European Regulator Grants Complete Approval To AstraZeneca's COVID-19 Vaccine

  • The European Medicines Agency (EMA) has granted full Marketing Authorisation to AstraZeneca Plc's AZN COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]).
  • Vaxzevria was initially granted a conditional Marketing Authorisation due to the urgency of the COVID-19 pandemic. As there continues to be sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the EMA has now granted full approval. 
  • The approval covers the use of Vaxzevria in both a primary vaccination series and as both a heterologous (with an approved mRNA COVID-19 vaccine) or homologous (all the same vaccine) third-dose booster.
  • Related: AstraZeneca-Oxford University Partnered Nasal COVID-19 Vaccine Flunks Human Trial.
  • Vaxzevria has been demonstrated to be effective against all forms of COVID-19, from mild symptomatic to severe disease, including hospitalization and death, according to clinical studies and real-world evidence. 
  • These include an expert review of data from 52 real-world studies that showed that Vaxzevria and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following three doses.
  • There is also a substantial body of evidence supporting boosting with Vaxzevria following all primary vaccination schedules tested to date.
  • Price Action: AZN shares are up 1.82% at $59.88 during the premarket session on the last check Tuesday.
  • Photo by Paul McManus from Pixabay
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