It has taken me over one month to prepare this post on the COVID19 vaccine. It is extensive and required a great deal of research. Many may not read it. That’s okay. I am not trying to reach puppets or androids. I am trying to reach those who take personal ownership of their own well-being, and who don’t follow everything that they are told to do.
This post is not intended to change anyone’s mind or to convert them. It simply provides facts, additional information, and of course, my opinion, on which you should solidify your decision if they are into that. Kevy
We’ve gotten so touchy and evangelistic about everything these days, racial issues, healthcare, taxes, global warming, and now it’s the COVID19 vaccine.
I appreciate that everyone has a right to have their own opinion about the vaccine. Whether they are taking it or not doesn’t bother me. But some people just get out right upset with you, if like myself, have decided that you’re just not taking it.
I haven’t taken the flu, pneumonia, measles, shingles, or none of those vaccines. The last vaccines I remember taking were when I was anywhere from 5 to 8 years old, and I’m standing strong. Those who take them regularly as adults often have poorer health than I do.
The Center For Disease Control (CDC) recommends 13 different vaccines for adults. I have taken none of these as an adult.
I will never say never. I never say never about anything in life, so I can’t never say I take the vaccine. But it’s not anything that I am considering anytime soon. I’ve done my research and I’ve provided a list of reasons why I’m not rushing to take the COVID19 vaccine. Maybe you should consider these things as well, especially if you fit into my demographic.
Deciding not to take the vaccine wasn’t a difficult decision. I arrived at this decision rather easily, in spite of being exposed to COVID19, testing positive, then subsequently testing negative 3 times.
I have several reasons and I’m sure that further research will probably give more reasons why taking the COVID19 vaccine is not right for me, at this time.
I respect those who choose to take the vaccine as soon as it becomes available to them. That is their choice and right, such as mine. I am not trying to convince anyone of anything with regard to the vaccine, except for one thing.
This one thing I encourage everyone to do on every decision, research. Do not make your decisions purely based on fear, media, hearsay, or even religion. After doing your due diligence, then follow your heart, the part of us all where God’s spirit resides. My heart tells me not now for the COVID19 vaccine.
First of all, I am a Black man, and it is true that Black people are suspicious about the medical profession and about the US government, many of us, but not all of us.
Think about it. Blacks have the Tuskegee experiment on which to reflect. Personally, I also noticed from caring for my elderly mother that when Black people reach a certain age, and sometimes at an early age, we’re all on the same medicines, and dying for the same reasons. Whether we’re on asthma, blood pressure (usually 2 or 3 at a time), cholesterol, diabetes, and sometimes thyroid medicines, we’re all on the same things. And the interesting aspect of the medicines that were on, is that we have to be on them for the rest of our lives. Still we die more than Whites do for the very diseases for which we aree being treated!
I have no problem surrendering to God’s will for me. But I feel uncomfortable surrendering to science that has financial interests, front and center. I feel uncomfortable relying totally on the US government as well. Most racial atrocities in this country were mandated and enforced by the US government.
We must address the ways racism and slavery have shaped American medicine, not only to right past wrongs but also to confront how that influence continues to affect how patients are treated today. Racists’ beliefs associated with slavery provided perceived ethical justifications for conducting repeated invasive experiments on slaves. J. Marion Sims carried out his experiments on women’s genitalia from 1845 to 1849 without anesthesia, which had recently been introduced. In addition to their status as enslaved people, black women were considered appropriate subjects for such experiments based on the widespread belief that black people experienced less pain than white people. Read More
Another reason stems from a situation involving a friend, who has a high cholesterol problem. I suspected that it was a medicine that he was taking all along. But he didn’t want to hear me. Many people, particularly Black people, when they do cross the medicine line, which most do, become evangelistic about their medicines. It can feel like telling trying to convince a Black person that Jesus doesn’t exist when you suggest alternative protocols or spark suspicion about prescription drugs and traditional medicine in general.
One day I got my friend on a 3-way call with the pharmaceutical that manufactures the medicine that he’s taking. I asked him to remain silent, as I asked questions. I inquired about the side effect of high cholesterol when taking his medication. They agreed that it did increase cholesterol, but informed me that it had been reformulated, and the increase was now less severe.
I asked more questions; I dug deeper. I asked how many Black people were included in the clinical trial for this drug, and they told me about 11%. That was remarkably interesting because Blacks have a 30% greater chance of dying from heart disease. Science is unsure why Blacks’ cholesterol levels are comparable to Whites but are more likely to die from heart disease than Whites. There are several known differences in how the metabolism of Blacks works differently, and how Blacks respond to various medications relative to Whites, particularly cancer, and asthma medications. Many differences are socioeconomic, access-to-healthcare, genetics, stress-based, and due to other factors, that usually lead back to racism, inequality, and inequity.
