Anna Kovacevich

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. On Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.

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 Biden administration plans to host a virtual summit Wednesday on the global COVID-19 response, during which President Joe Biden will call on leaders from around the world to make new commitments to fight the pandemic. The summit’s goals, similar to those laid out by the World Health Organization (WHO) and other global health experts, include vaccinating at least 70 percent of the world’s population by next September; providing billions of dollars in tests, oxygen, and other supplies to low- and middle-income countries; setting up a financing system to pay for the global health response by next year; and more worldwide objectives to end the pandemic. The event will be the first in a series of planned summits intended to hold participants accountable for their commitments.The European Union will fund a new agency intended to bolster the region’s health preparedness and rapid response for future crises, the European Commission confirmed last week. The Health Emergency Preparedness and Response Authority (HERA) will establish new, adaptable production capacities and secure supply chains to ensure critical equipment, medicines, and vaccines are available when needed. The agency will receive EUR€30 billion, or around US$35 billion, in funding from the European Union over the next six years, in addition to potential financing from individual member nations or the private sector. The overall total could reach EUR€50 billion, or US$59 billion, by 2027. HERA should be fully operational as of early next year.A single dose of typhoid conjugate vaccine is safe and 84 percent effective in protecting against the infection, according to a study conducted in Malawi. The results, part of a five-year, multi-country project to accelerate introduction of the vaccine, are the first efficacy results from Africa and will be critical as typhoid is increasing as a public health threat across the continent due to the emergence and spread of multidrug-resistant strains. WHO recommended the vaccine in 2017 for children six months of age and older in typhoid endemic settings, making it the only approved typhoid shot for children and infants less than two years old.

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. Moderna and Novavax are both developing vaccines for combined protection against COVID-19 and the flu, the companies announced last week. Moderna is working on a single-dose vaccine that combines a booster dose of its authorized COVID-19 and a booster of its furthest along experimental flu shot. Novavax has launched an early-stage trial for a combined flu and COVID-19 vaccine composed of its COVID-19 vaccine candidate, not yet authorized by the US Food and Drug Administration, and its influenza shot NanoFlu, along with an adjuvant or vaccine booster. The Novavax trial will be conducted in Australia among 640 healthy adults between the ages of 50 and 70 who have been previously infected with COVID-19 or given an authorized COVID-19 vaccine at least eight weeks prior to the study. Results are expected in the first half of 2022.The COVAX vaccine-sharing facility’s global vaccine deliveries will fall almost 30 percent below its original target of distributing 2 billion doses in 2021, the initiative’s leaders estimate. The new supply forecast predicts another 1.1 billion doses will be made available this year, in addition to the 330 million already released for delivery before the end of August, for an estimated total of 1.4 billion vaccine deliveries by the end of 2021. The shortfall is the result of a variety of factors, including restrictions on exports from the Serum Institute of India, problems increasing manufacturing at vaccine facilities, and lags in regulatory approval, according to COVAX leaders. Under the most likely forecast, COVAX would reach 2 billion available doses between January and February of 2022.COVID-19 has set back the fight against other global health challenges like HIV, tuberculosis (TB), and malaria, according to a report released by the Global Fund to Fight AIDS, Tuberculosis and Malaria. Compared to 2019, the number of people tested and treated for TB fell by about 18 percent in 2020—and the number of people treated for extensively drug-resistant TB by 37 percent. The number of people who sought testing for HIV declined by 22 percent, and those opting for HIV prevention services fell by 12 percent. However, the report also noted the adoption of innovations, from dispensing multi-month supplies of TB and HIV drugs to using digital tools to monitor TB treatment, adopted by health agencies and ministries around the world, which will hopefully outlast the pandemic.

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.Pfizer and Merck have both announced the launch of trials for their oral antiviral candidates to combat COVID-19, the companies stated separately last week. Pfizer’s phase 2/3 trial will enroll non-hospitalized, low-risk adults who have tested positive for COVID-19 to evaluate its pill, PF-07321332, alongside a low dose of ritonavir, a medication widely used in combination treatments for HIV. The antiviral treatment is designed to block the activity of a key enzyme that is needed for the coronavirus to multiply. Merck’s trial will enroll adults who live in the same household as someone diagnosed with symptomatic coronavirus infection to evaluate molnupiravir for the prevention of COVID-19. A separate trial is underway to test the drug’s use in treating non-hospitalized COVID-19 patients. Molnupiravir is designed to introduce errors into the RNA of the virus that eventually prevent it from replicating.A phase 3 trial for SK Bioscience and GlaxoSmithKline’s (GSK) COVID-19 vaccine began last week, seeking to enroll around 4,000 people around the world. In phase 1/2 data, the adjuvanted vaccine candidate induced strong neutralizing antibody responses to COVID-19. The phase 3 trial will compare results of the vaccine candidate against those of the AstraZeneca/Oxford University vaccine, making it one of the first global phase 3 trials to actively evaluate two different COVID-19 vaccine candidates against each other for safety and immunogenicity. Results from the trial are expected in the first half of 2022, and SK Bioscience, GSK, and supporting partners hope to begin supply of the vaccine through the COVAX vaccine-sharing facility in that same period, depending on data and regulatory review.The World Health Organization (WHO) and Germany last week launched a pandemic intelligence hub to help governments identify future pandemics at an earlier stage and improve monitoring of new variant strains of COVID-19. The hub, based in Berlin, is designed to streamline global data-sharing by making it easier for governments to compare notes on emerging infectious diseases and pull in additional relevant information on travel patterns, trade routes, or human-animal interactions in agriculture. While governments and non-governmental organizations are collecting more and more information relevant to public health, databases rarely allow easy international comparisons, according to WHO. Improving global tracking of COVID-19 variants via genome sequencing is likely to be the new hub’s initial priority.

