In 2020, researchers from across the globe united under pressure to find a vaccine for Covid-19. Now, four years later, the world is facing another global emergency as mpox breaks out worldwide. Although vaccines are available, there are still many challenges with the virus. As a result, the research space is preparing to get on the battlefield again.

In August 2024, the World Health Organization (WHO) declared the mpox outbreak in Africa a Public Health Emergency of International Concern (PHEIC). The organisation has also called for more efforts to provide treatments to the continent to curb the virus, with many countries promising to help.

There are several unmet needs for mpox, including the availability of vaccines and lack of treatment for patients affected by the infection.

Several trials are already underway for mpox treatments and vaccines, however many of these are not in patients who are in need now. For example, Moderna’s mRNA vaccine is only being investigated in the UK which is yet to report a case of the most recent strain.

It is hoped that the research community will use the learnings gained during the Covid-19 pandemic to accelerate trial development and rollout in nations across Africa where the disease is spreading the fastest.

Anaelle Tannen, infectious disease analyst at GlobalData, said lessons from the Covid-19 pandemic can be replicated, but trial integrity must remain at the heart.

“The urgency to find solutions during the Covid-19 pandemic led to the rapid generation of evidence and accumulating literature. This brought about challenges for systematic reviews and put pressure on regulatory agencies with massive emergency authorisations, with some of these having to be rescinded,” Tannen explained.

“The pandemic re-emphasised the importance of well-designed clinical trials, as well as highlighting the need for transparency and maintaining high standards of scientific integrity.”

Speed, target population and adaptive designs

The same three key principles adopted in the Covid-19 vaccine trials will likely be implemented in mpox trials - those are speed of initiation, identifying and targeting in-need populations and adaptive trial design.

One of the main techniques used to expedite trials is real-time data collection, which adaptive trial designs can assist with. These trial designs allow researchers to quickly determine dose levels in early arms and adjust incoming cohorts of patients as needed without it being considered a protocol violation or requiring a new trial to be approved.

This means that sponsors can add arms and amend protocols as they learn more and avoid running several trials consecutively which can add years to the approval process.

Seth Lederman, co-founder, and president of Tonix Pharmaceuticals, said that his company used skills developed in the Covid-19 pandemic to initiate a trial of its pipeline mpox vaccine.

“The Covid-19 pandemic has bolstered preparedness for the mpox global emergency, especially regarding clinical trials and vaccine development,” Lederman said.

“The rapid advancement of trials during Covid-19 demonstrated that adaptive, real-time data collection could accelerate clinical development. The pandemic taught the industry how to quickly enrol patients and initiate studies to ensure the mpox vaccine progresses quickly through clinical stages.”

Regulatory agencies are better prepared

The Covid-19 pandemic also helped develop a framework of quick backing from regulatory bodies. Approval processes for trials such as FDA’s Emergency Use Authorizations (EUAs) have been set up to streamline processes to allow sponsors to move quicker in the initiation phases which can ordinarily take months.

“The streamlined regulatory processes established during the pandemic, such as EUAs have set a precedent for fast-tracking vaccines and treatments for emerging diseases. These also allow trials to start faster without compromising safety. These streamlined processes are now aiding mpox treatment trials, expediting approval timelines while ensuring rigorous review standards are taken,” Lederman explained.

Trials are already being initiated and regulatory pathways are being explored in mpox, showing that sponsors are indeed utilising the infrastructure that has been developed to speed up trial processes.

“We can see that trials are already underway and drug approval processes have been expedited for specific mpox products, such as Emergent BioSolutions’s ACAM2000 receiving FDA expanded approval this week for use in adults at high risk of mpox infection. The WHO PHEIC declaration has also spurred international bodies to act fast in combatting the spread of mpox,” Tannen said.

Financing and infrastructure could be a barrier

One of the potential drawbacks of the mpox emergency could be financing. The WHO has called on governments to step up. During the Covid-19 pandemic, global governments worked with big Pharma to assist in vaccine development, both practically and financially.

With mpox, there is already a marketed vaccine and as the disease is primarily isolated to Africa, many countries in other continents may not have the same vested interest in supporting research.

Therefore there are likely to be several barriers. Research will also face difficulties due to the lack of infrastructure in the African countries that are most impacted, said Dr David Schwartz, medical epidemiologist and a board-certified pathologist in infectious diseases.

“There are financial problems, issues of manpower, problems in providing access to the affected areas if they are small villages with no proper road networks. If you have a vaccine that requires refrigeration, it's difficult to maintain refrigeration while getting to these areas,” explained Schwartz.

“Even if you manage to work all of that out, you have the problem of acceptance. Depending on where we're talking about, often certain people at risk, such as women, don't have the capability of making their own medical decisions within some of these countries.”

There have been some developments however since the Covid-19 pandemic, with custom-built facilities to manufacture mRNA vaccines now available which should make it more feasible to run more trials. It also improved global collaboration on a huge scale in the medical industry. These kinds of learnings will need to be replicated in mpox to try to curb the virus.

“Covid-19 fostered unprecedented global collaboration between private industry, governments, and regulatory bodies, an infrastructure that can now support rapid clinical responses to mpox. This existing network enables pharma companies to engage global trial sites and research partners, reducing barriers to patient recruitment and data collection for their vaccine trials,” said Lederman.

Schwartz added: “We can take the lessons we've learned from vaccine development and implementation and networking during Covid-19 in resource-rich countries and bring them to Africa but that doesn't mean that they're necessarily going to translate very well into implementation due to these issues.

“An international effort is required with these kinds of viruses. I think that the WHO and other international organisations will be important in implementing these strategies.”

Listen to the GlobalData Thematic Intelligence podcast: Mpox: How international cooperation can tackle the spread