Breakthroughs Blog: Medicines

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 issued an emergency use listing for the Covaxin COVID-19 vaccine, developed by Indian pharmaceutical company Bharat Biotech, making it the eighth vaccine to receive WHO authorization. Covaxin, which is formulated from an inactivated SARS-CoV-2 antigen, was found to be 78 percent effective against COVID-19 of any severity 14 or more days after the second dose. WHO review groups determined the vaccine meets standards for protection against COVID-19, with benefits far outweighing the risks, and recommended it be used in two doses with a dose interval of four weeks for people 18 and above. The WHO approval makes Covaxin eligible for distribution through the COVAX vaccine-sharing facility, and the vaccine’s easy storage requirements make it especially suited for global distribution.Merck’s oral COVID-19 treatment, molnupiravir, received approval from its first regulatory body Thursday when the UK Medicines and Healthcare products Regulatory Agency authorized its use for individuals with mild to moderate COVID-19 and at least one risk factor for developing severe illness. The treatment—the first antiviral medication for COVID-19 that can be taken as a pill rather than injected or given intravenously—cut the risk of hospitalization or death by about half in clinical trials. Given twice a day, starting within five days of symptoms developing to be most effective, the pill targets an enzyme that the virus uses to replicate, preventing it from multiplying—an approach that should make the treatment equally effective against new variants of the virus as it evolves, according to Merck.On Friday, Pfizer released results from a late-stage clinical trial of its antiviral pill to combat COVID-19 showing it to be highly effective at preventing severe illness among at-risk individuals who receive the drug shortly after the onset of symptoms. The pill cut the risk of hospitalization or death by 89 percent when given within three days of exhibiting symptoms, according to data from the trial, which an independent board of experts recommended be stopped early because the drug’s benefit to patients had proved so convincing. Pfizer plans to submit the data as soon as possible to the US Food and Drug Administration to seek authorization for the pill to be used in the United States.

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.Pharmaceutical company Merck has announced an agreement to share its license for the oral COVID-19 drug molnupiravir with the United Nations–backed Medicines Patent Pool to expand access to the treatment in more than 100 countries. Molnupiravir, an easy-to-take pill, reduced hospitalizations and deaths by half among higher-risk COVID-19 patients diagnosed with mild to moderate illness in a global clinical trial. The agreement is the first public health license for a COVID-19 treatment or vaccine, allowing the medicine to be produced by all capable manufacturers—once the drug receives regulatory approval—to expand the drug’s availability, widen its manufacturing base, and potentially push down the price. Merck has applied to the US Food and Drug Administration for emergency use authorization, and the European Medicines Agency recently began a rolling review of the drug.The Access to COVID-19 Tools Accelerator (ACT-A) on Thursday launched its new strategic plan outlining a focus on addressing access inequities to tools in underserved areas. Over the next year, ACT-A—a global partnership set up to accelerate the development and delivery of COVID-19 tests, treatments, and vaccines—will aim to support low- and middle-income countries in vaccinating 70 percent of their populations, increasing their testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases through deployment of existing treatments and enabling access to new therapies. The plan outlines a required budget of $23.4 billion between now and September 2022, including $840 million for research and development.Inexpensive drug fluvoxamine could reduce hospitalization in adults with severe COVID-19, according to research published Wednesday in The Lancet Global Health. The findings, based on a clinical trial in Brazil evaluating high-risk, symptomatic adults who had recently contracted COVID-19, showed participants were less likely to require hospitalization or an extended emergency room stay when given a 100-milligram dose of fluvoxamine twice daily for ten days. Fluvoxamine is commonly prescribed to treat depression and obsessive-compulsive disorder and is known to reduce inflammation, which COVID-19 can cause throughout the body. The study findings, part of the larger TOGETHER Trial aiming to identify repurposed therapies effective against COVID-19 disease progression, have been shared with the World Health Organization and the US National Institutes of Health.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists and has market approval. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination.  Loading...(function(i,s,o,g,r,a,m){var ql=document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if(ql){if(ql.length){for(var k=0;k

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 six-month oral treatment regimen for rifampicin-resistant tuberculosis (TB) is substantially more effective than the current standard of care, according to preliminary trial results presented at the 52nd Union World Conference on Lung Health on Wednesday. The TB-Practecal trial tested a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) among 552 patients against the locally accepted standard of care at seven trial sites across Belarus, South Africa, and Uzbekistan. Findings showed around 89 percent of patients in the BPaLM group were cured, compared to 52 percent in the standard of care group. Current standard care for rifampicin-resistant TB can require up to 20 pills daily, along with injections, for up to 20 months.A new fingerstick blood test could be a promising tool for screening TB patients, interim study results indicate. The test, developed by Cepheid, gives results in under one hour using a few drops of blood. The new results, from a study of 195 participants in Gambia, Uganda, South Africa, and Vietnam, show an overall sensitivity of 91 percent and specificity of 86 percent, regardless of HIV status or geographical location, which meets the World Health Organization’s minimum specifications for a TB triage test. Researchers plan to expand trials to further test the technology’s accuracy, including among people who have other risk factors for TB, as well for people who have both TB and COVID-19.On Friday, the US Food and Drug Administration (FDA) released a briefing document indicating the Pfizer-BioNTech COVID-19 vaccine is more than 90 percent effective against symptomatic COVID-19 among children ages 5 to 11. The data is based on a 10-microgram vaccine dose, a third of the dose used for adults and older children, which minimizes side effects but still induces a strong immune response. The antibody response was comparable to the one seen in individuals 16 to 25 years old, and no new safety problems were identified in the companies' studies. The FDA also released an analysis later Friday showing the protection “would clearly outweigh” the risks of the shot. FDA advisers will meet Tuesday to discuss expanding authorization of the vaccine, currently greenlit for people over 12, to those ages 5 to 11.