Preventive HIV vaccines
1.0 Global investment in preventive HIV vaccines R&D
In 2019, funding for preventive HIV vaccine R&D increased by a marginal 0.7 percent or US$6 million from the previous year, and totaled US$848 million. The public sector accounted for 81 percent of overall investment, at US$686 million, with the philanthropic and commercial sectors contributing 13 percent and six percent, respectively. At US$662 million or 78 percent of all public sector funding, the US remained the largest donor of preventive vaccine research globally. US public sector funding increased by six percent from 2018 levels, an uptick bolstered by the six percent increase in funding from the National Institutes of Health (NIH) that brought its contribution to US$597 million.
European investment in preventive vaccine R&D decreased by 22 percent and amounted to US$18 million, the lowest levels observed since 2000. Philanthropic contributions decreased by 15 percent and totaled US$111 million. This trend is mostly attributed to the US$19 million decrease in funding from the Bill and Melinda Gates Foundation (BMGF), which funded preventive vaccine research at US$99 million in 2019.
The commercial sector contributed US$50.7 million although this number is likely a result of under-reporting from the sector.
The Netherlands, Denmark and Canada increased their commitments in 2019, which helped cushion against decreases from France, UK, Italy, Switzerland and Germany. Funding from the European Commission also decreased from US$9.5 million to US$9.3 million in 2019.
1.1 Developments in the field of preventive HIV vaccine researchThe diverse pipeline for HIV vaccine candidates continues to advance, with multiple large-scale trials underway. This is the busiest the pipeline has ever been with dozens of innovative new approaches under investigation.
- “Mosaic-based” vaccines designed to protect against a wide variety of HIV subtypes are being tested in two efficacy trials: Imbokodo (HPX2008/HVTN 705), a trial in five countries in sub-Saharan Africa1, and the Mosaico trial (HPX3002/HVTN 706) in eight countries across the Americas and Europe2.
- The innovative PrEPVacc study began enrollment in December 2020 and will be conducted in four African countries, testing two vaccine regimens and comparing two daily oral pre-exposure prophylaxis (PrEP) options, F/TDF (Truvada) and F/TAF (Descovy)3.
1.2 Funding allocations for preventive HIV vaccine R&D
Funding for HIV vaccine R&D was allocated to the following areas in 2019: basic research (17.3 percent), preclinical (46.5 percent), clinical (34.4 percent), cohort and site development (1.3 percent) and advocacy and policy (0.5 percent). As observed since 2016, preclinical research out-funded clinical trials. Further information about the categories used to define R&D can be found in the Methodology section of the Appendix.a
2.0 Global investment in microbicide R&D
Investment in microbicide R&D totaled US$154 million in 2019, a six percent (US$9 million) decrease from 2018 funding levels. Not only is this the seventh consecutive year of declining microbicide funding, but it also represents the lowest level recorded since 2005. The public sector remained the largest donor at 98 percent of funding, with the remaining two percent originating from philanthropy. Public funding decreased by six percent and fell to US$151 million, while philanthropic funding increased by 95 percent from the previous year to US$3.5 million. Even though philanthropic funding increased nearly 100 percent due to increased commitments from BMGF, it was not enough to make up for the US$10 million decrease in public sector funding.
The US remained the largest funder of microbicide research at US$134 million, with USAID contributing US$45 million and the NIH US$87.8 million. European funding shrunk by 33 percent to US$16.9 million. Zero allocations for microbicide R&D from the German Federal Ministry of Education and Research (BMBF) and the Netherlands Ministry of Foreign Affairs explain the drop in European funding. In 2018, these funders collectively contributed US$9 million. The two philanthropies backing microbicide R&D saw an increase in funding from 2018 levels, with BMGF rising to US$3.2 million and Institut Pasteur to US$0.3 million.
2.1 Developments in the field of microbicide researchA diverse range of microbicide strategies are under investigation and some products are closer than ever to being rolled out as discreet and female-initiated HIV prevention options.
- The first microbicide to be submitted for regulatory approval, the Dapivirine Vaginal Ring (DPV-VR), was recommended by the World Health Organization (WHO) as an additional prevention choice for women at substantial risk of HIV infection5. The ring, which is designed as a 28-day long-acting product, had previously received a positive opinion from the European Medicines Agency in July 2020 and was added to the list of WHO’s prequalified medicines in November 2020.
