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i am going to share the posts i made on prior research as the might help piece stuff:
1)Saturday Oct 3 at 11:53pm
How does a COVID-19 Vaccine trial work? I wanted to first research and write in brief about this to understand how these trials work personally. To start, they get a group of people. Moderna is getting 30,000 and Pfizer is getting 44,000 people . To give us a picture, for example, at the manufacturing plant, Pfizer is creating 22,000 vaccine doses and 22,000 placebo doses, and it’s being administered randomly. So, 22,000 people will get injected with the vaccine, and 22,000 will get the placebo. Each week these people record in a diary how they are feeling and if they have any symptoms of COVID19. Over time, some of the people of the 44,000 will catch COVID19. Pfizer will know they caught COVID19 because of these logged diaries and will check to ensure the people did catch it . Once a pharmaceutical company hits certain benchmarks of a number of infections, they will look at the data . Say a number of people get infected, and the pharmaceutical company will look at patients who got the virus. They go back to that data file and look up the specific patients. If they find out 26 of the 32 patients were placebo, then they proved the vaccine. If it is 20 out of 32, that could be a chance. There are specific numbers that make it much more likely to be the vaccine working than chance. It is estimated that before the end of the year, they will have enough information to say the vaccine works, and at that time, the vaccine is approved .
The difference between this and other vaccines is that it tries to prevent a disease that kills one of 200 people it infects . This is vastly different than a disease that kills 6,000 people in the US each year . Because of this, it is important to get the vaccine to the market as soon as possible. The rushing of the vaccine doesn’t mean that we will have a vaccine that doesn’t work. It means that we might not know the very rare side effects and that we won’t know how good it is to stop COVID. Basically, the way the current trials are being run is that the vaccine will be approved once they know the vaccine works. More information found on clinicaltrial.gov . Moreover, this is important because, again, COVID kills one in 200 people. Adverse reaction from the vaccine is much less for individuals than catching the illness and having the complications. We can also keep waiting and keep the social distancing and the lockdowns going for as long as the vaccine takes to develop. But in reality, no one is going to wait for three years. If we take a vaccine now or if we take it in a year, we still wouldn’t know the long term effects perhaps for another ten years.
There’s so much unknown. I think that a lot of people feel the same way I do that it is rushed and that it might be unsafe, and a longer testing phase would be better and would make people a bit more comfortable, but this is unrealistic. The concern is it hasn’t been tested to see the longer effects. Nevertheless, the pharmaceutical company is doing this test on an ongoing basis sort of parallel and side by side. It usually takes such a long time to develop a vaccine, but it is good to consider that 8-10 years is not all the testing. It’s all the process, including all the administrative work. Usually, step 1 happens, then you do step two. Then you finish step 2, then you do step three. This time, because it is so urgent, step 1 and step 2 overlap; step 2 and step 3 overlap. These pharmaceuticals haven’t quite finished step 2, and then they begin step 3. They’re cutting the time to do each portion. That’s not changing the understanding of the efficacy, but just changing the administrative process, and then the other part that is getting saved is how long things are sitting on somebody’s desk to get approved to go to the next step. With the rushing of the vaccines, it could be that vaccine number 7 is never able to get tested because vaccines 1-4 get approved. And what is 1-4 are only 60% effective, and 7 is 100%? But that is really a risk that needs to be taken to stop the 600-1000 deaths that happen each day.
I would also like to point out that if vaccine becomes available, will Congress pass any law that restricts our ability to sue the pharmaceutical companies because if they do, that to me would be an indication that the pharmaceutical company is not concerned for everyone’s health. This would be a significant indicator of how much to trust the vaccines as they come out. This article discusses the Congress’ funding of DHHS 30 billion this year for countermeasures (i.e., isolation, testing, quarantine, vaccine) . So while the President might announce a vaccine works a month before we know it actually does, I have faith and I stand with Dr. Fauci’s interview that the way the trials are set up it will prove the vaccine works against COVID and the side effects that we might miss are not as crucial as preventing this disease and allowing people to get back to work . COVID19 is a public health epidemic. Epidemiologists are telling us that once a vaccine is passed, this is the best treatment for the situation. The only way we know that it is effective if we have information and try it. If nobody tries it, we won’t know if it’s effective. We have to be willing to take it. This is a total unknown for everyone. But the willingness to take a bit of a risk, for the rest of the society is needed during this time. I would take a vaccine that is 70% effective tomorrow over a vaccine that is 100% effective late next year. All of this is based on data from 4 months ago. Furthermore, the main advantage is that we begin to protect people in the population by taking the vaccine the soonest. Fewer people will get the disease, and fewer people will be out potentially spreading the disease.