Science clearly acknowledges Blacks’ cardiovascular problems, yet they represented only about 10 or 11% of the clinical trial patients for my friend’s medication, and in most clinical trials. It is possible that half of that number were never really treated with the medication, receiving placebos instead. No one knows, but the pharmaceuticals conducting the studies.
Pharmaceutical clinical trial administrators have a lot of discretion in deciding who gets admitted to their studies. Many Black are excluded from trials for reasons other than mistrust. Sometimes it’s due to economic factors, not being made aware of the trial, communication issues, and the existence of comorbidities, of which we often have many.
The same applies to the COVID19 vaccines. Blacks are about 10% of the clinical trial patients for most COVID19 vaccine trials, yet the coronavirus affects Blacks more severely than other races. The Center for Disease Control (CD) reported that Blacks and Hispanics are about 3 times more likely to die from COVID19 than Whites. …About 4 times as likely to be hospitalized. Read More
There is clearly racism in medicine and clinical trials, beyond myths about Blacks during slavery and when medicine was at the pioneering stage of being practiced. Mixing racism with “Lobster Politics”, makes it even more racist. Many of those who don’t want to wear masks, practice social distancing, and who believe that the coronavirus is a hoax, are simply racist. They want herd immunity to occur naturally. According to statistics, that would mean that many Blacks and Latinos will simply die. The CDC predicts that for every White person that dies of COVID19, four Blacks and Latinos will die. Others believe that Whites just won’t die in large numbers from the coronavirus. They are correct to an extent. With better access to healthcare, less stress, and the ability to afford healthier lifestyles, Whites are less likely to be severely affected by COVID19.
It seems to me that we should have vaccine trials with primarily Black and Latinos. Furthermore, it seems that all trial patients should be skewed towards or exclusive to the races that are most affected by the disease being researched. But clinical trials are administered mainly by Whites and the results are very slanted towards White patients. Whites will continue to convince minorities that vaccines and prescription drugs are safe. But would they be so passionate if few Whites were included in clinical trials, and few White administered them? That’s the question.
Another reason that I wouldn’t take the COVID19 vaccine is that the population of Black people that are in these clinical trials are not necessarily African Americans. The US Department of Health & Human Services enacted a policy in 2001 that addresses the Inclusion of Minority Subject in Clinical Research. In this updated policy “Black or African American” is defined as “a person having origins in any of the Black racial groups of Africa. Terms such as Haitian or Negro can be used in addition to “Black or African American”.
Africans and people from other regions of the world can fulfill the African American demographic for clinical research. I have friends from Africa, and I have to say they have extraordinarily strong metabolisms. They don’t get many colds, the flu, or anything much of that nature. They tend to persevere through illness much better than African Americans do. This is just from observation. But look to Africa today. It is not affected by COVID19 as severely as in the United States and other more European countries. Senegal has been widely praised for its handling of the coronavirus pandemic, with few infections and life returning to normal. Read More
Yet Haitians and Africans can be used to represent African Americans in clinical trials and used in the smallest population percentage of clinical trials than other races. It’s all enough to give me justification for being reluctant to the COVID19 vaccine, and vaccines and prescription drugs in general.
At a high level, it seems that African Americans are being more vigorously tested on new drugs, in everyday life once they are approved by the FDA. In a way, African Americans are taking prescription drugs that have not been heavily tested on their population. Money influences this. There is more money to be made on the larger White population, and if African Americans happen to experience side-effects, the same pharmaceutical companies make the medicine that their doctors prescribe the life-long prescriptions to “treat” those side-effects.
It seems that many Americans are being tested with prescription drugs that they take every day, but more so than others. This likely explains why drugs and vaccines are regularly reformulated, and why there are so many lawsuits against pharmaceuticals. The desire for increased profits blemishes my ability to see pharmaceuticals as having moral or humanitarian intentions.
Percent of 50+ Blacks Prescription Use – Source AARP# Of Perscription Medications
- 1 – 17%
- 2 – 3 – 39%
- 6 – 10 – 11%
- 11 or More (As my 90+-year-old mother did) – 9%
Based on observing friends, family, and my elderly mother, who take or took every prescription and vaccine prescribed to them, they seem regularly sick, and often require medical procedures that I just haven’t had to deal with. Most, with all their trust in the hands of prescription medicine, vaccines, and doctors, live unhealthy lifestyles. Many are not mentally, emotionally, or spiritually strong. I see a clear correlation between – Vaccines, Taking Prescription Drugs, Not Living Healthy Lifestyles, Being Religious (Not Spiritual), Living in Fear, Not taking ownership for their own wellbeing, and being Black or Latino.
