Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...

Mary Moran and colleagues survey global investment into research and development of new pharmaceutical products to prevent, manage, or cure diseases of the developing world.

New research suggests that long-held beliefs on neglected disease drug development activity are no longer accurate.

Product Development Partnerships (PDPs) are playing an increasingly important role in the development of new medicines for neglected diseases of the developing world; however, there has been limited information on their funding and expenditure patterns. This paper analyses funding for the 14 PDPs working on neglected disease research and development (R&D) by using unpublished data from the Global Funding of Innovation for Neglected Diseases (G-FINDER) project, which surveyed 2007 global investments into R&D of products for neglected diseases. PDPs captured US$469 million or 23% of 'external' R&D funding for neglected diseases, i.e. funding granted by donors to research organisations, as opposed to internal investments by donors. PDP's funding sources were highly concentrated with the Gates Foundation providing nearly half of PDPs' combined income (49%) and four public funders (the US Agency for International Development (USAID), the UK Department for International Development (DFID), the Dutch government and Irish Aid) providing 28%. PDPs collectively spent US$262 million on R&D activities in 2007, with 88% of this expenditure going to academic institutions, contract research organisations and companies in the developed world. Our analysis confirms the central role played by PDPs in R&D for neglected diseases, but highlights the need to diversify their funding sources.

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