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. Last Wednesday, Moderna announced that its combination COVID-19 and flu shot, mRNA-1083, demonstrated strong immunogenicity in a phase 1/2 trial. The trial found that mRNA-1083 was similarly effective to two already approved flu vaccines developed by GSK and Sanofi and Moderna’s own SpikeVax COVID-19 vaccine. There were also no new safety concerns reported with the combination vaccine compared to each of the vaccines used alone. A phase 3 trial testing the combination shot will begin before the end of the year with potential regulatory approval in 2025 if successful. The company also laid out its broader efforts on combination vaccines, including a combination shot for COVID-19, flu, and respiratory syncytial virus.The Biomedical Advanced Research and Development Authority (BARDA) has awarded Vir Biotechnology $50 million in Project NextGen funds to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions for COVID-19 and future pandemic threats.  The new funding will support development of alternative mAb delivery technologies that increase antibody expression relative to existing solutions, which could revolutionize mAb delivery by expanding administration options and shortening development and manufacturing timelines. Four-fifth of the funding will specifically go toward advancing Vir’s next-generation COVID-19 mAb, Vir-7229, through a phase 1 trial, expected to be completed in late 2025, while the remainder will support the discovery of new mAbs against a second pathogen of pandemic potential.The World Health Organization (WHO) last week recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford. This follows two years after WHO recommended RTS,S, the first malaria vaccine. Both vaccines have a similar efficacy profile and delivery method and are targeted to children, but doses of R21 are expected to be cheaper—between $2.00 and $4.00 compared to about $7.25 now charged for RTS,S. The Serum Institute, which will produce R21, has also announced plans to deliver a much higher volume of doses compared to GSK’s current marketing plans for RTS,S. Although it will take more time to collect further safety monitoring data for R21, the recommendation of a second vaccine will hopefully help to ensure adequate supply for malaria-endemic countries that are planning to integrate a vaccine into their national malaria control plans.

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 latest funding from the Biomedical Advanced Research and Development Authority’s (BARDA’s) Project NextGen will go to Gritstone bio for a large-scale phase 2b study of its mRNA COVID-19 vaccine candidate. $433 million will go toward the trial, expected to start early next year, which will test the company’s vaccine against an already approved one. Gritstone’s candidate aims to provide broader and longer-lasting clinical protection than first-generation COVID-19 vaccines by inducing multiple types of immunity against current and future variants of the virus that causes COVID-19.Two recent studies reviewing the efficacy and safety of higher dose regimens of the antimalarial drug primaquine bolster support for increasing doses in malaria-endemic countries. Primaquine has been used against Plasmodium vivax malaria for more than 60 years, but this new research provides the answer to a problem designated by the World Health Organization as a key research priority: how to reduce malaria relapse. The studies found that doubling the currently used dose of primaquine halved malaria relapses, while delivering a similar safety profile to the lower dose regimen, suggesting widespread implementation of higher dosing could have a significant impact on reducing P. vivax malaria relapses, deaths, and transmission in endemic countries.New research into an innovative injected hydrogel drug method for treating HIV offers hope of a completely novel management method that could drastically reduce the frequency of treatment and eliminate the need for daily pills, greatly improving the quality of life of people living with HIV. The researchers found that one injection of the gel in mice was enough to maintain effective and lasting concentrations of the drug lamivudine for 42 days with nearly no side effects by ensuring the drug was released slowly and consistently in the body. Further tests will look at the hydrogel used in combination with others drugs to prevent HIV as well as simultaneously address HIV and hepatitis B.

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 US Food and Drug Administration (FDA) has given 510(k) clearance to the BD Respiratory Viral Panel, an automated, multiplexed, and real-time PCR test that can be used to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) from only one sample, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA). The panel runs on a BD system widely used by hospitals and labs across the United States that can process hundreds of samples a day and deliver results in two hours. By reducing the need for multiple tests to distinguish the cause of respiratory infections, the test will help patients receive appropriate care faster and reduce burdens on the health system, which is important as the United States faces the rising threat of these viruses over the coming months.FDA is expected shortly to approve updated versions of the COVID-19 boosters, which although originally designed to target the XBB.1.5. omicron subvariant should still protect against the currently circulating subvariants, as cases and hospitalizations linked to the new variants rise. While it remains unclear whether the agency will grant emergency use authorizations or full approval licenses, either will trigger the Centers for Disease Control and Prevention to make its recommendations for who should receive the shots, allowing vaccinations to likely begin soon in the United States.Ghana recently became the first country in Africa to manufacture a cholera vaccine. The private-sector pharmaceutical consortium DEK Vaccines Limited produced the vaccine, as well as six others, including against malaria, HPV, pneumonia, and rotavirus, which are expected to be available by 2026. This was made possible through a licensing and technology transfer agreement with the International Vaccine Institute (IVI). Scaling up local production of vaccines is seen as an important step toward enabling Ghana, the West African region, and the continent at large to reduce the critical shortage of vaccines and reliance on foreign countries and companies and to ensure greater access to vaccines that protect against endemic diseases.

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) last week announced its first COVID-19 vaccine license agreement through the COVID-19 Technology Access Pool (C-TAP) with Taiwanese manufacturer Medigen Vaccine Biologics Corp. The vaccine license was acquired through the Medicines Patent Pool, which also enabled last week additional agreements under C-TAP for a COVID-19 vaccine prototype and a test used to measure COVID-19 antibody levels. While C-TAP was launched at the height of the pandemic to promote technology sharing to improve access, particularly to vaccines, in low-income countries, major pharmaceutical companies have thus far declined to join the initiative.A clinical trial led by researchers at St George’s, University of London found that a higher dose of the antibiotic rifampicin for an abbreviated four-month treatment regimen for tuberculous (TB) was safe with no increases in side effects or toxicities, compared to the standard six months, which is WHO-recommended. The trial took place among adults with newly diagnosed pulmonary tuberculosis in Uganda, Guinea, Peru, Nepal, Botswana, and Pakistan. Experts say shorter treatment regimens will help lower costs and increase patient compliance, which will in turn reduce transmission and the development of resistance to available TB drugs. CSL Sequiris announced that it received an award from the Biomedical Advanced Research and Development Authority (BARDA) to deliver a vaccine for bird flu to the US government, increasing BARDA’s stockpile in case of an outbreak. The company will deliver one bulk lot of the H5N8 A/Astrakhan antigen to the US government, whose development has been supported by BARDA in recent years. The agreement is intended to improve US national vaccine preparedness and is especially significant as bird flu continues to be detected around the world, including a small number of human cases.