Though I resist taking vaccines and most prescriptions, I am not foolish. I compliment not taking vaccines and medications with maintaining a high-quality lifestyle, including addressing diet, stress management, taking supplements, exercise, spirituality, and creative expression, with a strengthened spirit and state of emotions. This requires a lot of work.
It requires discipline that many don’t have or are too lazy to try. Taking a pill or shot is much easier for them. And once on prescription drugs and vaccines for years, it becomes difficult to impossible to ween off of them.
A particularly important reason why I will not take the COVID19 vaccine right away is that the vaccine really only prevents severe symptoms and possible hospitalization. It’s not known if this vaccine will protect a person for an extended amount of time, if vaccine recipients can still die, or if recipients can still transmit the virus. Millions of Americans could get the vaccine, and perpetuate it spreading even more. They may continue life with a false sense of security after getting vaccinated.
This huge disclaimer is because the vaccine has only been out for a few months. I am not sure if you realize it, but it took 50 years to develop the polio vaccine. It took I think about 20 years or so to develop the flu vaccine. The shortest development of a vaccine prior to the COVID19 vaccine is about 5 years!
This vaccine is coming out in a matter of months, so that has to mean that the completion of the clinical trials will be in real life when the vaccine is available to the public. Vaccines are always reformulating, so researchers will use that real public data to reformulate a better vaccine, based upon how people react in the general public. I don’t want to be a Guinea pig.
I’ve been exposed to Corona I’ve tested positive for it. I later tested negative repeatedly afterward. I never experienced many symptoms when I tested positive in late 2019. I was diagnosed at that time as having flu-like symptoms. It felt like a bad flu. I had body aches, overall weakness, and felt exhausted. But I didn’t lose my sense of taste or smell. And I didn’t experience many of the other symptoms of the coronavirus. I didn’t have problems breathing either.
I simply recovered with rest, nutrition, drinking lots of water, and taking lots of vitamin C, zinc, selenium, vitamin D, garlic, and I took a lot of probiotics. I got over it and moved on with life, never fearing COVID19, though practicing all of the recommended protocols.
Luckily right now I don’t have to worry about pressure to take the vaccine. I am not in the groups who are first recommended to get vaccinated. Those groups include the most vulnerable, elderly, and front-line workers. Coincidentally, those groups were predominately underrepresented in the COVID19 clinical trials and represent a significant percentage of Blacks and Latinos.
Additionally, some doctors are recommending that those who have been exposed to the coronavirus, wait, and allow the “priority groups” to receive the vaccine (to facilitate their further testing) immediately. That’s right in order for me because I can sit back and watch how the vaccine affects others, maybe a year or 2 later. Surely by that time, the vaccines will be reformulated. Some in trials now are being reformulated before release. By then I will decide if it’s something that’s necessary for me. …Probably not.
Doctors and scientists are saying that if the vaccine is given to 75% of the US population, herd immunity can be achieved. That says to me that I can be the 25% of the US population that never receives it. I can step back and not get the vaccine, allowing others who may be more receptive to it. Waiting, I can better discern whether I trust the vaccine. But I am just not comfortable right now.
I am not a fanatic about this issue. I don’t believe that millions or even tens of thousands will die from the vaccine. What I believe is that vaccines (and prescription drugs) can cause problems as it did with my friend’s high cholesterol, or heart, liver problems, kidney, or diabetes problems. Please keep in mind (again) that treatment for all of these conditions will come from the same drug makers that put the vaccine out.
I noticed, when I cared for my elderly mother, that the medical community makes decisions for you that you may not necessarily agree with. Let me explain. This vaccine has been touted by the medical and scientific community as being essentially the lesser of two evils, that the benefits of the vaccine are far greater than the side effects and consequences of getting it.
I want to make that decision for myself! When I cared for my mother there were medications that they wanted to give my 90+-year-old plus mother that they knew had dangerous side effects. When I questioned doctors, they would say that the benefit outweighs the risk. They would explain that my mother, being in her nineties, would not be around for much longer, and the side effects shouldn’t be much of a concern. One of her blood pressure prescriptions (one of three), Lisinopril, had the side effect of making her cough constantly and persistently. Doctors justified her taking it without giving her quality-of-life priority as I did. The same applies to a gallbladder surgery that doctors recommended, that my siblings agreed to. I did not agree with taking a 92-year-old woman’s gallbladder! I treated her naturally and she died with her gallbladder intact for nearly another 5 years.
As a caregiver for my mother, and through speaking with and observing other caregivers who were less meticulous than me, I realized that strictly following doctors on every treatment and procedure, for the elderly is a way of killing them legally.
