As we move into the second half of 2020 and our fifth month since the novel coronavirus has caused shut downs of varying degrees across the nation and the world, the question in the forefront of our minds is often “when can we go back to normal?” Experts recommend that even as the country begins to initiate stages of re-opening, people continue to wear masks, maintain a distance of six feet from other people, and continue to observe proper social distancing tactics to prevent spread until a vaccine is developed. The only way we can truly move forward to a future without risk of exposure is through the mass production of a vaccine, but when can that be expected?
Below, we take an in-depth look at the challenges present in developing a vaccine, the efforts that have been made so far, and what distribution could look like. We are joined by Carsten Thiel, a biopharmaceutical expert with over twenty-five years of leadership experience within the pharmaceutical industry. He is currently the president of European commercialization efforts for EUSA Pharma, an international biopharmaceutical company that typically specializes on developments within oncology and rare diseases, but as with many pharmaceutical companies during this pandemic has been working on utilizing their resources to aid in the treatment of COVID-19 patients with extreme respiratory issues. Thiel provides valuable insight on the many questions facing us as the world waits for a vaccine.
Coronavirus vaccines could come in waves
As much as we would all love for the day a vaccine is announced to be the day we can go back to intimate dinner parties and church choirs, in all likelihood the process will be much more extended. There are more than 100 potential vaccines for COVID-19 currently in development around the world, with Oxford University currently in the lead as their potential vaccine is advancing to clinical trials. Moderna, a biotech company based in Massachusetts is also seeing significant progress for their vaccine and intend to move on to large-scale clinical trials soon as well.
There are four different methods that can be used to design vaccines: from a protein derived from the coronavirus, via a hybrid virus, from an injection of chemically treated coronavirus that disables its growth and spread, or from antigens delivered by DNA/RNA that are injected into muscle cells and prompt the body to manufacture agents that harm the coronavirus. Regardless of the technique used, a vaccine’s efficacy can be determined by either it’s ability to prevent people from getting sick, or to prevent people from getting infected at all. While in an ideal world the first vaccine available would prevent people from being infected by the coronavirus in the first place, it would still be a huge win to have a vaccine available that reduced the severity of COVID-19, leading to far fewer deaths, caused a decrease in hospitalizations that increasingly come close to overwhelming our healthcare system, and minimize symptoms for all who are infected.
In all likelihood, the first version of the vaccine available may have some limitations, but it will provide much more protection that our immune systems have currently (ideally at least 50% efficacy against symptoms and 70% against moderate to severe disease) and version 2.0, 3.0 etc will be able to follow and provide even further solutions. Until then, Thiel says “slowing down the spreading of COVID-19 is the best thing we can do to save more lives.”
An antibody treatment may be available sooner for strategic usage
One solution that is less talked about is the use of antibody treatments to prevent cases of and reduce symptoms for COVID-19. Antibodies are proteins the body makes to fight infections, and whereas a vaccine works to make your body create antibodies capable of fighting diseases, antibody treatments introduce the antibodies themselves to the body either through convalescent plasma or monoclonal antibodies. Convalescent plasma is antibody-filled blood plasma from patients who have recovered from the disease and has been used since the Victorian era to treat the 1918 flu pandemic, as well as MERS and SARS in the more recent past and some success has been seen in treating COVID-19 as well. However, there isn’t enough donated plasma available to treat all COVID-19 patients, but thankfully science can fill in the gaps by creating monoclonal antibodies, or lab-made antibodies created specifically to target infection.
It is important to note that antibody treatments would only be a short-term solution as they’re effectiveness only lasts for a month or two before wearing off, but the push for development of these treatments has been so great that they may be available as early as this year. These antibody treatments could be selectively used on the populations most vulnerable to the virus such as nursing home residents. “I feel sorry for the many people who are affected by COVID-19, the people who spend time in quarantine and the families who have lost grandma or grandpa to this viral outbreak, as this coronavirus shows mortality mostly in patients over seventy,” says Thiel. Healthcare workers and those with chronic diseases could also benefit from these treatments, which though temporary could still make major strides in preventing mortalities as well as the spread of the virus.
