Unfortunately, not all people are aware of this success or the need for vaccines that prevent infections with dangerous pathogens. There is a long history of hesitation in vaccination. In the earliest times, there was legitimate concern for the safety and efficacy of the proposed vaccine products due to the lack of a meticulous process of clinical trials and formal review under the supervision of scientific experts. vaccines, epidemiology, and statistical analysis. It is only now, however, that with our increasing understanding of the biology of infectious diseases, the establishment of robust and well-deserved clinical trial methods for the evaluation of vaccine products and good review by government health agencies and outside experts, the applicability of a given vaccine is unclear before it is approved. Mandatory reporting of adverse effects after real -world use ensures that occasional or long -term concerns are properly assessed.
Consider, for example, the findings from a recent review of 57 vaccines approved by the FDA from January 1, 1996, to December 31, 2015. More than 90% of vaccines are supported by data from randomized controlled trials, each with more than 4100 study participants.4 The authors reported that the postsurveillance mechanism worked well, with a total of 58 safety-related changes added to FDA-approved vaccine labels involving approximately half of vaccines (n = 25). Most of the changes are related to the additional warnings stemming from the expanded vaccine experience. A total of 8 contraindications were added to the labels, and only 1 vaccine product was removed from the market due to safety -related issues.
Restrictions on the patient population that must be eligible to receive vaccines are the most common change mandated by the FDA, with more awareness of potential allergic reactions being the second most common issue arising from the following- next review. The investigators concluded: “Over a 20 -year period, vaccines have been found to be much safer. A large proportion of safety issues have been identified through existing postmarketing surveillance programs and have limited importance. in the clinic. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance. ”4
Following the introduction of several COVID-19 vaccines, there have been reports of a rare blood clotting disease associated with at least 2 products not available in real world use. Incidents were quickly assessed, with public health agencies making recommendations for future delivery of vaccines. Even if the launch of the COVID-19 vaccine has not yet reached its speed and scope, the postapproval monitoring process has been shown to be robust and should serve as a source of public reassurance about the effectiveness of initial and follow-up measures. review process.
HUMAN BEING COMPLICATES SCIENCE
Let’s face it, this is an overly multifaceted view of the whole color of the vaccination process. In a most provocative commentary, Naomi Oreskes, PhD, a professor of scientific history at Harvard University, found that we may also need to reiterate the nature of difficulty associated with developing and implementing an effective approach to vaccinate.5 The author points to the fact that we are accustomed to considering problems “difficult” in relation to key technological challenges or understanding of more complex theories (e.g., physics as a whole). The development of several effective COVID-19 vaccines and their release for non-investment management less than 1 year following the identification of the molecular structure of the causative virus is not surprising- an, although we have fought so far to implement a nationwide vaccine. distribution strategy. What is the benefit of a vaccine that stays in a bowl rather than being inserted into the arm of an individual who is susceptible to COVID-19 infection?
Oreskes concludes: “We call the physical sciences‘ difficult ’because they deal with issues that are largely not independent of the human genitals; they offer laws that (at least in the right context) provide exact answers. But physics and chemistry never tell us how to design an effective vaccination program… in part because it doesn’t help us understand human behavior. The social sciences can rarely provide exact answers. But that won’t make them easy. ”5
Even if COVID-19 vaccines should be considered to have truly told scientific success stories,6 we face the reality of human morality, and we know that overcoming the barriers of existing and strongly rooted beliefs, reinforced by social media sources and conspiracy theories, maglisud.7.8
We need to be aware that this conclusion is also relevant to the administration of vaccination that has been documented to be safe and highly effective in preventing cancer. We now have conclusive evidence that vaccination against human papillomavirus (HPV) may reduce the risk of developing cervical cancer.9 However, recently reported data revealed that, among 12,644 women and men aged 18 to 21 years in the United States, only 55% of women and 34% of men are received at least 1 dose of HPV vaccine.10 Clearly, we still have a long way to go to solve this “difficult” prob-lem to increase the delivery of this critically important cancer prevention strategy.
- Roush SW, Murphy TV; Vaccine Disease Record Working Group. Historical comparisons of morbidity and mortality for vaccine -preventable diseases in the United States. JAMA. 2007; 298 (18): 2155-2163. doi: 10.1001 / jama.298.18.2155
- Zhou F, Shefer A, Wenger J, et al. Economic analysis of the conventional infant immunization program in the United States, 2009. Pediatrics. 2014; 133 (4): 577-585. doi: 10.1542 / peds.2013-0698
- Centers for Disease Prevention and Prevention. Ten best achievements in public health – United States, 1900-1999. MMWR Morb Mortal Wkly Rep. 1999; 48 (12): 241-243.
- Tau N, Yahav D, Shepshelovich D. Postmarketing safety of vaccines approved by the U.S. Food and Drug Administration: a cohort study. Ann Intern Med. 2020; 173 (6): 445-449. doi: 10.7326 / M20-2726
- Oreskes N. What causes a “difficult” problem? The breakdown of vaccination shows that we need to rethink the term. Stated by sci Am. 2021; 324 (5): 77. doi: 10.1038 / scienceamerican0521-77
- COVID-19 breakthrough case investigations and reporting. CDC. Updated May 14, 2021. Accessed May 17, 2021. https://bit.ly/3olHzXl
- Larson HJ. The greatest risk of pandemic? viral misinformation. Nature. 2018; 562 (7729): 309. doi: 10.1038 / d41586-018-07034-4
- Del Rio C, Malani P. COVID-19 in 2021-continuing uncertainty. JAMA. 2021; 325 (14): 1389-1390. doi: 10.1001 / jama.2021.3760
- Lei J, Ploner A, Elfström KM, et al. HPV vaccination and the risk of developing cervical cancer. N Engl J Med. 2020; 383 (14): 1340-1348. doi: 10.1056 / NEJMoa1917338
- Chen MM, Mott N, Clark SJ, et al. HPV vaccination among young adults in the US. JAMA. 2021; 325 (16): 1673-1674. doi: 10.1001 / jama.2021.0725