If I would have followed every whim of the hospitals’ and doctors’ recommendations for my mother, as my siblings did before I took over, my mother would have died a much soon death, in a poor quality-of-life scenario. Their approach was the easy way out, as is for many Americans, especially African Americans. Running to the COVID19 vaccine and prescription medicine without feeling passionate to first take charge of health and lifestyle is foolish to me.
We have a constitutional right to decide what’s done with our bodies, and what we allow to be done with our bodies.
At this point, there’s a little bit too much uncertainty, and there are billions of dollars being poured into this effort. Billions of dollars of revenue will result from COVID19. It is quite likely additional billions in revenues will be generated from the side effects of the vaccine.
So, let 75% of the population achieve herd immunity. I won’t be taking the vaccine anytime soon, if ever. I am simply going to live well, holistically.
Please read our medical disclaimer statement. Alternative regimens work best if you practice a holistic lifestyle and believe in the benefits of the regimens you follow.
Why No Vaccine For Me
I believe that the COVID19 vaccine serves a good purpose for many people, especially for those who take vaccines. I have not had a vaccine in many years. I don’t remember the last time I had a vaccine of any kind, and I’ve done quite well, have been relatively healthy. To be quite honest with you I’ve been healthy than the people that take vaccines and prescription meds regularly.
I believe that the COVID19 vaccine is good for people who take vaccines, but my rationale goes a little bit further. I see a correlation between those people who take vaccines, those who run to prescription drugs on a regular, and who treat doctors like their saviors. I don’t do any of those things.
As you can see, I have many reasons for not jumping to the vaccine as soon as it comes out. I have found that not jumping to pharmaceutical solutions too quickly has caused me to elevate my role in my own health. I find that because I don’t take vaccines, and a bunch of prescription medicines, I take better care of myself. I eat better. I detoxify, sleep well, manage stress, exercise, meditate, and pray more. I do all things that are also beneficial to my health, and I don’t really fear this disease or any dis-ease, whatever you want to call it.
I simply live well, using the diagnostics of doctors, the tests, lab work, and the procedures that they diagnose to decide whether I want to go with a traditional approach, or with a nontraditional one. More often than not, I go with a nontraditional approach.
I believe that this vaccine is being built up a little bit too much. People are generally very gullible now because they are anxious to get back to normal, and want the economy to recover soon. They want to return to making money!
I have good reasons beyond just the fact that I’m a Black man, and that Black people generally don’t trust vaccines or the medical community. It is true that in history, medical practices were really geared for the White man. In fact, slaves had to depend on their slave masters to ensure that they received proper medical care. The slave master’s main objective was to put that slave back to work, so the slave just received medical care that was just adequate. Historically good medical practice has never really been for Blacks. It remains this way today. The majority of the subjects in clinical trials are White, even if the disease being researched affects Blacks disproportionately.
I won’t be running to take the COVID19 vaccine anytime soon. I want to be more in charge of my health and life. I want to be more responsible. I can’t say that I’ll never take it, but at this time, getting the COVID19 vaccine is not something that interests me.
I will not trust the vaccine when it comes out until many try it (about 2 – 3 years later), I will not even consider trying it. If I must die, let me go naturally.
I knew what medical research has revealed over many years. I have always done prudent research to find the other side of the story. That is why I am pragmatic about prescription drugs too.
Many Americans hold their doctors higher than their God. I don’t.
For example, Blacks have high Cardiovascular, Pressure, and Diabetes issues. But we are a small percentage of patients in the trials for these drugs, though we take them most.
I spoke to a hematologist just this week who agrees.
Racism goes deeper than most realize. Another example: My DSLR Camera has autofocus and auto light settings. It doesn’t calculate properly for Black people, especially those with more melanin.
The physiology, environment, lifestyle, diet, stress level, etc. are different for Blacks. This affects chemicals in our bodies and how vaccines and prescription meds affect us. In huge numbers, Blacks are taking prescription medications that were not tested specifically on us, even if we are the main users of those drugs. The Covid19 trials have about 10% Blacks, though the pandemic affects Black in a much larger proportion.
There are many reasons why I am skeptical about this vaccine. I list more below, with support.
What originally motivated me to do this post was a friend, Jenny. She is White, and I believe Liberal. But she wasn’t liberal when I mentioned that I wouldn’t take the vaccine. I told her about Blacks’ lack of representation in the trials, and she asked me, “Well, what about women.” Jenny didn’t realize it, but that response was laden with White Privilege.
I believe that the Black scenario circumstance is unique to everyone else’s. We cannot keep combining our issues with everyone else’s. It dilutes the importance of addressing our specific inequity and inequality. America must deal with Blacks exclusively and resolve our specific inequities and inequalities before we move on to trying to create a virtual melting pot that is imaginary. We cannot achieve a true Melting Pot America until there is full Equality and Equity.
