Many fear the rapid rollout of new vaccines

By Nathan Tsukroff

AUGUSTA – “Operation Warp Speed” was intended to facilitate and accelerate the creation and distribution of a COVD-19 vaccine.

That very same rush to the finish line now has a percentage of Americans, both healthcare workers and regular citizens, concerned that the vaccines have not been tested enough or been around long enough to be safe.

Then-President Donald Trump announced OWS in May 2020 from the White House Rose Garden.

This parternership between the Departments of Health and Human Services and Defense helped to motivate companies around the globe to develop anti-virus vaccines, and the start of manufacturing during clinical trials, along with concurrent clinical trials, led to an emergency use authorization by the U.S. Food and Drug Administration by the end of the year for both the Pfizer-BioNtech and the Moderna vaccines. The Johnson and Johnson Janseen single-dose vaccine received emergency use authorization in February 2021.

Katie Rodzen of Greene, a registered nurse who started working at Maine General Hospital in Augusta shortly before the pandemic hit, said she doesn’t trust any of three vaccines against COVID-19

The current COVID-19 Moderna and Pfizer vaccines are manufactured, not made from small amounts of a virus.

This process, referred to as mRNA, or messenger RNA, inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. What is essentially a little piece of code created in the mRNA process is delivered to the cells in a person’s body. The code serves as an instruction manual for the immune system, teaching it to recognize the virus that causes COVID-19 and attack it, should it encounter the real thing.

And that is one of the reasons healthcare workers such as Rodzen do not feel the Moderna and Pfizer vaccines against COVID-19  are safe, which is why some of them are pushing back against the recent vaccination mandate from Maine Governor Janet Mills.

Previous vaccines, such as those for polio or smallpox, were manufactured using small amounts of the virus itself, which triggered the desired immune response.

The Johnson&Johnson Janssen COVID-19 vaccine is made with that more traditional method that uses a disabled adenovirus to deliver the instructions.

The Pfizer vaccine was fully approved last week by the FDA for use by anyone 16 years old and older.

However, the push for quick approval of the various vaccines has kept Rodzen worried. “The FDA approval did not change my concerns about the safety of the COVID-19 vaccines,” she said. “The FDA has approved other medications that after years of use have turned out to be harmful.”

Donna Harris from Auburn, who asked that her workplace not be mentioned, echoes that sentiment. “I think the big debates is why is it being mandated before long-term human study results are completed,” she said. “It should not be mandated until we have a five-year study of those who received the vaccine, and the results of (that) study, both on effectiveness and long term side effects.”

Only after that should a mandate be allowed, although only at the local levels, not the state or federal levels, Harris said.

In the early 1950’s, poliovirus outbreaks across the United States caused more than 15,000 cases of a paralysis a year. The paralysis could be in just the arms or legs, or could spread to the lungs, requiring the patient to be placed in a device called an “iron lung” that helped them to breath. Less than 1% of poliovirus infections resulted in acute flaccid paralysis, which is defined by the acute onset of weakness or paralysis with reduced muscle tone in children.

Polio was first identified in around 1835 with four cases in Europe. The annual outbreaks eventually became severe, spreading throughout Europe and the U.S. at the beginning of the 20^th century. In 1916, a major outbreak in the Northeast was attributed to 27,000 cases and 6,000 deaths.

A trial of a polio vaccine with inactivated viruses by Maurice Brodie in 1935 involved 20 monkeys first, and then 3,000 children in California. Angry reactions from other researchers cancelled any further projects, and polio vaccine trials were not tried again for another 20 years.

In March of 1953, Dr. Jonas Salk announced he had successfully tested a vaccine against the polio virus. This followed an epidemic year for polio in 1952 with 58,000 cases of polio and 3,000 reported deaths across the U.S. Clinical trials began in 1954, using both the Salk vaccine and a placebo on some two million school children. The vaccine was announced a safe and effective in April 1955 and a nationwide inoculation campaign began.

