Study on the Safety and Efficiency of Vaccines

Vaccines are a crucial aspect of the health care sectors since they help in preventing the spread of deadly infections and illnesses among children and adults. However, for vaccines to be the most effective standard for preventive care, they must pass the efficacy and safety threshold as outlined by the CDC and other regulatory agencies. The effectiveness of any vaccines is of utmost concern to the medical community and scientists as it means the difference between better and worse health outcomes. In this regard then, it is the duty of scientists and the medical community to study the efficacy and safety of vaccines regularly. Vaccines refer to biological substances that are designed to protect individuals from viral and bacterial infections by taking over the work of the natural immune system. Vaccines work by stimulating the antibodies to work as if they are fighting a real illness and in this way promote the health of an individual. Having known the workings of vaccines, it is paramount for the individual to be vaccinated so that in the event of an illness or infection, one will be safe. The study into the safety and efficacy of vaccines is crucial as it ensures that all the existing and new vaccines help to promote the well-being of individuals across the globe.

History of Vaccines 

Vaccines are considered one of the greatest success stories in the field of public health owing to their ability to bring down the rate at which diseases and illnesses are spread. Vaccines, as they are today, have an expansive history going back to 1796 when the first vaccine for smallpox was developed (Plotkin, 2014). Moreover, by the late 19 th century, scientists had steered the development of four other vaccines for typhoid, rabies, plague and cholera In spite of this early discovery, smallpox, measles, and diphtheria claimed lives in tens and hundreds of thousands as their use was not widely spread. The turn of the twentieth century marked a new beginning for vaccines as their acceptance as well as development increased. As a result, nine vaccines for preventable diseases were recommended to be used universally to inoculate children. These vaccines include poliomyelitis, smallpox, pertussis, diphtheria, measles, tetanus, mumps, Haemophilus influenza and rubella (Edwards, 2017). Additionally, the concerned authorities made efforts to obtain more information regarding diseases and health of populations that were then used as the basis for publishing medical studies.

The past few decades have continued to shape how the vaccine is developed and use in bringing down the rate at which preventable diseases spread. There have national efforts to ensure that all children get polio vaccines by setting aside funds to enhance the vaccination process. The success of this vaccine is attributed to the collaboration between healthcare providers, state, federal, and local governments in developing and maintaining the US vaccine delivery system. As of 1997, the US had recorded high levels of vaccination coverage for children aged from 19 to 35 months (Plotkin, 2014). 90 percent of all these children had received three or more doses of diphtheria, tetanus, and pertussis vaccine (DTP), poliovirus, Hib, vaccine and measles vaccine. Eighty-one percent of all children had taken four doses of DTP while those who had taken three doses of hepatitis B stood at 84 percent. Around that time, the government had introduced the varicella vaccine and only about 26 percent of all children had been vaccinated. By 1980, the number had increased significantly with 95 percent of children aged from 5-6 years vaccinated against DTP, mumps, measles, polio, and rubella (Edwards, 2017). These vaccines had had positive impacts on children considering that there has been a considerable decline in morbidity for nine-vaccine preventable diseases mentioned before. In particular, morbidity for polio and smallpox, which has been eradicated completely, has declined by 100 percent, as is in the case with the other even diseases.

The future of vaccines offers much hope in promoting better health outcomes in spite of the current challenge in the vaccine-delivery system. There has been an increasingly complex vaccination schedule considering that in the US alone around 11,000 children are born every day (Edwards, 2017). Each of these children requires about 15 to 19 doses of vaccine before they turn 18 months for eleven childhood diseases. The vaccinations become more complex as the world grapple with new meningococcal and pneumococcal infections as well as chronic diseases. In particular, new vaccines must be developed to deal with the respiratory syncytial virus (RSV), parainfluenza, gastric ulcers, cervical cancer, rheumatic heart disease, and influenza. As of now, there are numerous ongoing clinical tails for vaccines aimed at preventing human immunodeficiency virus infection. If these vaccines will be effective in bringing down the infection rate, parents must accept that vaccines are the most effective way of mobilizing the immune system. More so, healthcare providers must be updated on the latest recommendations and developments. Of importance is the need for researchers to address the question of efficacy, safety, and vaccine delivery to accommodate new populations especially in developing nations.

