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Medical research proves the COVID-19 vaccination is safe and effective

By Gina DiPietro
Novant Health

• The COVID-19 vaccines won’t make you sick or give you the virus.   

The mRNA technology used by the leading vaccine candidates (Moderna, AstraZeneca, Pfizer-BioNTec and Johnson & Johnson) is so fragile that it only lasts in your cells about 24 to 48 hours before it degrades, said Dr. David Priest, Novant Health’s chief safety, quality and epidemiology officer. So, there’s really no mechanism that would lead to long-term effects. “We feel very good about the safety profile not only from what was observed in the clinical trials, but also how the vaccines work,” he said.

And the temporary “expected effects” like possibility of a short-lived fever and achiness are simply a sign the vaccine is taking effect.

• Vaccine development happens independently of politics.

Worried that politics may have rushed approval the vaccines? Government scientists in charge of protecting us are not political appointees, said Mark J. King, Novant Health’s vice president of research and innovation. The Centers for Disease Control and Prevention, Food and Drug Administration and the Department of Health & Human Services’ (HHS) Office of Human Research Protections are staffed mostly by career professionals.

“Those scientists are free to do their jobs of protecting public health without political interference,” King said.

• The HHS website explains how the government fast-tracked a coronavirus vaccine without sacrificing safety.

Protocols for demonstrating safety and efficacy were aligned. They happened on parallel, sometimes overlapping tracks, rather than sequentially. “The urgency around vaccine development during the pandemic resulted in novel government-industry partnerships and funding,” King explained. “Normally, a biopharmaceutical company follows a very linear development path comprised of distinct phases.” At the end of each phase, the clinical data is assembled, and a decision about proceeding with research and development is made.

And while the vaccine was indeed developed quickly, the work was based on decades of science.

• Safety monitoring has happened at every stage.

“Before any clinical trial is initiated in the United States, the trial protocol and other documents must be reviewed and approved by an independent Institutional Review Board to protect the volunteer trial participants,” King said. “Data safety monitoring boards are also required to review reported adverse effects of study treatments. These independent groups have the responsibility to stop a trial at any point should there be an issue with safety or the ethical conduct of a clinical trial. COVID-19 trial protocols also had oversight by the federal government, beyond traditional public-private partnerships.”

King added: “I believe the clinical trial process is beyond rigorous. I intend to get the vaccine.”