During the COVID-19 pandemic, therapeutic development took a backseat to vaccines – a potentially disastrous gamble had vaccines not been found.

In future pandemics, therapeutics and vaccines should be treated equally – particularly as COVID-19 treatment options remain expensive and mostly only available in high-income countries, speakers told at a webinar this week hosted by the Cumming Global Centre for Pandemic Therapeutics in Melbourne.

During the first 12 months of the COVID-19 pandemic, $91 billion was publicly invested globally in vaccines compared to just $4.6 billion in therapeutics. 

“The first COVID-19 vaccine was approved in July 2020 and delivered to people in December 2020. However, the therapeutic drug, Paxlovid, was only first administered in late 2021 and approved by the US Federal Drug Administration in May 2023,” according to Cumming Centre, which is based at the Peter Doherty Institute for Infection and Immunity.

“If Paxlovid and Molnupiravir, or a similar therapeutic drug, had been available at scale in July 2020, in line with COVID-19 vaccine approval, millions of lives globally could have been prevented.”

Problems with ACT Accelerator

One of the problems during COVID-19 was the structure of the Access to COVID Tools Accelerator (ACT-A), the global structure that was set up to ensure low and middle-income countries had access to health products such as tests, vaccines, treatments and PPE, said Eloise Todd, executive director of the Pandemic Action Network.

ACT-A was divided into four separate pillars – vaccines, therapeutics, diagnostics, and a ‘health systems connector’.

Civil society warned from early on that unless ACT-A had “a single fundraising strategy and a single entity that’s going to spend against an epidemiological strategy, you’re essentially setting up a competition between those forces”, added Todd.

Sure enough, “by September 2021, the vaccines pillar had achieved 95% of its fundraising target and the therapeutics pillar, just 19%”, she said, adding that the “vaccine gold rush approach” undermined the holistic management of COVID.

Generics also “came too late in the process to have an impact in lower middle income countries”, said Todd.

“When the next threat comes around, the epidemiological approach we need to take means that we have to have a bird’s eye, focused view on saving lives from Day One. So by all means, let’s have the R&D for vaccines, but we have to have the R&D for therapeutics. We also have to look at how to repurpose existing therapeutics.”

Shingai Machingaidze, co-chair of the Science and Technology Expert Group (STEG) of the International Pandemic Preparedness Secretariat (IPPS), said that the development pipeline for therapeutics faced “multiple hurdles, including long development timelines, regulatory challenges, and the need for robust clinical trial infrastructure growth globally”. 

A key recommendation of an expert review of the COVID-19 response commissioned by the G7 and G20 was the need for a global coalition focused on therapeutics, she said, adding that the IPPS is currently working on establishing such a coalition.

The aim is not to create a new entity but to bring together the existing entities and to ensure sustained R&D funding to develop at least two Phase 2-ready therapeutic candidates against individual viral pathogen families of greatest pandemic potential, added Machingaidze.

HIV: No vaccine but effective ARVs

“Imagine a situation where we have a new pandemic, and we can’t make a vaccine or it takes 10 years to make a vaccine, not one year,” said Prof Sharon Lewin, director of both the Doherty and Cumming centres.

“As an example, after 40 years of research for HIV, there is still no HIV vaccine. However, therapeutics, but what I mean here is direct-acting antivirals or drugs that stop HIV from replicating, have turned HIV from a death sentence to a chronic manageable disease,” she added.

“Direct-acting antivirals can fill a gap. They can be a second layer of protection, or they can actually be the only intervention we have. So we need to really think hard about how we can make them better, make them faster and make them equitable.”

The Cumming Centre was launched in September 2022 as a joint venture of the University of Melbourne and Royal Melbourne Hospital following a $250-million donation from Geoffrey Cumming, making it the “biggest philanthropic gift in the history of Australia”, said Lewin.

“We’re not a drug company, nor do we plan to do what companies already do well,” she added. 

“We plan to expand the pipeline for drug companies to ultimately commercialise and implement new therapeutics, so our goal is to focus on new platform technologies to develop therapeutics at speed for pathogens of pandemic potential.”

The centre’s goal is to provide “really long-term funding” to  projects that are “high risk, but also high reward”, added Lewin.

“We need treatment solutions, not only for pathogens that we know about but for pathogens that are totally unexpected. And we need to be able to develop those solutions in a much shorter time frame than what’s currently possible with our current technologies. I personally think this can be done but it will need new science, new ideas and transformational changes in how we approach therapeutics.”

Lewin added that her centre had a smaller focus on anti-microbial resistant (AMR) pathogens “because we think the likelihood it of causing a global pandemic is much smaller than a viral cause”.