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Covid Vaccine Thoughts 1/5

Why do we care about research? What are some sources and examples of research that have been done?

Post 1 of 5 Covid Vaccination Education

My purpose: is share within my social media outreach to help give a list of resources and educational direction, meant for the general public using my literary skills of medical research and my own opinion as a doctor of physical therapy.

Vaccinations are incredibly complicated and this series of posts is not sufficient to explain them, especially at a medically interpreted level, these posts will be very simplified to help both medical and non-medical people have a chance at understanding what the Covid-19 vaccine is. I will also not break down Covid-19, it’s complexity cannot be handled through one post or several posts, and should only be interpreted by those qualified.

My biases: I’d like to declare a few. I’ve received the Covid-19 vaccine. I’ve experienced Covid-19 personally. I work in the ICU as a physical therapist and have seen people die from and recover from Covid-19.

My limitations: Prescribing vaccines is not appropriate or in my scope. I’m not a virologist, epidemiologist, or medical doctor. I also will not change my practice based off shared opinions, gurus, Youtube, or means outside of academic journals especially political views (all) and social media.

Please take into account that I’m attempting to share my thoughts, not choose for you or convert you to a belief. We are all in this together and we need each other.

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I’d like to share a profound quote from Chris Hadfield of NASA & CSA, “No astronaut launches in space with their fingers crossed. That is not how we deal with risk... the more you know the less you fear.” I would like to apply his concept of shedding light on darkness or the unknown empowers you. This has been my experience with Covid-19 and it’s vaccine. Please understand I’m nowhere near knowing everything or professing to, but I have grown a lot by studying what we do know or has been shown. My hope is to empower you.

Why research?

Research is purposefully and strategically investigating information observed or collected to establish further knowledge about the topic. Research is the process in which scientific and medical communities advance knowledge and make educated decisions based on what is known. The Covid-19 vaccine purposes were to investigate the safety, level of effectiveness, and begin to investigate how long the vaccine effects are effective. This is different from a clinician observing treatment and monitoring progress, maintenance, or decline of a patient; although still very valuable for their care (yes, I'm very aware of case studies). A single patient cannot represent an entire population of the human family, subpopulation of disease, comorbidities, sex, or race. For example insulin, a common type II diabetes medication, is incredibly helpful for those with type II diabetes but could be very dangerous for those without type II diabetes; hence it worked for me may not be sufficient evidence to say it will work for them based on one person.

Research and Science Applications:

Please consider research is extremely hard to complete in general, each study has limitations but is completed in a very purposeful way to gain knowledge. Research is slow moving and takes time. I would propose that it will not satisfy the “I need the answer now” or “have the cure now” type personalities or crowds. It is also not a popularity contest, research is designed to increase knowledge objectively as possible, meaning how an experiment goes is how it goes. It is not perfect, but it gives a direction of knowledge to explore further until more detailed conclusions can be made. As more research is completed it will either support or refute current evidence, the more supported a topic is, the stronger it is regarded as correct knowledge with less doubt.

What stages are required for a vaccine to develop?

According to the CDC: Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety. Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed. (https://www.cdc.gov/.../distribu.../steps-ensure-safety.html)

  • Exploratory Stage

  • Pre-clinical stage

  • Clinical development

  • Regulatory review and approval

  • Manufacturing

  • Quality control

Pfizer Vaccine History:

Clinical Study Registration of Methods: this is done to declare the protocol of the study prior to publication of results as an additional step to ensure honesty and factual data. Keep in mind several studies may be published off one protocol. For FDA (FDAAA section 801).

History of Changes to Study Parameters: it is not uncommon to change methods during a study based on barriers faced and practicality of completing the study.