Benefits of Vaccination 

Vaccines as a way of bringing down the rate at which preventable diseases are spread are quite beneficial. Vaccines help in protecting both children and adults from deadly and dangerous diseases considering that statistics indicate that vaccinations reduce these chances significantly. Prior to the development and universal adoption of vaccines, the mortality rate from diseases such as smallpox and measles was quite high with tens and hundreds of thousands of people succumbing from these diseases. However, this trend has been reversed and now it is rare for individuals including newborns to die as a result of these preventable diseases. Vaccines work by strengthening the body’s immune system and this is important especially for newborn babies whose immune systems are yet to develop fully (Orenstein and Ahmed, 2017). The undeveloped immune system means that the chances of contracting the disease from the environment are quite high but thanks to vaccines, these chances are reduced drastically.

CDC Recommended Vaccine Schedule 

Centers for Disease Control and Prevention are mandated with the responsibility of developing and implementing vaccines schedule to harness their effectiveness. It outlines the doses that each child requires for each disease as well as the time the child is to be vaccinated. The vaccination schedule is not constant considering that there has been an increase in the number of vaccines over the years. In the years 1945 to 1954, there were only two vaccines that were recommended that is smallpox and DTP with smallpox being recommended for children aged one. Polio was licensed in 1955 and together with smallpox and DTP became the recommended vaccines for periods lasting from 1955 to 1964. The next ten years up to 1974 witnessed the licensing of the measles vaccines in 1971 and the phasing out of smallpox vaccines owing to a lowered risk of infection. In this case, then there were only three vaccines at the time that is DTP, polio, and measles (McGuire-Wolfe, 2018). Between 1975 and 1984, the number of vaccines remained at three with the measles vaccines being improved into MMR to deal with measles, mumps, and rubella in 1977. The period from 1985 to 1994 witnessed a change into the immunization schedule with the introduction of Haemophilus influenza (Hb) and Hepatitis B vaccines in 1990 and 1991 respectively (History of Vaccines, 2018). The Hib vaccine was to be used to vaccinate children who had attained 18 months or older.

The next ten years witnessed a sporadic increase and modification in the number of recommended vaccines from five to nine. DTP vaccine was modified to DTaP an abbreviation for diphtheria-tetanus-acellular pertussis to indicate that the vaccines only used parts of pertussis bacteria in line with reducing its side effects (McGuire-Wolfe 2018). The new vaccines that were added to the schedule include Influenza for children between 6 and 23 months, Varicella for all children, Rotavirus, and pneumococcal for children under 2 years (Ventola, 2016). Three more vaccines had been added from 2005 to present, they are HPV, and Meningococcal for adolescents aged between 11 to 12 and Hepatitis A for all children. CDC gives direction regarding the number of doses that each individual ought to be given and at what age to enhance their efficacy and safety. Health providers must adhere to these schedules while parents and guardians ought to cooperate with heat providers to get the best out of the schedule.

Whether Vaccines Improve Health and Immunity 

Vaccines do improve the health and immunity standards of individuals especially if they follow the immunizations schedules. Vaccines work by stimulating the immune system so that it reacts immediately to the onset of any of the preventable diseases. In case an individual is to contact any of these diseases, the overall effects will be minimal, as the vaccine will suppress them. According to Orenstein and Ahmed (2017), decreased severity of illnesses translates to better health outcomes, as individuals do not have to develop full-blown diseases or infections that could incapacitate them. Vaccines ought to be given early enough especially to newborns whose immune system is not yet fully developed. The vaccines here will take the place of the immune system and fight any disease that may affect the newborns. Overall vaccines are an excellent way of reducing the morbidity associated with preventable diseases and in this way reduce mortality rates owing to improved health and immunity.

Data Collection Methods 

Medical community and scientists are tasked with the responsibility of ensuring that the existing and new vaccines pass the safety and efficacy test before being licensed for administration. There are various data collection methods, which are ta, the disposal of vaccines safety and efficacy researchers as follows:

Double-blind Placebo Studies 

Double-blind placebo studies are an efficient way of collecting data regarding the efficacy and safety of vaccines as it removes researcher bias as it rules out the placebo effect. The reason for this proposition is the fact that neither the participants nor the researchers know who is receiving which treatment. In this kind of study, the placebo and the target vaccines are given randomly to both the control and the experimental groups. In this case, only the results of the study will reveal who receive the placebo and who received the actual vaccine. Double-blind placebo studies are heralded for their ability to reduce the influence of variables that are confounding (Omosa-Manyonyi et al., 2015). Researchers have no way of unknowingly influencing results during the administration of the vaccine stage or the data collection stage. In this way then, the researchers will have objective findings, which will help to determine the truest efficacy associated with particular vaccines.

