Not that the decision to approve the vaccine wasn’t controversial in itself. The EMA had been unhappy with the quality of the data received from the Anglo-Swedish drugmaker and equally concerned about the optics of giving a thumbs-up up when the company’s plans to slash the bloc’s short-time supply by 60% looked like a potential breach of contract.

Due to missing data for people aged 65 and older – who were not recruited for AstraZeneca’s Phase 3 trials – the medicines watchdog had been expected to recommend the shot, developed originally by the University of Oxford, only for younger people. Suprisingly, it gave a blanket approval, despite rumors of diverging opinions within the review panel, especially about the drugmaker’s communication of efficacy numbers that the EMA said came to no more than 60% overall, compared with 95% for the Pfizer-BioNTech and Moderna shots.

Germany’s standing vaccine commission had pushed back against recommending this candidate for older population groups but it was unclear on the weekend whether the EMA’s decision would cause a rethink in Berlin. Italy, too, had previously said it wouldn’t administer the AstraZeneca shot to anyone over 55.

Any decision to restrict administration of the doses would push the EU farther behind the UK and the US in the number of people vaccinated. To date, the EU’s 27 governments have administered 2.6 doses of vaccine per 100 people, compared with 12.5 doses in the UK and 8.8 in the US.

The European Commission has ordered up to 400 million doses of the Oxford vaccine but instead of the 80 million expected to be delivered in the first quarter, AstraZeneca said last week it could supply no more only 31 million, due to problems at a CDMO located in the EU (which was reported to be Novasep). It said, however, that this would not interfere with deliveries to the UK.

Making matters worse for Europeans waiting to be vaccinated, Moderna subsequently informed the Commission that it, too, would be unable to entirely meet its Q1 commitment. The Maryland-based US vaccine manufacturer said it was providing “short-term revised delivery guidance” outside the country because of a ramp-up at a manufacturing plant for the drug substance in Switzerland – where it is being supplied by Lonza.

Italy said it had been advised that delivery volumes would be less than planned from early February, and France said it was now expecting 25% fewer doses than had originally been scheduled to arrive next month.

Moderna’s announcement was the third blow to the EU vaccination campaign, coming on the heels of BioNTech-Pfizer’s warning to the bloc two weeks earlier to prepare for smaller than expected deliveries in the early part of the year, due to expansion work at a Pfizer plant in Belgium. The biotech, which is being funded By the US Warp Speed initiative, later backtracked, saying the supply cuts would not come immediately.

The EU’s plight left the rest of the world mostly cold, amid accusations that member states had been too slow to begin vaccinating. Led by outraged UK Brexit cheerleaders, criticism quickly began piling up on the Commission’s doorstep after Brussels announced a plan to restrict exports of vaccine ingredients produced within its borders. Complaints also came from international NGOs as well as government and company leaders.

In a nutshell, the Commission said it wants drugmakers to notify national authorities in the EU countries of the amounts and destination of any vaccine shipments they plan outside the bloc. The plans would be in effect until the end of March, “in order to improve transparency” in the market. Shipments abroad would be allowed only if they did not impact EU supplies.  Non-EU European nations would be exempted from any restrictions in any case.

One provision of the Commission’s initial proposal, which would have prevented shipments of vaccines from EU member state Ireland to Northern Ireland, part of the UK, was scrapped as it would have violated article 16 of the Brexit treaty, the so-called Good Friday agreement.

Speaking at the virtual World Economic Forum, Albert Bourla, Pfizer’s CEO, said he feared a lose-lose situation for all, rather than a win for Europe if a trade a war results from its actions. The World Health Organization’s director-general Tedros Adhanom Ghebreyesu also criticized the EU plans, and the European Federation of Pharmaceutical Industries and Associations commented that “risking retaliatory measures from other regions at this crucial moment in the fight against COVID-19 is not in anyone’s best interest.”

The sharpest criticism came from Northern Ireland’s First Minister Arlene Foster, who described the proposed export curbs as an “absolutely incredible act of hostility towards those of us in Northern Ireland.” She called on the UK government to dissolve the clause, which is controversial in the devolved region.

As the last day of January, a Sunday, dawned, Commission chief Ursula von der Leyen hosted a video call with CEOs of pharmaceutical companies including AstraZeneca and Moderna to discuss how vaccines could be more rapidly deployed, manufactured and approved in future.

“The pandemic highlighted that manufacturing capacities are a limiting factor. It is essential to address these challenges,” the Commission said in a statement afterward, adding that “the emergence of variants of concern raises the imminent threat of reduced efficacy of recently approved vaccines.”

Tensions also appeared to have calmed somewhat, nevertheless. AstraZeneca said it would begin shipping vaccines to the EU on Feb. 1, a week earlier than planned, and deliver 9 million more shots than advised last week. This would reduce the shortfall to “only” 50%. The company also said it would seek to expand its European production base. “We are working 24/7 to increase this capacity,” CEO Pascal Soriot said.

Also on Sunday, AstraZeneca agreed to publish its vaccine supply contract with the EU, signed in August 2020. Although redacted, the document is said to clarify several points of the raging discussion, foremostly that the company’s UK production facilities do not earmark output for that country alone.

By the reverse token, documents showed that the drugmaker supplies vaccines or ingredients to the UK from the Netherlands and Germany, where the vaccine is being filled & finished. In a call to UK prime minister Boris Johnson, Von der Leyen said the EU, which is supporting the drugmaker’s Covid-19 vaccine production with €330 million upfront, would not restrict these shipments.

The drugmaker declined to clarify whether the advised number of doses was a contractual obligation or not. The Commission upheld its stance that a clause in the August agreement, in which AstraZeneca said only that it would make its “best reasonable effort” to deliver the doses as ordered, no longer applied after production was up and running and the vaccine cleared by the EMA. Details on doses and delivery dates were blacked out.

Somewhat of an eye opener was another provision of the contract between the European Commission and the drugmaker that had not been made public up to now.  In exchange for a lower per-dose cost in the  EU – the shot is being administered free in the UK at the request of Oxford University – AstraZeneca will be exempted from any legal costs in connection with potential lawsuits, up to a certain undisclosed threshold. This is a privilege not extended to vaccine makers charging higher prices, the Commission has acknowledged

The threshold agreed has not been disclosed nor has any arrangement with the Commission or member state government on cost sharing. The financial shield is said to cover both legal costs and potential compensation to parties who might sue.

Author: Dede Williams, Freelance Journalist