I am just not sure that I want to take the COVID19 vaccine. I don’t want to ill effects on my God-granted body. The body is full of all kinds of chemicals, enzymes. hormones. Human bodily processes involve many chemical and electrical sub-processes. Introducing something different than what God intended, could be like substituting an ingredient in a recipe while expecting the same end result. This is too big a risk for me, so I won’t be taking the vaccine.
15 Reasons Why I Won’t Rush To Get A COVID19 Vaccine
- Reduces Symptoms Only – The vaccines only prevent severe symptoms and becoming hospital-bound from COVID-19. We only know that it makes symptoms milder. It is not known to cure COVID19.
- Length of Time To Evaluate – The length of time that it reports reducing symptoms is still unknown. Many of those who support The Lobster applaud him for cutting the red tape that delays the release of vaccines and new drugs. …The Lobster, the one who said that COVID19 was a hoax, and who prematurely recommended hydroxychloroquine, and injecting bleach into the veins, stupidly. The Lobster may have reduced the red tape, but he cannot speed up time. Time is necessary to evaluate something so far-reaching. Many of his supporters are pure racists. They figure that many of the poor, Blacks and Latinos will suffer most, which is not a concern of theirs.
- Transmission/Reinfection – It is unknown, after receiving the vaccine, if patients can become re-infected, as well as if patients can still transmit the virus. The vaccine does not seem to prevent the COVID19 virus, nor does it stop transmission.
- Fear-Based Decisions – I don’t make decisions based on FEAR. Many are frightened into rushing for the vaccine. Not me.
- CDC Is Big Pharma – My brothers once worked at the CDC. He died of cancer and found the CDC’s perspective on cancer research and treatment to be a farce. He led me years ago to distrust the US government and big pharma collaborations out the gate. The CDC and FDA’s board members are from Big Pharma, hospital interests, and politicians.
Is the CDC Sleeping With Drug Companies? You Decide…
“…CDC gets millions of dollars annually from Big Pharma and then turns around and recommends testing and drugs created and marketed by those same companies, and this is often done upon the contributing company’s demand.” Read More
- Money Influences – Money, the Economy, and Politics are involved the speed release and strong encouragement behind the vaccine. This can only be a bad influence on moral and humanitarian efforts. It always has.
Defining “Big Pharma”
What is Big Pharma, you ask? It’s a collective term to describe the world’s largest publicly traded pharmaceutical companies. While no concrete definition exists, the big difference between Big Pharma and just plain old “pharmaceutical companies” is market valuation, while the difference between Big Pharma and biotechnology is that Big Pharma has a more diverse product portfolio and pipeline. Big Pharma product portfolios are often mature, while biotech portfolios contain a lot more risk but offer a faster rate of growth. I like to think of the Big Pharma sector as being represented by the following 15 companies:
- Johnson & Johnson: $276 billion (market value)
- Novartis: $273 billion
- Roche: $248 billion
- Pfizer: $212 billion
- Merck: $164 billion
- Sanofi: $134 billion
- Bayer: $123 billion
- Novo-Nordisk: $118 billion
- Bristol-Myers Squibb: $115 billion
- AbbVie: $110 billion
- GlaxoSmithKline: $103 billion
- Eli Lilly: $98 billion
- AstraZeneca: $84 billion
- Teva Pharmaceutical: $59 billion
- Shire: $49 billion Read More
- Vaxxer For Other Vaccines – I have a history of objection to receiving vaccines. I haven’t in my adult life and fair well without them.
- Racial Exclusions – Very few Blacks or Latinos are included in the clinical trials though they represent two groups most severely affected by the virus. This is the case for clinical trial participation for other drugs that affect Blacks and Latinos most. Of the small percentage, it is unknown how many actually received the real vaccine and not a placebo.
Strategies to Support Better Development of Eligibility – Criteria and Increase Enrollment – FDA
Although there are several reasons patients can be excluded from clinical trials or are unable to enroll, participants in the public workshop highlighted a number of strategies to support better development of eligibility criteria and to increase enrollment:
- Improving Transparency and Increasing Patient Involvement in Clinical Trial Design – Participants called for more transparency in how eligibility criteria are determined. Patients screened for enrollment in a clinical trial may not understand why they were ultimately excluded from participation or how the eligibility criteria were determined.
- Re-examining Exclusion and Inclusion Practices – There may be longstanding eligibility criteria practices that unnecessarily limit eligibility for certain patient populations.
- Increasing the Use of Innovative and Alternative Trial Designs and Methods to Support Inclusion – Pediatric Studies – There is often a lag time after the completion of the adult trial before pediatric trials are undertaken, leaving practitioners with no choice but to utilize data from adults in their decision to treat children.
