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Skepticism over fast-tracking new vaccine continues

Updated: Dec 17, 2020

By Tara Bailey

-Did you Know?-

→ Did you know because of the seriousness of the COVID-19 pandemic, vaccine regulators’ fast-tracked steps toward approval? The Food and Drug Administration can permit emergency authorization for the use of a COVID-19 vaccine in the third phase of clinical trials. If the results show the vaccine is safe and effective, then it will receive the green light for distribution. But is this enough reassurance for the public?

Darcia Reed, of Crafton Heights, said she does not feel assured by the lightning speed production of the vaccine. Ms. Reed vehemently refuses vaccination against the coronavirus.

“I don’t trust the government. 2020 has shown me lots of things, and I can’t trust my so-called president,” said Reed. “The vaccine came about too fast. I am following my intuition. How can you have a new disease and create the vaccine for it in the same year? Not enough people were tested. Overall, 2020 gave me trust issues. I have to see what happens in the next 3-4 years.”

Reed is not alone in her skepticism. According to the Pew Research Center, most of the U.S. public is uncomfortable being among the first to receive the vaccine.

So, what would it take for people to eventually get vaccinated? “I would have to see if the vaccine works and all the side effects that come with it. I’m usually open to certain vaccines, but right now I consider myself an Anti-vaxxer,” said Reed.

→ Did you know that even with mass skepticism, overall, 60% of Americans would take the vaccine if it were available today.

There are valid reasons to vaccinate or to not. Vaccines have suppressed numerous infectious diseases, but there are religious and personal beliefs that prohibit it. Many factors also contribute to the public’s indecisiveness. From the brief span of creation to distribution to unknown side effects. To date, more than 270,000 Americans have died because of the coronavirus.

Did you know the term vaccine is thought to have been based on the Latin word vacca, meaning cow? History points to English physician and scientist Edward Jenner for credit as to the construction of the term. Jenner spearheaded the concept of vaccines in 1796 when he created the world’s first vaccine for smallpox. Although the scientific community considers Jenner the inventor of vaccines, evidence exists the Chinese administered smallpox inoculation as early as 1000 CE. Africa and Turkey also practiced smallpox inoculation before it reached Europe and the Americas.

With Jenner’s success, further innovations followed. His use of cowpox material to create immunity to smallpox became common practice. Over the next 200 years, his method sustained medical and technological changes. From these advances, it eradicated the smallpox disease.

The next major impact on human infectious disease was Louis Pasteur’s rabies vaccine. Pasteur, a French biologist, microbiologist, and chemist celebrated for his discoveries on the principles of vaccination, microbial fermentation, and pasteurization. From his discovery, other developments succeeded. Antitoxins and vaccines to combat diphtheria, tetanus, cholera, plague, typhoid, and tuberculosis. Bacteriology developments continued throughout the 1930s into the present time.

→ Did you know there are four types of vaccines? Scientists design each vaccine to teach a person’s immune system how to fight off various infections. Live-attenuated vaccines contain a weakened microbe that causes a disease. Inactivated vaccines are used to kill the microbe. Subunit, recombinant, polysaccharide, and conjugate vaccines use the protein, sugar, or capsid around the microbe. Toxoid vaccines use toxins made from the microbe.

When read out loud, it sounds like a bunch of “mad scientists” with dubious intentions got together to create something “yucky” to inject into human beings. In actuality, scientists created vaccines to save lives.

→ Did you know there are six phases of vaccine development? According to the Centers for Disease Control and Prevention (CDC), the six stages are exploratory, pre-clinical, clinical development, regulatory reviewed and approved, manufacturing, and quality control.

Vaccine development is a long and multiplex process. Often, vaccine development takes 10-15 years and involves the public and private sectors. During the early years of vaccinations, government oversight and regulation of vaccine production were absent.

On July 1, 1902, the U.S. Congress passed the Biological Control Act. This was the first federal legislation to provide authority over the sale of viruses, serums, toxins, and analogous products. Congress created the act because of the two tetanus outbreaks in 1901. Contaminated diphtheria antitoxin in St. Louis, and contaminated smallpox vaccine in Camden, N.J. Those outbreaks raised public concern about pharmaceutical safety and became the first pharmacoepidemiology investigation. The foundation of the Biologic Control Act was to restore the public’s trust in products. Therefore, in 1906 the Food and Drug Act betrothed the Food and Drug Administration (FDA).

The Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration regulates the vaccine-approval process in the United States. Through each stage of development from preclinical studies to after licensure, vaccines are subject to scrupulous testing and oversight. Manufacturers must adhere to superior practices and control procedures to ensure the quality of vaccines. Title 21 of the Code of Regulations states licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

→ Did you know in order to meet the FDA criteria for approval, scientists test the vaccine in animals? This stage usually takes between 3-6 months. Next comes Phase I clinical trials, which test the safety of the vaccine in humans and can take anywhere from 7 months to a year. In Phase II, the formulation and doses of the vaccines prove effectiveness which takes 2 years. Phase III, the last stage, tests the safety and efficacy of the vaccine on a larger group of people, and the timeframe is between 1-4 years.



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