Opinion article

16 of june - 2021

What do we know about
COVID-19 vaccines?

| Soyanne Muzard
  Columnist

It is not news that since the beginning of the coronavirus originated in Wuhan there has been a huge discrepancy and disagreement between the health strategies of the World Health Organization (WHO) and the reality of many scientists/physicians who give priority to the lives of patients. Since this pandemic entered the scene, according to official statistics the virus has spread to at least 206 countries and has killed more than 3,775,261 (1) people in the world. That is, approximately five out of every hundred (5/100) of 1% of the world's total population has died of COVID-19 (or 0.048% of the 7,673,533,970 total world population = 5 people out of every 10,000 people have died of COVID-19 in the world).

According to the World Health Organization (WHO) there are more than 200 COVID-19 vaccines in development to date, 60 are in the clinical phase, but only a few have managed to enter the market (2). Since inoculation began, approximately 2,434,125,035 (1) doses of vaccine have been administered worldwide.

 

How can we have an accurate and comprehensive perspective of what we are living today? I do not think it is wise to rely on a single source of information to understand the complex (unprecedented) reality we are facing. If we are rigorous, and we take the trouble to analyze the different positions in relation to this pandemic (see Annex 1) we will be able to have a broader view of these main lines of thought that have been formulated during this time. The different positions have been opposed since the origins of the virus, but both offer clues that should encourage us to investigate further. No one position provides all the answers.

Appendix 1| Delve into the different positions on the pandemic here:

 


 

WHAT ARE THOSE TESTIMONIES, DATA, AND

EVIDENCE THAT SUPPORT EACH OF THEM?

 

When we say we believe in science, we are generally talking about living things that stand or fall in time depending on their evidence. Its method is through observation and reasoning. Each new discovery is a benchmark for moving forward. The development of a vaccine is normally a long and complex process, and involves the combined participation of public and private organizations. In the case of vaccines in Chile, safety is guaranteed through the approval of a sanitary registration and subsequent surveillance by the Chilean Institute of Public Health (ISP). (5) The monitoring and evaluation of vaccine safety is carried out in the following stages:

  

  • Exploratory and preclinical stage lasting 5 to 10 years. It is performed without human beings. 

  • Clinical stage which lasts 9 years divided into 3 phases (3 different stages). It is performed with human volunteers. 

  • Regulatory review stage and post-approval stage that lasts during the whole time of use of the vaccine in the normal population.

The normal development time of a vaccine in Chile can last between 10 and 20 years approximately. Between antigen and adjuvant testing, animal testing, cell culture, etc.; small, medium and mass human volunteer trials, they evaluate the extent of the immune response, define the number of doses, efficacy and safety and identify common adverse events.(5)


After having completed these stages, the ISP would be ready to decide whether the vaccine meets the requirements of safety, efficacy and quality to be used by the population. And the process continues, the product is checked for compliance with quality standards and finally the events attributable to vaccination and immunization are monitored. It is a complex and linear process that takes years.

In the case of COVID-19 vaccines, the ISP (5), CDC (6), FDA (7) say that they are using technologies that had been developed for other coronaviruses (such as SARS and MERS) (8), which had already been tested in experimental animals. Therefore, the normal timelines have been modified and adapted to "accelerated development", where research and regulatory process times are shortened, in addition to accelerating and even overlapping the experimental stages of clinical and preclinical trials. 

 

The FDA says the accelerated vaccine development time for COVID-19 is approximately 18 months. 

 

At present, no coronavirus vaccines in the US are licensed but are licensed on an emergency basis by the FDA. At present, the agency has licensed three for emergency use. (9)

These include vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson. The latter was suspended and then reinstated after potentially dangerous blood clots formed in a small number of women according to the CDC.


The U.S. Food and Drug Administration (FDA) plays the role of protecting the United States from threats such as emerging infectious diseases. (10)

Emergency use authorization (EUA) is the authorization that allows a vaccine to be made available prior to full approval (or licensure) in the event of public health emergencies. FDA can revoke EUA at any time. (9)

 

What are the criteria that must be met for vaccines to be fully approved by the FDA? How long does it take for a vaccine to be fully approved by the FDA?" 


