Vaccination for COVID-19 may be the Biggest Human Experiment Ever (and the Least Monitored)

Dear Leaders,

My friend and I were discussing the new vaccines for COVID-19 (coronavirus disease 2019) now that millions have already been vaccinated. COVID-19 is caused by a virus, a coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). My friend found this excellent review article about vaccines for coronaviruses:

Here are some thoughts about vaccines for COVID-19 from my perspective as a scientist with a Ph.D. Microbiology and Immunology (

In response to SARS (severe acute respiratory syndrome) coronavirus that emerged in 2002-2003 and MERS (Middle East respiratory syndrome) coronavirus that emerged in 2012, many studies have been conducted around the world in efforts to develop vaccines. However, these studies resulted in few human trials and no commercial vaccines for SARS or MERS.

Photo by CDC on

None of the studies used mRNA-based vaccines like the first two vaccines currently being used in the USA. The mRNA-based vaccine technology is relatively new. How well this new technology will perform with coronavirus diseases like COVID-19 is still to be determined. In fact, the mRNA-based technology used in the Pfizer-BioNTech COVID-19 vaccine was being developed for cancer treatment before COVID-19.

If the vaccine makers are really convinced of the safety and efficacy of their vaccines, then why did they insist on no liability before vaccinating? Studies about the safety of vaccines against SARS and MERS are relatively scarce. Nevertheless, there are concerns about adverse effects from vaccination or natural re-exposure. For example, antigen-dependent enhancement (ADE) can occur when non-neutralizing antibodies against viral proteins enhance entry to host cells and increase virus infectivity. That means getting vaccinated could actually help you get sick in some cases.

Operation Warp Speed was designed to quickly fund efforts by pharmaceutical companies to develop vaccines and drugs for COVID-19, financing manufacturing and guaranteeing purchase of vaccines ahead of clinical trials showing whether or not they work. In the USA, the federal government is spending up to $18 billion dollars on Operation Warp Speed. Some of the money was taken from funds originally meant to replenish stocks of medical protective gear, ventilators, and testing supplies, all of which have experienced shortages during the pandemic.

The idea is to develop a vaccine for COVID-19 in one year, even though that previously took about 10-15 years. This rush job is concerning from every point of view.  Driven by economic concerns more than health and safety, it is one giant conflict of interest. Who could say no to $18 billion dollars with no liability?

hands with latex gloves holding a globe with a face mask
Photo by Anna Shvets on

There are complaints that it is taking too long to vaccinate people for COVID-19. So why not hire more scientists? Retired and unemployed doctors and nurses have been asked back to work, but what about all the unemployed scientists in the USA? Now that pharmaceutical companies in the USA are making billions of dollars risk-free, will they hire back some of the tens of thousands of scientists they laid off in the last 20 years of mergers and acquisitions?

How many experts are getting paid to monitor all the people, including children and elderly, who have been vaccinated to see if they get COVID-19 or any adverse reactions in the short- and long-term? Who are these people and who is paying them? Are there experts who are prepared and funded to further investigate remaining questions and problems as they arise? Who is accountable to the public? How many regulators are overseeing vaccine production, distribution, and administration to ensure quality and consistency? Where are their reports to the public? The public has the right to know the outcomes of spending $18 billion tax dollars on vaccine development for COVID-19.

The new Pfizer-BioNTech and Moderna vaccines are both mRNA-based vaccines. The immunology is poorly understood. Unlike vaccines based on use of the whole SARS-CoV virus (live-attenuated or inactivated), the new vaccines require expression of viral components in host cells (your cells) to elicit a host immune response. The immunology is poorly understood.

It is still under debate whether long-term protection can be achieved by means of vaccination or even exposure to coronaviruses. More information is needed. Ultimately it will depend on the ability of the virus to gain advantages through emergence of variant strains faster than new vaccines can be developed. In the case of flu caused by influenza virus, vaccination is required every year and it is a guessing game which strains of the virus will be prevalent. If the vaccine makers do not guess correctly, then the flu vaccine will not protect against strains that are prevalent that year.

With the new COVID-19 vaccines, which cells are expressing the injected genes, and what is the fate of those host cells? It is possible that those parts of your body that take up the vaccine may be seen as infected cells and destroyed by your immune system. This can decrease efficacy of the vaccine and cause harm to your body.

Photo by Nataliya Vaitkevich on

In evaluating new technologies, the risk to benefit ratio is considered. A favorable risk to benefit ratio has not been demonstrated for COVID-19 vaccines, in my opinion. This is because efficacy is unclear, especially in light of new viral variant strains causing disease globally. Follow-up has not been long-term, and there are unresolved safety issues and severe adverse reactions such as anaphylactic shock that can be fatal.

The Oxford-AstraZeneca vaccine, recently approved for use in Britain and India, is based on a recombinant viral vector from another virus, adenovirus, that can infect host cells and that has been genetically engineered to express components of the coronavirus.

I am uncomfortable with the potential for recombination of viral vectors (e.g., in a co-infected host cell). Recombination of viral vectors can produce new viruses with unknown consequences. For more of that story and why I feel the way I do, see

When I finished my Ph.D. in human gene therapy and moved to a different laboratory in another state to work as a post-doctoral researcher, I got an adenovirus infection resulting in a really bad cold. At first, I could not understand why I was sick because I had already been sick from working with adenoviruses for the last four years and should have been immune. But then I realized this lab was using a different strain than the lab I had come from. I realized the limitations of containment of viruses.

COVID-19 vaccination may be the biggest human experiment ever, and should be documented in as much detail as possible.

Good sources of information in general: Reuters, WordPress, and DemocracyNow.

Lots of Love, Marie

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