The European Medicines Agency has approved AstraZeneca’s Covid-19 vaccine for use in all those aged over 18 on Friday.
It means doses can now be rolled out in Ireland as soon as deliveries are made available by the British-Swedish pharmaceutical.
The decision is a boost for vaccine programmes, after Germany’s public health agency recommended the vaccine for use only in those aged 18-64, citing a lack of data from AstraZeneca’s trials among those aged 65 and over.
“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,” said EMA chief Emer Cooke.
“As in previous cases, the CHMP [the committe on human medicines] has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”
In a statement, the EMA acknowledge that a low number of older people took part in AstraZeneca’s trials. However, the balance of evidence supported approving the vaccine for all age groups over 18, the regulator said.
“Protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines,” the EMA said in a statement.
“As there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.”
The recommendation will now go to the European Commission for final approval.
The recommendation comes amid a simmering row over AstraZeneca’s announcement that EU states will only get a fraction of the supplies expected in the first quarter.
Ursula von der Leyen has said it is “crystal clear” that AstraZeneca is bound by its contract to deliver coronavirus vaccine doses produced in the UK to the EU to make up for a shortfall in production in Belgium.
As a redacted version of the disputed contract was published on Friday, the commission’s president dismissed the arguments of AstraZeneca’s chief executive, Pascal Soriot, that the British government had a first claim on doses produced in Oxford and Staffordshire.
Dr von der Leyen said the Anglo-Swedish pharmaceutical company was legally obliged to use all four plants named in its contract – two in the UK, one in Belgium and a fourth in the Netherlands – to deliver on its promised order.
The European commission has paid €336 million for 400 million doses, the first 100 million of which were due to be delivered in the first quarter of this year.
Dr von der Leyen continue to demand that the British-based pharma group offer a “plausible explanation” for its looming shortfall in vaccine deliveries to the EU.
Her remarks on German public radio came hours before the EU’s medical agency is expected to recommend approving the vaccine for use in member states, which then goes before the commission for formal approval.
The published contract confirms the EU position that supply for its contracted 300 million doses of the vaccine was to be delivered from plants including those based in the UK.
There is no provision in the contract that supplies destined for the EU from any of the plants were subordinate to supplies from those plants for other customers, including the UK.
“We want to know what’s going on,” said Dr von der Leyen on Deutschlandfunk. “What I’m demanding is transparency and dependable planning.”
A week after the company announced it was reducing its deliveries to the EU from 80 million to 31 million doses, the European Commission will on Friday publish its contract with AstraZeneca – with sensitive passages blacked out.
While the firm claims its contract with the EU contains a “best effort” clause, Dr von der Leyen said this applied only to the period before a vaccine had been developed.
“This period is now behind us, the vaccine is here and just has to go through the final tests,” she said. “Now there is very clear delivery quantities for December of last years and also for the first, second and third quarters (of 2021).
The contract with the EU was “crystal clear”, she added, with “binding” delivery capacities listed.
“AstraZeneca promised us explicitly that no other obligations stand in the way of fulfilling this contract, and that is all that counts here,” she said.
It was understandable – given the speed of Covid-19 vaccine development and production – that problems could arise, she said.
But production issues with BioNTech, another vaccine firm, had been ironed out and things were “running well”, she said, after open talks with her commission officials.
She said that there was no reason why, given reported problems at AstraZeneca’s Belgian production facility, that two UK firms could not step in to fill the gap.
“The contract has production facilities which can produce the delivery quantities,” she said.
The firm has said its contract with the UK obliges it to prioritise vaccines manufactured there for the British health service.
The European Medicines Agency (EMA) will on Friday decide whether to approve the AstraZeneca’s Covid-19 vaccine amid a fierce row over a drastic cut in expected deliveries by the British-Swedish pharmaceutical company.
The move has spurred the EU to move to control exports of vaccines from the bloc.
German health authorities on Thursday recommended that AstraZeneca’s Covid-19 vaccine should be not be given to those aged over 65 due to a lack of data, in a potential fresh blow to vaccination efforts in Ireland and across the European Union.
There is “insufficient data currently available to ascertain how effective the vaccination is above 65 years”, the vaccine committee of Germany’s main public health agency the Robert Koch Institute said in a statement. “The AstraZeneca vaccine, unlike the mRNA vaccines, should only be offered to people aged 18-64 years at each stage.”
Only 341 people aged over 65 in AstraZeneca’s trial received the vaccine, and 319 were given a placebo, meaning that too little data is available to show the vaccine’s effectiveness in that age group with certainty, the committee said.
The UK has already rolled out the vaccine and thousands of people have received it in Northern Ireland. Public Health England has said that while there were too few cases in older people in AstraZeneca’s trials to measure protection with certainty, data on immune responses were “very reassuring”.
AstraZeneca’s trial data is also being challenged in the United States, where a pension fund has launched a lawsuit on behalf of investors faulting the company for including too few older people, and for a mix-up in the trial in which some participants were accidentally only given a half-dose as one of their shots.
The EMA is expected to make a decision on authorising the vaccine on Friday, and so far has not indicated whether doses could be approved only for younger age groups.
AstraZeneca would be the third Covid-19 vaccine available in the EU if approved, following BioNTech-Pfizer and Moderna, and is key to national vaccination strategies because it is easier to roll out as it does not need to be deeply frozen.
In Dublin, the Government is developing contingency plans if it is not able to administer AstraZeneca to the over-65s. However, Government sources said there is confidence there would be sufficient Pfizer supplies from mid-February onwards to allow for the vaccination of older people, but conceded that logistical issues would be more challenging if this was required.
Sources said the third cohort in the vaccine list – the over 70s – could still be done by the end of spring, rather than March, if AstraZeneca were not available.
Novavax Inc said on Thursday its coronavirus vaccine was 89.3 per cent effective in preventing Covid-19 in a trial conducted in the UK, and was nearly as effective in protecting against the more contagious variant of Covid-19 first discovered in the UK, according to a preliminary analysis.
A mid-stage trial of the vaccine in South Africa, where a potent variant of the virus is common, showed 60 per cent effectiveness among people who did not have HIV.
Novavax said the UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for regulatory review in the UK, the EU and other countries. Some 27 per cent of people in the trial are over the age of 65. – Additional reporting from Reuters