Applying for a license is no joke: there are 21 pages of criteria for a Biologics License Application (BLA) for the COVID-19 vaccine on the FDA website. They take into account chemistry, manufacturing and clinical trials. They typically expect manufacturers to provide data from study participants at least six months after vaccination when they apply for a license. (11)

Applying for a license is no joke: there are 21 pages of criteria for a Biologics License Application (BLA) for the COVID-19 vaccine on the FDA website. They take into account chemistry, manufacturing and clinical trials. They typically expect manufacturers to provide data from study participants at least six months after vaccination when they apply for a license. (11).

WHAT ARE THE WHO-APPROVED COVID-19 VACCINES? (13)

Since the Covid-19 pandemic began, WHO has approved only seven vaccines for emergency use, based on their safety and efficacy.

 

Pfizer-BioNTech (13A)

Johnson & Johnson (13B)

Moderna (13C)

Sinopharm (13D)

AstraZeneca's two versions (in collaboration with Oxford and the Serum Institute of India) (13 E)

Coronovac's Sinovac. (13F)

 

Vaccination against COVID-19 in Chile started on December 24, 2020. Since then, more than 10 million people have been vaccinated (14). At that time, there were five operational vaccines in the country.(15) Due to 6 cases of thrombosis detected in the USA, the European Union, South Africa and the FDA suspended the Johnson and Johnson vaccine and recently (as of June 10) the ISP authorized it for emergency use. (16) On May 31, inoculation with the Pfizer-BioNTech vaccine was approved for children between 12 and 16 years of age.(17).


Of the 206 countries in the world infected by the virus, (18) in slightly more than half of them, i.e. 105 countries, between 1 and 1,000 people have died in each country to date (June 16).

Captura de Pantalla 2021-06-21 a la(s) 10.31.25.png
Captura de Pantalla 2021-06-21 a la(s) 10.31.43.png

To date, in the United States 600,287 have died of COVID 19 out of a total of 328,239, 523 people, or 0.018% of the 328,238,523 total population.  Approximately 2/100 of 1% of the total U.S. population or two people out of every 10,000 people have died from COVID 19.

 

To keep this pandemic in perspective, during the Spanish Flu of 1918, 500 million people worldwide were infected with the virus (approximately 1/3 of the population) and approximately 50 million individuals died, including 675,000 Americans in just 18 months. (19)

And the only infectious disease that has been eradicated in humans is smallpox. It took 200 years to eradicate it after at least 3,000 years in which this infection was present in the world. Smallpox was officially declared eradicated by the World Health Organization in 1980. (20) And it was not asymptomatic and is not transmitted to animals.

 

At all levels, we hear that coronaviruses are going to be part of the new normal. That the variants will continue and that being vaccinated is the only thing that can stop the advance of deaths.

WE SHOULD ASK OURSELVES SOME HARD QUESTIONS:

  • How many people die from flu each year in the world? Why do we attribute almost all hospital deaths to coronaviruses when they are NOT the cause of all those deaths? In other words, how many people would normally die anyway? What is the actual increase in death rate or average from previous years?

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  • Why is this virus so particular in its effects that many people don't get it or get over it quickly? Why are the manifestations so different?

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  • Why do governments and CDC, WHO, etc. not provide answers about specific demographics?

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  • How is it explained that statistics vary so much from country to country? 

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  • Why is there no questioning of the intent of the Chinese and what nefarious plans caused such an "accident"?

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  • Why does the Culture of Cancellation stifle our ability to debate these questions?

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  • What is the long term effect on the world if this pressure to vaccinate against a disease that generally occurs infrequently produces worse effects (heart inflammation, etc.) than the virus itself?

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  • Is Dr. Fauci being investigated for his deviations and misinformation?

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  • Why do many people upon receiving the first dose of Sinovac become infected with the virus immediately? 

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  • Clearly, there are still no scientific or legal timelines in place to confirm that vaccines are safe. If this is so, how could we be vaccinating underage children? 

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  • What if the FDA or ISP decide not to approve or withdraw approval of some of the vaccines that have already been used by millions of people because of new adverse events?

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  • Why are so many scientists and physicians in the world opposed to current vaccines?

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  • Why have the sanitary measures that have been implemented in many countries such as quarantines and masks not made a real difference in the number of infections?

WHAT DO THE EXPERTS HAVE TO SAY ON THE SUBJECT?

