Those residents of the European Union 18 years or older will now be able to get AstraZeneca’s COVID-19 vaccine to prevent COVID-19, following a conditional marketing authorization granted by the European Medicines Agency (EMA).
The approval will allow AstraZeneca to begin working with the EU to provide active immunization across member states. A separate Emergency Use Listing is still being pursued through the World Health Organization (WHO) to accelerate the vaccine’s availability in low-income countries.
“Today’s approval underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” AstraZeneca CEO Pascal Soriot said. “We are deeply grateful to Oxford University, participants in the clinical trials, and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans.”
Presently, the Committee for Medicinal Products for Human Use (CHMP) of the EMA, which reviewed the vaccine’s application, recommends two doses of COVID-19 Vaccine AstraZeneca to be administered at a four to 12-week interval. It was a path shown to be safe and effective in preventing symptomatic COVID-19 cases during trials. During those trials — led by the University of Oxford — no severe cases and ho hospitalizations emerged more than 14 days after the second dose.
Unlike some of the other COVID-19 vaccines developed, COVID-19 Vaccine AstraZeneca can be stored, transported, and handled at basic refrigeration levels of 36-46 degrees Fahrenheit, rather than deep freeze. This will allow it greater ability to reach more rural areas, especially since this storage would allow it to survive for at least six months.
“The approval by the European Commission is an important milestone in extending access to the Oxford/ AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic,” professor Andrew Pollard, director of the Oxford Vaccine Group and Chief Investigator on the Oxford vaccine trials, said.
Oxford co-invented COVID-19 Vaccine AstraZeneca — formerly AZD1222 — alongside its spin-off company, Vaccitech. CHMP based its analysis of the drug on trials of 23,745 participants in UK and Brazil-based phase three trials. During these, 232 symptomatic COVID-19 infections emerged, but the vaccine proved well-tolerated. Another large trial of approximately 60,000 people is being pursued in the U.S. and globally.