Breakthroughs Blog: 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. The National Institute of Allergy and Infectious Diseases and the Democratic Republic of the Congo’s National Institute for Biomedical Research are co-leading a clinical trial evaluating the safety and efficacy of the antiviral drug, tecovirimat (TPOXX), in mitigating symptoms and preventing serious outcomes in 450 adults (including pregnant individuals) and children with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States. The drug impedes the spread of virus in the body by preventing virus particles from exiting human cells. Trial participants will be randomly assigned to receive the oral pill or placebos twice daily for two weeks. The World Health Organization (WHO) has announced that a clinical trial of vaccines aimed at preventing the rare Sudan strain of Ebola could start within weeks, pending regulatory approvals from the Ugandan government. There is no vaccine for the Sudan strain, which is behind the rapidly growing outbreak in Uganda. The trial will test two vaccines in development that have shown potential to treat this strain. Details about the specific vaccine candidates were not released. While the Sudan strain is less transmissible and has had a lower fatality rate in past outbreaks, compared to the Zaire strain, the Ugandan outbreak is incredibly concerning, and vaccines are urgently needed. By raising public awareness of emerging diseases and the need for laboratory capacity to address them, COVID-19 has inspired several Asian countries, including India, to invest in advanced biosafety laboratories. These labs are needed for working on dangerous pathogens and live viruses like SARS-CoV2. Some researchers have expressed concerns about the high cost of maintaining these facilities due to extensive safety measures including extra security, self-closing doors, and filtered air, among others. Concerns have also arisen about the potential risk of these labs handling extremely dangerous pathogens, however new labs could also improve overall safety practices that would reduce this risk. These new labs could play an important role in supporting more vaccine research, including for endemic infectious diseases in the region, as well as improving working conditions for researchers. 

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.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.Scientists in eastern China have identified an animal virus that has jumped to people, infecting 35 since 2018. Named the Langa henipavirus, it causes respiratory symptoms and is closely related to two other human henipaviruses, Hendra and Nipa. While scientists believe the virus is not fatal, nor does it seem to spread easily between humans, experts have urged ongoing surveillance and further research into the virus, especially as zoonotic disease outbreaks become more common worldwide. The virus is believed to be carried by wild shrews although it is unclear whether people are infected directly or indirectly by these animals.Last week, Pfizer and BioNTech announced new trials will start later this month of their updated mRNA vaccine aimed at protecting against the B.A.4 and B.A.5 Omicron subvariants, which have spread quickly and demonstrated heightened ability to evade existing vaccine protection. If the vaccines receive regulatory approval, the companies expect to roll out the updated vaccines by October. The approval process should be quicker than normal as the US Food and Drug Administration (FDA) is not requiring updated clinical data for the B.A.4- and B.A.5-updated shots, instead basing their approval on clinical data from the companies’ Omicron B.A.1-focused vaccine trials, which have already been submitted.The Biden administration is stretching out its limited supply of Jynneos monkeypox vaccine to address the growing public health issue and supply shortage in the face of high demand for the vaccine. On Tuesday, August 9, the FDA issued an emergency use authorization to allow the method of injecting one-fifth of the normal dose amount into the skin rather than a full dose into the fat. The guidance still urges health care providers to continue to follow the regimen of two shots 28 days apart with the lower dose amount. The administration is recommending this method to ensure more high-risk people can access at least some vaccine protection.