The first blow against the 27-member bloc came two weeks ago when Pfizer said it would slash deliveries of the Comirnaty vaccine it developed with Germany’s BioNTech, and the second hit home a week later when AstraZeneca announced it would not be able to meet commitments for its still-to-be-approved vaccine, potentially facing a 60% shortfall.

On Jan. 26, then, the EU Commission announced that until the supply situation is remedied, it may consider requiring vaccine manufacturers to provide advance notice about their plans to export any product made on European soil. This would include deliveries to the UK, no longer a bloc member.

The Commission has ordered 300 million doses of AstraZeneca’s viral vector vaccine with an option to take 100 million more. It has also signed on for 500 million doses of the Pfizer-BioNTech vaccine and 160 million doses of Moderna’s, both mRNA-based.

Amid all the smoke, it seemed unclear how long the battle would rage and which way it would go, but after EU officials began turning up the heat early this week, some of the ice on the supply side seemed to be thawing. AstraZeneca proposed minor concessions, and a joker’s entry into the pack offered promise as a game changer.

In a letter to Pfizer, seeking "further clarification,” health commissioner Stella Kyriakides argued that production scale-ups must take place concurrently with clinical trials and thus not interfere with supply commitments.  In a phone call to AstraZeneca CEO Pascal Soriot, EU Commission president Ursula von der Leyen said she expected the drugmaker to fulfill its established orders to Europe, despite reported production setbacks.

EU provided support for vaccine development

If trailing the rest of the industrialized world in vaccine deployment were not reason enough to be angry at suppliers, the EU is particularly incensed about being left behind when it has provided financial support for development.

Last year, Germany funneled nearly €400 million in federal funding to Pfizer and BioNTech for Stage 3 clinical trials and to boost production capacity, and it also took a 23% stake in Tübingen-based CureVac. The EU altogether has spent close to €3 billion to fund development and production of Covid-19 vaccines.

“Europe invested billions to help develop the world’s first covid-19 vaccines, to create a truly global common good,” Von der Leyen said at a virtual meeting of the World Economic Forum. “And now, the companies must deliver. They must honor their obligations.”

Holding out an olive branch of sorts to Brussels, Soriot said AstraZeneca could potentially begin delivering vaccines on Feb. 7, earlier than planned, although it would not be able to send more. The company did not immediately react to Commission suggestions that it divert doses made in the UK – where the government has said supply is sufficient – to Europe.

London approved the vaccine the Anglo-Swedish drugmaker developed with Oxford University early on, without waiting for clarification of efficacy questions, and AstraZeneca subsequently shipped EU-made output to its home territory to meet commitments.

As a stop-gap measure to keep vaccine supply flowing as Covid infections continue rising steadily, the European Medicines Agency (EMA) is expected to grant conditional marketing approval to AstraZeneca’s candidate as early as this week. Due to the drastic reduction in deliveries advised by the major suppliers, any hope of being able to vaccinate much of the population under 80 years old has evaporated, however.

Sanofi to help Pfizer and BioNTech meet commitments

Although the supply situation in Europe is currently dire, there may be some light on the horizon, at least in the medium term. French drugmaker Sanofi has now confirmed reports that it has signed on to help Pfizer and BioNTech produce 100 million additional doses of their vaccine. The first batches will be delivered from Sanofi’s site in Frankfurt, Germany – presumably to EU countries – by August, the company said.

The Paris-headquartered drugmaker and its British adjuvant partner, GlaxoSmithKline, recently delayed their planned launch of a Covid-19 vaccine to late 2021 rather than mid-year as originally expected. With another partner, Translate Bio, Sanofi is pursuing an mRNA-based vaccine. The pair are gearing up for a Phase 2b study set to begin next month.

Beyond this unanticipated windfall, all eyes are now fixed on US healthcare group Johnson & Johnson, which has hinted it could begin supplying its vaccine worldwide as early as Apr 1.  J&J’s candidate has not yet been approved anywhere but it hopes to clear this hurdle soon. Results of Phase 3 clinincal trials are due to be reported next week.

Bayer’s pact to help manufacture compatriot CureVac’s Covid candidate in its own plants in Germany and the US could also help to lengthen European supply, even if the region may continue to trail the rest of the developed world for the near future. CureVac, which has just started Phase 3 trials, hopes for a launch late this year.

Author: Dede Williams, Freelance Journalist