Hannah Sachs-Wetstone

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. In a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.

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.President Biden signed an executive order establishing a new national biomanufacturing initiative and pledging more than US$2 billion to fund building or expanding drug manufacturing facilities and ensuring an adequate supply of raw materials. The Biden administration’s goal is to strengthen the biotech supply chain and maintain US competitiveness with foreign manufacturers in the wake of major supply chain challenges and shortages during the COVID-19 pandemic. $40 million of the pledge will go toward expanding the production of antibiotics and the base materials needed to produce products for future pandemic responses.A new study looking at antimicrobial resistance (AMR) records from laboratories in 14 African countries found that the basic requirements for testing for drug-resistant pathogens are unmet in most areas despite plans to tackle antimicrobial resistance on the continent. The researchers found that only 1.3 percent of the 50,000 medical laboratories included in the study were conducting bacteriology testing. Of those laboratories that were, even fewer were equipped to test for AMR and among those who were testing for AMR, only a third of the high-priority antibiotic-resistant pathogens designated by the World Health Organizations were being tested consistently. The study highlights larger challenges in Africa including limited access to antibiotics, imperfect use of antibiotics, and a lack of information about the impact of AMR because of incomplete and fragmented data.The smallpox treatment tecovirimat, or TPOXX, is undergoing a phase 3 clinical trial to test efficacy in treating monkeypox after preliminary data from the Centers for Disease Control and Prevention showed some alleviation of symptoms in patients. The trial is being run by the AIDS Clinical Trial Group in locations nationwide and will enroll more than 500 people who test positive for monkeypox. The intent is to provide stronger data that federal officials and agencies can use to inform decisions about the use of TPOXX in the national response to monkeypox.

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 University of Oxford research team published promising results for a new malaria vaccine, R21. The trial, conducted among 409 children in Burkina Faso, found that an initial three doses followed by a booster after one year showed up to 80 percent efficacy in preventing malaria. The developers say the vaccine can be produced for just a few dollars and that they expect the vaccine to be rolled out next year through a manufacturing deal for more than 100 million doses a year with the Serum Institute of India. The rollout of the vaccine will follow an approval process that hinges on the results from a larger trial, which will be published in the coming months. Both India and China have approved needle-free COVID-19 vaccines­—nasal and inhaled versions, respectively. The nasal version, licensed to Bharat Biotech, was developed by scientists at Washington University in St. Louis. CanSino Biologics has developed the inhaled version, which is a version of their own injected vaccine. Both vaccines use harmless cold viruses although the developers of the nasal version are seeking approval to use the vaccine as a regular and booster dose whereas the inhaled version was only tested as a booster. It is unclear when either vaccine will be available for distribution. These needle-free vaccines are just two of more than ten candidates being studied, as scientists are pursuing needle-free vaccines as a potential strategy to improve protection and make vaccines easier to administer, particularly in low-income countries.A new study published in the journal Radiology looked at Google’s artificial intelligence (AI) model for automating tuberculosis (TB) detection compared to radiologists identifying TB on chest X-rays. The model uses AI to analyze X-ray images to determine which patients should receive follow-up confirmatory molecular testing that is expensive and time-consuming. The AI model could address physician shortages as well as improve TB outcomes and lower costs. While the study revealed promising results across large and diverse patient populations, the model needs to be further tested in real world environments with populations that are older and have more atypical presentations of the disease or other lung abnormalities. A study in a Zambian clinic, which will be finished in the coming months will provide further insight into the potential of the model. 

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.Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks. 

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.The World Health Organization (WHO) awarded the first prequalification to an African-manufactured antimalarial drug used to prevention infection in pregnant women and infants. The medicine, sulfadoxine-pyrimethamine, marketed as Wiwal, is made by Kenyan drug company Universal Corporation Limited. The approval is a step toward strengthening local production of medicines, as well as addressing the disproportionate burden of malaria in Africa.An Oxford University research team announced their new PLATINUM trial assessing whether SIGA Technologies’ tecovirimat (Tpoxx) is an effective treatment for monkeypox. The study seeks to recruit at least 500 participants, who will be given a 14-day treatment of two doses daily or a placebo. Tpoxx has been cleared by the United Kingdom and European Union to treat diseases caused by the family of orthopoxvirus that includes smallpox and monkeypox based on studies in animals and healthy humans, though it has only been used in severe cases in Great Britain. In the United States and Canada, the drug has only been approved to treat smallpox. There have been no studies assessing the effectiveness of the drug in hastening recovery in those infected with monkeypox.Moderna announced that it has requested emergency approval from the US Food and Drug Administration (FDA) for its variant-updated COVID-19 vaccine. The vaccine is a booster dose for adults 18 years and older targeting Omicron subvariants B.A.4 and B.A.5. If approved, doses could be ready to ship in September. Moderna’s announcement follows Pfizer and BioNTech’s news that they have applied for FDA approval for their updated booster.

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.The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) announced a joint development agreement to support phase 2 trials evaluating two investigational combination treatment regimens for active pulmonary tuberculosis (TB). Both regimens combine already registered products with new chemical entities (NCEs). The first combines delamanid and bedaquiline with two NCEs, OPC-167832 and sutezolid, while the second includes pretomanid and bedaquiline with the two NCEs. The trials will test whether these regimens can substantially shorten treatment duration, with the goal of advancing a suitable regimen into phase 3 development. UNICEF has awarded GSK a contract valued at up to US$170 million to produce the first malaria vaccine. The award will pay for 18 million doses of GSK’s RTS,S vaccine over the next three years. UNICEF has stated their hopes that the award will encourage other malaria vaccine developers to continue to innovate new technologies in order to address the burden of malaria, especially to mitigate preventable deaths of children under five years old from the disease. The United Nations agency expects high demand for the vaccine and believes that costs per dose will decrease over time as supply and manufacturing capacity grow in turn.On Monday, August 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) gave conditional approval to Moderna’s Omicron variant-updated COVID-19 vaccine for use as a booster in adults. The approval is based on clinical data that demonstrated “strong immune response” against the original virus and B.A.1 subvariant and exploratory analysis showing a “good immune response” against the B.A.4 and B.A.5 subvariants as well as no serious safety concerns. The UK’s Joint Committee on Vaccination and Immunisation followed by supporting the use of the updated vaccine the national booster shot campaign starting next month.