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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.

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Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

The Pharma Data

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

XTalks

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Bimervax Covid-19 vaccine authorised in UK

Drug Discovery World

Bimervax from HIPRA Human Health has been authorised in the UK after meeting the Medicines & Healthcare products Regulatory Agency’s (MHRA) required safety, quality and effectiveness standards. It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Vaccines and various response rates

Drug Discovery World

DDW Editor Reece Armstrong speaks to Dr Katrina Pollock from the Oxford Vaccine Group at the University of Oxford. Dr Pollock is the Chief Investigator of the LEGACY03 clinical trial, a study aiming to investigate lymph nodes and vaccination responses across age groups.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.