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Cruise Planners travel agent asks, "Why are travel companies mandating experimental COVID-19 vaccines?"

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Which COVID-19 vaccine statement sounds more appealing to you?

“For your health and safety our company requires you to get the experimental COVID-19 vaccine to travel with us. The experimental vaccine utilizes a type of genetic program like an operating system and is only authorized under an FDA Emergency Use Authorization.

“For your health and safety our company requires you to get the COVID-19 vaccine in order to travel with us.”

In looking at these statements, the first one gives more fidelity on the nature of the Moderna and Pfizer experimental COVID-19 vaccines, while the second one only gives a vague description. In early February, American Queen Steamboat Company and Victory cruise lines became the first American cruise lines to require the experimental COVID-19 vaccines for their clients. They were preceded by British cruise line Saga, which specializes in cruises for clients 50 years and older, and Australian airline Quantas. Crystal Cruises and Virgin Voyages recently mandated COVID-19 vaccines for all clients and Royal Caribbean International, in an agreement with Israeli authorities, is launching a fully vaccinated cruise from Israel.

The Moderna and Pfizer COVID-19 vaccines were developed in record time under Operation Warp Speed. What is not widely advertised about these vaccines is that they are still classified by the FDA as "experimental” or “investigational.” These terms are used synonymously by the medical community in regards to unapproved drugs. The FDA clarifies what the purpose of experimental / investigational drugs are and states:

“An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.”

For further clarification, the Center for Disease Controls (CDC) glossary states an investigational vaccine is: 

“A vaccine that has been approved by the Food and Drug Administration (FDA) for use in clinical trials on humans. However, investigational vaccines are still in the testing and evaluation phase and are not licensed for use in the general public.”

What this means is that experimental COVID-19 vaccines are still in their analytical phase in order to fully determine their safety and efficacy. As it stands now, millions of people worldwide are effectively volunteering themselves as “guinea pigs” before long term vaccine safety and efficacy data is known.

What exactly are the Moderna and Pfizer vaccines and how can they be used if they are experimental / investigational?

Many people may not be aware that the FDA didn’t approve the Moderna and Pfizer vaccines. You would think that when a vaccine recipient signs a COVID-19 vaccine consent form, “experimental or investigational” would be clearly stated. In the two vaccine consent forms I reviewed, it’s not. While one consent form from Florida states, “I understand this product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19)…,” another one cryptically mentions just the EUA. Both the Moderna vaccine fact sheet and Pfizer vaccine fact sheet for caregivers and recipients also state both drugs are unapproved vaccines authorized for EUA and that there is no FDA approved vaccine to prevent COVID-19, as shown below in the Moderna fact sheet extract.

“The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.”

“The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).”

These experimental COVID-19 vaccines are only authorized under an Emergency Use Authorization (EUA). The EUA is driven by the Health and Human Services declaration of a national public health emergency in January 2020. The long term goal of the drug companies for their vaccines is to get FDA approval based upon submission and approval of a Biological License Application (BLA). This approval is dependent on long term data collection supporting the vaccines safety and efficacy. The latest COVID-19 vaccine authorized under an EUA is made by Johnson & Johnson uses Viral Vector technology. It’s also not approved by the FDA.

The experimental COVID-19 vaccines are not like traditional vaccines

The numerous vaccines that many of us are familiar with contain live or dead fragments of a specific virus. As defined in the CDC’s glossary of terms, a vaccine is: “a suspension of live (usually attenuated) or inactivated microorganisms (e.g. bacteria or viruses) or fractions thereof administered to induce immunity and prevent infectious diseases and their sequelae…”

The Moderna and Pfizer vaccines don’t meet the CDC’s vaccine definition since those drugs do not contain “live or inactive microorganisms” in them. As such, these new vaccines are now referred to as mRNA Vaccines. The mRNA vaccines use a synthetic copy of messenger ribonucleic acid (mRNA) which is a molecule that sends genetic coding instructions to your cells to make the COVID-19 spike protein. The protein is the toxin, or antigen, which triggers anti-body production. The mRNA technology has never been previously used or approved in any drug for humans by the FDA and is also considered gene therapy by the American Society of Gene and Health Therapy. Moderna states on their website that mRNA technology, “functions very much like an operating system on a computer.”

