Coronavirus Notebook: Moderna Vaccine First To Get GB Conditional MA, EMA To Update On AstraZeneca Blood Clot Issue
The EU has agreed to provide ‘solidarity vaccines’ to five member states and the WHO has published a progress report on its assessments of COVID-19 vaccines.
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Coronavirus Notebook: EMA Probes Janssen Vaccine Blood Clot Reports, UK Advises 12-Week Dosing Gap For Moderna
The AZ vaccine is now under EU scrutiny over capillary leak syndrome, while Valneva has reported positive results with its product. The global COVAX initiative has delivered more than 38 million doses of vaccines to over a hundred countries.
Target product profiles, database locks, infarct size as a surrogate endpoint, and changes in the manufacturing process featured in a session of this year’s TOPRA Symposium on dealing with tricky regulatory questions.
Amid growing concern over the new Omicron variant of the coronavirus, member states of the WHO are gathering this week to discuss the negotiation of a convention on future pandemic preparedness and response, with access to medical countermeasures on the agenda. A parallel WTO ministerial meeting that would have discussed the proposed TRIPS IP waiver has been postponed until further notice.