- Open-Label Safety Studies – Even if the population in the controlled trials is not broadened, it may be possible to gain experience in the broader population through open-label safety studies. Open-label safety studies are uncontrolled studies (meaning there is no control arm, and they are unblinded) and are usually conducted after the conclusion of phase 3 studies to obtain additional safety data.
- Clinical Pharmacology Approaches – For patient subgroups in which there may be differences in the systemic exposure of the drug, such as those with kidney or liver disease or the elderly, pharmacokinetic data may provide sufficient bridging information to generate dosing information for the purposes of labeling
- Other Possible Clinical Trial Designs – Incorporating a broad study population in a clinical trial enhances the generalizability of the results. Discussions addressed several design options that may enhance the inclusion of a broader population. One option discussed was using a design with a broader patient population but including only a pre-specified subset of the population in the primary analysis.
- Utilizing Data From Expanded Access – Workshop participants discussed expanded access programs as a pathway that can support broader patient access to an experimental drug. Expanded access allows access to an investigational therapy for patients with a serious or immediately life-threatening disease or condition who might not meet eligibility criteria for a clinical trial. FDA grants over 99 percent of sponsor and provider applications for expanded access. Read More
- Underrepresentation of Blacks – Because African Americans are challenging to recruit (or big pharma doesn’t try hard enough), the US Government allows Africans, Haitians, and other African-decent demographics to be used as substitutes for African Americans. Their immunity, social-economic factors, healthcare, diets, and lifestyles are different than those of African Americans.
As COVID-19 Vaccine Trials Move At Warp Speed, Recruiting Black Volunteers Takes Time
September 11, 20203: – NPR
“Trials are moving at a pace that is unprecedented for medical research, with the Trump administration’s vaccine acceleration effort dubbed “Operation Warp Speed.” Yet recruiting minority participants into these ongoing trials requires sensitivity to a legacy of mistrust based on past and current medical mistreatment, and that trust-building cannot be rushed.” Read More
- Win-Win For Big Pharma – They will likely benefit the most if the vaccine is determined to cause side-effect related medical issues further down the road.
- Unknown & Known Side Effects – Some vaccines under clinical trials have halted their research due to side effects. Sanofi GlaxoSmithKline’s vaccine not working well for those greater than 55 years. AstraZeneca is adjusting due to confusion with clinical trial doses. They are already reformulating. Some patients have already experienced serious side effects from the two approved vaccines.
- Unknown Long-Term Effects – Vaccine long term side effects are unknown beyond a few months.
COVID-19 Vaccine Safety – US National Library of Medicine – National Institutes of Health
“The cost-benefit tradeoff for a COVID-19 vaccine would be different for groups with different vulnerabilities to the disease. For simplicity, the target population for vaccination could be divided into 2 groups: The highly vulnerable, and the remainder of the population. The demographic population most vulnerable to the more severe consequences of COVID-19 tends to be the elderly with high comorbidities and others with compromised immune systems (2). It is a small fraction of the total population, although a somewhat greater fraction of the senior population.” Read More
- Intentional Exclusions – Those with allergic reactions, comorbidities, of certain racial demographics, and due to logistics, are often excluded from the clinical trials. But, when researched medications and vaccines become FDA-approved, they are not excluded from receiving them. This exists for various clinical trial excluded groups, not just the COVID19 vaccine.
- Manufacturing and Distribution Challenges – Think about this! Pharmaceuticals around the world are attempting to manufacture billions of doses of this vaccine, following various approaches. This is an unimaginable undertaking! Beyond this magnificent medical attempt, this seems like an insurmountable manufacturing and distribution undertaking. Please note that most vaccine recalls are due to quality assurance and distribution issues.
Why would a vaccine, or certain batches of a vaccine, be withdrawn or recalled? – CDC
There have been only a few vaccine recalls or withdrawals due to concerns about either how well the vaccine was working or about its safety. Several vaccine lots have been recalled in recent years because of a possible safety concern before anyone reported any injury. Rather, the manufacturer’s quality testing noticed some irregularity in some vaccine vials. In these cases, the safety of these vaccines was monitored continuously before and after they were in use. CDC analyzed reports to the Vaccine Adverse Event Reporting System (VAERS) to search for any side effects that might have been caused by the irregularity and found none. Any time such an irregularity is found in a vaccine lot which could make it unsafe, the manufacturer, in collaboration with the U.S. Food and Drug Administration (FDA), will recall it immediately. Read More
- Pure Racism – There is racism in medicine and clinical trials. This must be addressed directly for those demographics.
What Is Medical Racism? – Eric Bronson – July 21, 2020
Towards Anti-Racist Care – To truly abolish medical racism, we’ll need to attack it from each of these three angles. We need to make investments in improving the housing and environmental conditions for people of color, expand healthcare access to each and every person, and reform the medical education and training system to teach anti-racist medical practices.
