The Executive Director of the European Medicines Agency, Emer Cooke, has said the pharmaceutical company AstraZeneca is still providing the agency with clinical data, but that the EMA hopes to be able to authorise its Covid-19 vaccine by the end of this week.
During a hearing in Brussels, Ms Cooke would not be drawn on the criticisms levelled at AstraZeneca by the European Commission and member states over a significant shortfall in dose supply.
It follows the escalating row between the European Union and AstraZeneca over a shortfall of up to 60% in the amount due to be delivered to European capitals in the first quarter, once the vaccine is authorised, as expected, on Friday.
Ms Cooke took questions from members of the European Parliament's health committee for nearly two hours, during which there were numerous questions about the shortfall.
She said she shared the frustrations over delayed deliveries and said the EMA could help facilitate the inclusion of additional production facilities at manufacturing plants, but she sidestepped the politics of the controversy.
Ms Cooke told the European Parliament that while the much quicker authorisations the UK regulator has given the Pfizer and AstraZeneca vaccines, these were temporary and the vaccines remained unlicensed.
It was not within the remit of the EMA to grant such emergency authorisations to vaccines, she said, although it was the prerogative of member states to do so depending on the situation in their own territory.
She insisted that the process of authorisation was based on robust science and data, and that all 27 member states had to be satisfied that vaccines were safe.
She said agency staff were working round the clock in order to complete authorisation as soon as possible.
Meanwhile, European Commission President Ursula von der Leyen has said the EU will set up a vaccine transparency mechanism to monitor the export of Covid vaccines out of the EU.
President von der Leyen told the World Economic Forum that vaccine producers must honour their obligations.
"Europe invested billions to help develop the world's first Covid-19 vaccines," she said in a live video address to an online-only version of the WEF, usually held in Davos, Switzerland. "And now, the companies must deliver. They must honour their obligations."
The European Commission hopes to produce a mechanism by the end of this week which would register all Covid-19 vaccines manufactured in Europe and exported to non-EU countries.
Although the commission has not spelled it out, the suspicion among officials is that none of AstraZeneca's other customers, notably the UK, suffered any big drop in supply.
The commission said the transparency mechanism is not about blocking exports of vaccines, but about knowing who is getting what, given the hundreds of millions of euro the EU invested in the development and production of the AstraZeneca vaccine.
However, German health minister Jens Spahn has gone further and said any vaccine doses leaving the EU should require a licence to be exported.
AstraZeneca will hold a third meeting with the so-called Steering Board, comprising member states and the commission tomorrow.
So far its explanations have not convinced the EU, nor has it apparently indicated how the shortfall will be made up.
The commission issued an angry warning to AstraZeneca yesterday over the delivery delays to the bloc and threatening to block vaccine exports.
Last Friday, AstraZeneca said it would not meet its contractual delivery commitments to the EU because of unexplained "reduced yields" in its European supply chain.
The EU has currently authorised two vaccines for widespread distribution, manufactured by Pfizer/BioNTech and Moderna.
It was set to add the AstraZeneca vaccine to that list this week, on the understanding that it would be already on hand and available for immediate roll-out.
"This is not about blocking, this is about knowing..." European Commission spokes @MamerEric says the proposed mechanism to monitor what Covid vaccines are being exported from the EU is about "transparency"— Tony Connelly (@tconnellyRTE) January 26, 2021
Minister for Health Stephen Donnelly said the Government was very disappointed with the news from AstraZeneca.
Speaking on his way into Cabinet this morning, he said: "There are ongoing talks with the company, both in terms of ensuring that we get as much volume is possible, particularly in the first quarter when it's really, really important to vaccinate the most vulnerable.
"And secondly, I'm pushing to have it delivered before the agreed date, which is mid February, if it's authorised before then."
AstraZeneca rejects 'incorrect' reports on Covid-19 jab efficacy in elderly
AstraZeneca has defended the efficacy of its Covid-19 vaccine after media reports said the German government had doubts about its effectiveness among those over 65.
The Handelsblatt economic daily reported yesterday that Berlin had estimated the efficacy of the jab among over-65s was just 8%, citing sources.
Bild also said that Berlin did not expect the vaccine, which was developed with Oxford University and set to get the green light from the EU this week, would receive a licence for use in the elderly.
It quoted an efficacy rate of "less than 10%".
But the company rejected the claims as erroneous.
"Reports that the AstraZeneca/Oxford vaccine efficacy is as low as 8% in adults over 65 years are completely incorrect," the firm said in a statement late last night.
"In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose," it added.
Germany's health ministry said it "appears that two things have been mixed up in the reports".
"Around 8% of the volunteers in AstraZeneca's efficacy studies were around 56 and 69 years old and 3-4% are above 70 years old," said the ministry.
"However, this does not mean that it is effective only in 8% of older people," it added.
The health ministry added that European regulator EMA will evaluate the effectiveness of the vaccine.
"It has been known since the autumn that fewer older people were involved in AstraZeneca's first studies than in other manufacturers'," it said.
AstraZeneca CEO Pascal Soriot told Germany's Die Welt newspaper he had "no idea" where the false claim came from, saying it was incredulous to think regulators would approve a vaccine that had an efficacy of just eight percent.
He also hit back in a growing row with the EU that erupted after AstraZeneca last week announced a delay in delivering millions of doses of its Covid-19 vaccine over unexplained "reduced yields" in its European supply chain.
Mr Soriot told Welt that the pharma company has a "best effort" agreement with the bloc to deliver a certain number of doses by a certain time, but was not contractually bound by it.
He also said that Britain, which is further along in its vaccine drive, had signed a deal for the jabs three months before Brussels did, which had allowed for more time to iron out supply issues.
Irish MEPs urge transparency over vaccines
Dublin MEP Barry Andrews said it is time to "deescalate the row" between the EU and AstraZeneca.
Speaking to Times Radio, he said: "We need now to make sure that AstraZeneca and Pfizer provides the European Union with full transparency.
"We as MEPs have not seen any of the contracts, apart from one, and that was redacted.
"So we do not know exactly what has been promised [to vaccine firms] in terms of liability, we don't know what’s been promised in terms of delivery, we don’t know what the price is, so there are a lot of unknowns."
Ireland South MEP Billy Kelleher said "we have to find out definitively" whether AstraZeneca is "fulfillng its contractual obligations to the European Union in an impartial way - in other words, that it is not prioritising other countries for any other reasons".
Speaking to Euronews, he said: "So we need to ensure that it is at capacity and is able to produce the vaccines that it said it could produce.
"And then we wait for approval hopefully this Friday from the European Medicines Agency that should allow the roll-out."
Johnson & Johnson expects Covid-19 vaccine data next week
Johnson & Johnson has said it expected to report eagerly-awaited data on its Covid-19 vaccine early next week, and that it would be able to meet the delivery target for doses to countries with which it had signed supply agreements.
Public health officials are increasingly counting on single-dose options like the one being tested by J&J to simplify and boost inoculations given the complications and slower-than-hoped roll out of authorised vaccines from Pfizer Inc and Moderna Inc, which require second shots weeks after the first.
The company said pricing of the vaccine would depend on the number of doses secured by countries and organisations.
Additional reporting AFP/Reuters