Pre-Clinical Data:

  • Khehra, N., Padda, I., Jaferi, U., Atwal, H., Narain, S., & Parmar, M. S. (2021). Tozinameran (Bnt162b2) vaccine: The journey from preclinical research to clinical trials and authorization. AAPS PharmSciTech, 22(5), 172. https://doi.org/10.1208/s12249-021-02058-y

  • Vogel, A. B., Kanevsky, I., Che, Y., Swanson, K. A., Muik, A., Vormehr, M., Kranz, L. M., Walzer, K. C., Hein, S., Güler, A., Loschko, J., Maddur, M. S., Ota-Setlik, A., Tompkins, K., Cole, J., Lui, B. G., Ziegenhals, T., Plaschke, A., Eisel, D., … Sahin, U. (2021). BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature, 592(7853), 283–289. https://doi.org/10.1038/s41586-021-03275-y

Phase I/II

  • Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Walsh, E. E., … Jansen, K. U. (2020). Phase i/ii study of covid-19 rna vaccine bnt162b1 in adults. Nature, 586(7830), 589–593.

Phase III Clinical Trial (Pivotal Efficacy Trial) Ongoing multinational, observer blinded, placebo controlled trial

  • Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R. W., Hammitt, L. L., … Gruber, W. C. (2020). Safety and efficacy of the bnt162b2 mrna covid-19 vaccine. New England Journal of Medicine, 383(27), 2603–2615. https://doi.org/10.1056/NEJMoa2034577

  • SARS-CoV-2 vaccines in advanced clinical trials: Where do we stand? (2021). Advanced Drug Delivery Reviews, 172, 314–338. https://doi.org/10.1016/j.addr.2021.01.014

Post Phase Trial Considerations:

FDA Emergency Use Approval:

Various Types of Studies of Efficacy, Transmission, Delta Variant,

and in Different Subgroups and Nations

  • Britton, A., Jacobs Slifka, K. M., Edens, C., Nanduri, S. A., Bart, S. M., Shang, N., Harizaj, A., Armstrong, J., Xu, K., Ehrlich, H. Y., Soda, E., Derado, G., Verani, J. R., Schrag, S. J., Jernigan, J. A., Leung, V. H., & Parikh, S. (2021). Effectiveness of the pfizer-biontech covid-19 vaccine among residents of two skilled nursing facilities experiencing covid-19 outbreaks—Connecticut, december 2020-february 2021. MMWR. Morbidity and Mortality Weekly Report, 70(11), 396–401. https://doi.org/10.15585/mmwr.mm7011e3

  • Goldshtein I, Nevo D, Steinberg DM, et al. Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women. JAMA. Published online July 12, 2021. doi:10.1001/jama.2021.11035

  • Angel Y, Spitzer A, Henig O, et al. Association Between Vaccination With BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers. JAMA. 2021;325(24):2457–2465. doi:10.1001/jama.2021.7152

  • Salo, J., Hägg, M., Kortelainen, M., Leino, T., Saxell, T., Siikanen, M., & Sääksvuori, L. (2021). The indirect effect of mRNA-based Covid-19 vaccination on unvaccinated household members. MedRxiv, 2021.05.27.21257896. https://doi.org/10.1101/2021.05.27.21257896

  • Bernal, J. L., Andrews, N., Gower, C., Gallagher, E., Simmons, R., Thelwall, S., Stowe, J., Tessier, E., Groves, N., Dabrera, G., Myers, R., Campbell, C. N. J., Amirthalingam, G., Edmunds, M., Zambon, M., Brown, K. E., Hopkins, S., Chand, M., & Ramsay, M. (2021). Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2108891

  • Layan, M., Gilboa, M., Gonen, T., Goldenfeld, M., Meltzer, L., Andronico, A., Hozé, N., Cauchemez, S., & Regev-Yochay, G. (2021). Impact of BNT162b2 vaccination and isolation on SARS-CoV-2 transmission in Israeli households: An observational study. MedRxiv, 2021.07.12.21260377. https://doi.org/10.1101/2021.07.12.21260377

  • Harris, R. J., Hall, J. A., Zaidi, A., Andrews, N. J., Dunbar, J. K., & Dabrera, G. (2021). Effect of vaccination on household transmission of sars-cov-2 in england. New England Journal of Medicine. https://doi.org/10.1056/NEJMc2107717

