Despite government efforts pushing to reopen the economy and return to a pre-coronavirus world, the growing consensus is that the only solution to a safe and effective reopening is a vaccine. Mask-wearing and social distancing regulations are successful only to a certain degree, and with limited medical treatments and high death rates, scientists are looking for a vaccine to eradicate COVID-19 rather than mitigate its effects.
The race to develop the first COVID-19 vaccine began early this year, motivated by the need to contain the pandemic and the prospect of massive advantages to the first nation and pharmaceutical companies that can produce it. This is expressed by the cross industry and international collaboration efforts already undertaken. On July 15th, the World Health Organization announced that more than 150 countries have committed to supporting global access to a COVID-19 vaccine.
However, increased international cooperation and funding do not necessarily expedite a vaccine. The quickest timeline to develop a safe and effective COVID-19 vaccine remains one year, or in this case early 2021. This is a best case scenario. Put into perspective, the fastest developed vaccine in history took four years and was for mumps in 1971. On average, vaccine development takes ten to fifteen years. Better technology and holistic advances in the medical field will definitely help hasten the coronavirus vaccine development, but they do not guarantee a solution in the next few months.
Successful developments in multiple research facilities bring hope to communities across the globe. Notably, the partnership of the University of Oxford and the pharmaceutical firm Astrazeneca have made significant strides in the right direction. On July 20, 2020, the United Kingdom medical journal, The Lancet, published the promising results of the University of Oxford’s trials. The trials indicated that their vaccine, ChAdOx1, did provoke an immune response from its participants and did not cause any serious side effects. This information will allow researchers to determine whether that immune response is enough to protect against the contraction of the coronavirus. Though there is tremendous work to be done, success in this stage indicates the “go-ahead” for trials on the mass scale.
Scientists at the University of Oxford developed this vaccine by genetically engineering a strain of the common cold virus that typically infects chimpanzees. This technique is commonly used prior to the trial, especially in the development treatment for Middle East Respiratory Syndrome (MERS) and Ebola. First, the virus was altered so it could not grow and infect humans. Then its genome was edited to look more like the coronavirus, by adding the genes that produce the proteins from COVID-19, glycoprotein, to the chimp cold. Scientists believe that by doing this, human bodies are better equipped to recognize and trigger an immune response to the rapid increase of glycoprotein. Human immune systems that encounter COVID-19 with this vaccine will be better equipped to defend against the foreign protein and trigger the production of neutralising antibodies to defend against it.
The trial conducted by the University of Oxford and Astrazeneca began on April 23rd with 1,077 participants aged between 18 and 55. The participants were split into two groups, with half receiving the new COVID-19 vaccine and the other half, designated the control variable, receiving a vaccine for a bacterial infection. During distribution, volunteers were not informed of which vaccine they had been given in order to avoid the Pygmalion effect–a psychological phenomenon in which positive expectations influence performance positively. All patients were warned of potential side effects, including mild nausea, heachaches, severe weakness, fatality, and even theoretical concerns, in which the vaccine could worsen the effects of COVID-19 if contracted. Over the course of May, June, and July, participants followed a stringent schedule of symptom reporting, blood sampling, and nasal and tonsil swabbing. This process took place once a week and will continue through the next year.
The University of Oxford’s study publication on July 20th indicated a number of promising results. The first and most important finding determined that in nine of ten patients dosed with the ChAdOx1 nCoV-19 vaccine, neutralising antibodies were prompted to defend cells from the virus. Scientists also noted that the immune response peaked on day 28 and has remained at high levels until the last reported day, though the trial is ongoing. Equally as important, no serious side effects have been reported, though approximately 70% of participants reported a fever or headache; however, scientists noted that these symptoms are easily treated with paracetamol (also known as acetaminophen). Overall, the findings are considered fairly promising and allow the vaccine to progress to further assessments.
