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. Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine candidate showed 66 percent efficacy in preventing moderate to severe disease 28 days after vaccination, according to results from a phase 3 global study released Friday. The trial data differed across geographies, with the vaccine demonstrating 72 percent efficacy among participants in the United States, 66 percent efficacy in Latin America, and 57 percent efficacy in South Africa—adding to concerns about diminished vaccine efficacy against the COVID-19 variant circulating in South Africa and recently detected in the United States. The J&J vaccine also showed complete protection in preventing hospitalization and death due to COVID-19, as well as 85 percent efficacy in preventing severe forms of the disease. J&J plans to apply for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) in early February.On Thursday, Novavax announced 90 percent efficacy of its two-dose COVID-19 vaccine candidate in preliminary results from a phase 3 clinical trial in the United Kingdom, while results from a separate trial indicated 49 percent efficacy of the vaccine in South Africa. The company has said it is already working on a new version of the vaccine designed to combat more infectious strains of the virus, which could also be used as a booster for already-inoculated individuals. The vaccine is also undergoing testing in the United States and Mexico, supported by Operation Warp Speed, which is expected to complete phase 3 enrollment in the first half of February. Novavax expects to file for emergency authorization in the United Kingdom in the coming months once it has final data from the UK trial.In preliminary data released Tuesday, Regeneron reported that its antibody cocktail REGEN-COV was 100 percent effective at preventing symptomatic COVID-19 in participants of an ongoing phase 3 trial among people at high risk of contracting COVID-19 due to exposure to family members with the disease. The data also showed a 50 percent reduction in the overall rate of infection. REGEN-COV was granted an EUA from the FDA in November as a treatment method for patients with mild COVID-19 at high risk of progressing to severe infection, and pending a full readout expected next quarter from the phase 3 prevention trial, the company intends to file to expand the EUA for use as a “passive vaccination” method.

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) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.

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. Interim data from the phase 1/2a clinical trial of Johnson & Johnson’s (J&J) COVID-19 vaccine candidate indicates the single-dose shot induced an immune response and was generally well-tolerated among trial participants aged 18 to 55. Neutralizing antibodies against COVID-19 were observed in more than 90 percent of volunteers 29 days post-vaccination and in 100 percent of volunteers 57 days post-vaccination. The vaccine—the furthest along candidate that only requires one dose—was developed by Janssen Pharmaceutical Companies of J&J using its AdVac vaccine platform, which was also used to develop Janssen’s Ebola vaccine as well as investigational Zika, RSV, and HIV vaccine candidates. The company expects to release data on participants over the age of 65 as well as results from its phase 3 trial later this month, after which it would submit applications for authorization from the US Food and Drug Administration and regulatory bodies globally.The African Union (AU) has secured provisional commitments to procure around 270 million COVID-19 vaccine doses, 50 million of which would be available before April 2021. The doses—to be supplied by Pfizer, AstraZeneca, and J&J—will be distributed among the AU’s 55 member states in pursuit of achieving herd immunity across the content. The new agreements are independent from doses secured through the COVAX Facility, a global mechanism to speed up development, manufacturing, and equitable distribution of COVID-19 vaccines, which has pledged to procure and supply vaccines for about 20 percent of each participating country’s population. The continent’s vaccine strategic plan entails vaccinating at least 60 percent of its 1.2 billion individuals, according to the director of the Africa Centers for Disease Control and Prevention.As the first COVID-19 vaccines—from Pfizer, Moderna, and AstraZeneca—are manufactured and distributed around the world, experts say there will still be plenty of need for follow-up products in the fight against the pandemic. While current vaccine launches provide hope for an end to the “acute phase of the pandemic,” longer-term management of the disease will require a larger arsenal of technologies. The next generation of vaccines could also offer advantages to the fight that the first round could not, including potential for single doses, easier mass manufacturing ability, or less rigid temperate requirements. There are currently at least 20 COVID-19 vaccine candidates in the final phase of clinical trials and dozens more in preclinical and early clinical stages.

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’ (NIAID) ACTIV-2 clinical trial has begun testing two monoclonal antibody therapies for treatment of mild to moderate cases of COVID-19. ACTIV-2, part of NIAID’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, was established in August to test investigational COVID-19 therapeutics, including Eli Lilly’s monoclonal antibody treatment LY-CoV555, which was subsequently granted emergency use authorization by the US Food and Drug Administration for a subset of mild to moderate COVID-19 patients. The recently begun trials will test BRII-196 and BRII-198, both monoclonal antibody therapies developed by Brii Biosciences that use synthetic versions of naturally produced antibodies to bind to viruses and prevent them from infecting cells. The study will begin with 220 participants, half of which will receive the treatment through intravenous infusions while the other half receive placebos.Convalescent plasma from patients previously infected with COVID-19 may delay or stop progression of illness in mildly ill older adults, according to a new study published in the New England Journal of Medicine. The data comes from a small randomized, controlled, and double-blind trial conducted by Fundacion INFANT in Buenos Aires, Argentina, which tested the effects of infusing convalescent plasma in older adults. Among 80 patients given convalescent plasma, 16 percent developed severe COVID-19, compared with 31 percent of the population given a placebo. In a modified analysis, results showed a larger effect after excluding a subset of patients who developed severe illness before plasma or placebo infusion. Authors of the study hope the treatment—which they say is relatively easy to access and administer at low costs—can be used to reduce demands on health care systems.Pfizer and BioNTech’s COVID-19 vaccine appears effective against a key mutation found in new variants of the virus discovered in the United Kingdom and South Africa, according to a not yet peer-reviewed laboratory study conducted by Pfizer and the University of Texas Medical Branch. The study tested the vaccine against the N501Y spike protein mutation found in both new variants of COVID-19, which could be responsible for greater virus transmissibility. Blood samples from individuals who have received the vaccine indicated it is effective against the mutation—along with 15 other mutations the company has previously tested the vaccine against—but the findings remain limited, as the study has yet to address the full set of mutations found in either of the new variants. Researchers plan to continue running tests against other mutations found in both variants and hope to have more data in upcoming weeks.