The pipeline for pandemic products is bare. Here's why it matters

One of the key concepts born out of the COVID-19 pandemic is the 100 Days Mission, an initiative endorsed by the Group of Seven major economies and the Group of 20 industrialized and emerging-market nations whose goal is to have effective diagnostics, treatments, and vaccines within 100 days of a public health emergency declaration. But a new report reveals serious gaps in the clinical pipeline for diseases with pandemic potential, and limited investments in their research and development over the years. There are no approved treatments and very few in clinical trials for diseases with high fatality rates, such as Marburg and Nipah. There are also no diagnostics in late-stage clinical development for Zika and SARS. Most of the available diagnostics, treatments, and vaccines that are approved or in clinical development are for COVID-19, which is unsurprising given the need to address the pandemic. But much of those investments came in the middle of the crisis, not before, showing the reactive nature of R&D funding. Before COVID-19, only $154 million had been invested in research and development for any coronavirus, but that shot up to over $14 billion during the acute phase of the crisis from 2020 to 2022, according to the report by the International Pandemic Preparedness Secretariat, or IPPS, an entity set up to support the 100 Days Mission. In comparison, the combined R&D funding for the other nine priority pathogens with pandemic potential identified by the World Health Organization totals just $1.7 billion. A separate landscape analysis by the INTREPID Alliance, a small nonprofit with seven big pharmaceutical companies as members, also confirmed that there isn’t much in the antiviral clinical pipeline outside of coronaviruses and influenza. Why this matters The idea behind the 100 Days Mission is to have a ready pipeline of diagnostics, treatments, and vaccines that can be developed and made available at speed in the event of a public health emergency and prevent the crisis from spiraling into a pandemic. The goal is to reduce the time it takes to develop these lifesaving products and save lives in the early phase of a crisis. While COVID-19 vaccines were developed at record speed, it still wasn’t fast enough to prevent deaths during the first year of the pandemic. According to the Coalition for Epidemic Preparedness Innovations, or CEPI, 1.6 million deaths were recorded globally before the first COVID-19 vaccine by Pfizer and BioNTech was given emergency use authorization. And even then, the supply was limited and was only available in a few countries. It took even longer — close to two years — before an effective oral antiviral treatment for COVID-19 became available. “When COVID came along … there weren’t many treatments for coronaviruses in development that could then be brought into play and tested rapidly against SARS-CoV-2 for COVID-19,” James Anderson, executive director of global health at the International Federation of Pharmaceutical Manufacturers & Associations, or IFPMA, and chair of the INTREPID Alliance, told Devex. “That meant that they were slower to come through, and there simply wasn’t the breadth of choice that would be desired.” What are the concerns Apart from a thin clinical pipeline, proponents of the 100 Days Mission are concerned about the concentration of investments and funders. Between 2014 and 2022, $11.3 billion of R&D funding went to vaccines, as opposed to just $1.3 billion for diagnostics, according to Policy Cures Research. A huge bulk of the total R&D funding from 2014 to 2022 — 50% of all investments — came from the U.S., making the funding landscape vulnerable to political changes. Regarding antiviral treatments, the INTREPID Alliance found that 88% of developers were from the biopharmaceutical industry. Many of them are based in the U.S. and China, and some in Europe and Japan. “There … isn't really much in terms of companies yet still in Africa, although you might expect that to change in the future,” Anderson said. There is also concern about the lack of a lead organization that would help coordinate the work on treatments as part of the 100 Days Mission. CEPI is leading that work for vaccines, and FIND on diagnostics. Anderson said they would like to see greater priority given to encouraging research in antiviral treatments for pandemic preparedness. He said there is little on that now in the context of the pandemic treaty discussions or the World Trade Organization’s 13th Ministerial Conference. What’s the caveat Equitable access is a key guiding principle of the 100 Days Mission, a spokesperson for IPPS told Devex. There’s a range of measures needed to ensure equitable access to medical countermeasures globally, including strengthening clinical trials and regulatory processes for expedited approval of products, as well as having sustainable, distributed manufacturing. These all require investments and equal attention. But as Carmen Pérez Casas, Unitaid’s senior technical manager, told Devex: “You need a product to actually have a possibly enabled access to it for the populations in need.” But Pérez Casas emphasized the need for discussions to take place now on access commitments alongside product development. That includes discussions on transparency, product pricing, and volumes. “We cannot have anymore a situation where we are all improvising. Because that led … to a huge delay as well on access to products once they were already approved and recommended,” she said, adding many formal and informal conversations are now happening on this. Mariângela Simão, former WHO assistant director-general for drug access, vaccines, and therapeutics and a member of the Science and Technology Expert Group of IPPS, said during a panel on Wednesday that medical products need to also be affordable and easy to deliver. “They should also offer broad coverage and be based on technology and manufacturing processes that are easy to transfer, which is always a contentious issue,” she said. “It’s not enough to develop technologies fast.” What’s next The secretariat, together with several partners, such as INTREPID Alliance and Unitaid, have launched a therapeutics road map that sets out specific objectives, such as developing at least two phase 2-ready treatment candidates for each of the WHO priority pathogen families with pandemic potential. No timeline has been set yet when this goal should be reached. WHO is also expected to publish an updated priority pathogens list in the first quarter of 2024. Proponents hope the road map would lead to identifying a lead coordinator and procurer for treatments, similar to Gavi for vaccines. Whether that’s repurposing or remandating an existing organization is for further discussion, according to the IPPS spokesperson. The INTREPID Alliance will publish a list of promising antiviral compounds in clinical development in February, as well as a list of promising preclinical compounds in June. According to Anderson, they aim to have a more complete picture of the gaps in antiviral treatment R&D and identify the most promising programs and how the Alliance can support them. Meanwhile, CEPI is expected to complete preclinical tests for the development of initial prototype vaccines for a range of diseases, including Lassa and Nipah, and have further candidates in the preclinical phase, according to the report. The IPPS secretariat will also advocate for investments in treatments and diagnostics in 2024.