As the coronavirus pandemic continues worldwide, there has been a fight to release a safe and effective vaccine.
More than 140 candidate vaccines have been developed globally, and 18 of them are currently in human trials.
Vaccine trials generally undergo three rounds of testing: phase 1, phase 2, and phase 3. The first two trials are typically smaller, primarily evaluating vaccine safety and biological activity, requiring 50 to hundreds of volunteers, respectively. Due to its smaller size, it is relatively easy for pharmaceutical companies to conduct these studies in their home countries.
Comparatively, phase 3 trials are much more difficult as they require thousands of volunteers to assess whether the vaccine works in the real world.
“Most phase 3 vaccine trials need to enroll tens of thousands of patients … It takes a lot of people to show a statistically significant difference,” said Dr. Todd Ellerin, director of infectious diseases at South Shore Health.
As companies speed up their research deadlines, many have begun to look beyond their own borders, looking for volunteers in places where the epidemic is still in full swing.
“You want to be able to assess the efficacy of a vaccine in a country that has continuous infections,” said Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic.
Although infections occur globally, they are not evenly divided at any given time. Now companies in the UK, China, South Korea, and Germany, countries where the pandemic is relatively under control, are looking for new places to start their phase 3 studies.
According to the World Health Organization, only one candidate, the University of Oxford, UK, which is partnering with the pharmaceutical company AstraZeneca, has officially launched a phase 3 trial.
The other leaders include Moderna, Inovio and Pfizer, based in the United States, which is associated with the German biotech company BioNTech. Chinese-based companies CanSino, Sinovac and Sinopharm are also preparing for their own Phase 3 tests in the coming months.
With the pandemic still spreading in the United States, American companies may not need to seek phase 3 studies abroad. In fact, Moderna has announced that it will begin a phase 3 trial with 30,000 participants within the US, beginning in July.
And a spokesperson for Inovio told ABC News that the company will not test its vaccine abroad, as “infection rates in the US are currently high and therefore we will be able to evaluate the efficacy of the vaccine. in subjects in the US ”
However, Pfizer, a US company that partners with Germany-based BioNTech, is looking to conduct phase 3 trials globally, although partners have not yet announced where these trials would be conducted.
In contrast, the UK’s Oxford COVID-19 vaccine will be evaluated not only in the United Kingdom but also in South Africa, the United States, Brazil and India.
“These listed sites are a priority for your study due to the upward curve of COVID-19,” a representative from the University of Oxford told ABC News.
Companies based in China, where the coronavirus is largely controlled, are also making similar plans to test their vaccines abroad.
Sinovac of China is preparing phase 3 trials in China and Brazil, while Sinopharm’s phase 3 trial will be held in the United Arab Emirates. China’s CanSino is also looking to further test its vaccine abroad in Canada, as well as in the Chinese military. However, the lower rates of circulating viruses in Canada and the UAE can cause challenges.
“In China now, the pandemic is basically well controlled, so at least for now, no one can expect an optimal test environment for the efficacy study,” said a spokesman for the Chinese biotech company Walvax, currently in the phase 1 of tests.
“Consequently, we are likely to conduct the phase 3 clinical trial in countries where the population is large and the number of infected continues to rise,” the spokesperson said.
Meanwhile, South Korea-based Genexine, also in Phase 1, has already established collaborations with foreign parties such as Indonesia, Thailand and Turkey for its upcoming Phase 2 trial. A spokesperson told ABC News that if the company Moving on to phase 3, you would also consider countries like the United States, Brazil, and Russia, where large numbers of new cases of COVID-19 occur.
While all of these companies seek to test their vaccines on citizens of countries with high rates of coronavirus infection, Ellerin warned that companies will have to find a way not to compete with each other, “so finding different parts of the world to conduct these trials is key.”
In addition to concerns about increased competition between companies, there are also concerns about how vaccines will be distributed if one is shown to be effective. Bioethicists warn that it may be unethical to conduct studies in one county, but then prioritize vaccination for citizens of another country once the vaccine is successful.
“Most countries that accept testing vaccines in their country do so with the provision that they will have access to the product if efficacy is observed,” Goepfert said.
Vaccine developers have also explicitly expressed such intentions.
“We will spare no effort to ensure that people living in countries where a trial could be conducted have equitable access to the vaccine,” said a spokesman for Walvax Biotech in China, for example.
A spokesman for the University of Oxford told ABC News that it is committed to equitable global access, although “policy-makers will make the decisions about who gets the vaccine first and are likely to focus on the people most at risk, including health workers. ”
Interestingly, the multinational pharmaceutical company GlaxoSmithKline (GSK) is taking a different approach to help address the high global demand for an effective vaccine. They will provide their “pandemic adjuvant technology” to their numerous vaccine candidate partner companies.
The technology “can reduce the amount of vaccine protein required per dose, allowing more doses of vaccine to be produced and therefore helping to protect more people.” In addition, the company aims to make its adjuvants available to all countries and “will offer donations … to global institutions that can determine the need and help with delivery on the ground.”
As the world searches for a solution to the COVID-19 pandemic, large vaccine trials are likely to be conducted in countries with a high and increasing infection rate. Currently, these countries include the United States, Brazil, India, and South Africa.
Due to ethical concerns regarding such a setup for foreign vaccine testing, experts agree that unprecedented levels of international collaboration will be required for rapid production of an effective COVID-19 vaccine.
Hassal Lee, a PhD in neuroscience. and a medical student at Cambridge University, he is a collaborator of the ABC News Medical Unit.
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