The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
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The European Medicines Agency (EMA)
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In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
Production of CureVac’s CVnCoV vaccine will take place in Germany, with over 50 million doses expected to be produced in 2021.
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
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 submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
According to GlobalData, AstraZeneca’s and Janssen’s COVID-19 vaccines could be impacted by global viral vector shortages.
Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.