Racism within medicine begins far outside of what we typically think of as the healthcare system. Black women are made less healthy by things such as increased levels of homelessness, or unsafe housing. Similarly, environmental racism means that Black people are much more likely to develop health conditions like asthma, due to the prevalence of high-polluting industries in and near Black neighborhoods.
- Health Disparities – are also part of the reason why people of color generally have higher mortality rates from COVID-19, as they are more likely to have a condition making COVID-19 more dangerous.
- Bedside Racism – Even when Black people do have access to healthcare, they’re discriminated against in the doctor’s office.
- No Door Open – While racism in our society from housing to hate crimes harms the health of Black people, they’re also much less likely to have access to healthcare to treat those conditions. Read More
Covid-19: why vaccine mistrust is growing | The Economist – 540,416 views•Nov 18, 2020 – The Economist
A vaccine for covid-19 could be rolled out before the end of the year. But a worrying rise in mistrust of vaccines threatens its effectiveness.
History of Vaccines – The Origin of Vaccines – Apr 28, 2016 – Open Mind
Vaccines 101: Origin of Vaccines – Mar 13, 2017 – Youreka Science
The Clinical Trial Process Explained From Study Start To Closeout – Apr 13, 2016 – Dan Sfera
The FDA Is Killing People and Has Been for Years – Apr 9, 2020 – Foundation for Economic Education
The Hidden Side Of Clinical Trials | Sile Lane | Ted X Madrid – Sep 28, 2016
The Tuskegee Study – Premiered Feb 7, 2020 – Black History in Two Minutes
Until Now, What’s The Quickest A Vaccine Has Ever Been Developed? – Tess Cagle – 7 Months Ago
In fact, the mumps vaccine was the quickest to have ever been developed, according to National Geographic. And that took four years, from collecting viral samples to licensing the drug in 1967.
Typically, vaccines take as long as 10-15 years to develop, according to the History of Vaccines. Researchers have to employ three phases to create one, beginning with testing animals before slowly moving to test on people. Development takes so long because researchers have to wait for thousands of healthy people to contract a virus and then volunteer to get the vaccine—unless they use ethically questionable human challenge trials. In a human challenge trial, people voluntarily get infected with a virus so they can test out the vaccine. Read More
Data from clinical trials are important in approving new medicines and discovering new treatments. But Big Pharma funds and runs most clinical trials. According to critics, this could allow drug companies to fake study results or hide dangerous side effects to get their drug approved or increase sales. Read More
New poll shows Black Americans put far less trust in doctors and hospitals than white people – Many report health care providers didn’t believe them and denied tests and treatment – BY JESSE WASHINGTON
Seven of 10 African Americans say the health care system treats people unfairly based on race “very often” or “somewhat often,” a notable increase from 56% when a similar question was asked in a 1999 poll. Read More
A draft guidance from the FDA calls on companies to consider nontraditional factors, such as geography, education, and income, to increase trial diversity. In its draft guidance, the FDA urges companies to consider locating trial sites in locations with higher concentrations of racial and ethnic minorities. The agency’s proposal also suggests companies hold trial recruiting events during evening and weekend hours to attract working adults and to consider recruiting sites such as churches and barbershops. Read More
Clinical Trials Have ‘Much Work To Do’ In Boosting Diversity – By Jennie Spinner – October 8, 2020 – Outsourcing Pharma
A recent story on NPR’s Morning Edition noted that about “40 percent of Americans belong to a racial or ethnic minority, but clinical trial participants tend to be more homogeneous.”
Lack of diversity in clinical trials is still a problem, despite that the fact that increased diversity in clinical trials has been on the National Institutes of Health’s (NIH) priority list for almost 30 years. Read More
Clinical trials in oncology, for example, represent a higher number of clinical trials than any other diseases across all countries, which is in line with the massive R&D spend across cancer indications.
This is understandable given that cancer is consistently one of the leading causes of death globally. However, less than 5% of adult patients with cancer have access to clinical trials, meaning that more than 95% of adult cancer patients may be missing out on potentially lifesaving new treatments. Read More
African American men are twice as likely to die from prostate cancer as white men, yet, they make up less than 5% of participants in prostate cancer clinical trials. Statistics like this motivated a recent article in the journal Cancer that examines racial disparities in clinical trials and calls for action to improve minority participation. The article, funded by a National Institute on Minority Health and Health Disparities grant and the National Cancer Institute, has reinvigorated debates regarding and ethics of participant selection. The debate queries the existing regulatory framework and leads to considering regulations that might catalyze or compel changing the demographics of clinical trial participants to better reflect both the population at large, and the population most vulnerable to the condition or disease probed by the trial. Read More
The U.S. is one of only 13 countries in the world where more women die in childbirth today than they did 25 years ago, and African American women are three to four times more likely to die than whites, said Harvard Chan School Dean Michelle A. Williams (podium), who was joined by Linda Villarosa (from left), Evelynn M. Hammonds, and Mary Bassett at the symposium, “400 Years of Inequality.” Read More
Without trial participation that is reflective of the general population, pharmaceutical companies and medical professionals are left guessing how various drugs work across racial lines. For example, albuterol, a widely used asthma treatment, was found to have decreased effectiveness for black American and Puerto Rican children. Many high mortality conditions, like cancer, also show different outcomes based on race.
