Research Roundup: Contraceptives and HIV trial, identification of protective antibodies may be key to malaria vaccine, and Drug Transparency Observatory launched In France

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A large new study confirms previous research suggesting that a vaccine against rotavirus—a highly contagious virus that can cause severe illness and death in infants and young children— may have an added benefit: lowering the risk for Type 1 diabetes, an autoimmune disease that usually develops in childhood. The study showed a 33 percent reduction in the incidence of Type 1 diabetes among children who completed the three-dose RotaTeq series compared with unvaccinated children. RotaTeq, which protects against five different strains of rotavirus, is one of two orally administered rotavirus vaccines. Among those children in the study who took only one or two of the required three RotaTeq doses, there was no reduction in incidence compared with unvaccinated children. The reductions in risk in those who took the other version of the rotavirus vaccine, Rotarix, were not statistically significant. Approximately one million treatment courses of new child-friendly, easy-to-administer tuberculosis (TB) medicines have been ordered by 93 countries since they were first introduced in 2016, according to developer TB Alliance. Prior to the development of these treatments, caregivers would approximate children’s dosing by crushing or splitting bitter-flavored adult pills, which created adherence challenges. The new treatments meet World Health Organization (WHO) guidelines for childhood TB treatment and are dissolvable in water and flavored for palatability, making it easier for caregivers to administer. The 93 countries in which these treatments have been introduced account for 75 percent of the estimated global childhood TB burden. According to WHO, one million children are diagnosed with TB every year. US President Donald Trump recently issued an executive order calling for all US federal agencies to cut at least one-third of their advisory committees by September—a move many previous agency heads and critics say would weaken science-based regulation processes and the use of evidence-based policymaking. When excluding agencies that are mandated by law, a total of 462 boards and advisory committees that advise on government regulations and provide scientific oversight on other agency decisions are potentially on the chopping block as a result of the executive order. Critics of the executive order said that the one-third number put forth by the Trump administration seemed completely arbitrary and also pushed back on the notion that cutting the committees would save taxpayer dollars.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year. A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country. Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.