AstraZeneca’s COVID-19 Vaccine Finally Wins Full Authorization in the European Union

The European Medicines Agency (EMA) granted full Marketing Authorization to Astrazeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), in the European Union on November 1. Though having previously received conditional marketing authorization, the full authorization comes after a positive opinion given by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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Finally Granted Full Authorization in the European Union

Invented by the University of Oxford, Vaxzevria is AstraZeneca’s COVID-19 vaccine. Unlike the more commonly used mRNA vaccines, like Pfizer’s or Moderna’s, Vaxzevria uses a weakened version of a common cold virus and the genetic material of the SARS-CoV-2 virus spike protein for immunization. 

Though AstraZeneca’s vaccine was a contemporary of Pfizer’s and Moderna’s early on in the pandemic, manufacturing issues and safety concerns over rare blood clots saw the vaccine lose momentum for the company. For a time, the company shifted its focus away from its vaccine to instead create treatments for the novel virus, like Evusheld. 

However, on November 1, the EMA granted AstraZeneca vaccine full Marketing Authorization. Due to the urgency of the COVID-19 pandemic, the agency previously only granted conditional authorization. This full approval is based on the CHMP’s positive opinion after their review of clinical studies and real-world evidence. 

This data showed that the three-shot series provides equally effective protection against hospitalization and death from COVID-19. The CHMP also found that Vaxzevria provided adequate defense against all forms of COVID-19.

On the approval, Iskra Reic, Executive Vice President, Vaccines and Immune Therapies at AstraZeneca, said, “The move from conditional to full marketing authorization for Vaxzevria is an important confirmation by the EMA of the safety and efficacy of Vaxzevria, demonstrating that the benefits continue to outweigh the potential risks.”

Since Vaxzevria’s rollout, AstraZeneca estimates that its vaccine helped save more than six million lives worldwide through the over three billion doses administered in over one hundred and eighty countries. 

Author

Max Heirich