Coronavirus vaccine development – Donald Trump gets it all wrong again

Donald Trump’s ignorant comments about how the COVID-19 pandemic would be over by April makes people believe there is a coronavirus vaccine just around the corner. There isn’t. 

Of course, Trump is ignorant about the vast swaths of science from climate change to vaccines, so if he says anything about science, it should be immediately ignored.

Even if he claimed that the blue sky was caused refraction of light, I’d immediately go outside, check the color of the sky, then pull out a physics textbook to confirm what he said. I’m that skeptical of anything that comes out of his ignorant, anti-science mouth.

His claim that the epidemic will be over by April is in direct opposition to real scientists and experts at the CDC, WHO, and elsewhere, all of whom are extremely concerned about a coronavirus pandemic.

His comments, and questions across the internet, seem to imply that a coronavirus vaccine is around the corner, and we shouldn’t worry. Nothing could be further from the truth.

Let’s take a look at vaccine development, and I am going to especially focus on some of the technical challenges for a coronavirus vaccine. Just because we need some fact-based evidence so that pro- and anti-vaccine people understand what’s going on.

I’m assuming that most anti-vaxxers will publicly or secretly get the coronavirus vaccine. Just a guess, but maybe they’ll get information here first.

All about the coronavirus

Coronaviruses (there are seven that infect humans) are species of virus belonging to the subfamily Coronavirinae in the family Coronaviridae, in the order Nidovirales. They are an RNA virus of around 26-32 thousand base pairs.

The coronavirus name is derived from the Latin word which means crown or halo. Apparently, the infectious form of the virus appears under an electron microscope to have a fringe of large, bulbous surface projections that appear to be reminiscent of a crown. And that will be good for a trivia question somewhere.

This 2019 coronavirus outbreak is known as COVID-19m and is caused by the SARS-CoV-2 virus, which is closely related to other SARS-related viruses. The virus is spread easily by small droplets from infected individuals when they breathe or cough. The time from exposure to the SARS-CoV-2 virus to onset of symptoms is generally between 2 and 14 days

The CDC and WHO have recommended handwashing, maintaining distance from individuals who are coughing, and not touching one’s face as preventative measures. It is also recommended that individuals cover their nose and mouth with a bent elbow when coughing

The early symptoms of COVID-19 can mimic many other viral diseases – fever, cough, and shortness of breath. However, many cases progress to pneumonia and multi-organ failure. As of now, we don’t know if the disease favors particular groups. For example, smokers, individuals with chronic pulmonary disease, or seniors may be at higher risk of dangerous complications like death.

As I mentioned above, severe acute respiratory syndrome (SARS) is caused by SARS-associated coronavirus (SARS-CoV), which means that the current coronavirus outbreak is related to SARS. In addition, the Middle East respiratory syndrome (MERS) is caused by the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). 

Coronaviruses, like the SARS-CoV-2, MERS-CoV and SARS-CoV species, infect the upper respiratory and gastrointestinal tracts of mammals and birds. Interestingly, coronaviruses may cause a substantial percentage of all common colds in humans.

The SARS coronaviruses have unique pathophysiologies because it causes more severe upper and lower respiratory tract infections

At this point, we don’t have firm evidence for a particular non-human reservoir for the SARS-CoV-2 virus, the viruses mutation rate, or just about anything important. But we have a lot of myths

Developing a coronavirus vaccine

I remain convinced that a lot of people, whether they are pro-vaccine or anti-science, think that researchers grab a handful of viruses, a little water, some mercury, an aluminum Diet Coke can, and an aborted fetus, throw it in a Waring blender, put it in a vial, and then inject them into innocent children. 

Nothing could be further from the truth. So let’s go through the whole process of vaccine development (which I have discussed before) but focusing on the coronavirus vaccine.

The first step in coronavirus vaccine development is to have the full RNA sequence of the SARS-CoV-2 virus, which has been recently announced. This was necessary to begin the arduous process of giving us a vaccine. This research is a collaborative effort across the world to reduce the time to manufacture a coronavirus vaccine.

The next step is to culture the virus successfully, which is one of the first critically important steps. Doherty Institute, in Melbourne, Australia, was the first to produce the virus, and they have shared samples with researchers in other countries.

With these samples, researchers at high-containment facilities (research facilities that are built to keep dangerous pathogens from spreading outside of its walls) can begin to understand the infectious and biochemical characteristics of the SARS-CoV-2 virus.

An average vaccine takes anywhere from 2-5 years to develop before a clinical trial can begin. However, with the worldwide collaboration, we might have a coronavirus vaccine ready for clinical trials sooner than that. 

I want to list out the actual steps in order. Hopefully, this allows those who land on this article to understand that it’s much more than throwing ingredients in a blender and saying “here we go.”

