Vaxzevria COVID-19 vaccine wins full authorization in Europe

Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union.

European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to rare cases of blood clots with low platelet levels. Johnson & Johnson’s COVID-19 vaccine was linked to similar reports.

European regulators’ decision to grant full authorization to the AstraZeneca vaccine follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The marketing authorization covers the use of the vaccine for primary vaccination and as a heterologous or homologous booster.

European regulatory authorities decided to provide full authorization for the vaccine after reviewing data from four clinical trials in the UK, Brazil and South Africa. The data indicated that the vaccine was safe and effective at protecting against COVID-19 in adults. The total sum of clinical trial data involved about 24,000 people, with nearly one-half of the population receiving two doses of the Vaxzevria vaccine and the other half getting two doses of a dummy vaccine.

The trial data concluded that the vaccine led to a 59.5% reduction in symptomatic COVID-19 cases relative to those given control injections. Thus, the vaccine had approximately 60% efficacy in clinical trials.

“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,” said Iskra Reic, executive vice president of vaccines and immune therapies, AstraZeneca, in a news release. “Vaxzevria is estimated to have helped save over six million lives in the first year of vaccination, which reflects the strength of the evidence showing Vaxzevria’s protection against severe disease and death caused by COVID-19.”

AstraZeneca stock ticked up almost a percentage point to £10,346.00 yesterday.

To date, the Vaxzevria vaccine has been the subject of more than 300 studies, according to AdisInsight.