EU sues AstraZeneca over COVID-19 vaccine delays

• EU asks Belgian court to fine AstraZeneca over failure to deliver COVID vaccines
• AstraZeneca could be forced to pay millions of euro’s (EUR) in daily penalties
• Three people in the UK suffer a stroke after receiving AstraZeneca COVID shots
• Scientist claim that manufacturers can optimise COVID vaccines to prevent blood clots

The European Commission has asked the Belgian court to fine AstraZeneca if they do not honour its contractual commitments and deliver its outstanding COVID vaccines to the bloc.

In the latest round of the bitter legal dispute, EU lawyer Rafael Jafferali told a Brussels court that “AstraZeneca has not even tried to respect the COVID vaccine contract” and demanded that the pharmaceutical firm compensate the bloc for its alleged non-compliance.

Mr Jafferali proposed a EUR 10 (USD 12/GBP 8) fine per dose for each day of delay. Given that there are approximately 150M doses yet to be delivered to the bloc, AstraZeneca could end up paying millions daily.

The EU’s lawyer said the penalty should apply from July 1st, giving AstraZeneca just over a month to deliver on its promise. The European Commission will also be seeking a minimum of EUR 10M in compensation for each breach of contract made by the pharmaceutical giant.

During a hearing on Wednesday, EU lawyers added that AstraZeneca’s failure to deliver the agreed 300M doses had damaged the region’s coronavirus vaccine rollout and the EU’s ability to begin recovery from the COVID crisis.

According to the latest reports, the Swedish-Anglo firm delivered only 30M of the 120M COVID-19 vaccine doses during the first quarter of 2021 and 50M by early May. While AstraZeneca is on course to supply 70M of the agreed 180M vaccine doses in Q2, 40M of the first batch are yet to be delivered to the bloc.

Mr Jafferali has also accused the pharmaceutical company of providing misleading information over the delivery timeframe as the Commission was unable to “fully understand the situation before the scheduled rollout date in mid-March.”

He argued that AstraZeneca should have made use of all four production plants to deliver on its contractual commitments with the European Union, suggesting that the 50M doses that were being manufactured offshore were sent to other countries instead.

Still, even if the Belgian court rules in the EU’s favour, it remains unclear whether AstraZeneca would be able to deliver the missing vaccine doses, especially as several EU member states have banned or restricted distribution of the vaccine.

AstraZeneca hits back over vaccine supply criticism

AstraZeneca’s lawyer, Hakim Boularbah, hit back at the EU, calling the bloc’s accusations “shocking” and adding that manufacturing a new vaccine is complex.

Mr Boularbah highlighted that the COVID vaccine contract between AstraZeneca and the EU was not binding. He also noted that commitments to deliver on coronavirus vaccine doses were made under “best reasonable efforts”.

When asked whether Europe should have received COVID vaccines manufactured at other plants in Britain and the US, Mr Jafferali said doses produced in the UK were reserved for use in Britain under a legally binding contract with the government.

The company said the shortfall in EU deliveries had nothing to do with its other two plants and blamed production difficulties at its European plants and export restrictions for the delays.

Despite delays to the first batch of vaccine doses, AstraZeneca is adamant that any legal action taken against them is “without merit”.

Legal experts have also suggested that the EU’s attack against AstraZeneca is not just about forcing the drug maker to deliver on its commitments but making a statement proving that the European Commission will not be misled or deceived.

While AstraZeneca could invoke a clause in the contract to support its defence, the Belgian court may reject the clause and refer to the performance of other vaccine suppliers such as Moderna, which has met its obligations despite the challenges brought about by COVID-19.

The EU currently expects to receive more than 1BN COVID-19 vaccines by September end – enough to vaccinate the entire adult population.

EU seeks penalties over AstraZeneca deliveries but reluctant to use the vaccine

The EU is set to receive 413M COVID vaccine doses in Q2 2021 and 529M in Q3, albeit most of these will come from Pfizer/BioNTech, Johnson & Johnson and Moderna plants.

Despite demanding millions in penalties from AstraZeneca, fears over recipients of the AstraZeneca vaccine developing rare blood clots has prompted several EU member states to ban or restrict distribution of the COVID jab.

Even the UK is only offering the AstraZeneca jab to over-40s after it emerged that younger people are at higher risk of developing rare blood clotting.

Meanwhile, other European countries such as Denmark only offer AstraZeneca’s jab to volunteers and donate existing stock to less-developed nations.

Italy has agreed to donate 15M doses to poorer countries, with France and Germany pledging 30M each to the Covax programme, co-led by the World Health Organisation (WHO) and Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI).

Recently, it has also emerged that three people under the age of 45 have suffered from a stroke after receiving the AstraZeneca vaccine, which resulted in the death of one patient.

A small number of COVID vaccine patients suffer a stroke

Health authorities have advised doctors to look out for signs of a stroke in patients administered the Oxford-AstraZeneca shot after one person died and two other people needed urgent medical treatment.

Although scientists have stressed that the chances of vaccine recipients suffering a stroke are minimal, experts from the National Hospital of Neurology and Neurosurgery at University College London (UCL) have urged the NHS to look out for tell-tale signs.

Health authorities highlighted the risk of stroke after two women and a man, all under 45-years-old developed blood clots, which led to a stroke within a month of receiving their COVID jab.

The first patient that suffered from the life-threatening medical condition was a 35-year-old Asian woman who said she had been receiving intermittent headaches on the right side a week after taking the AstraZeneca shot.

Five days later, she woke up feeling drowsy, and the whole right side of her body was insensate. She was rushed into hospital, and despite undergoing brain surgery and receiving several other treatments, the woman lost her life.

Experts told the NHS that people who suffer from a stroke need to be evaluated for an unusual syndrome called vaccine-induced thrombosis and thrombocytopenia (VITT), which blocks blood flow to part of the brain.

Due to fears over blood clots, the British government restricted use of the AstraZeneca jab in people under 40, who have been offered the PfizerBioNTech or Moderna alternatives since the beginning of May.

Clinical Neuroscience Professor Hugh Markus from the University of Cambridge said: “It is important to remember that these side-effects are rare, and much less common than both cerebral venous thrombosis and ischaemic stroke associated with COVID-19 infection itself.”

Meanwhile, MHRA Chief Executive, Dr June Raine, explained: “No effective medicine or vaccine is without risk.”

However, a group of German scientists believe that they have discovered why the AstraZeneca vaccine causes rare blood clots and other coronavirus jabs such as Moderna and Pfizer do not.

According to the German scientist, Professor Rolf Marschalek from Goethe University, AstraZeneca’s COVID jab causes blood clots due to the way it is delivered into the body.

Unlike the mRNA vaccines manufactured by PfizerBioNTech and Moderna, AstraZeneca and Johnson & Johnson use the adenovirus (the common cold virus) to deliver the spike protein of SARS-CoV-2 into the body, which increases the risk of blood clotting.

Professor Marschalek notes that Pfizer and Moderna do not use this delivery system, and there have been no cases of blood clots linked to their respective formulas.

The German scientist revealed that he is already talking with Johnson & Johnson about how they can re-optimise their vaccine to make it safer but has not yet been approached by AstraZeneca.

However, he insists that he’d be happy to inform them of what they can do to improve their formula to prevent “unintended splice reactions.”