#BTColumn – COVID-19 vaccines – risks versus benefits

Disclaimer: The views and opinions expressed by the author(s) do not represent the official position of Barbados TODAY.

1. What is the Food and Drug Authority (FDA)?
“FDA is globally respected for its scientific standards of vaccine safety, effectiveness, and quality.” The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by the FDA or authorised for emergency use.

FDA recognises the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 – vaccines that the public will trust and have confidence in receiving.”

2. What is an Emergency Use Authorisation (EUA)?
“An Emergency Use Authorisation (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.

Under a EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit a EUA request to FDA”.

Once submitted, FDA will evaluate a EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.”

Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people.
I

n phase 3, the vaccine is generally administered to thousands of people in randomised, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on the effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.

For a EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

A EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of the phase 3 clinical efficacy trial
or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery.

Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.

1. What decision-making is expected of those being vaccinated under a EUA?
FDA must ensure that recipients of the vaccine under a EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorised the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.

2. Should everyone be given the COVID-19 vaccine?
Not everyone can be vaccinated against COVID-19. People with specific allergies should not be given certain vaccines, and we have insufficient data on whether current vaccines are safe for children, pregnant women, and those with compromised immune systems, including people with HIV. Ref. CDC.

3. Are the COVID-19 vaccines safe?
The CDC says that “COVID-19 vaccines are safe and effective”. Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.

CDC recommends you get a COVID-19 vaccine as soon as possible. If you are fully vaccinated, you can resume activities that you did prior to the pandemic. Learn more about what you can do when you have been fully vaccinated.

The CDC does acknowledge that “Serious adverse events after COVID-19 vaccination are rare but may occur”. https:// www.cdc.gov/coronavirus/2019-nCoV/VAERS reported that on August 13, 2021, that there were 6,490 adverse vaccine-related deaths occurred. https://www.cdc.gov/coronavirus/2019-ncov/ vaccines/safety/adverse-events.html Some argue that more persons have died from COVID-19 vaccines than from all the other vaccines over the last 20 years.

Some argue that this is not so since VAERS data submissions have to be verified for the actual cause of death.

Was the VAERS data for all the other vaccines over the last 20 years treated similarly? What if only 25 per cent of the 6490 figure is directly caused by COVID-19 vaccines, is this acceptable? Not at all.

People’s lives cannot be equated with a cost-benefit analysis of “the benefits outweigh the cost” (by what ratio? Does it matter?) Or with some small probability that it would not affect someone negatively or kill them.

The average depth of a river may be 5 feet, at 6+ feet tall may step into the river and drown in 12 feet of water.

This is all for a disease that kills just over one per cent of those infected in Barbados.

How many breakthrough infections are there?

The CDC stopped counting all breakthrough infections for those fully vaccinated from May 1, 2021, and only now count those breakthrough cases that result in hospitalistion and death.

But the CDC continues to record total infections, total vaccinations, and total deaths from COVID-19, percent of population vaccinated, but not total breakthrough infections? What about the percent of the infected who recovered? Is this above-board behaviour? Does Barbados also provide this information? What is the recovery rate for those who contract COVID-19?

According to https://www.worldometers.info/ coronavirus/?utm_campaign=homeAdUOA?Si as of August 19, 2021, worldwide 210,014,695 became infected with COVID-19 and 4,403,873 have died, this represents a death rate of approximately 2.1 per cent and a recovery rate of 97.9 per cent In the case of Barbados a total of 4467 (adjustment made for the number presently in quarantine) and 48 have died. This represents a death rate of those that became infected of 1.07 per cent and a recovery rate of 98.93 per cent, https://www. worldometers.info/coronavirus/country/barbados/.

