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.On Thursday, AstraZeneca and Regeneron reported data on the effectiveness of their COVID-19 antibody treatments against the omicron variant of the virus. Regeneron’s therapy, REGEN-COV, is less effective against omicron, though is still active against the delta variant, confirming indications from lab tests and computer modelling late last month. AstraZeneca’s antibody cocktail, Evusheld, retained neutralizing activity against omicron, according to the lab study results. Earlier last week, researchers also announced that Eli Lilly’s antibody treatment lost effectiveness against omicron in lab tests, while GSK-Vir Biotechnology’s antibody treatment retained neutralizing activity against all tested coronavirus variants, including omicron. The omicron variant has been detected in 77 countries since it was first identified three weeks ago, driving concerns that its large number of mutations could help it evade protection by COVID-19 vaccines and therapeutics.A new needle-free COVID-19 vaccine to protect against future virus variants is being tested in the United Kingdom, researchers announced last week. The DIOS-CoVax vaccine, developed by scientists at Cambridge University, is administered through spring-powered jet injection and uses predictive methods to mimic the wider family of coronavirus antigens with the goal of providing more protection than existing vaccines. The trial, which will include participants aged 18 to 50, is a first step toward a universal coronavirus vaccine to protect people from COVID-19 variants and future coronaviruses—a vital part of next-generation vaccine candidates to help protect the world from the next virus threats, according to a researcher involved in its development.An antimalarial drug in development by Zydus Cadila in partnership with the Medicines for Malaria Venture received orphan drug designation from the US Food and Drug Administration (FDA) on Thursday. The designation makes the drug eligible for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven-year marketing exclusivity upon FDA approval. The drug, ZY19489, is a novel antimalarial compound that combats all current clinical strains of P. falciparum and P. vivax malaria, including drug-resistant strains. A phase 1 study indicated the drug has a long half-life and potential as a single-dose cure for malaria.

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’s COVID-19 Technology Access Pool and the Medicines Patent Pool last week finalized a licensing agreement with the Spanish National Research Council (CSIC) for its serological antibody test, marking the first non-exclusive license for a COVID-19 health tool. The CSIC test—a serological antibody test that evaluates for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine—is relatively simple and suitable for basic laboratory infrastructure. The new license will allow the test to be offered royalty-free to low- and middle-income countries in order to promote equitable access to COVID-19 tools and facilitate rapid manufacturing and commercialization of the tool worldwide. Last Monday, Pfizer and BioNTech announced their COVID-19 vaccine was 100 percent efficacious in preventing infection among 12- to 15-year-olds from seven days to four months after administration of the second dose. The new results come from a longer-term analysis of a phase 3 trial—so far the only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age. The vaccine has been authorized by the US Food and Drug Administration (FDA) for this age group since May and is fully licensed for individuals 16 years of age and older. The companies plan to submit the data to the FDA for an extension of their COVID-19 vaccine approval to cover the younger age group. The Coalition for Epidemic Preparedness Innovations (CEPI) plans to expand its centralized vaccine testing capabilities employed for COVID-19 to the development of vaccines for other epidemic and pandemic diseases. CEPI’s network, the world’s largest for assessing COVID-19 vaccines, comprises a global collection of labs, which more than 30 COVID-19 vaccine developers have used to access more than 15,000 clinical trial samples. The system will now be used to support vaccine development for other priority diseases, including chikungunya, Lassa fever, MERS, Nipah, Rift Valley fever, and Disease X. The testing network is intended to help quickly and accurately identify the most promising candidates with the best potential for late-stage clinical trial advancement and regulatory review, which also supports CEPI’s overarching goal of reducing the vaccine development timeline to just 100 days.

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.

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