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. New study results show that combining antimalarial drugs with a vaccine, given just before peak transmission period of rainy season, could reduce malaria deaths in children by more than 70 percent. The trial—conducted over three years among 6,000 young children in Burkina Faso and Mali—tested the RTS,S malaria vaccine, the world’s first-developed shot for the disease, along with seasonal malaria chemoprevention (SMC), an existing preventative drug regimen. Results indicated the RTS,S vaccine was as effective as SMC when administered to children ahead of rainy season in countries with seasonal transmission—and that combining the two methods reduced cases by around 60 percent, hospitalizations by around 70 percent, and deaths by around 73 percent, when compared to SMC alone. The World Health Organization (WHO) is set to review evidence from the study in October.The International Vaccine Institute (IVI) and Bharat Biotech have launched a phase 2/3 trial for their chikungunya vaccine candidate. The two-dose vaccine, BBV87, is an inactivated whole virion vaccine, which showed “optimum immune response” in phase 1 studies in India. The phase 2/3 trial, led by IVI through the Global Chikungunya vaccine Clinical Development Program (GCCDP) in partnership with Bharat Biotech and supported by the Coalition for Epidemic Preparedness Innovations and the government of India’s epidemic preparedness initiative, Ind-CEPI, will test BBV87 for safety and immunogenicity in healthy adults. GCCDP aims to develop and manufacture an affordable chikungunya vaccine with the goal of achieving WHO prequalification to enable distribution in low- and middle-income countries. The trial has begun in Costa Rica and is set to expand to Panama, Colombia, Thailand, and Guatemala in the coming months.On Tuesday, the US Food and Drug Administration granted its first emergency use authorization for an at-home COVID-19 diagnostic that delivers results through the user’s smartphone. The Veritor rapid antigen test, developed by BD and Scanwell Health, involves swishing a nasal swab in a tube of liquid reagents, after which drops on a testing strip trigger colored lines, which are then read and interpreted by the smartphone. The diagnostic is designed for use by individuals ages 14 and up and can be used for children as young as two with samples collected by an adult. The digital test, which does not require a prescription, will initially be made available to employers, schools, and public health organizations looking to support routine screening programs.

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. Moderna is launching human trials for two new HIV vaccines based on the mRNA technology used in its COVID-19 vaccine, the company announced last week. The phase 1 trial will recruit 56 participants between the ages of 18 and 50 to assess the vaccines’ safety and ability to generate a broad range of neutralizing antibodies against HIV. The two vaccine candidates, mRNA-1644 and mRNA-1574, are designed to combat HIV by inducing broadly neutralizing antibodies to levels not previously obtained by other shots. The antibodies can then target multiple variants of HIV and neutralize stable parts of the virus that won’t change as much as it mutates. The study, expected to run until May 2023, is a first step in a long, complex process, according to researchers.Researchers have discovered a series of drug compounds that are highly effective against the three main species of parasitic worms that cause human schistosomiasis, according to new research published in PLOS Neglected Tropical Diseases. Currently, the only treatment for schistosomiasis is praziquantel, which is effective at a high dose against adult worms, but less so against juvenile worms, requiring repeat treatment. The new research involved screening more than 300,000 compounds to evaluate their ability to kill the worms, compared against praziquantel. The researchers identified a series of promising new drug candidates that appeared safe and highly effective against adult and juvenile worms—in a single dose around 10 times smaller than required for praziquantel. The drugs are now being explored by Merck Global Health Institute as a potential treatment for schistosomiasis.In phase 3 trial results, AstraZeneca’s COVID-19 antibody treatment, AZD7442, significantly reduced the risk of developing COVID-19 symptoms. The drug, a combination of two long-acting antibodies, reduced the risk of developing symptoms by 77 percent when given to patients who had not been exposed to COVID-19. No participants who were given the treatment developed a severe form of the disease. The monoclonal antibodies used in AZD7442, which mimic the body's natural immune response, were modified to be more long-lasting, potentially affording up to 12 months of protection. The drug could be particularly useful as a preventative treatment in patients for whom vaccines might be less effective, including immunocompromised individuals, AstraZeneca said in its statement. The company plans to submit the phase 3 results to a peer-reviewed journal and file for regulatory approval of the drug.