 

Geert Vanden Bossche, DMV, Ph.D., an independent virologist formerly with Gavi, The Vaccine Alliance and the Bill & Melinda Gates Foundation says that the COVID vaccines approved so far have been developed by simply brilliant people and he has no criticism of them. But, he also says, "Please use the right vaccine in the right place. And don't use it in the middle of a pandemic on millions of millions of people." Bossche says that a mass vaccination campaign in the middle of a pandemic, with vaccines that do not prevent transmission, is disastrous on an individual and global level. In an open letter to the World Health Organization (WHO), Bossche wrote that "we are currently turning vaccinees into asymptomatic carriers shedding infectious variants."

Dr. Byram Bridle, Scientist Professor at the University of Guelph in Canada, Ontario Viral Immunologist says "the Spike Protein in vaccines is a very dangerous toxin." 

 

"Scary" new research finds that vaccine spike protein unexpectedly increases in the bloodstream. The protein is linked to blood clots, heart and brain damage, and potential risks to nursing babies and fertility.

The Doctors for COVID-19 Ethics group, co-founded by former Pfizer vice president Michael Yeadon, has more than 160 medical experts from around the world including Professor Sucharit Bhakdi MD, former president of the Institute of Medical Microbiology and Hygiene at Johannes Gutenberg University Mainz (Germany), and Dr. Wolfgang Wodarg, former head of the Health Committee of the Parliamentary Assembly of the Council of Europe have written several letters to the European Medicines Agency on issues related to the COVID-19 vaccine and are continuously censured. They have specifically warned against vaccines, such as those produced by Pfizer and Moderna, that are based on the new mRNA vaccination method.


Former Pfizer vice president Dr. Michael Yeadon: "I have two healthy adult girls, 25 and 29 years old, and I would be very upset if they ended up being forced to take these products because they are healthy and young, and there is no measurable risk from COVID-19."

Dr. Geert Vanden Bossche.jpg
Geert Vanden Bossche
Dr. Bryam Bridle
Dr. Michael Yeadon

We have seen that despite all the efforts to vaccinate the world's population against COVID-19, there are many variants in the process. In particular, there is no guarantee that the vaccines will be 100% effective, nor do we know their long-term implications and results, since they have been implemented as an emergency, bypassing all the timelines established by the same agencies that want to guarantee their safety. 

The purpose of this article is that you can have a better perspective on this controversial issue such as COVID 19. That you can weigh the pros and cons of getting vaccinated or not, and make a responsible decision and not moved by fear or social pressure. All the links here are meant to give you a more complete picture of what we are living and experiencing. I encourage you to go deeper. It is our responsibility to go to these sources of information and develop critical thinking in all situations.

REFERENCES:

(1) Scorecard from the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU).

 

(2) Coronavirus Vaccines in development

 

(3) The Origins of COVID-19: Policy Implications and Lessons for the Future

 

(4) 27 experts launch citizen petition calling on FDA to "slow down and do things right" before approving COVID vaccines

 

(5) ISP Vaccine Development Phase

 

(6) What are Emergency Use Authorizations (EUAs)?

 

(7) GUIDANCE DOCUMENT

Emergency Use Authorization of Vaccines to Prevent COVID-19

 

(8) How do SARS and MERS compare with COVID-19?

 

(9) Vaccines licensed for use in the United States - FDA

 

(10) What is the U.S. Food and Drug Administration (FDA)?

 

(11) Biologics License Application (BLA)

 

(12) European Medicines Agency 

 

(13) What are the Covid-19 vaccines approved by the WHO?

 

(13A) Pfizer-BioNTech 

 

(13B) Johnson & Johnson 

 

 (13C) Moderna 

 

 (13D) Sinopharm 

 

 (13E) AstraZeneca's two versions (in collaboration with Oxford and the Serum Institute of India)  

 

(13F) Coronovac's Sinovac

 

(14) Ministry of Health of Chile  

 

(15) Vaccines being administered in Chile by December 2020

 

(16) Approved Emergency Vaccines used to date in Chile 

 

(17) Vaccine approved for minors in Chile 

 

(18) Number of people killed by coronavirus in the world as of June 4, 2021, by country

 

(19) Spanish Flu 

 

(20) Smallpox Eradication