Links for reference:
 https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/ (Links to an external site.)
 https://clinicaltrials.gov/ct2/show/record/NCT04368728 (Links to an external site.)
 https://www.cdc.gov/vaccines/basics/test-approve.html (Links to an external site.)
 https://www.wsj.com/articles/modernas-coronavirus-vaccine-begins-final-stage-testing-11595854440 (Links to an external site.)
 https://coronavirus.jhu.edu/data/mortality (Links to an external site.)
 https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/pandemic-preparedness.htm (Links to an external site.)
 https://clinicaltrials.gov/ (Links to an external site.)
 https://www.insurancejournal.com/news/national/2020/08/14/579150.htm (Links to an external site.)
 (Links to an external site.)
Richa Yesterday Oct 4 at 1:04am
Reading your opinion about the COVID-19 vaccine made me see the other side of the canal, which I would have never seen otherwise. It is fascinating to view things from your perspectives. At least you are honest about accepting vaccines with 60% efficacy this year than waiting for a 100% efficacy vaccine next year. I really appreciate your honesty. Perhaps, some portion of the population may be resonating with your perspective too.
However, I still feel that I, being a public health professional, have an ethical duty to ensure the best interest of the public and not rule out the worst side effects that might occur with such vaccines whose side effects have not been adequately tested, while other steps of clinical trials have been skipped through. What if the harm becomes worst than the benefits? What if we do not know how to normalize the worst side effect once it kicks off? Honestly, I believe we should always have an antidote of something that will be tested, such that if God forbid such a situation comes, then we know how to get back to normal being. After all, known is always better than the unknown. Nonetheless, that is just my opinion. Do you still think you would encourage the public to try 60% efficacy vaccines this year than to have them wait, by following safety and mitigation guidelines, for 100% efficacy vaccines by next year?
Yesterday Oct 4 at 2:01am
Hi R, great questions. Historically, it takes many years and millions of dollars to achieve the level of “proof” that the FDA requires. We know that the FDA is a respectable and reliable entity. We think that they will not approve a vaccine without the certainty that the formula contents are safe. The process of launching foods or remedies into the market is very professional and based on scientific methods. Any quick fix will probably not meet other FDA approved vaccines’ rigorous standards, so the American people will be wary.
On the other hand, tens of thousands of people die of Covid19; many more suffer long-term or permanent disability. It would be a public service to introduce a vaccine that is safe and also effective. Even if the vaccine has not jumped through all the FDA hoops, it could well save many lives and reduce our healthcare system’s pressure. So why not approve a “fast track” vaccine and probably save many lives? Why can’t the scientific and policy wonks in our country respect, talk to, and compromise with each other for the country’s good? I could be wrong. Nevertheless, I personally know at least three of my friends going through the trial now. One of them is a medical doctor. People are usually challenging an epidemiologist like Dr. Fauci because his intervention and treatment limit someone’s individual rights. In our mind, it has nothing to do with us. Why would the action be limited for someone else’s benefit (Tragedy of the Common)? When we see our Primary Care Physician (PCP), we don’t usually challenge their medical advice because the only person that has to get the treatment, is for our own self. Plus, if we decide not to get the treatment advised by our PCP, it only hurts ourselves. But if we don’t take an epidemiologist’s treatment intervention, it hurts everybody.
Yesterday Oct 4 at 3:10pm
Hi S, Thank you for doing all this research, it was very informative and like Richa mentioned, you definitely back your reasoning which if I’m being honest, I wasn’t prepared for. This part in particular seem interesting to me, “I would also like to point out that if vaccine becomes available, will Congress pass any law that restricts our ability to sue the pharmaceutical companies because if they do, that to me would be an indication that the pharmaceutical company is not concerned for everyone’s health.” Just out of curiosity, what made you think about potential restrictions being placed by Congress if the vaccine becomes available? When it comes to the pharmaceutical company, that on itself I want to say is a political party on its own. Thank you for your posts and all the resources you provided. You raise very good points, and thank you for making me understand your reasoning behind your answer. Well done.
Yesterday Oct 4 at 11:52pm
Hi J, With that statement that if congress passes a law to reduce big pharm liabity, that that suggests the pharm companies don’t care about peoples health. I question this because I don’t think big pharmacy and Congress work in step like that. But I don’t really know any better. Perhaps It doesn’t make sense for them to pass a law like that. I don’t even know if it’s legal. Perhaps Dr. Stevens can answer this?
I also could have given more studies to show contrasts on what happened with previous vaccines and how and why that is different now. There seems to be a lot of assumptions about how long it takes for vaccine approval and what rate of immunization is considered success. Could it be that this may seem quick, but in reality numerous obstacles in the process may have been removed without sacrificing safety. Do we know what is being shortened? Vaccine makers have been shielded from defects for a long time. And Pfizer is injecting it in 22,000 people with no deaths. If it kills one in 100,000, it is still better than a disease that kills one in 200 and causes significant morbidity in the rest. Wildcard negative reactions are ALWAYS possible. This is simply a case of reward versus risk analysis.
