The Current Progress of a Coronavirus VaccineBy Haruna Tomono | Published 10/27/2020
On October 17, the US surpassed 8 million nationwide COVID-19 cases and is currently averaging over 50,000 new infections daily. As the pandemic grows in prominence and forces people to readjust to a new normal, much of people’s hope lies in the rapid development of a coronavirus vaccine that would allow for a return to pre-COVID society. This brings an important and complex question to mind: what is the status of the vaccines that are currently in development?
To understand the progress that companies and researchers have made, it is important to first understand the timeline of a vaccine’s creation to distribution. First, the treatment must be developed in the laboratory and undergo preclinical testing on cells and animals. Once its preclinical efficacy is confirmed, it then moves into Phase 1 in which a small number of participants are tested on for safety and proper dosage. Following this, Phase 2 and 3 expand into hundreds and thousands of participants respectively. Phase 3 is particularly critical in the development process, as the vaccine is compared to placebo treatments.
A study can be paused or put on hold at any point during the three phases in the case of an unexpected result or perceived failure. After successful completion of all phases, the vaccine then enters the legal process of acquiring production and distribution approval, from which widespread vaccinations can begin. To expedite the trial process, many administrations and developers are choosing to run Phase 1 and 2 simultaneously.
Of the 60+ vaccines that have entered the clinical trial phase (passed preclinical testing), only a few have reached Phase 3 and limited use approval. These vaccines can be categorized by the treatment type into 5 categories: genetic, viral vector, protein-based, inactivated coronavirus, and repurposed vaccines. Below are some of the most promising vaccines of each category.
Moderna Therapeutics’ approach uses mRNA sequences to produce viral proteins in the body. Beginning development in January, their mRNA-1273 vaccine has been one of the leaders in the race to vaccine development, and is currently in Phase 3 involving 30,000 volunteer patients (began July 27). They have been given over $2.5 billion in support from the US government in exchange for 100 million doses once approved. Canada has also agreed to purchase 20 million doses. Completion is projected to be at the end of 2020 or early 2021, before entering the legal approval process.
The German pharmaceutical companies Pfizer and BioNTech have partnered on a similar mRNA vaccine that entered Phased 3 on the same day as Moderna’s product. They expanded their trial to include 43,000 participants in September and gained permission to begin testing on children 12+ years old this month. This the first and only vaccine to gain testing permissions for minors in the US. The US, Japan, and EU are slated to purchase a total of over 320 million doses if successful. Completion of clinical trials will be at the end of October at the earliest.
Viral Vector Vaccines
Both CanSino Biologics (China) and Gamaleya Research Institute’s (Russia) vaccines contain engineered adenovirus Ad5 as the primary method for carrying coronavirus genes. Both vaccines entered limited approval phases in August with questionable validity due to a lack of information on their clinical trial results.
Janssen Pharmaceutica, owned by Johnson & Johnson, is currently in Phase 3 testing for their vaccine derived from adenovirus Ad26. The study was paused last week due to an unexplained illness in a participant. They have, however, received over $1 billion from the US government in exchange for 100 million doses should the vaccine be approved. The EU is also planning to purchase 200 million doses.
AstraZeneca (England) and the University of Oxford’s joint vaccine development, based on chimpanzee adenovirus ChAdOx1, is currently paused for Phase 3 testing in the US, but is continuing in other countries. The treatment known as “Covishield” in England and India caused a spinal inflammation called transverse myelitis in a participant last month and led to the sustained pause in the US. The EU is planning to purchase 400 million doses if successful.
Novavax has been awarded $1.6 billion from the US government and $384 million from the Coalition for Epidemic Preparedness Innovations for their protein-based vaccine, which entered Phase 3 trials last month in the UK. They are also planning for additional testing in the US later this month. An agreement was made last month with the Serum Institute of India that would allow them to manufacture up to 2 billion doses annually once the vaccine is approved (planned early 2021).
Inactivated Coronavirus Vaccines
Sinovac Biotech and Sinopharm (China) have separately developed a total of three vaccines using weakened coronaviruses. Trials for these vaccines are currently in Phase 3 being tested in the United Arab Emirates, Argentina, and Brazil. Sinovac’s vaccine named “CoronVac” has been given emergency approval for limited use by the Chinese government for medical workers, high-risk personnel, and public service workers. They are planning for worldwide distribution in early 2021. Similarly, Sinopharm’s two vaccines have been cleared by the U.A.E. for emergency approval for healthcare workers. The only information shared on its safety has been a dat set released in September.
There have been various clinical trials for vaccines originally created for other viruses. The only one known to be in Phase 3 is Murdoch Children’s Research Institute’s (Australia) BRACE trial that is using the Bacillus Calmette-Guerin vaccine, originally developed for tuberculosis. They are currently looking to see if it can partly protect against the coronavirus.
It is evident that there is significant progress being made on the developmental process for a coronavirus vaccine. However, many drugs remain in Phase 3 and will most likely remain so until at least the end of this year.
Yet, the public has high hopes for the development of an effective vaccine by early next year, with many governments awarding grants to companies and promising to purchase millions of doses once approved. Additionally, the US Centers for Medicare & Medicaid Services has partnered with CVS and Walgreens to provide free coronavirus vaccinations to residents and workers in long-term care facilities once a vaccine is approved by the US Food and Drug Administration. This initiative will allow those in nursing homes, residential care homes, and adult family homes, along others, to gain access to a vaccination without financial concerns. The world remains optimistic for rapid vaccine development and approval as the end of 2020 approaches and no signs of returning to “normal” by 2021.
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