The aforementioned processes of the ChAdOx1 nCoV-19 trials are a part of the Clinical Trials; however the first stage of vaccine development is referred to as the Exploratory Phase. In this stage, scientists, researchers, and drug companies pilot innovative approaches. For instance, other COVID-19 vaccine trials have been focusing on the genetic code of the virus rather than its proteins. Trials conducted by Pfizer Inc. and their German partner BioNTech SE, as well as China’s CanSino Biologics have released favorable findings around the same time. The Exploratory Phase has historically ranged from two to four years; however, COVID-19 is genetically similar to the first SARS virus. A sense of familiarity, international efforts, and technology are all assets to teams in this stage.
Once progress has been made in this phase, products are tested in cell cultures and animals to check for any immune responses or a negative one. Thereafter, Clinical Trials begin, in which the experimental vaccine is administered in rounds to a small group individuals, then a larger group, and finally a large outbreak area. Like the Exploratory Phase, these trials can last years. And if the experimental vaccine is successful through the large scale Clinical Trials, the next steps include Regulatory Review, when the vaccine is reviewed by governmental agencies to approve the use and distribution of the drug, and the Production Stage.
The results of the ChAdOx1 nCoV-19 vaccine as published on July 20 are considered the first round of clinical trials and have since progressed to larger scales of testing. In spite of this progress, it is important to note that there are still multiple, lengthy steps that must be accomplished thereafter. Due to the gravity of the Coronavirus pandemic, more extreme measures have been considered. For one, the possibility of challenge trials has been explored. During challenge trials, volunteers would be intentionally infected with COVID-19 in order to directly test the reliability of the vaccine. However, due to limited treatment options and resources, no such trial has been put to use.
Additionally, the United Kingdom government has preemptively begun production plans through three separate contracts to manufacture 190 million doses of the vaccine. Although this is seemingless overly ambitious as it is highly inefficient to begin production plans only after an experimental vaccine has been finalized. By developing production plans early, the UK has begun to prepare an infrastructure capable of manufacturing and distributing a vaccine, as soon as it is ready.
In terms of the vaccine itself, clinical trials have expanded to an international audience. Since the UK has significantly lower rates of COVID-19 infection and their patients are generally less at risk of contraction, the vaccine must be put to the test under diverse circumstances. The sample size of the first trial had a mere 1,000 participants, but more than 10,000 volunteers must be tested to obtain the most reliable results. Currently, trials using the same vaccine are being conducted with populations in Brazil and South Africa, where rates of contraction are much higher. In addition to this, more than 10,000 individuals have been recruited to continue trials at Oxford. With these methods, more populations missed by the original Oxford trial will be tested, including diverse ethnicities, age groups, geographic locations and medical backgrounds. Scientists hope that these large scale trials will account for shortcomings in sample size, patient diversity, and the short length of trial. The effectiveness of the vaccine must rely on an immunity that is enduring and capable of preventing coronavirus contraction instead of simply mitigating its effects.
Chairwoman of the UK Vaccine Taskforce Kate Bingham has even noted the unlikeliness of a “single vaccine for everybody,” and that we may “need different vaccines for different groups of people.” This statement reaffirms the need for international, diverse, and innovative vaccinations. While the vaccine trials initiated at the University of Oxford have been the most promising, this will not and should not deter the progress of other researchers or pharmaceutical countries. The ChAdOx1 nCoV-19 vaccine is only the first step in the right direction.
While the past few stages of this experimental vaccine have been encouraging, there is still significant work to do before we can get our hopes up for a return to “normalized” society. Understanding the complexity of vaccine development sheds light on the faults of political promises of anticipatory reopening plans. Politicians and public institutions cannot guarantee time sensitive because it is beyond their jurisdiction. A safe and effective reopening will be according to science’s schedule, not any government’s. Rushing a vaccine that has potential for adverse effects will only propel the sentiments of anti-vaxxers forward. So, until safe and effective coronavirus vaccines are confirmed, the norms of life pre-coronavirus must be abolished, and the norms of social distancing and mask-wearing must be embraced.