European Medicines Agency recommends the AstraZeneca COVID-19 vaccine for use in the EU, as tensions grow over potential shortages
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- The EMA on Friday recommended authorization of the Oxford/AstraZeneca COVID-19 vaccine.
- This makes it the third shot to be authorized 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 Authorization (CMA) granted by the EMA means that 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.
COVID-19 vaccines from Pfizer-BioNTech and Moderna have already been approved by the the EU regulator, and can be used in adults, including older people.
AstraZeneca's vaccine has authorization for emergency use in seven countries - the UK, India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco - for the immunization of "adults". Eighty-two year-old Brian Pinker was the first to receive the AstraZeneca shot outside of a trial on January 4.
The decision follows media reports Thursday that Germany's main public health agency, the Vaccine Commission at the Robert Koch Institute (RKI), had said AstraZeneca's shot shouldn't be given to people over 65, citing insufficient data available for this age group.
The EMA did not have to make the same decision as other regulators, and has had more data from older adults to look at.
Clinical trials showed AstraZeneca's vaccine was on average 70% effective at protecting against COVID-19. It is a two-dose vaccine, and the 70% figure was an average of two efficacy numbers from different tests of the shot - the vaccine was 62% effective if people got two full doses, but 90% effective when they got a half-strength version of the first dose.
In a paper publish in the journal Lancet in December 2020, Oxford researchers said there wasn't enough data to tell whether the vaccine works in older people, but were still collecting more data for a future analysis.
The researchers also said that earlier data on how the vaccine affects the immune systems of older people suggested that it should work in older adults.
The shots from Moderna and Pfizer have been shown to be about 95% effective in clinical trials.
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.
Read more: What's coming next for COVID-19 vaccines? Here's the latest on 11 leading programs.
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.
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