MANSFIELD -- The seeds that grew into the "miracle" behind today's COVID-19 vaccines were actually planted more than three decades ago.
And as the inoculations against the novel coronavirus are ramped up around the United States and the world, medical experts are assuring the public the new vaccines are safe and effective, based on improving technology that began more than 30 years before COVID-19 emerged as a pandemic.
In fact, scientists and doctors are likely concerned even usage of the word "miracle" may cause innoculation hesitation among U.S. residents, who have seen pharmaceutical companies Pifzer/BioNTech and Moderna successfully develop the vaccines from lab to market in 10 months.
"We can call it a miracle, but a miracle always has a sense that it just 'happened.' It didn't just happen," said Kathrin Jansen, head of vaccine research and development at Pifizer.
Speaking on the TV news program "60 Minutes" on Sunday, the German-born Jansen, who previously led the development of the HPV and pneumococcal vaccines, said development of COVID-19 vaccines was scientific and deliberate.
"It was done with passion and urgency," she said. "It was (done) always having in your sights that devastating disease. We are scientists. That's what we do for a living every day. Everything is new."
With more than 18 million U.S. residents infected and more than 326,000 deaths in America due to COVID-19 as of Thursday, the federal government's recent approval of both vaccines came as the virus continues to widen its spread across Ohio.
In Ohio, more than 640,000 of the state's 11 million residents have been infected and more than 8,300 deaths have been attributed to coronavirus. As of Thursday, more than 11,500 Ohio residents had received a first dose of the two-dose vaccines, both of which have been found to be more than 90 percent effective in preventing COVID-19.
The vaccines are based on synthetic mRNA technology that scientists have worked on to potentially treat a variety of conditions, including Parkinson's Disease to cancer and from spinal cord injuries to cystic fibrosis.
New vaccines. But not completely new medical research. And in this instance, the U.S. government's "Operation Warp Speed" provided incentives for the pharmaceutical companies, either by funding the research (Moderna) or agreeing to buy the vaccine (Pfizer) if it proved successful.
Scientists simply rapidly built upon work already done as mRNA vaccines have been studied for flu, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.
Future mRNA vaccine technology may allow for one vaccine to provide protection for multiple diseases, thus decreasing the number of shots needed for protection against common vaccine-preventable diseases.
"These biotech companies have been working on these mRNA vaccines for a long time," said Dr. Joe Gastaldo, OhioHealth medical director and infectious disease specialist in Columbus.
Gastaldo said the vaccines are safe, demonstrating his faith on Monday by becoming one of the first to receive the Pfizer vaccine.
“I’m here as a person of science — I always speak as a person of science — and I feel very safe and confident with the efficacy of the vaccine… and most importantly the safety of the vaccine,” Gastaldo said Monday.
Brad Schwartz, RPh, pharmacy clinical services manager for Avita Health System, said mRNA vaccines work by providing the body a recipe, or blueprint, to make copies of important, but harmless, "pieces of the virus that we want our immune system to be able to recognize and remember how to handle."
"By training our immune system to recognize these pieces, our body would be able to identify that part of the virus and neutralize it if we ever encounter the actual virus," he said.
The now familiar COVID-19 virus has discernible "spike" proteins that the synthetic mRNA vaccine duplicates.
"It's recognized by your immune system, creates an immune response, builds antibodies and primes the immune system," Gastaldo said. "So when your body actually encounters the virus, the antibodies are already formed and ready to go. It prevents the virus from causing an infection."
Gastaldo said many vaccines put a weakened or inactivated germ into the body to trigger an immune response.
mRNA vaccines, instead, teach cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside the body. That immune response, which produces antibodies, is what protects infection when the real virus enters our bodies, he said.
The Pfizer and Moderna vaccines give instructions for cells to make a harmless piece of what is called the “spike protein,” found on the surface of the virus that causes COVID-19. (Click here for a video from the Yale University School of Medicine on how the vaccines work.)
"Again, the spike protein itself isn’t infectious and the instructions are not to make an entire virus, just this small piece of it," Schwartz said. "We have different types of machinery in our cells with all sorts of specific jobs they perform; one of those pieces of cellular machinery is to make proteins, and it uses mRNA for the instructions on what to make.
"The vaccine delivers these instructions to our cells, the cells in turn use their normal functions to make spike proteins, the cell destroys the instructions as it normally would, and the spike proteins make their way to the surface of the cell.
"Once they reach the surface or outside of the cell, this gives our immune system an opportunity to recognize them and figure out how to handle them. There is sort of a cascade of events by our immune system at this point, but essentially it effectively trains itself on what to do about this spike by making antibodies and archiving info on what to do if our body sees these types of spikes again.
He said what makes the COVID-19 vaccines remarkable is that rather than manufacturing pieces of virus or killed virus in large scale manufacturing processes that take a very long time to grow and culture, they use the body’s cells as the “manufacturing plant” to make the target pieces, Schwartz said.
"Since mRNA vaccines are not conceptually new and mRNA is actually very easy and quick to produce relative to the traditional vaccine materials, it has allowed for a much faster development process," he said.
"Also, by taking the vaccine development process that involves moving in a stepwise fashion from concept, to a series of clinical trials, to approval, to manufacturing where the next step does not start until the previous is completed, the companies have completed some of the steps at the same time and therefore shortened the overall timeline significantly," Schwartz said.
Gastaldo said the launch of the vaccines and the continued developments of treatments for the virus are exciting, but the painful effects of the pandemic on everyday life are far from over.
"Our current state of affairs is very said. On a daily basis in this country, we are experiencing the equivalency of a mass casualty disaster with more than 2,000 deaths a day," Gastaldo said, urging residents to wear facial coverings, maintain social distancing and avoiding crowds.
"I know everyone is tired of talking about it. (But) it's going to take months to feel the effects of the vaccines in the country. We just have to work through it.
"I think that 2021, in addition to the vaccines, we have the capability of putting a lot of pain and suffering in the rearview mirror," Gastaldo said.