We are in the sixth month of quarantine in the United States and everyone is desperate for a vaccine. When is it going to be finished? What company is frontrunning the vaccine race? Will it be effective? While there is a great deal of uncertainty, many feel the most confident about Moderna’s progress. Of course, the process of creating and testing any vaccine takes an extremely long time, which is usually a few years. However, with the unforeseen impact of COVID-19, the FDA approval stage has been slightly rushed and Moderna seems to be in a respectful spot in mid-August. So, will Moderna be the potential hero to help us through this everlasting pandemic? Let’s do a brief overview of them and their progress to find out.
Who is Moderna?
Moderna is a biotechnology company founded in 2010 in Cambridge, Massachusetts that focuses on drug discovery/development and vaccine technologies for messenger RNA. Their concentration in mRNA is for creating medicines that will instruct patients’ cells to produce proteins that could prevent, treat, and cure diseases. Their targeted therapeutic areas include infectious diseases, immuno-oncology, rare diseases, and cardiovascular and autoimmune diseases. They currently have 21 developmental candidates in the pipeline; 13 of these are undergoing clinical studies. Some of their vaccines in the pipeline include the Zika vaccine, the Influenza H7N9 vaccine, the Respiratory syncytial virus vaccine, and most notably the Novel coronavirus vaccine.
Moderna has been relatively successful in its short ten-year existence. Ever since then, they have been active in creating vaccines in their target areas with partners. As a result, Moderna has raised a total of $3.2B through financing and partners, including working with Vertex, AstraZeneca, Barda, and DARPA. Nowadays, Moderna is more independent by creating more vaccines only within their company, which shows how far they have come. Furthermore, in the past year, Moderna’s stock has risen 235% and their Q2 2020 revenue was $66.35M, or a 407% increase from last year. Overall, Moderna is evidently trending in the right direction as a thriving biotechnology company, especially with its recent investment in creating and testing the coronavirus vaccine.
Where are they at right now?
Moderna is the first company to begin Phase 3 clinical trials of its coronavirus vaccine. In the FDA process, the Phase 3 trials are the “last” trials to be conducted which confirm whether the given vaccine is truly safe and effective enough to be released to the greater public. While we should all be excited that Moderna has made it to the final phase, it is important to note that this phase usually takes 1 to 4 years. Additionally, this phase usually involves 300 to 3,000 patients with tests designed to figure out the drug or vaccine’s long-term effects. For coronavirus, they may take as little time as possible while also testing as many people as they can. That is the ultimate goal, but testing usually doesn’t work that perfectly. Instead, Moderna may run into some setbacks that could further extend the timetable for a coronavirus vaccine.
As of last Friday, 4,536 study subjects have enrolled in the coronavirus clinical trials since they began testing on July 27th. Yet, Moderna is still determined to reach 30,000 volunteers, but it may take more time than they anticipated, even though there was an increase in study subjects from the last week of July to the first week of August. A volunteer’s purpose in this testing is to receive shots of the coronavirus vaccines in which, upon signing up, they will receive their first injection. However, they have to wait 28 days before Moderna can give subjects their second shot. Essentially, this means that this first batch of study subjects will be tested over the next two months, and then more people will be tested two months later, and so on. Despite Moderna having a slow start considering the urgency for the vaccine, their subject numbers will continue to grow and give us an honest representation of the effectiveness and safety of their vaccine.
Will the vaccine be 100% effective?
The common misconception about the coronavirus vaccine is that once it is approved and released, it will work for everyone with only one injection. Unfortunately, there has been little evidence of a vaccine that has been perfect in its execution towards curing a virus. Some such as Executive Director of WHO’s Health Emergencies Dr. Michael Ryan have even said that “vaccines are never 100% effective.” This primarily is because every human body does not act the same nor will it react equally to a vaccine. The most common example of this is the influenza vaccine, where effectiveness is about 40-60%. Even though the targeted strain of the vaccine may be incorrect, the inserted antibodies from the shot may still be able to protect certain people from the flu. Now, compare that to coronavirus, which still has many questions that have yet to be answered. Furthermore, scientists aren’t even sure that antibodies provide “immunity” or protection against a second coronavirus infection if that is even possible. Overall, while this vaccine isn’t going to be perfect, companies such as Moderna are striving to make sure that they can be as effective as possible.
When will the vaccine be released?
Here is the big question that everyone wants to answer, but no one has the answer. The media has repeatedly said that they expect a coronavirus vaccine to be available by late 2020 or early 2021. The optimism behind this claim is that everyone around the globe is focusing on finding and creating this cure. Since there is such an enormous amount of time dedicated to the vaccine, it should be completed soon, right? But, there are so many problems and blockades that come with testing vaccines through the FDA. Even though the vaccine is needed, the FDA will not approve a vaccine until they are entirely sure that it is safe, efficient, and effective. I wouldn’t expect the FDA to be lenient because of the situation we are in, but Moderna beginning the process very early on gives many reasons to hope and dream.
Additionally, Moderna has been very open in releasing information regarding its coronavirus vaccine. When good news happens, we will know. For example, it is encouraging to hear that Moderna is pricing their coronavirus vaccine at a range of $32 to $37, making it very affordable for anyone who needs it. On the other hand, if something goes wrong, such as if a test goes very south, then we will also be notified. At this point though, there is so much uncertainty about how close the vaccine is to being approved and released; it is extremely difficult and impossible to tell. Also, how many positive results from test subjects will it take for the vaccine to be approved? No one truly knows, but as more testing results come out, hopefully, that answer will become more transparent.
So overall, how should we feel about the status of the Moderna coronavirus vaccine? Confident, yet patient. This vaccine will take time to complete, and it is not expected that it will be completed before the last weeks of 2020, meaning that we all have to go through this fall with the same summer protocols. I encourage everyone to stay updated with Moderna’s progress (as I have) so that you also can have a better grasp of what our future holds. Additionally, it is absolutely possible that another company overtakes Moderna as the frontrunner of the coronavirus vaccine race, as there are 25 candidates in the running for the crown. However, like most questions and concerns related to the virus, we all have to sit back and just watch what happens.
Kyle Banker 