Preventive HIV vaccines
1.0 Global investment in preventive HIV vaccines R&D
In 2020, funding for preventive HIV vaccine R&D decreased by 5.5 percent or US$46 million from the previous year and totaled US$802 million. The public sector accounted for 87 percent of overall investment, at US$702 million, with the philanthropic and commercial sectors contributing 12 percent and one percent, respectively. The US remained the largest donor of preventive vaccine research globally, at US$646 million or 92 percent of all public sector funding. US public sector funding decreased by 2.4 percent from 2019 levels, highlighted by the three percent decrease in funding from the National Institutes of Health (NIH) that brought its contribution from US$598 million in 2019 to US$579 million in 2020.
European investment in preventive vaccine R&D decreased 31 percent, down to US$48 million. Philanthropic contributions decreased for the second consecutive year, by 16 percent, totaling US$93.6 million. This trend includes the US$7.5 million decrease in funding from the Bill and Melinda Gates Foundation (BMGF), which funded preventive vaccine research at US$92 million in 2020.
The commercial sector reported US$7 million in HIV vaccine R&D this year, although this number is likely a result of underreporting.
Denmark, France, Belgium and Canada increased their commitments in 2020. By contrast, Netherlands, the United Kingdom and Norway decreased their commitments. Funding from the European Union increased from US$10.5 million to US$11.5 million in 2020. This is highlighted by a 1.7-fold increase in funding from the European Developing Countries Clinical Trials Partnership, which helped cushion against a 31 percent decrease in funding from the European Commission.
An overall increase in commitments were seen in East Asia and the Oceanic regions in 2020 for HIV vaccine R&D. Japan contributed US$2 million via the World Bank. India’s funding increased eightfold, rising from US$0.2 million in 2019 to US$1.7 million in 2020. Australia also marginally increased their commitment, while a decrease was observed in the United Arab Emirates.
1.1 Developments in the field of preventive HIV vaccine research
The diverse pipeline for HIV vaccine candidates continues to advance, with multiple large-scale trials underway. This is the busiest the pipeline has ever been, as dozens of innovative new approaches are under investigation.
- “Mosaic-based” vaccines designed to protect against a wide variety of HIV subtypes have been 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. In August 2021, Johnson & Johnson announced that primary analysis of the data from the Imbokodo study found that that the mosaic vaccine regimen in that trial did not significantly reduce the overall risk of HIV acquisition among women in the countries where the trial took place. The vaccine regimen was shown to be safe, but results did not warrant moving forward for longer follow-up. The companion study, the Mosaico trial, will continue.
- 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 2020: basic research (19.2 percent), preclinical (39.7 percent), clinical (34.7 percent), cohort and site development (0.4 percent) and advocacy and policy (4.9 percent). As observed since 2016, preclinical research has out-funded clinical trials. Further information about the categories used to define R&D can be found in our Methodology.
2.0 Global investment in microbicide R&D
Investment in microbicide R&D totaled US$145 million in 2020, a 0.4 percent (US$0.6 million) increase from 2019 funding levels. After multiple years of continuous decline in microbicide funding, this presents a slight, hopeful change of wind. The public sector remained the largest donor, at 99 percent of funding, with the remaining one percent originating from philanthropy and commercial sectors. Public funding for microbicides research increased by 1.6 percent, to US$143 million, while philanthropic funding decreased by 65 percent from the previous year, to US$1.2 million.
The US remained the largest funder of microbicide research, at US$134 million, with the NIH contributing US$81 million and USAID contributing US$45 million. The Canadian Institute for Health Research (CIHR) contributed US$6 million, a significant increase from 2019 (US$0.4 million), and the UK Foreign, Commonwealth and Development Office contributed US$5 million, a sharp drop from 2019 (US$14 million). There was an increase in funding from the Netherlands Ministry of Foreign Affairs and ANRS. Although philanthropic funding decreased overall, more philanthropic organizations supported microbicides R&D in 2020, including Aidsfonds and the Campbell Foundation.
New support came from the commercial sectors for microbicide R&D in 2020, totaling US$0.5 million, compared to no support in 2019.