We must also consider that the vast majority of persons that died are over the age of 60 and more so over 70 years and also had other core morbidities. Why is there the threatening push to vaccinate the whole world with some vaccines that are made with previously untried genetic technology, have not completed the longitudinal aspect of the post-vaccine follow-up for safety (about two years or more) and other chemicals which should not be in our bodies even if in small amounts? The question also is, why is there so much fear-mongering when the vast majority of those who contract the COVID-19 virus recover even before the vaccines were used 98.93 per cent? We should compare this figure with other virus diseases that may be less contagious but have a significantly higher death rate? How many breakthrough cases are there and how many have died as a result of using the vaccines? More than 4,100 people have been hospitalised or died with COVID-19 in the U.S. even though they’ve been fully vaccinated, according to new data from the Centers for Disease Control and Prevention.

So far, at least 750 fully vaccinated people have died after contracting COVID, but the CDC noted that 142 of those fatalities were asymptomatic or unrelated to COVID-19, according to data as of Monday that was released Friday. https:// www.cnbc.com/2021/06/25/covid-breakthrough-cases-cdc-saysmore-than-4100-people-have-been-hospitalised-or-died-aftervaccination.html. Add to this the number worldwide.

Massachusetts health officials on Tuesday reported more than 2,500 new breakthrough cases over the past week and 18 more deaths. In the last week, 2,672 new breakthrough cases — infections in people who have been vaccinated — were reported, with 496 more people hospitalised and 18 new deaths, officials said Tuesday. That brings the total to 12,641 cases and 124 deaths in people with breakthrough infections. https:// www.nbcboston.com/news/coronavirus/massachusetts-newcovid-breakthrough-case-data/2 “July 30, 2021, 3:42 PM -04 / Updated July 30, 2021, 5:05 PM -04

By Laura Strickler

WASHINGTON — At least 125,000 fully vaccinated Americans have tested positive for COVID-19 and 1,400 of those have died, according to data collected by NBC News.

The 125,682 “breakthrough” cases in 38 states found by NBC News represent less than .08 percent of the 164.2 million-plus people who have been fully vaccinated since January or about one in every 1,300.”

https://www.nbcnews.com/health/ health-news/breakthrough-covid-cases-least-125-000-fullyvaccinated-americans-have-n1275500 https://theconversation.com/most-covid-deaths-in-englandnow-are-in-the-vaccinated-heres-why-that-shouldnt-alarmyou-163671.

This should not happen since the argument was that younger people did not need vaccines, only the high-risk groups. Are not persons over 70 part of the high-risk group that is protected? I know the explanation that will be given as was given in the article, that is, this is a new variant, the Delta variant. There is a reason why we never had a Corona vaccine that worked over the decades passed, coronaviruses mutate quickly.

Whatever the argument is this is not supposed to be so high for any vaccine. It would appear that the synthetic COVID -19 vaccines are no more than boosters that reduce the impact of the virus to cause hospitalisation and death. There are other safer known medications and therapies that also boost the immune system and reduce hospitalisation and death without using risky, previously not used gene therapy and other toxic chemicals, the long-term effects of which on humans are unknown.

We cannot return to the people of this country and tell them you made a mistake, you should have waited for the long-term results. Of note, my sister-in-law and her boyfriend both cancer patients, both had COVID-19, one was taken to Harrison’s Point and the other to a hotel, both used non-vaccine therapies, and both were discharged and sent home after the quarantine period was up. Oh, one is nearly 60 and the other near 70 years of age.

There is too much fear-mongering which is leading to persons being ready to victimize others.

What is the CDC definition of the vaccine?

“A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.”

https://www.google.com/search?q=how +does+the+cdc+define+a+caccine%3F&rlz=1C1GCEU_enBB9 29BB929&oq=how+does+the+cdc+define+a+caccine%3F&aqs =chrome..69i57j0i13i30j0i390l3.15588j0j15&sourceid=chrome &ie=UTF-8

The vaccines currently provided may stimulate a person’s immune system to produce antibodies but definitely no immunity to the COVID-19 disease. Persons are not protected from catching or spreading the disease in a manner equal to those who are unvaccinated. Let the unvaccinated make an informed decision, as time and data become more available it will show that the unvaccinated are the ones at more risk of being infected equally from vaccinated and unvaccinated.

