Supply shortages of Oxford/AstraZeneca vaccines witnessed in the European Union were the result of production shortfalls in serum or "drug substance", according to EU documents detailing inspections of three of the drug maker’s plants in Belgium, Italy and the Netherlands, cited by Politico and the Belgian magazine Knack.
A bitter vaccine row exploded between the European Commission and AstraZeneca in late January, when the drugmaker announced it would not be delivering tens of millions of promised doses to the EU.
Coming amid a sluggish vaccine rollout in the European Union, the move prompted bloc officials to dispatch a team, including three Commission staff members and nine national inspectors, to probe the root causes of the failings at European plants.
Documents obtained by Knack via a Freedom of Information request and cited by Politico reference two meetings between the team members on 29 January and 5 February.
The findings suggest that, based on AstraZeneca's existing supply chain, the company simply couldn't deliver the promised jabs.
Detailed inspections carried out in January and early February reportedly showed that a Belgian subcontractor originally owned by Henogen but bought by Thermo Fisher Scientific in early 2021 was producing enough serum to fulfill its contract with the pharmaceutical giant.
However, another plant in Halix, the Netherlands, was lagging far behind, and not producing enough to be included in the company’s application for approval to European regulators at the end of December.
Facing a dwindling stream of serum produced on the European continent, AstraZeneca was ostensibly forced to try and make up the shortfall by turning to its US plant in Maryland.
"According to our knowledge, the firm AstraZeneca is not able to honor the quantities defined in the contract with the European Commission and with the schedule defined at the origin," the inspectors reportedly wrote.
"Today the only solution would be to import more drug substance batches from" the United States, as "some capacity" for fill-finish (the process of filling vials with vaccine and finishing the process of packaging the medicine for distribution) is always available at the Italian site, added the documents, referencing the American plant owned by Catalent, Inc. (Catalent Pharma Solutions).
AstraZeneca taps Catalent Inc. to manufacture Covid-19 vaccine candidate in Maryland https://t.co/ULraQqPaxM #MTCMember pic.twitter.com/nQGzszicJU
— MD Tech Council (@MDTechCouncil) August 31, 2020
The latter had provided “the most important quantity" of drug substance that was subsequently put into vials in Italy in a process known as "fill and finish," according to the cited documents.
An EU official was cited as claiming that more than half of what formed the EU's Oxford/AstraZeneca vaccine supply at the time arrived from the US.
However, the documents stop short of offering any specific details as to how much drug substance actually came from America or how many more shipments have reached their European destination since early February.
EU Jab Row
What the cited documents do shed light on is America’s apparently more significant role in the EU's vaccine supply than previously estimated.
Furthermore, in light of the role purportedly played by the Maryland plant, the documents shed light on why European Commission President Ursula von der Leyen displayed a milder approach to the US when the EU threatened to cut off vaccine exports to countries that failed to send vaccines in return.
Amid criticism for the slow vaccination pace in the European Union member-states as compared to the UK making impressive strides in jab rollout, European Council President Charles Michel had insisted in a "newsletter” in early March that Europe was "well placed to lead the field in a marathon."
"The United Kingdom and the United States have imposed an outright ban on the export of vaccines or vaccine components produced on their territory," wrote the official.
London denied restricting any exports of vaccines or medications, with a government spokesman saying:
“The UK government has not blocked the export of a single COVID-19 vaccine… Any references to a UK export ban or any restrictions on vaccines are completely false."
European Commission President Ursula von der Leyen, however, had adopted a somewhat different tone when addressing jab setbacks at a press conference on 17 March.
After scores of European countries halted their use of the Oxford/AstraZeneca shot amid reports of blood clots, despite assurances from the European Medicines Agency that the benefits of the vaccine outweigh the risks, von der Leyen slammed countries over failing to reciprocate on the EU's openness.
Warning that unless they began exporting shots to the bloc, Europe would halt its exports to those countries, she cited the UK as the "No. 1" destination for EU vaccine exports, while not sending any shots back in the other direction.
EU Commission President Ursula Von Der Leyen threatened to ban exports of COVID-19 vaccines to Britain to safeguard scarce doses for the blocs citizens facing a third wave of the pandemic https://t.co/RYYpfwYkf2 pic.twitter.com/2vt6WVmnQM
— Reuters (@Reuters) March 17, 2021
"We're still waiting for doses to come from the UK", said the official, adding that the situation with the US was different and "there is a seamless flow back and forth of pre-products, raw materials and drug substance."
The ostensibly lack of reciprocity on vaccines between the EU and UK is supposedly confirmed by the EU documents seen by Politico.
"Nothing" in terms of drug substance "has been received" from the UK’s three AstraZeneca plants on its soil, claim the documents.
Furthermore, an unspecified portion of what the plant in The Netherlands was producing by early February was still slated for export to the UK.
There has not yet been any official comment on the report from AstraZeneca.
In the UK more than half of vaccinated Britons have gotten the Oxford/AstraZeneca jab.
This is how well the vaccines (mainly single shot AstraZeneca) are performing in the UK- each age group reaching high antibody levels with the over 70s now at over 80% +ve - a powerful shield.https://t.co/yNIyaOZbMB pic.twitter.com/ScbBafb0Hs
— Luke O'Neill (@laoneill111) April 16, 2021
In the US the vaccination effort is also proceeding with swiftness, which in theory, writes the outlet, should free up more vaccine substance for the EU, delivered from Maryland.
However, even if an influx of US supplies is factored in, it remains unclear whether AstraZeneca can meet its deliveries to the EU bearing in mind the huge shortfall in the first quarter. Only 30 million doses were delivered instead of the ambitious 100 million promised.
We reached 100 million vaccinations in 🇪🇺 !
— Ursula von der Leyen (@vonderleyen) April 14, 2021
And we’re accelerating vaccines delivery, to further speed up vaccination.
Soon every adult in 🇪🇺 will have access to vaccination. We want to have at least 70% of adults vaccinated by the summer.
We count on you, choose vaccination. pic.twitter.com/RP971aImPC
Currently, the drugmaker hopes to deliver another 70 million doses in the second quarter, totalling 100 million doses by July. The amount will still be no more than a third of the 300 million doses it promised when the contract was signed in August 2020.