2.1 Developments in the field of microbicide research
A 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 infection4. 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.
- A 90-day vaginal ring designed as a dual-purpose product conferring both contraceptive and HIV protection was found to be effective in early-phase testing. Results of the study, MTN-044/IPM 053/CCN019, were presented at the HIV Research for Prevention (HIVR4P) Virtual Conference in 20215.
2.2 Funding allocations for microbicide R&D
Allocations for microbicide R&D in 2020 were as follows: basic mechanisms of mucosal transmission (six percent), preclinical research (36 percent), formulations and modes of delivery (11 percent), clinical trials (30 percent), behavioral and social science research (five percent), research infrastructure (11 percent) and advocacy and policy (one percent).
Pre-Exposure Prophylaxis (PrEP)
3.0 Global investment in PrEP R&D
In 2020, global investment in PrEP R&D totaled US$107 million, a two percent decrease from levels observed in 2019. Investment from the philanthropic sector decreased by 42 percent, down to US$20 million. This trend is linked to a 48 percent dip in BMGF funding, from US$33 million to US$17 million. US public sector donors also recorded a five percent increase in funding, with the NIH funding up 19 percent, totaling US$50 million. There was a 21 percent increase in funding from commercial sectors, totaling US$24 million.
3.1 Developments in the field of PrEP research
Uptake of oral PrEP has grown substantially in 2021: there were over 1,307,000 new initiations globally in Q2 of 2021. Sub-Saharan Africa comprised 65 percent of global uptake. Yet scale-up remains concentrated, with only 14 countries counting more than 25,000 initiations by the end of Q2 in 2021. Strengthening oral PrEP implementation will lay a solid foundation for the 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)6, were released in 2020. HTPN 083 is a randomized, controlled, double-blind study that has enrolled 4,570 cisgender men and transgender women who have sex with men in the Americas, Asia and South Africa. HPTN 08387 found that CAB-LA was safe and highly effective in 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 has enrolled 3,223 cisgender women in sub-Saharan Africa. HPTN 08498 found CAB-LA to be comparatively more effective than oral PrEP in cisgender women, reducing HIV risk by 89 percent more than oral PrEP. Both options reduced risk and were found to be safe.
Promising interim findings from Phase IIa trials of the once-monthly pill of antiretroviral Islatravir were released in January 20219. The results found Islatravir to be safe and well tolerated in the blood over time, and it reached levels adequate for HIV prevention for a duration of at least one month10. Islatravir will move into efficacy trials in 2021.
Other biomedical prevention options
4.0 Global investment in treatment as prevention (TasP) R&D
Investment in TasP R&D saw a four-fold increase in 2020, totaling US$9 million, attributed to a spike in funding from the philanthropic sector, notably BMGF at US$5 million and the Wellcome Trust at US$1 million. The public sector also saw a significant increase, attributed to CIHR’s funding, at US$1.7 million. Whereas philanthropic support made up 26 percent of TasP investment in 2019, this grew to 72 percent in 2020. New support for TasP R&D came from Aidsfonds, the European Commission, the National Health and Medical Research Council and Institute Pasteur. Given the trend of declining TasP funds from 2015 to 2019, this is a promising sign that TasP is being given priority once again for the prevention of HIV/AIDS.
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.
5.0 Global investment in voluntary medical male circumcision (VMMC)
Investment in VMMC decreased by 37 percent and totaled US$6 million. BMGF was the only donor. A number of empirical studies have already affirmed the efficacy of VMMC as a prevention option, which is likely why all projects related to VMMC are dedicated to implementation science (50 percent), advocacy and policy (20 percent) and social and behavioral studies (30 percent).
6.0 Global investment in Prevention of vertical transmission
Funding for PMTCT decreased by 29 percent, with levels shrinking from US$35 million in 2019 to US$25 million in 2020. This decline is attributed to the elimination of BMGF from the list of funders for PMTCP R&D and decreases in funding from public donors. Most PMTCT research (99 percent) was funded by the public sector, with the NIH remaining the largest donor at US$22 million, although this represents a 22 percent decrease from the previous year. European funding also fell from US$3.4 million in 2019 to US$1.3 million in 2020.