Breakthroughs Blog: FDA

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. Sanofi and GlaxoSmithKline (GSK) plan to submit their COVID-19 vaccine for authorization following strong phase 3 trial results, the companies announced Wednesday. The two-dose adjuvanted protein-based vaccine showed 100 percent efficacy against severe disease and hospitalization and 57.9 percent overall efficacy against symptomatic COVID-19 disease, which, while lower than rates originally reported for other vaccines, reflects efficacy expectations in an environment now dominated by variants of concern, the companies said. The vaccine can also be used as a booster, including in people who originally received an mRNA vaccine, and is stable at refrigerator temperatures, making it more suitable to reach low-resource settings than vaccines with stricter cold-chain requirements. Sanofi and GSK are submitting the vaccine for authorization from the US Food and Drug Administration and the European Medicines Agency.  An international trial will investigate COVID-19 booster shots administered at reduced dosages in an effort to increase global access to vaccines. The trial, supported by the Coalition for Epidemic Preparedness Innovations, will test boosters of the Pfizer-BioNTech, Moderna, and Oxford-AstraZeneca vaccines among up to 3,300 healthy adults across Australia, Indonesia, and Mongolia. Results are expected to provide data on the merits of vaccinating with fractional booster doses of the COVID-19 vaccines and offer information on whether fractional doses produce fewer side effects, which could guide future vaccination strategies. The three booster vaccines being tested have received emergency use listing from the World Health Organization (WHO) and are being supplied to the COVAX vaccine-sharing initiative.WHO is establishing a new global biomanufacturing training hub in South Korea to support production of biologicals, including vaccines and monoclonal antibodies, in low- and middle-income countries. The hub, to be located in a large facility outside Seoul that is already providing biomanufacturing training for companies based in the country, will provide technical and hands-on guidance to trainees from around the world and complement specific trainings developed by the mRNA vaccine technology transfer hub recently established in South Africa. The WHO Academy will work with the Korean Ministry of Health and Welfare to develop a comprehensive curriculum on general biomanufacturing. South Korea plans to start training 370 professionals from Asia, Africa, and South America in July.

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. A third person appears to have been cured of HIV, scientists announced last week, using a new treatment method involving umbilical cord blood. Cord blood is more widely available than the adult stem cells used in bone marrow transplants—the method used for the previous two patients cured of HIV—and does not need to be matched as closely to the recipient. The patient, a mixed-race woman who also had leukemia, received the cord blood to treat her cancer in August 2017. She discontinued antiretroviral therapy 37 months after the transplant, and now, more than 14 months later, shows no signs of HIV in blood tests and does not seem to have detectable antibodies to the virus. The news opens up the possibility of curing more people of diverse racial backgrounds than was previously possible, scientists said.BioNTech plans to set up modular mRNA vaccine facilities to produce its COVID-19 vaccine, codeveloped with Pfizer, in Rwanda and Senegal, with a fill-and-finish collaboration in Ghana. The initiative involves modular factories, dubbed “BioNTainers,” that consist of one drug substance and one formulation module, each of which is built from six standard shipping containers fitted with the necessary equipment. The first containers will be delivered in mid-2022, and the first vaccine batches will be produced in the following months. The facilities will be equipped to manufacture a range of mRNA-based vaccines, including BioNTech’s investigational malaria and tuberculosis vaccines if successfully developed and authorized by regulatory authorities.Dr. Robert Califf was officially confirmed as commissioner of the US Food and Drug Administration (FDA) last week after a 50–46 Senate vote, the narrowest confirmation in the history of votes to lead the agency. The FDA has been without a permanent leader for nearly 400 days, instead being led by an acting commissioner, Janet Woodcock, who will now serve as principal deputy commissioner under Califf. Califf, a cardiologist and researcher, was nominated for the role by President Joe Biden in November and will take the helm at the FDA for the second time, having previously held the role during the final year of the Obama administration. Califf was officially sworn in as commissioner on Thursday.