Over the last decade, the pervasive lack of representation has left communities of color demanding higher levels of involvement in the research process. However, no consensus yet exists on how best to achieve this. Read More
Clinical Trials Need To Include More Black And Other Minority Participants. Here’s How – By Jocelyn Ashford – July 22, 2020
- Engage the target community in discussions around the recruitment plan.
- Recruit older Black participants for clinical trials is to engage the younger generation.
- Giving physician-investigators a goal for the number of Black participants they recruit, can help fill a clinical trial with a representative population. Black patients like to see Black doctors, so they should be among the investigators.
- When planning trials, companies tend to use similar guidelines and work with the same clinical sites time and time again. Establishing trial sites at clinics and medical centers with significant minority populations is a good place to start. Read More
Moderna vaccine trial lacks Black, Latinx and Indigenous participants – BY MEGAN CERULLO – AUGUST 25, 2020
The first U.S. phase three trial of a coronavirus vaccine has failed to attract a sufficient number of racial minorities, according to experts. The lack of diversity among participants reflects a long-standing obstacle and concern among health experts about drug trials. And while diversity in clinical trials is always essential, it’s even more vital in developing an effective COVID-19 vaccine, because the coronavirus has disproportionately affected minority communities. “It’s important that all clinical trials – not just vaccine trials – reflect the populations that will use the product or therapy in the real world,” said Bunny Ellerin, director of the Healthcare and Pharmaceutical Management Program at Columbia Business School. Read More
Clinical Trials Have Far Too Little Racial and Ethnic Diversity
This isn’t a new concern. In 1993 Congress passed the National Institutes of Health Revitalization Act, which required the agency to include more women and people of color in their research studies. It was a step in the right direction, and to be sure, the percentage of women in clinical trials has grown significantly since then. But participation by minorities has not increased much at all: a 2014 study found that fewer than 2 percent of more than 10,000 cancer clinical trials funded by the National Cancer Institute focused on a racial or ethnic minority. And even if the other trials fulfilled those goals, the 1993 law regulates only studies funded by the NIH, which represent a mere 6 percent of all clinical trials. Read More
For African Americans, clinical trial exclusion reflects institutional biases
According to the American Cancer Society’s 2018 report, racial and ethnic disparities in the disease burden point to the disproportionate poverty these communities face. Socioeconomic and environmental circumstances — for example, air pollution, stress levels from holding multiple jobs, and access to public transportation — can significantly contribute to conditions like cardiovascular, chronic diseases and cancer. “Racial and ethnic minorities tend to receive lower-quality healthcare than [non-Hispanic whites] even when insurance status, age, the severity of the disease, and health status are comparable,” the American Cancer Society report said. Clinical trial recruitment is often based on a study’s local demographics or the national population. The National Institute on Minority Health and Health Disparities’ Alvidrez said analyzing population subgroups by the risk specific diseases pose to them is vital. Oversampling, or examining a disease impact in a higher number of minorities than is reflected in the real population, may be a better approach, according to Alvidrez.
“You may want to stratify your sample, so you have 100 white men, 100 white women, 100 African American women, so on and so forth,” said Alvidrez, a program officer in the division of clinical and health services research. “That’s not going to reflect the U.S. population, but it will meet your analytical research question. I’d say representativeness as relative to U.S. population is not necessarily the best index of what minority inclusion should be.” Us Against Alzheimer’s chief of staff Jason Resendez said that because the industry tends to do what is cost-effective — clinical trials can run upward of several million dollars per phase — enrollment can be homogeneously white. Read More
Reparations as a Public Health Priority — A Strategy for Ending Black–White Health Disparities – List of authors Mary T. Bassett, M.D., M.P.H. – and Sandro Galea, M.D., Dr.P.H.
There has not been a single year since the founding of the United States when Black people in this country have not been sicker and died younger than White people. A growing consensus highlights a structural basis for these preventable disparities — structural racism — clarifying the need for a structural solution. Black reparations are one such solution and, we believe, a long-overdue approach to persistent Black-White health disparities in the United States. Read More
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