UK Authorizes ‘Gamechanger’ AstraZeneca Vaccine Despite Data Doubts
MHRA Rejects Low Dose Data
UK regulator admits evidence sparse on older patients, but believes longer gap between doses can boost efficacy and accelerate numbers of people immunized.
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A senior AstraZeneca executive gives a candid account of how the company recovered from the unexpected deluge of safety reports for its COVID-19 vaccine.
The European Medicines Agency may issue an opinion on approving AstraZeneca’s COVID-19 vaccine by 29 January if the data are robust and complete and any additional data requests are dealt with promptly.
AstraZeneca is expected to apply for the EU approval of its COVID-19 vaccine next week. The vaccine was developed in partnership with the University of Oxford.