Vaccinated vs. Unvaccinated Subject Health Comparison 

The study on the safety and efficacy of vaccines relies on comparing the health outcomes for both the vaccinated and unvaccinated subjects to find which cohort is healthier. There is a consensus that vaccinated subjects have better health outcomes than their unvaccinated counterparts. This proposition is drawn from existing research studies that have tried to compare these two groups of individuals. Mothers who are the most involved in childcare are asked to fill out anonymous online questionnaires about their biological 6-12 olds. The questionnaires revolve around pregnancy-related factors, vaccinations, birth history medications used, diagnoses and other health services. These studies have indicated that unvaccinated children are more likely to be diagnosed with pertussis and chickenpox while the vaccinated children are diagnosed with otitis media, pneumonia, neurodevelopmental disorders, and allergies (Mawson, Ray, Bhuiyan, 2017). In this case, then it is clear that while vaccines are meant to deal with preventable diseases they are risk factors for severe chronic and acute diseases.

National Vaccine Injury Compensation Program (NVICP) 

The National Vaccine Injury Compensation Program is a reliable resource for individuals keen on collecting information regarding the safety and efficacy of vaccines. The program was established in 1986 through the National Childhood Vaccine Injury Act following the DPT vaccine scare in 1980. Individuals who believe that their children or kin have been affected by certain vaccines are allowed to file their cases so that they can be compensated. In this regard then, it is possible to know the number of cases that have been brought before the program. As of October 2019, NVICP had paid about $4.2 billion in relation to over 53,000 autism petitioners (Meissner, Nair, and Plotkin, 2019). The petitioners claimed that some vaccines most notably MMR is a predisposing factor to developing autism spectrum disorders. In this case, it is evident that NCVIP has reliable statistics that can help one to establish whether the vaccines in question are safe and effective or not.

Vaccine Adverse Event Reporting System (VAERS) 

The Vaccine Adverse Event Reporting System is another reliable resource that can be used to assess the safety and efficacy of the vaccines that are administered in the US. VAERS is a surveillance program that is run by the CDC and FDA to assess the safety of the vaccines that are used in the nation. The program acts as a warning system that collects information regarding the safety of vaccines with the aim of detecting possible safety issues. VAERS provides credible information considering that vaccine manufactures, nurses, doctors and the public is free to submit information regarding health issues arising from vaccinations (Centers for Disease Control and Prevention, 2015). The information that is received at VAERS is documented and assigned an identification number for follow-ups. From here, the information is submitted to the FDA and CDC who follow on selected cases to determine their seriousness. The patient is followed cup for up to one year when the FDA and CDC determine when the patient has recovered or not. Researchers can use these reports to understand the severity of these cases and in this case, determine whether certain vaccines re safe or not.

Vaccine Excipients 

In an attempt to establish whether vaccines are safe and effective researchers have the alternative on looking at the vaccine excipients for a clue. Vaccine excipients are additional ingredients that are added on top of the weakened disease antigens for specific purposes. Some of the most common excipients include adjuvants for stimulating a stronger immune response, preservatives for preventing contamination and stabilizers for maintaining the vaccines’’ potency (Centers for Disease Control and Prevention, 2019). The most common ingredients used on excipients are egg protein, thimerosal, aluminum salts, ascorbic acid, and lactose. Researchers can establish if the excipients play a role in enhancing the safety and efficiency of vaccines or they make them unsafe and ineffective.

Package Inserts 

Vaccines are packaged in various ways to ensure that they remain potent and that they are not damaged while in transit. The packages provide basic information regarding the dosage, active ingredients, and excipients. Most importantly, the package inserts provide crucial information regarding the side effects associated with the vaccines. A closer look at the side effects could provide information into the safety and efficacy of vaccines. Vaccines with numerous side effects could be considered less safe and ineffective as compared to the one with fewer or no side effects. This information would help individuals researching vaccine safety to find ways of improving their safety by removing suspect ingredients.

