Apr 23 (Reuters) – Europe’s drug regulator reiterated on Friday that the benefits of AstraZeneca’s COVID-19 vaccine outweigh any risks, delivering a review-based assessment of cases of a rare type of blood clot to help to governments to determine their use.
The endorsement comes at a time when several countries in the European Union and elsewhere in the world have limited use of the vaccine, known as Vaxzevria.
Denmark stopped vaccination altogether, after finding links between episodes of thrombi and low blood platelets among people who were inoculated with doses of AstraZeneca.
Internal analysis by a committee of the European Medicines Agency (EMA) concluded that serious adverse effects from a rare type of blood coalgae could occur in 1 in 100,000 vaccinated people, the regulator said in a statement.
EMA officials told a news conference on Friday that they wanted to put the collected data and analysis in context to help the 27 EU member countries figure out how to use their doses based on their particular situations.
The benefits of receiving the vaccine increase with age and with any risk of high infection rates in a population, and these benefits are now apparent across all settings and ages, regulators said.
They added that the recommendation could be subject to change because more data is needed and will be collected later. For example, not all the EU member states that sent their figures differentiated by sex to people who received vaccines.
But Peter Arlett, head of the EMA panel’s commission for methodology and data analysis, said: “The balance of benefits versus risks for the AstraZeneca vaccine is positive. It prevents severe symptoms of the disease and saves lives.”
Earlier this month, EMA had said it found a possible link between AstraZeneca’s coronavirus vaccine and severe episodes of blood clots, similar to Johnson & Johnson’s adverse reaction cases, which led to some deaths.
There were not enough data from the Vaxzevria vaccine in Europe to determine whether the risks of thrombi with low platelet levels change according to dose, nor were any conclusions regarding benefits and risks based on sex, EMA said.
(Reporting by Pushkala Aripaka in Bengaluru, Ludwig Burger in Frankfurt, Alistair Smout and Keith Weir in London; written by Josephine Mason. Edited in Spanish by Marion Giraldo)