EU approves AstraZeneca Covid-19 vaccine
By Michele Maatouk
Date: Friday 29 Jan 2021
(Sharecast News) - The European Union drug regulator said on Friday that it has approved the use of AstraZeneca's Covid-19 for use in adults.
The European Medicines Agency, which had already approved vaccines from Pfizer and Moderna, said the Astra vaccine, developed alongside Oxford University, demonstrated around 60% efficacy in clinical trials.
Emer Cooke, executive director of the EMA, said: "With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens.
"As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens."
On Thursday, Germany's vaccine committee said AstraZeneca's Covid vaccine should only be given to people over the age of 65, as there was "insufficient data" over its efficacy for older people.
The EMA noted that most of the participants in the clinical trials for the AstraZeneca vaccine were between 18 and 55 years old.
"There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group," it said. "However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA's scientific experts considered that the vaccine can be used in older adults."
It added that more information is expected from ongoing studies, which include a higher proportion of elderly participants.
AstraZeneca chief executive Pascal Soriot said: "Today's recommendation 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.
"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."
News of the approval came amid reports the EU has rejected an offer from AstraZeneca of eight million more doses, with the European Commission chief insisting the company honour its existing "binding contract".
According to Reuters, the cuts to vaccine supplies, which were blamed on production issues at a Belgian plant, would mean that only 31m doses get delivered in the period to the end of March, a reduction of 60%.
Reuters cited an EU official as saying that AstraZeneca had offered to increase deliveries to 39m doses in the first quarter, but that this was deemed inadequate.
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