Analytical Summary 

The safety and the efficacy of vaccines are of utmost importance for scientists and the medical community as they mean the difference between desirable and poor health outcomes. In this case, then there are continuous efforts to ensure that the development, testing, and administration of vaccines adhere to CDC and FDA regulations. It must be noted that while vaccines are considered as the standard preventive care to reduce the spread of preventable diseases they may trigger other illnesses. In particular, some vaccines, most notably MMR has been linked to increased cases of autism while unvaccinated individuals report less severe conditions. In this case then one could conclude that the public needs more assurance on the safety and efficacy of existing and new vaccines.

Recommendations 

The focus on vaccine safety and efficacy need more attention especially in the era of an increase in chronic and acute diseases most of which have no cure. Vaccines, which are seen as the ultimate assurance of better health outcomes, are yet to provide better health outcomes going by the number of petitions at NVICP. It is time that the concerned authorities, intensified efforts to come up with the solution to vaccines' ineffectiveness witnessed so far. In particular, the stakeholders ought to find the suspect vaccines and find out which of the ingredients or excipients are responsible for predisposing individuals to chronic diseases. In line with this, the stakeholder ought to conduct thorough clinical tests on new vaccines before they are released for administration to reduce their adverse effects.

Concluding Summary 

Vaccines play a crucial role in the healthcare sector across the world as they help to bring down infection rates for preventable diseases. Prior to the discovery of vaccines mortality rates for diseases such as smallpox and measles ranged from tens to hundreds of thousands. However, with the development and circulation of vaccines, most of these diseases that at one time ravaged humans are no longer a threat. As ta now, there are more than ten vaccines targeting newborns, adolescents, and adults most specifically pregnant women. In spite of these successes, there are challenges when it comes to vaccine safety and efficacy in this era of increased chronic and acute diseases. Some of the vaccines most notably MMR has been linked to autism spectrum disorders raising questions on the safety of vaccines. Moreover, NVICP a vaccine claims the program has spent up to 4.5 billion in compensation fees for individuals who have experienced adverse effects having been vaccinated. These challenges ought to be addressed because no matter how one views it, vaccines help in mitigating the spread of preventable diseases.

References

Centers for Disease Control and Prevention. (2015, August 28). Vaccine Safety: VAERS. Retrieved on 10 December 2019, from https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html

Centers for Disease Control and Prevention. (2019, August 5). Vaccines & Immunizations: What’s in Vaccines? Retrieved on 10 December 2019, from https://www.cdc.gov/vaccines/vac-gen/additives.htm 

Edwards, K. M. (2017). Plotkin's Vaccines . New York: Elsevier.

Mawson, A. R., Ray, B. D., Bhuiyan, A. R., & Jacob, B. (2017). Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children. Journal of Translational Science, 3 (3), 1-12.

Meissner, H. C., Nair, N., & Plotkin, S. A. (2019). The National Vaccine Injury Compensation Program: Striking a balance between individual rights and community benefit. JAMA Network, 321 (4), 343-344.

Mcguire-Wolfe, C. (2018). Foundations of Infection Control and Prevention . Burlington, MA: Jones & Bartlett Learning.

Omosa-Manyonyi, G., Mpendo, J., Ruzagira, E., Kilembe, W., Chomba, E., Roman, F… Pridy, F. (2015). A phase I Double-Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults. PLoS ONE, 10 (5), e0125954

Orenstein, W. A., & Ahmed, R. (2017). Simply put: Vaccination saves lives. Proceedings of the National Academy of Sciences of the United States of America, 114 (16), 4031–4033.

Plotkin S. (2014). History of Vaccination. Proceedings of the National Academy of Sciences of the United States of America, 111 (34), 12283–12287.

The History of Vaccines. (2019). History of the Immunization Schedule . Retrieved on 10 December 2019, from https://www.historyofvaccines.org/content/history-immunization-schedule

Ventola C. L. (2016). Immunization in the United States: Recommendations, Barriers, and Measures to Improve Compliance: Part 1: Childhood Vaccinations. P & T: A Peer-reviewed Journal for Formulary Management , 41 (7), 426–436.