2.2 Funding allocations for microbicide R&D
Allocations for microbicide R&D in 2019 were as follows: basic mechanisms of mucosal transmission (six percent), preclinical research (13 percent), formulations and modes of delivery (12 percent), clinical trials (40 percent), behavioral and social science research (11 percent), research infrastructure (12 percent) and advocacy and policy (six percent).
Pre-Exposure Prophylaxis (PrEP)
3.0 Global investment in PrEP R&D
In 2019, global investment in PrEP R&D totaled US$99 million; a 16 percent increase from levels observed in 2018. Investment from the philanthropic sector increased by 56 percent, rising to US$33.8 million. This trend is linked to the rise in BMGF funding, from US$21 million to US$33 million. US public sector donors also recorded increased funding, with NIH funding up 15 percent to US$42 million and CDC funding up to US$1.4 million. Commercial sector investment in PrEP remained mostly unchanged at US$19 million.
3.1 Developments in the field of PrEP researchUptake of oral PrEP grew substantially in 2020: there were over 300,000 new initiations globally, bringing the total cumulative initiations since PrEP was introduced to 928,750. Sub-Saharan Africa comprised 56% of global uptake. Yet scale-up remains concentrated, with only 11 countries counting more than 25,000 initiations by the end of 2020. Strengthening oral PrEP implementation will lay a solid foundation for introduction of next-generation products. Recent results from trials of a long-acting injectable and once-monthly pill indicate that a diverse array of biomedical prevention products is on the horizon.
- Early results from HPTN 083 and HPTN 084, two Phase III studies of a long-acting injection of the antiretroviral cabotegravir (CAB-LA)77 were released in 2020. HTPN 083 is a randomized, controlled, double-blind study that enrolled 4,570 cisgender men and transgender women who have sex with men in the Americas, Asia, and South Africa. HPTN 08388 found that CAB-LA demonstrated safety and high efficacy for reducing HIV risk among gay men and other men who have sex with men and transgender women. HPTN 084 is a randomized, controlled, double-blind study that enrolled 3,223 cisgender women in sub-Saharan Africa. HPTN 08499 found CAB-LA to be comparatively more effective than oral PrEP in cisgender women – reducing HIV risk by 89 percent more compared to oral PrEP. Both options reduced risk and were found to be safe.
Other biomedical prevention options
4.0 Global investment in treatment as prevention (TasP) R&D
Investment in TasP R&D continued to decline in 2019, decreasing 19 percent to US$1.7 million. A marginal increase in philanthropic funding was neutralized by a 24 percent decrease in the public sector. However, recent decreases in TasP funding are linked to the completion of the CDC-funded Botswana Combination Prevention project, which had been ongoing since 2013. Multiple large-scale trials such as HPTN 052, PARTNER, Opposites Attract, PARTNER 220 and HPTN 071 have demonstrated the effectiveness of treatment to reduce onward transmission. This established and robust evidence base likely explains the sharp decline in R&D investment for TasP since 2015.
5.0 Global investment in the female condom
The Female Health Company remained the only funder for female condom research and contributed US$0.06 million. This was a 49 percent increase from 2018.
6.0 Global investment in voluntary medical male circumcision (VMMC)
Investment in VMMC research decreased by three percent and totaled US$9 million. BMGF was the largest donor at US$7.6 million, followed by the NIH at US$1.3 million. Sufficient empirical studies have already affirmed the efficacy of VMMC as a prevention option, which is likely why over 50 percent of the research is allocated to implementation science and the large-scale rollout of services. Other areas of focus include behavioral and social science research (25 percent) and advocacy and policy development (25 percent).
7.0 Global investment in Prevention of vertical transmission
Funding for PMTCT decreased by four percent, with levels shrinking from US$36 million to US$34.6 million. The number of donors financing PMTCT research decreased from twelve to eight, with BMGF being the only philanthropic donor. Most PMTCT research (almost 96 percent) was funded by the public sector, with the US NIH remaining the largest donor at US$29 million. European funding decreased by 12 percent, falling to US$2.9 million. Philanthropic funding levels also rose to US$1.5 million, bolstered by increased support from BMGF.p