  • Rossman, H., Shilo, S., Meir, T., Gorfine, M., Shalit, U., & Segal, E. (2021). COVID-19 dynamics after a national immunization program in Israel. Nature Medicine, 27(6), 1055–1061. https://doi.org/10.1038/s41591-021-01337-2

  • Bernal, J. L., Andrews, N., Gower, C., Robertson, C., Stowe, J., Tessier, E., Simmons, R., Cottrell, S., Roberts, R., O’Doherty, M., Brown, K., Cameron, C., Stockton, D., McMenamin, J., & Ramsay, M. (2021). Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in older adults in England: Test negative case-control study. BMJ, 373, n1088. https://doi.org/10.1136/bmj.n1088

  • Fix, O. K., Blumberg, E. A., Chang, K.-M., Chu, J., Chung, R. T., Goacher, E. K., Hameed, B., Kaul, D. R., Kulik, L. M., Kwok, R. M., McGuire, B. M., Mulligan, D. C., Price, J. C., Reau, N. S., Reddy, K. R., Reynolds, A., Rosen, H. R., Russo, M. W., Schilsky, M. L., … Fontana, R. J. (n.d.). Aasld expert panel consensus statement: Vaccines to prevent covid-19 infection in patients with liver disease. Hepatology, n/a(n/a). https://doi.org/10.1002/hep.31751

  • Mahase, E. (2020). Covid-19: Pfizer vaccine efficacy was 52% after first dose and 95% after second dose, paper shows. BMJ, 371, m4826. https://doi.org/10.1136/bmj.m482

  • Moore, J. P. (2021). Approaches for optimal use of different covid-19 vaccines: Issues of viral variants and vaccine efficacy. JAMA, 325(13), 1251–1252. https://doi.org/10.1001/jama.2021.3465

  • Paltiel, A. D., Zheng, A., & Schwartz, J. L. (2021). Speed versus efficacy: Quantifying potential tradeoffs in covid-19 vaccine deployment. Annals of Internal Medicine, 174(4), 568–570. https://doi.org/10.7326/M20-7866

  • Paltiel, A. D., Schwartz, J. L., Zheng, A., & Walensky, R. P. (2021). Clinical outcomes of a covid-19 vaccine: Implementation over efficacy. Health Affairs, 40(1), 42–52. https://doi.org/10.1377/hlthaff.2020.02054

  • Bernal, J. L., Andrews, N., Gower, C., Robertson, C., Stowe, J., Tessier, E., Simmons, R., Cottrell, S., Roberts, R., O’Doherty, M., Brown, K., Cameron, C., Stockton, D., McMenamin, J., & Ramsay, M. (2021). Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in older adults in England: Test negative case-control study. BMJ, 373, n1088. https://doi.org/10.1136/bmj.n1088

  • Thompson, M. G., Burgess, J. L., Naleway, A. L., Tyner, H. L., Yoon, S. K., Meece, J., Olsho, L. E. W., Caban-Martinez, A. J., Fowlkes, A., Lutrick, K., Kuntz, J. L., Dunnigan, K., Odean, M. J., Hegmann, K. T., Stefanski, E., Edwards, L. J., Schaefer-Solle, N., Grant, L., Ellingson, K., … Gaglani, M. (2021). Interim estimates of vaccine effectiveness of bnt162b2 and mrna-1273 covid-19 vaccines in preventing sars-cov-2 infection among health care personnel, first responders, and other essential and frontline workers—Eight u. S. Locations, december 2020–march 2021. Morbidity and Mortality Weekly Report, 70(13), 495–500. https://doi.org/10.15585/mmwr.mm7013e3

  • Paltiel, A. D., Zheng, A., & Schwartz, J. L. (2021). Speed versus efficacy: Quantifying potential tradeoffs in covid-19 vaccine deployment. Annals of Internal Medicine, 174(4), 568–570. https://doi.org/10.7326/M20-7866

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