Sprint to the Finish: The Race for a COVID-19 Vaccine
As the general population seemingly overcomes the emotional struggles of COVID-19, as evidenced by the public disregard for social distancing rules, the physical aspects of the pandemic continue to ascend. With the overall number of cases surpassing the ten million mark, a vaccine seems like our only hope to prevent further spread of the disease and to save our cratering economy. As of today, there are over 150 vaccine candidates ranging from independent research companies to partnerships between governmental organizations, universities, and large pharmaceutical companies. The range of technological approaches being assessed, which includes recombinant proteins, self-replicating vectors, and even engineered lipid nanoparticle carriers, is a striking feature of the global COVID-19 R&D landscape. Based on the widespread potential and the significant capital invested in COVID vaccine development, the race for a COVID-19 vaccine presents us with a unique opportunity to propel the biotechnology industry forward, adding further value to the $35 billion dollar vaccine market.
Normally, it takes 10-15 years for a vaccine to develop from the exploratory research stages to quality control and global distribution. Like therapeutic drugs, candidate vaccines undergo extensive testing in animals and humans before distribution to the general public. Infectious disease specialist, Dr. Raul Isturiz, summarizes the different stages of the clinical trial process: “The first phase deals with safety. Phase 2 is proof of concept. It produces the response you think will work. Then larger trials (phase 3) test the response in larger sets of patients. Sometimes phase 4 is required to ensure long-lasting results. Then, we move on to manufacturing.” During a pandemic, regulatory bodies like the Food & Drug Administration (FDA) have the authority to accelerate the vaccine development process, allowing certain companies with promising results to test phases I and II simultaneously.
Two of the vaccine candidates that have garnered public attention are an mRNA vaccine by American biotech company Moderna and the NIH, and a Chinese Adenovirus-5-based vaccine from Cansino Biological Inc and the Beijing Institute of Biotechnology. Reflecting an overarching struggle for economic and technological dominance between China and the US, these vaccine progressions have been competing head-to-head, and are set to begin recruiting for phase 3 clinical testing early in July.
CanSino Biological Inc., the first company to launch a vaccine into clinical testing on March 16th, did so only 10 weeks after the full SARS-CoV2 genome was published; by May 22nd, peer-reviewed results of the CanSino phase 1 clinical trials (CTs) were published in the Lancet, whereas Moderna lagged behind with preliminary data of questionable significance. It does seem, however, that the two companies have now caught up with each other on various fronts. Although CanSino was the quickest to complete this CT phase and publish their findings, researchers noted that the antibodies elicited by the vaccine weren’t overwhelming by any means, and that the highest doses provoked at least one adverse side effect which could be exacerbated in larger phase 3 trials. More recent data from Moderna suggests that its mRNA vaccine displays a better immunogenicity and toxicity profile, which may prove more effective for protecting vulnerable populations. Despite the uncertainty surrounding the efficacy of CanSino and Moderna's vaccines, one thing remains clear: the results of the phase 3 clinical trial will be critical in evaluating their relative successes.
In a surprising turn of events, the most advanced vaccine is actually one developed by researchers at the University of Oxford and licensed to AstraZeneca, the Anglo-Swiss Pharma giant. Although it began clinical testing well after CanSino and Moderna, the ChAdOx1-S vaccine is now well into the recruitment stage of phase 3 clinical trials in the UK, Brazil, India, and South Africa. The vaccine’s rapid development can be attributed to quickly generated robust clinical data, showing that a single dose could provoke a strong immune response to the SARS-CoV2 spike protein with limited side effects. Reflecting these successes, international partnerships have emerged to secure doses of the vaccine that looks like the world’s best bet against the coronavirus pandemic. France, the Netherlands, Italy, and Germany reached a deal for an estimated 400 million doses, while Serum Institute of India (SII), the world’s largest manufacturer of vaccines by volume, has claimed it can mass-produce up to 2 billion doses of the vaccine by the end of the year. At this rate, the Oxford/AstraZeneca vaccine is likely to be the first candidate to enter the global market.
Looking ahead, it’ll be important to consider the geopolitical and economic forces that will shape the global supply of vaccines in the short term. “There is no scenario in which we will have enough doses of a successful vaccine to immunize the world in the first 18 months,” says Seth Berkley, chief executive officer of Gavi.
Global access to late-stage vaccines is likely to be dictated by high-income countries’ interests rather than by high-risk regions. Wealthier countries have been striking deals to secure doses of promising late-stage vaccine candidates if they aren’t developing one themselves, a phenomenon known as vaccine nationalism. One interesting case is Moderna’s partnership with Swiss pharma mogul Lonza: boasting one of the largest drug manufacturing plants in the world with capacity to produce hundreds of millions of doses of the vaccine, Lonza accentuated that vaccine nationalism is against Swiss values of free trade. Partnering with a small, politically neutral country for manufacturing was a smart move on Moderna’s part. On the other hand, The SII has already stated that most of the Oxford vaccine shots produced would be distributed to India before being distributed abroad, and similar plans have been put in place by the Trump administration for vaccines manufactured on US soil.
Although wealthy countries with large-scale access to the COVID vaccine are likely to achieve herd immunity, the growing community of anti-vaxxers also stands in the way of protecting vulnerable populations. With the movement gaining momentum around the world in recent years, it is of utmost importance that stakeholders in the medical world devise strategies to curb its influence.
The answer to the question of when a vaccine will be available largely depends on which country you live in and vaccine candidates’ success in ongoing clinical trials. The U.S. has launched “Operation Warp Speed” in an attempt to have the first vaccine potentially hit American shelves by early 2021; however, health experts have criticised this approach, arguing that the integrity of clinical trials could be compromised if a vaccine is pushed out too quickly. To make sure developing countries are not left behind, the WHO has called for a “patent pool” for biomedical organizations to share intellectual property, and has outlined an $18 billion plan to distribute vaccine doses globally. One thing is certain: the vaccines released over time will vary greatly in terms of safety, efficacy, and accessibility, deepening global health inequalities for years to come.
Only time will tell who will win the COVID-19 vaccine race. Regardless of the outcome, the arrival of the first vaccine will be a historic achievement for the scientific community and the result of unprecedented levels of funding and international coordination. Nonetheless, the widespread availability of a COVID-19 vaccine remains unlikely before Summer 2021, so it looks like face masks and social distancing are here to stay.