In addition to preparing for and responding to COVID-19 in Blount County, officials at Blount Memorial Hospital are closely following developments currently underway in the phased trials of both therapeutics and vaccines for the virus.
"It’s amazing to see the number of therapeutics and vaccines that are involved in Operation Warp Speed,” said Blount Memorial Chief Medical Officer Dr. Harold Naramore. Operation Warp Speed, he explains, is the public-private partnership initiated by the Trump administration to facilitate and accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.
“Basically, you’ve got private companies and the national government’s resources being used, together, to develop and mass produce resources to fight COVID-19’s spread as quickly as possible,” Naramore said. “Because of this focused effort, we’re seeing therapeutics and vaccines advancing much faster than we’d typically see.” He says, that in a lot of cases, development for therapeutics and vaccines can take up to nine to 10 years, but that these likely will be complete in less than a year’s time.
To adequately develop, manufacture and distribute therapeutics and vaccines, these items must go through three phases of trials before being put into use. “Phase 1 is where the safety of a vaccine and/or therapeutic in humans is determined,” Naramore said. “Once this is concluded, it moves to phase 2, where researchers must determine that the vaccine and/or therapeutic causes the effect they think it should.”
When vaccines and/or therapeutics move to phase three, that’s where researchers begin testing the vaccine and/or therapeutic to see if they effectively treat or prevent the illness in individuals.
“And right now, we have two different things in phase three trials – therapeutics and vaccines,” Naramore said. “The two are not the same, though. Therapeutics are used to help prevent the virus and treat it in individuals who are acutely suffering from it in the moment. Vaccines, on the other hand, are used to help prevent the virus from rapidly spreading in the general population.”
Starting with therapeutics, Naramore said there are two drugs that are in phase three trials. “The first is a Pfizer drug that basically is the antibody to COVID-19 that your own body makes after exposure to the virus, but it’s not being produced by your body – it’s being produced in the lab. It’s a monoclonal antibody, meaning it binds to only one substance.”
Also in phase three trials for therapeutics is a Regeneron drug, he explains. “It is essentially the lab-made antibody that replicates what your own body can make, but also includes a neutralizing antibody that’s also created in the lab. The neutralizing antibodies defend our body’s cells,” Naramore said.
These two therapeutics are being developed in hopes that they can treat acutely ill COVID-19 patients, but also help to prevent the illness from occurring in vulnerable populations, including nursing homes.
On the vaccine development side, Naramore says, there are a lot of promising developments being made, too, with three in phase three trials.
“There are two types of vaccines that are in the works right now – messenger RNA vaccines and live virus vaccines,” Naramore said.
“The messenger RNA vaccine works when an injection of messenger RNA goes into your cells,” Naramore said. “Your cells produce the protein that’s found on the coronavirus spike, and your body begins to make antibodies to that. It essentially neutralizes – or stops – the virus in your body.”
There are two messenger RNA vaccines in the third phase of trials currently, with one being offered by Pfizer and another being offered by Moderna, Naramore said. “These trials are showing good progress, and there’s been good participation rates so far.”
Naramore says that, as with any vaccine, some individuals may report having minor side effects for a short period of time. “While the Pfizer and Moderna vaccine trials haven’t shown any major side effects to date, some individuals could show fever for about a week, some muscle aches and feelings of fatigue. Based on studies so far, these symptoms do appear to resolve on their own.”
A second type of vaccine that’s in the works is a monkey adenovirus – or live virus, Naramore explains. “With this type of vaccine, the virus does not replicate in us when the vaccine is injected. Instead, the vaccine produces the protein on the spike of the coronavirus, and your body begins to naturally make antibodies to that. This then allows your body to fight the virus yourself, with antibodies your own body has made.”
This type of vaccine is being developed by AstraZeneca and the University of Oxford, and while it is in its phase three trial currently, it’s one that, as of this week, has been put on hold after a standard review process indicated it should pause and review safety data after a participant had a suspected adverse reaction in the United Kingdom.
“It was halted this week to look at some unexpected complications in a participant,” Naramore said. The complication was transverse myelitis, which is inflammation of myelin in the spinal cord. “Myelin is essential in helping the body transmit neurological impulses through the body.”
While this halt is not uncommon, it’s a precautionary step and one that Naramore says is the right thing to do in the world of medical science and research. “Just because it’s halted, it doesn’t mean this is a bad thing. This gives researchers a chance to determine whether a complication, which isn’t all that uncommon, is due to the vaccine or is the result of a personal factor that is unrelated to the vaccine and /or illness.
“Personally, the attention that this got and the immediate pause that AstraZeneca and the University of Oxford have initiated reassures me that we’re following a process that’s guided by science and ensuring we’re being safe. It’s actually reassuring.”
With a lot of talk about when vaccines could be available to sections of the population and/or the general public, it’s important to remember that the more people who take the vaccine, the more effective we can be at eliminating the chance that this virus continues as a pandemic, Naramore said.
“We hear a lot of talk about herd immunity, and while the exact percentage of the population that needs to be vaccinated to achieve herd immunity hovers between 60-70 percent by most of the nation’s leading infectious disease experts, it’s important to remember that the more people who have ‘immunity’ to the virus means the virus has nowhere to go when someone coughs or sneezes in close proximity to another individual,” Naramore explained. “This helps to decrease the person-to-person transmission, and it makes it really hard for COVID-19 to continue existing in the way we’re seeing it right now.”
Until a vaccine is available and until we have enough people who opt to take it, Naramore emphasizes that the only line of defense that we have against the spread of the virus is a combination of three things: wearing a mask, social distancing and handwashing.
“In recent weeks, we’re encouraged that our community may be doing a little better job with these three things, as the number of people requiring medical treatment has decreased over the last couple of weeks,” Naramore said.
“This is a good sign, and we hope it continues – but we, as a community, can’t let up on adhering to the precautions that medical science says are our best and only line of defense for now.”