Variations of the polio vaccines, both the Salk version and those created by other scientists, were used around the world over the next two decades. However, different variations of the vaccines, and the occasional manufacturing issue, allowed outbreaks and spread of the virus in various years. It was only after many years of use and study that the most effective and safe vaccines helped to essentially eradicate polio from the U.S.

This history is what gives both Rodzen and Harris cause for concern.

Rodzen said that she, like all healthcare workers in Maine, has been properly immunized against diseases as required by the Maine Department of Health and Human Services. Vaccines are given to prevent rubeola (measles), mumps, rubella (German measles), varicella (chicken pox); hepatitis B, and influenza.

Rodzen also said she is okay with being required to wear a mask during her work, because masks are removable.

Harris said, “I do not support any mandates, be it for vaccine or masks, because I believe that we should have individual freedom over our bodies.”

She believes that getting vaccinated or wearing a mask should by choice. “Much like a parent does not always agree with their adult child’s choices, yet as part for their growth we let them do so. We can only educate them as best as we can, make them aware of the pros and cons of their choice, and then let their path unfold. So too should the government with its people.”

The process for the modern mRNA vaccines has been in use for about 10 years. Scientists now are able to actually view viruses with electron microscopes.

The worry on the part of scientists regarding vaccines remains an unexpected reaction in some humans.

While humans are very much alike, there are still enough variations between humans that what is found to be effective in one person may cause problems in another person.

Scientists suggest that determining the safety of a vaccine should not be just counting the number of severe issues, but rather looking at overall trends of minor issues that could have been triggered by a vaccine.

That is the reason for the concern by some parents that a vaccine could be the cause of autism in children.

In 1998, a study published in the medical journal The Lancet claimed that measles vaccines were found in most of a dozen children with autism. However, over the next 12 years it was revealed that the main author of that study, Andrew Wakefield MD, had been paid by attorneys seeking to file lawsuits against the vaccine manufacturers. This led to a retraction of the interpretation of the study by many of Wakefield’s fellow authors, and the paper itself was formally retracted by The Lancet in 2010. Wakefield was later reported to have committed research fraud for the study.

Harris said she takes a holistic approach to the COVID-19 vaccines. “I know that when it comes to Covid-19 and this human experience that we are all having, the commonality is fear,” she said. “Many that chose to get vaccinated did so out of fear that the virus would cause illness or death, while many that chose not to get vaccinated did so out of fear that the vaccine would cause illness or death.”

“When you look at it from this perspective you can see that we are all having the same experience only with a different perspective of the fear that cripples us all.  To quote Master Yoda – ‘Fear leads to anger, Anger leads to hate, Hate leads to suffering!’.”

Regardless of personal feelings about a vaccine, Maine is an at-will state, which means that an employee without a personal or union contract can be fired for any reason. So a hospital can declare that all staff members mut be vaccinated, and can fire any workers who do not comply.

There are exceptions under Title VII for medical and religious reasons, and a reasonable exception must be made by the employer, so long as that exception does not cause an undue hardship for the hospital. A nurse who did not wish to be vaccinated could be shifted to office duties away from other staff members or patients, for example.

The mandate issued by Gov. Janet Mills early in August requires all healthcare workers in Maine to be vaccinated against COVID-19 by Oct. 1, but does not refer to any exceptions for medical or religious reasons. It also does not require non-compliant healthcare workers to be fired. Instead, the mandates says that non-compliance by healthcare workers could affect the licensure of the healthcare facility. This places the decision for firing in the hands of the hospital or other healthcare facility.

Hospitals and other healthcare facilities throughout Maine have said employees who are not vaccinated by the deadline will be fired.

Rodzen said she has still not made a decision on getting the vaccine, but expects she will step away from the hospital after the deadline. She said she knows of other nurses who have already said they will leave the hospital.

About 20% of healthcare workers in Maine remain unvaccinated, according to the Maine CDC.