The coronavirus has had very few mutations so far
Thiel said “I worry about the admittedly unknown risk of a mutated version of the virus. Right now COVID-19 is highly infectious and has a mortality rate of two to three percent. But what if this virus mutates like the influenza virus does every year? Then things may change.” This is a concern that is rightfully on the mind of most biotechnicians, epidemiologists, and scientists all working around the clock to develop a vaccine. SARS-CoV-2 (the official name for the coronavirus) is a type of virus that has the capability to quickly change its genes, but so far the changes have been minimal with few mutations seen and none that are having an effect on the function of the virus itself.
This bodes well for scientists’ hope to have a vaccine available by the end of the year, as they have been amassing information on the coronavirus’s genome sequences since January and now have over 47,000 genomes collected. In particular, they are keeping an eye on the genetic locations that affect spike proteins, which are structures on the surface of a coronavirus that allows them to invade cells. All of the coronavirus vaccine candidates currently in development are designed to instruct the immune system to recognize spike proteins, so changes in the genetic makeup affecting the spike protein have the potential to set back progress on them significantly. Thankfully, the coronavirus so far is using a proofreading system to catch any errors in the genetic code when it begins generating copies of itself, correcting any potential mutations, meaning changes have been minimal.
Global research collaboration has been unprecedented
Scientists, along with the labs and companies they work for have been working closely together worldwide to tackle the coronavirus problem. Rather than let the political divides of their various nationalities or capitalistic competition promote division, research has been occurring broadly and simultaneously as people work in tandem to develop a vaccine. Whereas in the past the first step after a discovery or advancement would be to begin working on an article to public in a scientific journal, in the quest for a vaccine scientists are foregoing standards such as this and bringing the information straight to their peers and colleagues who can use it with immediacy. For example, vaccine researchers at Oxford University recently made use of animal testing results shared by the National Institutes of Health’s Rocky Mountain Laboratory in Montana. Says Thiel “it comes down to winning time to have more people immune and to have a vaccine commercially available,” and the pandemic is eroding the secrecy that is typically present in academic research. Scientists have previously often worked in secret in order to reap the benefits such as grants, promotions, and tenure that exclusive research can provide.
Even companies and scientists that were previously uninvolved with infectious disease research have begun to contribute. Thiel’s company EUSA Pharma has typically focused on oncology and the treatment of rare diseases, but have recently announced the preliminary results of a study conducted using their drug siltuximab at the Papa Giovanni XXIII Hospital in Italy. A monoclonal antibody initially approved by the FDA and EMA for the treatment of patients with multicentric Castleman disease, it is now under investigation as a treatment for COVID-19 patients who develop serious respiratory complications. The initial data showed that 33% of patients experienced clinical improvement, a promising start as the company enters into the next phase of the study that involves comparing outcomes in matched case-control patients not treated with siltuximab.
Even with the shortened timeline, a vaccine by the end of the year could be impossible
It is important to remember that here in the United States, the drug approval process from the FDA is long and arduous. Priority drugs such as a coronavirus vaccine have been known to advance faster than average, but the typical timeline for a new drug to be approved is two years. The process is complicated, with hurdles occurring at every state from lab tests, to human trials in the testing phases to production facilities and quality control in the distribution phase. To ensure products approved do not cause any significant harms to the people they are given to, the FDA is rigorous in its scrutiny.
The stakes are high in the road to defeating the coronavirus and its disease COVID-19, and those developing it have to walk a fine line between urgent and deliberate actions to ensure that the coming vaccine is both effective and safe. Until then, Thiel believes the best thing we can do is continue social distancing measures diligently to prevent sudden and catastrophic spikes in cases like we saw earlier in the year in Italy.
“Nurses and doctors in their clinics and hospitals became overwhelmed by their lack of capacity to handle so many patients, and PPE materials became harder and harder to maintain adequate stock of. This kind of sudden spread is what brings an otherwise functioning healthcare system to its knees.”