I am not a vaccine expert but from my awareness many of the vaccines are just about neutralizing the spike protuberances in the Coronavirus from being able to attack and penetrate cell walls thus enter the cell. This is not done with super science fiction wild process. It’s not even as dangerous a process as is already used extensively to genetically modify vegetables to produce their own internal insecticides. Do you hear people worrying about eating genetically modified vegetables or modified chickens, fish, fruits or any Numner of things were eat that are deeply genetically modified without FDA approval. There’s just too much unfounded hysteria! I don’t trust the President but I do trust the public health science experts on their future claims of a safe and effective vaccine, and I will help advocate for it.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443330/ (Links to an external site.)
2) another paper depicting another country as an example but the essence is there:
The administration of a vaccine in a given population requires cooperation with individuals, the public health department, and the government. The process involves delivering, handling, storing, and distributing the vaccine (Weintraub et al., 2020). However, sometimes misinformation circulates in times of a pandemic, which can negatively influence the health response’s effectiveness. Consequently, US communities have also developed social distrust towards health practitioners (US Department of Health and Human Services, 2020). The Democratic Republic of Congo (DRC), for instance, has been dealing with other public health-related problems, such as Ebola infections, since 2018 (Gavi, 2020). Therefore, as a clinical research coordinator, it is essential to apply effective strategies for communicating with my target population about the vaccine for increased uptake when it is available to the public.
I will be working with local groups in the DRC, as the country has had previous experience with the spread, control, and treatment of infectious diseases, such as Ebola. Misinformation about Ebola originated from social media platforms such as Facebook, which manipulated people into believing that the virus was fake (Gavi, 2020). Conspicuously, some information suggested that the medical response to Ebola was a scam by government officials seeking humanitarian financial support (Gavi, 2020). Consequently, the rate of infections increased within a short time, and many individuals died out of ignorance and misinformation. Based on the history of the DRC community’s uptake of vaccines, the COVID-19 virus is not an exception. Other stories argue that the DRC will serve as a laboratory for testing the effectiveness of various COVID-19 vaccines, which are perceived to be poisonous. The seriousness of the virus has been marred with rumors that suggest it neither exists nor kills people (Gavi, 2020). Besides, there has been misinformation that the Covid-19 virus has disproportionately affected White people and the rich (Kaufman & Danchin, 2020).
I would use mass media as a strategy for communicating with the DRC people about the vaccine. I would ensure that I utilize various mass media platforms, such as radio stations and TV channels, to broadcast the vaccine and its effectiveness. Notably, radios are the most accessible media in DRC, indicating that transmitting any health-related information through this platform would reach most people in the country (Gavi, 2020). For that reason, I would train radio presenters to campaign to promote the vaccine in their shows. I would also engage influential people in DRC, such as artists, chiefs, politicians, and religious leaders, to spread positive information about the vaccine. This strategy can be useful as these advocates would convince their followers into believing that the vaccine is not a scam created by the government (Gavi, 2020).
Additionally, I would sensitize the community by using posters with vaccine messages. I would hire volunteers to display posters with messages related to the vaccine in streets, buildings, and major roads. These strategies would improve awareness about the vaccine, improving the community’s uptake. My proposed plan would be effective since it would involve using local resources (radio, influential figures, and posters), which are trusted channels that many local people can relate to. Besides, working with local people, including nurses and other health workers, would encourage the community’s members to observe hygiene and social distancing (Riley, 2020). This practice would enhance the vaccine’s effectiveness and reduce the spread of the virus (World Health Organization, 2019). I would also ensure that I inform and assure the team members of the vaccine’s effectiveness for improved transparency (Gavi, 2020). The DRC people have a history of not taking vaccines seriously, primarily due to misinformation. This challenge has led to increased rates of COVID-19 infections, but with the use of appropriate communication strategies, I would ensure that DRC communities respond positively to the vaccine. Most importantly, I would ensure that there is transparent information about the vaccine’s effectiveness to the local people and leaders who would help me in my sensitization campaign.
Centers for Disease Control and Prevention. (2020, November 25). How CDC is making vaccine
recommendations. CDC. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html
How creative communication strategies are helping fight COVID-19 misinformation in DRC. (2020,
August 4). Gavi. https://www.gavi.org/vaccineswork/how-creative-communication-strategies-helping-fight-covid-19-misinformation-drc
Kaufman, J., & Danchin, M. (2020, August 21). 5 ways we can prepare the public to accept a COVID-19
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