Patience in a Pandemic: COVID-19 vaccine could take months or years to develop

A sick young woman rushed into the hospital. She was coughing up blood. The woman was seven months pregnant. Her baby was born that afternoon, but it was premature and died.

A nurse assured the mother that her son was fine and she would see him soon. The mother’s condition worsened and she died from Spanish Flu. The nurse placed the dead baby in the arms of his mother. When the father arrived, it looked like his wife and newborn baby were asleep in each others arms, author Catharine Arnold wrote in her book “Pandemic 1918.”

Scenes like that were commonplace worldwide during the Spanish Flu outbreak a century ago, and new viral infections have occurred throughout history, former virologist Dr. Melissa Taverner told Talk Business & Politics. The novel coronavirus, or COVID-19, is a new virus that has never been in the human population until months ago, but pandemics and our responses have been around for generations, she said.

Taverner, who received her doctorate in environmental science from the University of Virginia, Master of Science in virology from the University of Reading (UK), and is now the provost and dean of the faculty at Lyon College, warned that scientists are hoping to develop a vaccine for COVID-19, but it might not happen. Science isn’t always able to find a vaccine, she added.

“Novel means new … the human immune system is very adaptive. It’s remarkable how it works,” she said. “But until recently, the human immune system hadn’t been exposed to this virus.”

Dr. Jonathan Berman, an assistant professor of basic sciences at New York Institute of Technology College of Osteopathic Medicine at Arkansas State University, said a best case scenario might end with a vaccine sometime in late 2021.

“It might take 18 months or longer to develop a vaccine for the virus that causes COVID-19. Many have wondered why the process takes so long. Vaccines must be safe and effective before they’re ready to be delivered. Although the speed of development for many vaccines has increased significantly, it still takes many months for them to reach approval. Why be so cautious? It’s a lesson learned through trial and error,” he said.

One of the most notable vaccine development disasters occurred in 1901, he said. A horse named Jim was used to produce serum containing diphtheria antitoxin. However, Jim contracted tetanus and died. Nonetheless, Jim’s serum was distributed and was traced to the deaths of 12 children, all of whom died from tetanus, Berman said.

“As a result, the government saw the need to become more involved in the process, and the Biologics Control Act of 1902 was implemented to regulate biological products such as vaccines. Later, the Pure Food and Drug Act of 1906 added regulations. Since then, quality assurance has been folded into the Food and Drug Administration (FDA),” he said.

When Jonas Salk and Albert Sabin developed their polio vaccines, it wasn’t without problems. Salk’s vaccine used inactivated polio virus, which means the virus was “killed” by treatment with formalin so that it could not infect cells. Cutter and Wyeth Laboratories improperly inactivated more than 100,000 doses of polio vaccine. The vaccine contained a small amount of live virus, which caused polio infections and resulted in 250 cases of paralysis and 11 deaths. The Cutter incident led to greater oversight of vaccine production and testing, Berman added.

“Like any other drug or biologic that will be administered to many people, vaccines must be tested thoroughly to ensure their safety. As the previous examples show, a lack of precaution can have unintended effects, and that preparation takes time. It can’t be rushed. The process has become much safer but also much longer as researchers are required to adhere to more and more much-needed regulations,” Berman said.

Exploratory research helps to develop a protocol for producing a vaccine. It could be through inactivation of a virus, the attenuation of a live virus weakening it so it causes an immune response but doesn’t infect a host, or other methods, he said.

“These experimental vaccines are often tested in cultured cells — living cells grown in dishes — to make sure they don’t produce infections. Next, these drugs are typically tested in living animals because no culture mechanism adequately replicates the immune system of a living mammal with all its complexity,” he said. “These tests look for safety, and in animals vulnerable to infection, may look for the generation of immunity. This initial development and testing can take years or decades of continual iteration or refinement, although several strong COVID-19 vaccine candidates are already past this stage,” Berman continued.

“In clinical trials, vaccines that have proven safe and produced immunity in animal trials will first be tested for safety in humans. Here, increasing doses of vaccine are given to a small number of human volunteers to determine a safe dose that does not produce significant side effects. This is called a phase I trial,” he said.

Vaccine development stages can take months or years to complete. Occasionally, the FDA will fast-track approval of a drug for an urgent unmet medical need if the results are extremely promising, such as with the development of Gleevec, a common cancer medication, he said. Hundreds of trials are ongoing for either vaccines against the virus that causes COVID-19 or for treatments that might lessen the severity of its disease burden, such as antivirals or convalescent plasma.

“We’ve already experienced the risks of rushing treatments in this pandemic as studies have found that hydroxychloroquine, which was initially touted by some for a treatment of COVID-19 but seems to have no benefit and increases the risk of death. We must be cautious that when a vaccine does become available, it’s been proven to be both safe and effective,” Berman added.
Pandemic history has taught us a lot about how to handle this current crisis, Taverner said.

Social distancing, facial coverings and good hygiene were exercised during the Spanish Flu outbreak.

In Arkansas, that virus started at Camp Pike (Now Camp Robinson) in North Little Rock and quickly spread to Little Rock and Fort Smith in October 1918. Schools and businesses were shuttered for months, and people were required to wear facial coverings in public. An estimated 7,000 people died in the state, according to reports from the time.

Dr. Berman’s advice?

“Patience is a virtue that does not come easily in our world that is accustomed to immediate gratification, but it’s one that must be practiced as we let the scientific process play out,” he said.