Why are Travel Companies mandating experimental COVID-19 vaccines?

The short answer to this question is that, presumably, everyone in the travel industry wants to get back to travel and return to profitability. Some companies, like those mentioned above, may think mandating an experimental vaccine is one way to achieve this end state under the onus of health and safety of clients and employees. There is little doubt these travel companies have the health and safety of clients in mind, but are their decisions fully informed on the fact that these COVID-19 vaccines are experimental? Is it legal, or ethical, for a company to mandate that its clients, or employees, get an EXPERIMENTAL drug? “Employers are on shakier grounds because of the emergency use authorization,” said Robert Field, a law and public health professor at Drexel University, who added “there was no precedent for vaccine mandates during that phase.” Even the U.S. Department of Defense, which is in charge of Operation Warp Speed, won’t mandate the experimental vaccine on troops because the FDA has not formally approved it.  

The Nuremberg Code

The Nazi war crimes tribunal at Nuremberg published the Nuremberg Code in 1947, which established a new code of ethical standards for medical experiment on humans, stated that “…the person involved should have the legal capacity to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge of comprehension of elements of the subject matter involved as to enable him to make an understanding and enlighten decision.” Does a company’s mandate for a experimental / investigational vaccine, not widely advertised as such to the general population, violate the Nuremberg Code? Is mandating a experimental vaccine on clients to receive goods or services from a company constitute coercion? Are health care providers and government public health entities ensuring that all vaccine recipients know the Moderna and Pfizer COVID-19 vaccines are experimental / investigational? Are they adequately informing the public the vaccines are not approved by the FDA on the vaccine consent forms in order to enable "an understanding and enlightened decision" by people taking the experimental vaccines?”

Do research and make an informed decision on getting vaccinated, or not

We all want pandemic to end to get back to travel and normalcy, but we shouldn’t let short term results of experimental drugs determine long term strategic decisions. It may risk the health of clients and employees. Unlike the issue of mandatory COVID-19 testing requirements, these vaccines can have serious side effects, even death in some cases. Only short term safety data exists and there are also unanswered questions about the experimental vaccines. We don’t know how long any protection lasts, nor do we know if these experimental vaccines prevent COVID-19 transmission. Mandating approved drugs can be problematic by itself, let alone experimental ones. The FDA website documents 328 entries for drug safety recalls since August 2017. The swine flu vaccine fiasco of 1976 is also a cautionary tale on fast tracking vaccines. As of March 16th, 18 European countries have suspended AstraZeneca’s COVID-19 vaccine to investigate concerns about possible side effects, like blood clotting. Considering there is a significant history of failures and recalls for drugs of many types that were actually approved by the FDA, it seems irresponsible, and perhaps foolhardy, for travel companies to mandate experimental drugs like the COVID-19 vaccines. This is not an issue of being pro-vaccine or anti-vaccine. It’s an issue of ethical transparency with the public so people can make informed decisions what they inject into their bodies and to better assess risk. Estimate your risk from the effects of COVID-19 at websites like www.covidodds.com and the CDC’s website. In light of this information, I believe that injecting an experimental drug into your body should never be mandated by companies. Since the experimental vaccines are not fully approved, the former U.S. Surgeon General, Jerome Adams, stated, “Right now, we are not recommending that anyone mandate a vaccine.” The U.S. military won’t make it compulsory either, so let’s hope travel companies agree as well.

Regardless of your stance on the experimental COVID-19 vaccines, I’m standing by to help you get a great vacation, whether you have the vaccine, or not. I’ve taken six trips since the pandemic began in March 2020 and I hope you will join me in traveling the world. Check out my website at www.vacationlandandcruise.com and contact me at brad.striegel@cruiseplanners.com to book your next vacation!

Brad Striegel, Cruise planners

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