- The EMA on Friday recommended authorization of the Oxford/AstraZeneca COVID-19 vaccine.
- This makes it the third shot to be authorised in the EU.
- The EMA gave the green light to Pfizer-BioNTech’s shot December 21, and Moderna’s January 6.
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The COVID-19 shot developed by AstraZeneca and the University of Oxford has been approved for use in the EU, the European medicines regulator announced Friday.
“Combined results from four clinical trials in the UK, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age,” said Emer Cooke, executive director of the EMA, in a statement.
The Conditional Marketing Authorisation (CMA) granted by the EMA means the shot can be used in all 27 member states of the EU for the next year, but the drugmaker is required to submit more data.
It is the third coronavirus vaccine that the European Medicines Agency (EMA) has given the green light to.
AstraZeneca’s vaccine has authorization for emergency use in seven countries â€” the UK, India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco. Eighty-two year-old Brian Pinker was the first to receive the AstraZeneca shot outside of a trial on January 4.
The EMA said in a statement that the vaccine demonstrated around a 60% efficacy in the clinical trials. But there wasn’t yet enough results for older people over 55 years old to provide a figure for how well the vaccine works in this group. Protection is expected because earlier data showed the vaccine produced an immune response in this age group, the EMA said.
“There is reliable information on safety in this population,” the EMA added.
Germany’s main public health agency, the Vaccine Commission at the Robert Koch Institute (RKI), however, said AstraZeneca’s shot shouldn’t be given to people over 65 in Germany, citing insufficient data available for this age group.
The shots from Moderna and Pfizer have been shown to be about 95% effective in clinical trials, and can be given to older people in all European countries, including Germany.
Moderna and Pfizer’s vaccines are mRNA vaccines, meaning they use a genetic code to trigger the immune system. The AstraZeneca vaccine uses inactivated chimpanzee virus to generate an immune response.
The COVID-19 vaccine from AstraZeneca could be advantageous because it is cheaper, and easier to use. Unlike Pfizer’s shot, it doesn’t require ultra cold fridges to store it, for examplee.
The European Commission secured 300 million doses of the vaccine August 2020, and the EMA’s decision means AstraZeneca can now start sending shipments to the EU.
There are ongoing tensions, however, between AstraZeneca and the EU due to potential vaccine shortages.