensure the immediacy of response to them.

What are Some of the Most Common Side Effects?

• Mild problems: fever, rash, swelling (CDC, 2012).
• Moderate problems: seizure, joint stiffness, and pain (CDC, 2012).
• Severe problems: allergy, deafness, long-term seizures, etc. (CDC, 2012).
• Mild problems: 1 case in 6-75 vaccinations (CDC, 2012).
• Moderate problems: 1 out of 3.000-30.000 (CDC, 2012).
• Severe side effects are extremely rare.

Note: The incidence of severe AE is so uncommon that it is impossible to establish if they actually have a link to MMR vaccination.

What is the Average Cost of the Medication?

• M-M-R®II vaccine (10 pack): $70.92 (CDC, 2017).
• MMR/Varicella by ProQuad® (10 pack): $202.41 (CDC, 2017).
• Associated with a high level of cost-effectiveness (Betáková et al., 2013).
• Adverse consequences of viruses induce greater costs.
• MMR vaccinations are economically justified (Lambert et al., 2015).

Note: The private sector costs are provided. Lower-price vaccines are associated with greater cost-effectiveness.

Clinical Practice Guideline

• Children should receive vaccines at age 12-15 months (McLean, Fiebelkorn, Temte, & Wallace, 2013).
• The standard is applicable to eligible children only.
• The report comprises recent ACIP revisions on vaccination.
• The ACIP advises the CDC regarding all vaccines.
• Supported by the evidence from the nation-wide study.

Note: Eligibility of children is defined by risk factors including problems with the immune system, chemotherapy, etc.

The controversy that Surrounds the Use of Medication

• Parents often associate MMR vaccination with autism (Jain et al., 2015).
• Origins: the report by Wakefield et al. published in 1998 (Colaizzo, 2016).
• An additional association between thimerosal and autism was reported after (Colaizzo, 2016).
• Since then, a large number of studies did not find the vaccination-autism correlation (Jain et al., 2015).
• High levels of parental disinformation and fear result in reduced levels of vaccination.

Note: Wakefield’s report provided low-quality evidence and was poorly designed (Colaizzo, 2016). Therefore, it should not be used to support decision making.

Economics and Ethics

• Childhood mortality due to MMR before the 1960s: >2 million (Betáková et al., 2013).
• Global rates of measles-induced blindness before 1963: 15,000-60,000 cases annually (Betáková et al., 2013).
• The refusal of vaccination poses a threat to public health.
• The controversy may negatively affect individual well-being.
• MMR-associated health problems are related to high treatment costs.

Note: Vaccination cannot be forced, but the current level of parental distrust may lead to negative outcomes in their children’s health.

Who Has Been Impacted by the Controversy?

• Without vaccination, the risk for infection among children in high.
• Children with ASD and their siblings are often under-vaccinated (Jain et al., 2015).
• Controversy affects the community on a broader scale.
• Many people remain misinformed and still believe in Wakefield’s research (Colaizzo, 2016).
• The elimination of disease burden by vaccines is now compromised (Colaizzo, 2016).

Note: Children are especially vulnerable to the negative consequences of the given controversy because they cannot decide for immunization themselves.

Researchers’ Conclusions

• No qualitative evidence for the MMR vaccination-autism link (Taylor et al., 2014; Jain et al., 2015).
• Vaccinated African American males (age 24-36 months): prone to autism (Hooker, 2014).
• AE due MMR vaccinations are rare (Maglione et al., 2014).
• Vaccines are associated with greater benefits than threats.
• Immunization programs should be continued (Taylor et al., 2014).

Note: The factors of ethnicity and gender may pose some risks. However, the evidence similar to Hooker’s findings is scared.

What are Alternatives to the Controversial Medication?

• “Vaccines are one of the most valuable public health interventions” (Colaizzo, 2016, p. 1).
• Vaccines’ effectiveness against viruses is higher than of other existing methods.
• Parents may use no particular substitutes for vaccination (Fadda, Depping, & Schulz, 2015).
• The use of CAM methods draws parental attention.
• Efficient natural antiviral therapies are not yet developed (Lin, Hsu, & Lin, 2014).

Note: Only little alternatives to vaccination exist nowadays. Vaccines remain the only efficient preventive method.

Examples

• Some parents prefer to stimulate natural immunity in children (Fadda et al., 2015).
• Practices include hand hygiene, healthy dieting, etc.
• The stimulation of natural immunity is cost-efficient.
• Its effectiveness compared to vaccination is not proved.
• Plant-based medicines, e.g., Cajanus cajan extract, can inhibit infection in vitro (Lin et al., 2014).
• No dosages are identified in the literature.
• The evidence to support CAM’s effectiveness on human subjects is scarce.

Note: Some parents consider that it is not necessary to take specific measures in case there are no epidemics (Fadda et al., 2015).

Recommendation for Clinical Practice

• Parents should be recommended to vaccinate their children.
• Risk and genetic/demographic factors should be considered to avoid adverse events.
• Parents must be instructed on how to reduce vaccination-associated risks.
• Alternative methods can be prescribed as well.
• Parents must be educated about the threat-benefit ratio.

Note: Vaccination is important to prevent MMR epidemics and reduce the burden associated with it. Parents must be provided informed about the pros and cons of immunization before decision making.

References

Betáková, T., Svetlíková, D., & Gocník, M. (2013). Overview of measles and mumps vaccine: Origin, present, and future of vaccine production. Acta Virologica, 57(2), 91-96.

Centers for Disease Control and Prevention. (2012). MMR (measles, mumps, & rubella) VIS.

Centers for Disease Control and Prevention. (2017). CDC vaccine price list.

Colaizzo, G. R. (2016). Misinformed parents, unvaccinated children and the fabricated vaccine-autism scare. Paediatrics and Health, 4(1), 1.

College of the Physicians of Philadelphia. (2017). Rubella. Web.

Fadda, M., Depping, M. K., & Schulz, P. J. (2015). Addressing issues of vaccination literacy and psychological empowerment in the measles-mumps-rubella (MMR) vaccination decision-making: a qualitative study. BMC Public Health, 15, 836.

Hooker, B. S. (2014). Measles-mumps-rubella vaccination timing and autism among young African American boys: A reanalysis of CDC data. Translational Neurodegeneration, 3(1), 16.

Jain, A., Marshall, J., Buikema, A., Bancroft, T., Kelly, J. P., & Newschaffer, C. J. (2015). Autism occurrence by MMR vaccine status among US children with older siblings with and without autism. Journal of the American Medical Association, 313(15), 1534-1540.

Lambert, N., Strebel, P., Orenstein, W., Icenogle, J., & Poland, G. A. (2015). Rubella. Lancet, 385(9984), 2297–2307.

Lin, L. T., Hsu, W. C., & Lin, C. C. (2014). Antiviral natural products and herbal medicines. Journal of Traditional and Complementary Medicine, 4(1), 24–35.

Maglione, M. A., Das, L., Raaen, L., Smith, A., Chari, R., Newberry, S.,… Gidengil, C. (2014). Safety of vaccines used for routine immunization of US children: A systematic review. Pediatrics, 134(2), 325-337.

McLean, H. Q., Fiebelkorn, A. P., Temte, J. L., & Wallace, G. S. (2013). Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: Summary recommendations of the Advisory Committee on Immunization Practices (ACIP).

Taylor, L. E., Swerdfeger, A. L., & Eslick, G. D. (2014). Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine, 32(29), 3623-3629.

Vaccine, MMR information from DrugsUpdate. (n.d.). Web.