Research Roundup: Researchers identify drugs for COVID-19 repurposing, malaria vaccine shows promise in early trials, and CoronaVac vaccine appears safe for those 3 and over

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, the World Health Organization (WHO) recommended the use of interleukin-6 receptor blockers as a treatment for severe and critical COVID-19, making these only the second set of drugs it has deemed effective in treating the disease. The interleukin-6 blocking drugs, tocilizumab and sarilumab, showed efficacy in reducing deaths in data from more than 10,000 patients involved in 27 clinical trials. Tocilizumab, made by Roche under the brand name Actemra, and sarilumab, made by Regeneron and Sanofi under the brand name Kevzara, are monoclonal antibodies used to suppress overreactions of the immune system in patients with severe COVID-19. In its recommendation, WHO also emphasized a need for equitable access to the treatments, calling on manufacturers to reduce the drugs’ prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging. A chikungunya vaccine candidate developed by Valneva has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The single-dose, live-attenuated vaccine, VLA1553, also received FDA Fast Track designation in December 2018 and European Medicines Agency PRIME designation in October 2020. Valneva’s phase 3 trial to evaluate immunogenicity and safety of VLA1553 at 28 days following immunization completed recruitment in April, and top-line data is expected in the summer. The Breakthrough Therapy Designation is meant to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates the drug may have substantial improvement for at least one endpoint over available therapies.Pfizer intends to seek FDA authorization for a third dose of its COVID-19 vaccine in August, the company said Thursday, claiming another shot within 12 months could boost immunity and help combat virus variants. Early data from Pfizer’s booster study showed participants’ antibody levels jumped five- to ten-fold after a third dose, compared to their second dose months earlier. Research has also shown the current vaccine regimen offers strong protection against the delta variant, which is now spreading rapidly around the world and accounts for the majority of new US infections. On the same day as Pfizer’s announcement, the US Centers for Disease Control and Prevention and FDA issued a joint statement saying fully vaccinated Americans don’t need a booster shot yet, and any decision on boosters would happen only when “the science demonstrates that they are needed.”

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 first technology transfer hub for mRNA COVID-19 vaccines will be established in South Africa, the World Health Organization (WHO) announced last week. The hub will assist in scaling production of and access to doses across the African continent by providing training on mRNA technologies for manufacturers from low- and middle-income countries and licensing them for local production. The hub is still in the process of securing agreements with manufacturers of mRNA vaccines, the technology of which is potentially easier to scale than alternatives and could be faster and easier to adapt for COVID-19 variants of concern. If knowledge of the way to produce an existing mRNA COVID-19 vaccine is transferred to the new hub in South Africa, doses could be produced at the site in the next 9 to 12 months, according to WHO.Scientists at the University of Oxford will evaluate Ivermectin in a new clinical trial to prevent hospitalization among people with COVID-19 symptoms. Ivermectin, most commonly used to treat parasitic infections, has been promoted for use against COVID-19 in several regions despite a current lack of clinical data to support its use. There have been early, “promising” results from small and observational studies, but it would be “premature” to recommend Ivermectin for COVID-19, according to a researcher from the upcoming trial. The Oxford team said they selected Ivermectin to be included in the trial because it was readily available globally and known to be relatively safe.The US Food and Drug Administration granted emergency use authorization to a COVID-19 antibody test that uses mouth swabs, rather than blood samples, to detect the presence of IgA, IgG, and IgM antibodies. The rapid, saliva-based test, called CovAb, delivers a result within 15 minutes and does not require any additional hardware or instruments. The authorization allows the diagnostic to be used at the point of care among adults and children. In clinical trials, CovAb demonstrated a false-negative rate of less than 3 percent and a false-positive rate of nearly 1 percent when administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels.