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Covid-19 Human Challenge Trial Found Safe - 0 views

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    The world's first human challenge trial in which volunteers were deliberately exposed to Covid-19 to advance research into the disease was found to be safe in healthy young adults, one of the companies running the study said on Wednesday. The data supports the safety of this model which could theoretically provide a "plug and play" platform for testing therapies and vaccines using the original Covid-19 strain as well as variants of the virus, Open Orphan, which carried out the study, said in a statement. Open Orphan is running the project, launched a year ago, with Imperial College London, the UK government's vaccines task force and the clinical company  hVIVO. The trial infected 36 healthy male and female volunteers aged 18-29 years with the original SARS-CoV-2 strain of the virus and closely monitored them in a controlled quarantined setting. They will be followed up for 12 months after discharge from the quarantine facility.
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Walgreens:New clinical trial business to use patients data - 0 views

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    Walgreens Boots Alliance has announced the launch of its new clinical trials business that aims to use patient data from its pharmacies to help drive up recruitment in studies conducted by drugmakers. With patient recruitment and enrollment remain key challenges in clinical trials, further exacerbated by the COVID-19 pandemic, the company said it can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location with its patient reach and access to an extensive foundation of pharmacy and patient-authorised clinical data. The Boots owner also believes that by leveraging a tech-enabled approach to patient identification and creating a large registry of clinical trial participants, the company will be able to reduce the time it takes to match eligible patients to clinical trials. "Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable," said Ramita Tandon, chief clinical trials officer, Walgreens.
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Covid-19 booster vaccine : MHRA approves second bivalent - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."
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HIV vaccine trial : Johnson & Johnson to discontinue - 0 views

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    Johnson & Johnson said on Wednesday (January 18) that it was pulling the plug on a late-stage global trial of an HIV vaccine after the shot was found ineffective at preventing infections. The failure of the trial marks yet another setback in the search for a vaccine against a virus known to mutate rapidly and find unique ways to evade the immune system, and comes more than a year after another of J&J's HIV vaccine failed a study. "It's not the outcome we had hoped for, unfortunately," said a spokesperson for the National Institute of Allergy and Infectious Diseases, a J&J partner in the trial. "The development of a safe and effective HIV vaccine has been a considerable scientific challenge, but we will learn from this study and continue forward." The trial involved administering two different types of a shot, which uses a cold-causing virus to deliver the genetic code of HIV, spread over four vaccination visits in a year. J&J used similar technology for its COVID-19 vaccine. The study, which began in 2019, was conducted at over 50 sites and included about 3,900 gay men and transgender people - groups that are considered vulnerable to the infection.
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