THE recent COVID-19 pandemic ushered in a new era of vaccine research.
An unprecedented global collaboration of scientists (and the development of mRNA vaccines that followed) was said to be akin to the ‘landing on the moon moment’.
To develop a vaccine (without compromising safety) in under one year was a mammoth achievement for mankind.
While the coronavirus pandemic made wearing masks and physical distancing the ‘new normal’, it also drove unprecedented global co-operation for vaccine research and distribution.
Under normal circumstances, due to the complexity of vaccine development, making a new vaccine can take fom 10 to 15 years.
The fastest vaccine to have been developed to date, according to Yale Medicine, was the vaccine for mumps, which took four years.
Considering the speed at which the various COVID-19 vaccines were developed, many people were naturally concerned regarding their safety and effectiveness; and as expected, with these concerns came vaccine hesitancy.
Such hesitancy could be a particular problem for cancer sufferers.
Certain types of cancer, particularly blood cancers like leukemia and lymphoma as well as certain types of cancer treatment, can have a major impact on the immune system.
A study in Nature Medicine surveyed 19 countries and found that 71,5 percent of the respondents would consider taking a COVID-19 vaccine and that only 61,4 percent would take it if their employer recommended it.
But, according to those in the know, ‘a vaccine is only effective if people are willing to receive it’.
Amid the deadly global pandemic, time was of the essence.
Thus, researchers swiftly mobilised themselves and shared their records on coronavirus with other scientists.
The director of inDemic Foundation, a non-profit organisation that provided information about COVID-19, and a chief resident at Baylor College of Medicine in Houston, Tx, Dr Sam Sun, told MNT that transparency throughout the vaccine process was key to “…debunking misinformation and building the public’s trust”.
But researchers were not starting their research from scratch when the SARS-CoV-2, the virus that causes COVID-19, broke out — scientists had already been studying coronaviruses for over 50 years.
In fact, scientists had existing data on the structure, genome and life cycle of this type of virus, which they shared among themselves.
SARS-CoV-2 is a member of the coronavirus family.
According to the National Institute of Allergy and Infectious Diseases, there are hundreds of coronaviruses — including four that can cause the common cold, as well as the coronaviruses that sparked the SARS (severe acute respiratory syndrome) epidemic in 2002, and the emergence of MERS, or Middle East Respiratory Syndrome, in 2012.
According to Dr Eric J. Yager, an associate professor of microbiology at Albany College of Pharmacy and Health Sciences in Albany, NY: “Research on these viruses established the importance of the viral spike (S) protein in viral attachment, fusion and entry, and identified the S proteins as a target for the development of antibody therapies and vaccines. Early efforts by scientists at Oxford University to create an adenovirus-based vaccine against MERS provided the necessary experimental experience and groundwork to develop an adenovirus vaccine for COVID-19.”
Dr Michael Parry, the chair of Infectious Diseases at Stamford Health in Stamford, CT, said that, thanks to advances in genomic sequencing, researchers successfully uncovered the viral sequence of SARS-CoV-2 in January 2020; roughly 10 days after the first reported pneumonia cases in Wuhan, China.
The ability to fast-track research and clinical trials was a direct result of this worldwide collaboration and co-operation between virologists, scientists and researchers.
Before any clinical trial can start, a data monitoring and safety board must approve a study protocol. A Phase One trial focuses on the safety of the vaccine candidate.
Escalating doses of the vaccine are given to healthy volunteers to determine side effects and tolerability.
Phase Two trials expand their recruitment and may include participants with health conditions such as obesity, cancer, and diabetes.
There is also active recruitment of participants of various demographics.
The trial continues to test the safety of the vaccine and looks at the drug’s initial efficacy and how it affects the immune system.
During Phase Three trials, thousands of participants are recruited to measure the efficacy of the vaccine in preventing disease.
A common practice is to combine the phases of clinical trials, but they are still held to the same ethical, scientific and statistical standards as when each phase is done separately.
A potential benefit of combined trials, particularly in Phase Two and Three, is that since the vaccine is evaluated in sub-groups of individuals, results from the study expedites the identification of patient factors that impact vaccine safety or efficacy.
The high interest in volunteers for vaccine studies was a major factor behind the rapid completion of clinical trials.
Another factor was the increased number of testing sites established to facilitate enrollment and to collect large amounts of data.
In the US, the Food and Drug Administration (FDA) meticulously reviewed the data from each clinical trial phase before approval or, in the case of public health emergencies, before granting emergency-use-authorisation.
Vaccine research is very costly.
A study in 2018, published in The Lancet Global Health,estimated the cost of early development and initial clinical safety trials for a typical vaccine at between US$31 to US$68 million.
Added to these figures would be large scale trials to determine the efficacy of a vaccine candidate. In the accelerated timetable with a new coronavirus, this cost was naturally higher.
Thus, funding from both governments and the private sectors was critical in making COVID-19 vaccines available as quickly as possible.
By providing resources, assuming the financial risk and investing in multiple companies and vaccine platforms at once, OWS enabled companies to produce and stockpile vaccine doses even before they knew if the vaccines would work; increasing the odds of a vaccine, or vaccines, available by the beginning of 2021.
For their part, the European Commission funded several vaccine candidates and worked with others in pledging billions for COVID-19 research.
According to Dr Kenyon: “Even after emergency use authorisation has been granted, safety data will continue to be collected, as participants are followed for up to two years. This adds another layer of reassurance as a person shifts from a trial to a real-life setting.”
After vaccination, the CDC continued to monitor safety via a smartphone application for acute care and long-term care facilities.
“It is a smartphone-based system where you will be contacted actively by CDC to see how you are doing after being vaccinated and, therefore, pick up any adverse events that were not picked up in the trials,” explained Dr Kenyon.
Dr Tony M. Monda BSc, DVM, DPVM, is currently conducting Veterinary epidemiology, and Agro-economic research in Zimbabwe. E-mail:tonym.MONDA@gmail.com
THE recent COVID-19 pandemic ushered in a new era of vaccine research.