  1. The first step, generally called pre-clinical studies, is to understand the SARS-CoV-2 virus’s characteristics and pathophysiology in humans. Since it would be unethical to do these studies in actual humans, researchers need to develop an animal model that mimics a human. Also, researchers need to determine if the vaccine is safe and triggers an adaptive immune response in that animal model. For the SARS vaccine, ferrets were used, because their physiology and immune responses are similar to humans.
  2. After successful pre-clinical testing, the potential coronavirus vaccine then can be used in institutions that are capable of running human clinical trials. This process is fairly complicated.
  3. The sponsoring organization (probably a Big Pharma company) must make an Investigational New Drug (IND) application to the FDA’s Center for Biologics Evaluation and Research (CBER) to begin clinical trials. CBER reviews the IND, which will include preclinical data. Then the sponsoring organization must get Institutional Review Board (IRB) approval to proceed with clinical trials (see this article for more information about the process). The clinical studies must go through three phases like all drugs, although the process could be shortened if the data is very clear.
  4. After all of the preclinical and clinical is completed, the sponsoring organization must make a Biologics License Application (BLA) to CBER. Although this process is what is done in the USA, it’s similar in most other countries (and some countries accept FDA review for their own country.
  5. If the safety and effectiveness aspects of the new coronavirus vaccine, then the final data and application are submitted to regulatory agencies for final approval.
  6. During this research, regulatory agencies must review manufacturing plans for the new vaccine and any pharmaceutical company that intends to produce it must develop a cost-effective and consistent method for production.

None of these steps will be easy or quick. Step 1 could take a year, maybe more. Clinical trials could take several years. And FDA review and approval of a BLA could take several months, even if the process is expedited. 

Once clinical trials begin for the new coronavirus vaccine, it will take several years before the studies are completed and final results are submitted to regulatory bodies like the FDA. There is really no way to speed up this process since we need to know if the vaccine is safe and if it’s effective. Although there will be great pressure to speed this along, even I, as a solidly pro-vaccine person, would be reluctant to support a high-speed clinical trial.

But anti-science individuals like Donald Trump will probably put pressure on the FDA through his Twitter blasts to move it along. Of course, if we do speed up the process, every anti-vaxxer will be whining that the vaccine wasn’t properly tested, once the vaccine has eliminated the threat. 

So, if you think we’ll have a coronavirus vaccine in April 2020, which Trump implies will happen, don’t hold your breath (unless you think that’s a good way to keep from getting the virus). If everything goes right, if every study is completed without a hitch, and if every regulatory agency has reviewers working 24/7 to examine the NDA, it will still take 2-3 years before we see a real vaccine. And I’m guessing it will be much longer than that.

Coronavirus vaccine challenges

Again, I’m going to list out the biggest issues that researchers will face that could complicate the process.

  1. Producing enough viruses for research and vaccine production. Although the Doherty Institute has cultured the virus to share with researchers, it is well below what is necessary for animal and clinical testing, let alone for mass production of vaccines. Again, despite what you may think about vaccine manufacturing, producing the viruses themselves is often one of the most expensive, difficult barriers to producing the vaccine.
  2. Finding an animal model is not going to be easy. Again, we need this model to understand the coronavirus pathophysiology and to see if the vaccine candidates have any shot at working. We cannot just use the vaccine candidate in human volunteers and then expose them to coronavirus. No one will sign up for that kind of study, and no regulatory agency or IRB would approve a study like that. So, we need an animal model, and because the ferret model worked well with the study of SARS and the SARS vaccine, there is some confidence that the model will work with the SARS-CoV-2 virus.
  3. The mutation rate of the SARS-CoV-2 virus is not well-known, but it seems to have a high mutation rate. The virus likely arose in another animal, so it probably mutated when it jumped from that animal to humans. It might mean that a new coronavirus vaccine could be ineffective by the time it is released to humans if the virus has undergone a significant mutation. It’s also possible that different mutations might occur at different rates depending on location, season, and population density. I get a headache thinking of all of the different variables that could be the difference between a successful and useless vaccine.
  4. Again, a vaccine generally doesn’t contain ground-up viruses particles. Researchers need to determine if there’s some glycoprotein or some other biochemical on the viral coat that stimulates an immune response. If they can find such an antigen, then reproduce it consistently and economically, and then find a way to make sure that antigen actually works in a vaccine, that would be good. But that’s not easy.
  5. If the antigen isn’t easily produced, then a vaccine must be developed with attenuated coronaviruses, that is, the virus is weakened so that it doesn’t reproduce, but it still stimulates an immune response. This is also not an easy process, and we can predict comments from anti-vaxxers about the attenuated vaccine. 

Summary

Despite the moronic claims of Donald Trump, there is more and more evidence that CORVID-19 will lead to a deadly pandemic.

A respected epidemiologist has predicted that 40-70% of the world might get infected by the virus during this pandemic. That might mean billions of people who contract the disease and with a 2-3% mortality rate (this is very preliminary, it could be much higher depending on comorbidities like smoking), over 100 million people across the world could be dead. 

And don’t think that developed countries will avoid this pandemic. Think about this – the healthcare systems of the USA, Europe, Canada, Japan, and other “developed” countries lack the infrastructure to handle massive pandemics.

As an example, the USA has lost around 75% of its hospital beds since 1960. This didn’t happen because of closed hospitals, it’s because we don’t need beds for massive disease outbreaks. Although anti-vaxxers like to deny history, hospitals had polio wards just to treat paralytic polio. Thus, in a pandemic, infected individuals may not be able to receive proper treatment, so the mortality rate, even in developed countries, could be much higher than 2-3%.

If the infection rate is as high as scientists are thinking, we will be witnessing a dystopian future.

I’m not currently worried about it, but my stress level is increasing because my optimism about a potential coronavirus vaccine is mitigated by the difficult trail from today until we actually see a vaccine. Despite Trump’s claims, this is a dangerous disease with no effective prevention at this time.

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!