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.A phase 3 trial to evaluate Valneva’s chikungunya vaccine candidate in adolescents has launched in Brazil, the company announced last week. The live-attenuated, single-shot vaccine, VLA1553, is currently the most clinically advanced chikungunya vaccine candidate worldwide, having completed phase 3 trials in adults. Valneva announced positive top-line results of the phase 3 trial in adults 18 and over in August 2021, indicating the vaccine induced protective chikungunya virus neutralizing antibody titers in 98.5 percent of trial participants and was well-tolerated across age groups. The recently launched trial, funded by the Coalition for Epidemic Preparedness Innovations, is designed to evaluate the vaccine in adolescents aged 12 to 17 and to support its extension to use in the younger age group following potential initial regulatory approval in adults from the US Food and Drug Administration (FDA).Healthy, young people who were intentionally exposed to SARS-CoV-2 developed mild symptoms, if any, in a first-of-its-kind COVID-19 human challenge study, according to a UK study of 34 individuals aged 18 to 30. Around half of the participants who received a low dose of virus became infected, some of whom had no symptoms, while others reported mild-to-moderate symptoms, including sore throats, runny noses, and loss of smell and taste. While controversial due to the risk to participants, challenge trials present an opportunity to study viral infections in detail­—and, according to scientists interviewed, the new study results show such trials can be done safely and lay the groundwork for more in-depth studies of vaccines, antivirals, and immune responses to SARS-CoV-2 infection.The HIV treatment Cabenuva has been approved by the FDA for use every two months, reducing treatments to only six times a year. The injectable treatment was first approved last year for use once a month, offering an alternative to antiretroviral regimens that require daily pills. The updated approval is based on data from a phase 3b study that showed dosing of Cabenuva every other month was non-inferior to monthly dosing and that rates of virologic suppression were similar for dosing monthly or every two months. Cabenuva is a combination of cabotegravir and rilpivirine, forming a complete regimen for HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.

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.Novavax has completed submission of the final data package for its COVID-19 vaccine to fulfill the prerequisites for an emergency use authorization (EUA) request from the US Food and Drug Administration. The company plans to complete an official EUA application by the end of the month. The vaccine, NVX-CoV2373, received emergency use listing from the World Health Organization last month for its formulations manufactured in Europe and India, allowing Novavax and partner Serum Institute of India to ship doses to the COVAX initiative, which aims to supply vaccines to low- and middle-income countries. NVX-CoV2373 was also granted conditional marketing authorization in December by the European Medicines Agency to be produced in Europe. Novavax expects its global supply chain to exceed 2 billion doses in 2022.A new COVID-19 vaccine developed by researchers from the Texas Children’s Hospital and Baylor College of Medicine is being offered patent-free to vaccine manufacturers around the world. The CORBEVAX vaccine—originally developed to combat SARS, which is caused by a strain of coronavirus—employs a long-established protein subunit technology that uses proteins from a virus or bacterium to induce an immune response but not cause disease. Clinical trials conducted in India found the vaccine to be 90 percent effective in preventing disease caused by the original COVID-19 virus strain and 80 percent effective against the delta variant, leading India’s regulatory agency to grant emergency use authorization in December. Indian vaccine manufacturer Biological E Limited has sold 300 million doses to the Indian government and plans to produce 100 million doses per month.Dolutegravir-based antiretroviral therapy (ART) is more effective than standard treatments for HIV-positive children, reducing treatment failure by 40 percent, according to a new study published in The New England Journal of Medicine. The clinical trial, conducted at 29 clinical centers across Africa, Europe, and Asia, evaluated the safety and efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV in comparison to non-dolutegravir-based, standard-care ART. Results showed the dolutegravir-based ART reduced treatment failure by 40 percent in HIV-positive children 3 to 18 years old, indicating dolutegravir-based ART is superior to current standard-care treatment in children and adolescents living with HIV, according to researchers.