Norman Hulme gets injected with an experimental COVID-19 vaccine. (photo submitted)
Scientists around the globe are racing to find a vaccine for COVID-19, and a 1973 Bethlehem High grad is offering his body as a laboratory in one of the leading efforts, and one of the most cutting edge approaches, to combat the worst public health crisis in generations.
“You think about our parents and our grandparents and World War I and World War II and you think about what they had to deal with rationing of food stamps and gasoline and this, in many ways, is our world war because it is effecting the entire world,” Norman Hulme said from his home in Atlanta. “I think most people are looking to do what they can because it is the right thing to do. That is the spirit everyone should take instead of hoarding toilet paper.”
Hulme is one of 60 volunteers to get injected with the test vaccine during a study by Moderna, a biotech company based in Massachusetts, sponsored by the National Institutes of Health and the National Institute of Allergy and Infectious Disease. And it’s not the first time he stepped up. After the Sept. 11, 2001 attacks Hulme was similarly injected with chemicals during a study to find a vaccine for Anthrax, a virus-causing chemical terrorists used to attack the U.S.
Asked if he was worried about getting sick, he said, with conviction, “not at all.” He said he has faith in the process, and the science, and whatever risk is far offset by the potential benefits of a widespread vaccine for the virus that has that has infected more than 5.7 million people and killed nearly 353,000 around the globe.
Unlike traditional vaccines, including seasonal flu shots, which inject the body with small doses of a virus to encourage it to produce antibodies, the theory behind the Moderna messenger RNA, or mRNA, vaccine focuses on the molecular components that attach the virus’s vessel to the body.
We have all seen what a caronavirus molecule looks like — a ball with spoke-like protrusions which are called an S proteins. When that molecule enters the body, the spokes attach to a body’s healthy cells and allow the virus to attack. Rather than treat the cells after they’re infected with the virus, the Moderna vaccine focuses on ways to convince the body to produce antibodies that prevent the spokes from attaching to the body’s healthy cells. In other words, if the treatment works, even if the virus gets in the body, it will not get a foothold before the body flushes it out.
It is a two part process, and Hulme said his bloodwork is showing his body has the same level of antibodies as someone who had the virus and recovered. Using the blood of someone who has recovered is another treatment method, called convalescence plasma therapy, which has been used since for at least a century.
While the results are preliminary, they are encouraging. Moderna is reporting “after two doses all participants evaluated to date … seroconverted with binding antibody levels at or above levels seen in convalescent sera.” Basically, that means there is an equivalent amount of antibodies as someone who has recovered from the virus. As during any testing phase for any vaccination, there are some risks associated and three of the subjects — Hulme is not one of them — who got the largest dose of experimental vaccine did suffer what is known as Grade 3 symptoms that include pain, nausea and fever.
The first round of tests focused on healthy subjects. Hulme — who runs five miles a day and hikes and bikes — said an otherwise healthy friend was willing to be part of the experiment but was refused because she had kidney issues. The next step, which recently got the expedited OK by the federal Food and Drug Administration, is to expand the number of subjects to 600 and then, in July, if those results are as promising, the Phase III efficacy trial will expand the sampling to 10,000 people. Testing will then, since a successful vaccination will have to be available to everyone, expand to who are the most vulnerable to serious illness from COVID-19 like the elderly and those with underlying health conditions.
It is one of more than 100 serious efforts around the world to develop a vaccine for the virus and is widely considered one of the leading contenders. In the end, there could be three or four companies that make vaccines. The notion of stopping a disease before it attaches to a body has far reaching implications and, conceptually, could be applied to other coronaviruses, the season flu, cancer, Multiple Sclerosis and a host of other illnesses.
“It is truly an honor to be a part of something like this,” said Hulme, a graphic designer at Emory University whose father did pharmaceutical research and mother had an advanced degree in chemistry, an uncommon accomplishment for a woman in the 1950s. “I grew up in a scientific household, and had an appreciation for the rigors of science instilled at an early age.”
Developing a vaccine is an exact science, and can take years. Once it passes a battery of trials to determine if the vaccine is safe — since traditional vaccines do involve injecting a person with a dose of the actual virus, the cure can’t be worse than the illness — it must navigate the FDA licensure process.
Once a viable vaccine is produced in a laboratory setting, it has to be mass manufactured to, theoretically in the case of COVID-19, treat everyone on the globe and then distributed and administered. According to the U.S Census World Clock, there were 7.7 billion people on the planet as of Tuesday, May 26. In the U.S. there are 329.7 million people with a birth every nine seconds and a death every 12 seconds.
There are more than 100 viable vaccination experiments going on and the timeframe — including the conventional method of growing the virus in a petri dish — is on an unprecedented fast track. But, even given the best case scenario, the soonest a vaccine will be ready for widespread dissemination is January, 2021. And even that is a longshot.
“This is a highly ambitious goal and, although a possibility, it far exceeds any vaccine development timeline in the past,” Dr. Larry S. Schlesinger, an infectious disease specialist and the chief executive officer and president of the Texas Biomedical Research Institute, told Healthline. “Several steps done in parallel can cut some time (e.g., starting manufacturing vaccines during early clinical studies) but the fundamental steps that need to be taken through clinical trials and animal studies take time and cannot be short circuited when working to create a safe and effective vaccine that will be used worldwide in different types of people of different ages.”
While social distancing, wearing masks and eliminating mass gatherings like concerts and sporting events is effective, a vaccine is a more effective and efficient way to control the spread while we return to some semblance of normalcy.
“It really is cutting edge. This vaccine approach has never been done before,” Hulme said. “We all have our fingers crossed it will work.”