Observers said it was hard to know which of the three developments was most worrying, though in striking a somewhat optimistic tone on supply industry commissioner Thierry Breton said the EU will still be able to meet to its vaccination targets for the first quarter, as BioNTech/Pfizer will be able to make up the difference. At the same time, he urged AstraZeneca’s board of directors to take action to solve its logistics problems.

Speaking on France’s Europe 1 radio on Mar. 14, Breton said AstraZeneca’s repeated delay is unacceptable, but the EU has no plans to sue. “Pfizer is producing faster than planned,” Breton said, “much more than planned and is going to deliver more to us. The European Commission said on Mar. 10 that it had agreed to acquire 4 million additional doses from the German-American vaccine partners for delivery in the next two weeks.

AstraZeneca originally had pledged to deliver 90 million doses to the EU in the first the first three months of 2021, but slashed the outlook to 31 million in late January after protests from the Commission, which is in charge of procurement for the 27-member bloc. The announcement came on the day the EU approved the shot for conditional marketing.

After subsequent talks with European leaders and the bloc’s decision to place export restrictions on vaccines manufactured in one of its member states, AstraZeneca CEO Pascal Soriot walked back the cuts somewhat. He said the company would be able to supply 40 million doses by diverting them from other buyers, without mentioning where the doses would come from.

The UK drugmaker has blamed its troubles mainly on production shortfalls at its European suppliers. To get the vaccine out, it is working with multiple CDMOs in different countries. In January, problems at Novasep in Belgium were spotlighted More recently, the finger has been pointed at Emergent Biosolutions’ plant in the Netherlands.

Soriot, it now emerges, has called on the US to release some of the “millions of doses” manufactured by Emergent that are being stored in the states of in Ohio and Maryland. AstraZeneca has not yet applied to the US Food and Drug Administration for an Emergency Use Authorization as the FDA is waiting for results from a Phase 3 trial.

President Joe Biden has made it clear that the US will not release any of the doses. Press secretary Jen Psaki said the administration wants to ensure that the country is “oversupplied and over prepared” to meet the president’s target of vaccinating all Americans by May. The US has signed purchase orders for 800 million doses, not including AstraZeneca’s promised 300 million, more than enough to vaccinate the entire population.

Biden’s Covid-19 response coordinator Jeff Zient said Washington has “a small inventory of AstraZeneca so that if approved, we can get that inventory out to the American people as quickly as possible.” More than 500,000 people have died of the disease across the US.

EMA wants anaphylaxis included in AZ side effects

Amid the acrid discussion on several fronts, the vaccine developed by Oxford University – one of four approved by Brussels for conditional marketing – is leaving a sour taste in the mouths of the many still unvaccinated European citizens. Following last week’s discussion over blood clots, more than a third of the EU 27 member states have temporarily halted shots with the AstraZeneca doses.

Joining the list over the weekend were Ireland and Bulgaria, bringing the halts to ten. In Asia, Thailand, which has not yet administered any doses, said it would wait to see what the EU does. France, Germany and Portugal said they planned to continue administering the vaccine, despite widespread distrust of AstraZeneca in the population. The World Health Organization also recommended that vaccinations continue.

 A recent YouGov poll found that Europeans were less receptive to the vaccine than people in the UK, where the vaccine is a matter of national pride. According to the European Center for Disease Prevention and Control, more than half of the AstraZeneca vaccines doses in Germany, France, Italy and Poland have gone unused.

In response to the blood clot discussion, the EMA last week said it was examining the batch that raised alarm in Austria after the death of a healthcare worker, while adding that “there is no immediate evidence” the vaccine was to blame. But pointing to not widely reported incidents in which 41 out of among some 5 million people receiving the AstraZeneca shot in the UK may have suffered a severe anaphylaxis reaction, the European drugs regulator recommended including anaphylaxis and hypersensitivity among side effects.

The Amsterdam-based agency noted that anaphylaxis has been seen in other vaccines. In February, Johnson & Johnson said two of its trial participants had suffered severe allergic reactions shortly after vaccination with its Covid-19 candidate. Several incidences of allergic shock were reported with the mRNA shots of Pfizer/BioNTech and Moderna.

"After careful review of the data”, the EMA said its medicinal products committee considered that a link to the AstraZeneca vaccine “was likely” in at least some of the UK cases.  The company’s product information already advises that people receiving its vaccine be kept under close observation for at least 15 minutes afterward in case of allergic reactions.

Author: Dede Williams, Freelance Journalist