The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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COVID-19 Vaccine Moderna
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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…
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.
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
Preliminary Phase II data shows a dose of mRNA-1273.351, Moderna’s strain-matched booster, is safe and may offer protection against the B.1.351 and P.1 variants of concern.
According to Moderna, its new investments could increase global supply of its COVID-19 vaccine to one billion doses in 2021 and three billion in 2022.
The trial will evaluate the safety and immunogenicity of the mRNA-1273.351 vaccine candidate in 200 healthy adult volunteers.
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
The Phase II/III trial will assess the safety and efficacy of the COVID-19 Vaccine Moderna in children aged six months to less than 12 years.
New research shows a second COVID-19 vaccine dose may be unnecessary in individuals previously infected with SARS-CoV-2 and needlessly exposes individuals to higher rates of adverse effects.