Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
Trial shows the single-shot Janssen COVID-19 Vaccine generates robust immune responses against several COVID-19 variants.
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
Governments and life science leaders agree to work towards slashing the time to develop and deploy interventions and diagnostics for future pandemic threats to 100 days.
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
The US National Institutes of Health have begun a first-in-human trial to assess the safety and immunogenicity of a potential universal influenza vaccine candidate, FluMos-v1.
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
The first-in-human study will evaluate the safety and efficacy AGT103-T, a cell and gene therapy product for HIV, in up to six participants.
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.