There are too many contradictions, conflict of financial interest, constantly changing and contradicting so-called evidence, changing definitions and laws, constantly changing rationales, politicisation of COVID-19 vaccines, and so on…

Are COVID-19 non-vaccine measures working?
It is clear that most of the COVID-19 measures will work but they require the discipline of all Barbadians to be effective.
The population of Barbados needs to cooperate. When the longitudinal 3rd stage trials are over (18 months to two years after vaccines were administered) I will take the vaccine if the death rate increases to more than 2.1 per cent. Bajans should avoid travelling unless necessary. Neither the unvaccinated nor the vaccinated are fully protected. Only that one may be believed to be a little better protected.

Recommendations:
1. Government may encourage but not force nor allow employers to force workers by removing their employment.
There are international conventions, the Constitution of Barbados, the Employee Rights Bill, and so on that say this is illegal. Governments are established to protect the people of the country, the employers also have rights to protect their work environment, but should not be allowed to interpret those rights to be in breach of the laws that protect the employees.
Remember government passes the laws and are to ensures that they protect the rights of the people over the economic interest of the business class.

2. Negative PCR tests weekly, do not report for work; autonomy over their bodies;

3. Unvaccinated persons causing undue risk to the vaccinated persons is largely untrue and this argument should be discontinued. It is unvaccinated that is being infected by the vaccinated at a rate similar to the infections that come from the unvaccinated. Let the unvaccinated weigh their risk of infection from the vaccinated and unvaccinated and respect their right to self-determination on this issue.

4. If tourists who we are begging to spend their money here in Barbados require that persons dealing with them be vaccinated, then move the unvaccinated to the back office until the COVID-19 crisis abates, longitudinal (not short-term or interim) studies on the safety of the COVID-19 vaccines are in (in about another year or two) and the majority of persons presently declining a vaccine, including myself will reconsider.
If employers do not want to do this, then try working from home. If not practical in the worker’s current position, do so in another position, if not, make the person redundant with full severance plus a package in lieu of unfair dismissal charges being brought. Some workers will agree. A consideration for re-employment after the crisis is resolved in a year or two.

5. Testing yes, but there may be other methods that are less invasive that may be efficacious and the cost should be shared by the employer and government, or in an extreme case, the cost may be shared by all. And surely requesting that a PCR test be done weekly or every three days is very onerous, and in my view, may be considered to be a constructive obstruction that may constitute force by the employer.
6. All workers who are intent on exercising their right to not take the vaccine should note and pursue the following:

• Demand that your employer has an authorised representative present to sign an assumption of liability agreement for your employer or school to assume liability for any injury or sickness or death that may occur from following your employer’s or school’s vaccine mandate;

• After the clinical trials are completed in two years and the safety data is analysed and available so that employees, parents, and students may provide informed consent. Let your employer be bold and heartless enough to fire you, you may then bring a lawsuit against them for wrongful termination. Under no condition should you quit your job or school.

• Forced vaccination is against the Nuremberg Code accepted worldwide, the Geneva Convention, the declaration of Geneva, the UN Charter, the UN constitution, the Labour laws, and the Employee Rights Bill of Barbados. The government’s responsibility is to protect the rights of not just the many but also the few – that is true republicanism. Rights and laws should not be given when there is peace and justice and unceremoniously removed by the government/business class or vote of the majority when those rights are needed because they are now being tested. Otherwise, what is the purpose?

7. Democracy versus republicanism. Barbados is considered to be a democracy and is presently considering the transition to a republic. One must recognise, at least in theory, that while in democracies, the majority is considered to rule, and with republicanism, the system recognises that though the majority may rule that rule must not be as a consequence of the rights of the individual. I think we must take note of this. History will judge our actions.

This article was submitted as a Letter to the Editor.