The EU’s medicines regulator on Friday recommended the authorisation of AstraZeneca’s coronavirus vaccine for adults of all ages, saying it believed it would be safe for older people too.
The green light by the European Medicines Agency (EMA) had been expected, but there had been questions about whether it would follow the lead of Germany, which declined to recommend it for the elderly.
“With the recommendation today, we are further expanding the range of Covid-19 vaccines available to EU states to bring the pandemic under control,” EMA chief Emer Cooke told a press conference at the agency’s Amsterdam headquarters.
“None of them is a magic wand on their own, but together they provide tools and options that we need,” she added.
The vaccine developed by the British-Swedish company and Oxford University had demonstrated a 60 percent efficacy against Covid-19 across various clinical trials, the EMA said in a statement.
The regulator added that there were “not yet enough results in older participants” over 55 to show how it would work but that “EMA’s scientific experts considered that the vaccine can be used in older adults”.
AstraZeneca has defended its vaccine’s use for all ages, along with Britain, which has already used the shot widely on older people.
“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,” said AstraZeneca boss Pascal Soriot in a statement.
The EMA has already approved the Pfizer/BioNTech and Moderna jabs for the 27-nation European Union, plus the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.
The deployment of AstraZeneca’s vaccine has been awaited with impatience by European countries as it is cheaper to produce than its rivals, and easier to stock and transport.
An age limit on the jab would have been a blow for governments that have based their vaccination campaigns on prioritising the frail and elderly.
“According to the information we have, it can be used in patients over 18 and we’re not restricting it to under 55s. This is based on the science in the trials, the safety profile, and the immunity effect in older populations,” Cooke said.
EU countries needed to “have these options available to them”, she said
Germany had said there was insufficient data for a recommendation for older people, and on Friday its vaccines advisory panel said it was maintaining its advice against using the jab on over-65s.
Casting a shadow over the EMA decision is the bitter row over the supply of AstraZeneca doses between the EU and Britain.
The firm says there is not enough to go around as production issues have slowed promised deliveries.
The European Commission published a redacted copy of its contract with the drugs giant on Friday, demanding the company meet its prior commitments.
EU Health Commissioner Stella Kyriakides welcomed the EMA decision on the AstraZeneca vaccine.
“We stand ready to work together and find solutions to give citizens access to more vaccinations as swiftly as possible,” she said.
Formal authorisation from the European Commission in Brussels “will follow”, she said.
The EMA has been under huge pressure to authorise vaccines as quickly as possible as frustration and pressure grow over Europe’s stumbling start to the inoculation campaign.
AstraZeneca was the first to launch a “rolling review” of data on the vaccine with the EMA, in October, but is only the third to receive authorisation, for which it made a formal application on January 12.
Cooke said the AstraZeneca case took longer because of a complex situation involving four clinical trials with conflicting data.
“We’ve heard many voices questioning the time that has been taken for the evaluation of this vaccine… but the evaluation of vaccines is not a first-in first-out process.”
The EMA said there should be a four to 12 week interval between the two injections needed for the vaccine.
The EMA chief meanwhile said she “shortly” expected to receive the “promising” data and an application for authorisation from US firm Johnson & Johnson.
The regulator said separately on Friday that it had found no link between the Pfizer/BioNTech vaccine and a number of deaths of older people.