MADRID – Pharmaceutical company AstraZeneca and the University of Oxford applied to the European Medicines Agency (EMA) on Tuesday for conditional marketing authorization for use of their COVID-19 vaccine in the European Union, which could be approved as soon as Jan. 29.
If supported by EMA experts, this vaccine would be the third COVID-19 vaccine to get the green light in the EU, after Pfizer/BioNTech and Moderna.
The EMA has been assessing data on the production process, ingredients and overall quality of the vaccine, as well as some evidence on its safety and efficacy from a joint analysis of interim clinical data from four ongoing trials in the United Kingdom, Brazil and South Africa.
If approved, AstraZeneca and Oxford would be granted a conditional, rather than a permanent, license, allowing a fast-track authorization procedure to speed up approval of vaccines during public health emergencies.
The conditional license also means the companies would have to commit to monitoring vaccination campaigns and, for at least two years, observe the volunteers from its clinical trials to detect any problems with efficacy or side effects so far not observed.
AstraZeneca’s is not the only new vaccine in the pipeline for use in the EU; the European Commission concluded exploratory talks with the pharmaceutical company Valneva on Tuesday to purchase 30 million doses of their coronavirus vaccine.
This brings the number of secured vaccines for the EU to seven, together with Pfizer-BioNTech, Moderna, AstraZeneca, Johnson and Johnson, Sanofi-GSK and Curevac.
“The continuing COVID-19 pandemic in Europe and around the globe makes it more important than ever that all Member States have access to the broadest possible portfolio of vaccines to help protect people in Europe and beyond,” said the president of the European Commission, Ursula von der Leyen.
“Today’s step toward reaching an agreement with Valneva further complements the EU’s vaccines portfolio and demonstrates the Commission’s commitment to find a lasting solution to the pandemic.”
At a time when coronavirus infection rates continue to soar across Europe and the need for vaccinations intensifies, the envisioned contract with Valneva would give all EU Member States the opportunity to purchase together 30 million doses of the vaccine, with the possibility to purchase another 30 million more doses.