Breakthroughs Blog: COVID-19

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 June, South Sudan is expecting to begin the rollout of the preventive malaria intervention seasonal malaria chemoprevention (SMC), although there are concerns that high parasite resistance in eastern and southern African countries will limit its long-term efficacy. In June 2022, the World Health Organization (WHO) updated its recommendations that previously restricted SMC’s use to the Sahel region, where malaria transmission is highly seasonal, to encourage its use in other regions after pilot studies showed positive results in countries with high resistance, including South Sudan. Experts have emphasized the need for rigorous monitoring and evaluation to assess SMC’s efficacy in areas of high resistance and to detect any parasite resistance in the Sahel, as well as the development of alternative tools and drugs for malaria chemoprevention.Last week, the European Medicines Agency recommended authorization of GSK’s Arezvy vaccine for respiratory syncytial virus (RSV) in adults 60 years of age and older, which if approved, will be the world’s first available vaccine for RSV. Regulatory agencies in the United Kingdom and United States are expected to make decisions on GSK’s vaccine in the coming months. Pfizer and Moderna are also developing vaccines for the virus, with Pfizer’s candidate already having gained the backing of a panel of US Food and Drug Administration (FDA) advisors earlier this year.Bavarian Nordic, the maker of the Jynneos vaccine, which is approved by the FDA to protect against both smallpox and mpox, is planning to dramatically scale up production capacity for their vaccine. The company’s CEO connected the move to the rapid spread of mpox last year, which highlighted the need to be able to manufacture at a much greater scale than currently available: from tens of millions to hundreds of millions of doses. Bavarian Nordic plans to simplify its production process to facilitate partnerships with other manufacturers in order to have adequate production capacity for stockpiling and in case of a future emergency.

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.Last Thursday, the World Health Organization (WHO) officially launched its mRNA vaccine technology hub in Cape Town, South Africa. During the COVID-19 pandemic, the facility was established in response to global vaccine access inequity to pursue mRNA vaccines for COVID-19 and potentially other poverty-related diseases. South African biotech firm Afrigen Biologics and vaccine producer Biovac are working with the publicly available sequence of Moderna’s mRNA COVID-19 vaccine to create a similar vaccine candidate, which will be tested on humans early next year. The candidate will the first to be made based on a widely used vaccine (like Moderna’s) without the developer’s approval and assistance and the first mRNA vaccine designed, developed, and produced at lab scale on the African continent.The White House plans to nominate cancer surgeon Dr. Monica Bertagnolli to become the director of the US National Institutes of Health (NIH), succeeding Dr. Francis Collins, who stepped down in 2021. Dr. Bertagnolli has served as the director of the National Cancer Institute since last fall. If confirmed by the Senate, she will inherit COVID-19 pandemic-era challenges around increased scrutiny of the agency’s funding of virus research, including grants to EcoHealth Alliance, which studied coronaviruses in Wuhan, China.Two studies published last week found that repurposed drug combinations lowered the risk of severe COVID-19 in high-risk patients. Stanford University researchers looked at the combination of the antidepressant fluvoxamine and the corticosteroid budesonide among nonhospitalized adults with early symptomatic COVID-19 and at least one risk factor. A second team from Weill Cornell Medicine looked at the combination of the monoclonal antibodies amubarvimab and romlusevimab in nonhospitalized adult COVID-19 patients with high-risk factors. Using combinations of repurposed drugs to treat severe COVID-19 (if successful in further testing) could prove to be an important tool in reducing the burden of COVID-19 in low- and middle-income countries, where oral therapeutics for COVID-19 are largely unavailable.

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.Last week, Ghana became the first country to approve a new malaria vaccine developed by the University of Oxford’s Jenner Institute. The vaccine, R21, is the second-ever vaccine for malaria authorized for use by regulators. Ghana’s Food and Drugs Authority approved the shot for use in children between 5 and 36 months old based on final data from an ongoing phase 3 trial in almost 5,000 children. The results have yet to be published but were shared with regulatory agencies. The vaccine could become an important tool in the fight against malaria and in reducing child mortality, especially if Ghana’s approval is echoed in other countries and by the World Health Organization. The COVID-19 pandemic revealed the consequences of limited genome sequencing capabilities on the African continent and has pushed national laboratories to ramp up their ability in preparation for future pandemics. Thirty-nine African countries now have the equipment and skilled workforce for sequencing, as part of a continent-wide network with specialized training centers and regional hubs. However, capacity levels across laboratories vary, and there is a need to move beyond sequencing the virus that causes COVID-19 to broader applications and for increased training in data analysis.The Biden administration last week announced the launch of Project Next Gen, the US$5 billion-plus program that succeeds the President Trump-era Operation Warp Speed to accelerate the development of new coronavirus vaccines and treatments to address COVID-19 and future coronavirus threats. The program will primarily focus on three objectives: creating long-lasting monoclonal antibodies, advancing vaccines that produce mucosal immunity, and developing pan-coronavirus vaccines. Administration officials expressed their hope that the program can generate strong next-generation vaccines and treatments, delivering breakthroughs that could also potentially benefit other health R&D areas as well

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.French researchers are investigating after 59 percent of individuals in a new mpox outbreak cluster claim to be vaccinated, raising fears that the virus has mutated. The investigation will look at various questions, including when the individuals were vaccinated and at what dose, as well as whether they share a common characteristic like having HIV that could impact the effectiveness of the vaccine. If other possibilities are ruled out, French health authorities will start looking at the possibility of a mutation in the virus. The vaccine, Imvanex or Jynneos, is a third-generation smallpox vaccine. There is no specific vaccine for mpox, and this investigation could yield important data about the real-life efficacy of this vaccine for the virus, which is expected to remain a public health issue.This week, German diagnostics startup Midge Medical announced a partnership with the Institut Pasteur de Dakar to offer a rapid molecular diagnostic test for Marburg virus for field testing on the African continent. The collaboration started with a request from the Institut to adapt the startup’s Minoo system, a portable, battery-operated, isothermal amplification instrument with smartphone connectivity enabling data analysis and readout of results, which was previously used for COVID-19 testing. Midge Medical said they integrated the Marburg virus test into the Minoo platform within a month and delivered a prototype assay and provided training to staff at the Institut for field testing, where it has been favorably received.German scientists have reported promising results for a nasal vaccine for COVID-19 tested in hamsters. While this vaccine is not yet close to rollout, other nasal vaccines have been in use in China and India since last fall (although studies about their effectiveness has not yet been published) and at least four other nasal vaccines for COVID-19 are in late-stage clinical trials. While strong data to back up these vaccines is still needed, the hope is that these next-generation vaccines could better prevent people from getting sick and spreading infection by blocking the virus at the point of entry in the nose and throat where it first gains a foothold.