AstraZeneca EU vaccine disaster escalates over clots, nationalism

Photographer: Anthony Devlin / Bloomberg

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AstraZeneca Plc’s European vaccine nightmare worsens, with a number of countries halting firing for safety concerns as further delivery delays prompt governments around the world to rack up the doses they already have.

At least 10 countries including Italy and Norway reacted after Austria, and later Denmark, raised concerns about the possible side effects of two batches. While Europe The drug regulator said there was no indication of any problems, leading to a wave of suspensions spreading as far as Thailand.

The fear of health arose against the background of new supply problems. The drugmaker’s efforts to offset the European Union’s deficit by sourcing elsewhere have hit a wall as governments around the world protect their own supplies. The United States has stepped up the pressure to share the doses and is keep his stock of Astra, even if the shot is not yet authorized for use there.

The drama keeps Astra at the center of a political storm in Europe, weeks after manufacturing issues put the two sides in conflict. Meanwhile, the EU is further behind the UK and US on vaccinations, creating a political crisis for the bloc’s leaders.

In addition to low yields producing less vaccine than expected, a factory in the Netherlands is still awaiting regulatory approval to deploy doses. The site, owned by manufacturer Halix, manufactures the vaccine drug substance for Astra and is part of the EU and UK supply chains.

A spokesperson for Astra said the approval schedule was in line with original plans and had no impact on EU deliveries. Halix did not respond to an after-hours request for comment.

But the various problems mean that Astra will only be able to deliver around 100 million doses to the EU in the first half, he said on Friday, about a third of the number initially expected. Thirty million doses are expected to be delivered by the end of this quarter, with the rest to be delivered within the next three months.

Italy has already responded with direct action, using a new EU measure to prevent Astra from sending certain doses to Australia. Prime Minister Mario Draghi hinted on Friday that he would do it again if he had to.

“The European Union has made clear commitments with the pharmaceutical companies and we hope they will be honored,” Draghi said. “We have taken strong decisions against companies that have delayed deliveries and we will continue to do so.”

The latest developments will do little to encourage the adoption of the Astra vaccine in the EU, which had already encountered problems in recent weeks in light of varying rates of effectiveness, the potential loss of protection against newer variants of the virus, and questions about its effectiveness in the elderly. Until recently, a number of countries restricted the use of shooting to these aged under 65.

In a March 7 YouGov survey, perceptions in EU countries of the shooting safety of Astra and Oxford University were lower than those of vaccines from Pfizer Inc. and its partner BioNTech SE and Moderna Inc. In contrast , the British considered Astra the safest of the three.

Suspensions may also incorporate negative opinions, despite the advice from the European Medicines Agency.

The number of reported incidents – about 30 out of a group of around five million – is no more than what would have happened naturally in this population size, according to regulators and scientists.

“True problems with a batch are very rare and are almost always related to contamination with bacteria or physical particles” such as the glass detected by the manufacturer, said Stephen Evans, professor at the London School of Hygiene & Tropical Medicine. “The suspension of use in this case is not evidence-based.”

Astra said an analysis of safety data from more than 10 million records showed no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any age group, sex, lot or country.

The Astra vaccine has become an emblem of growing pandemic nationalism as countries rush to vaccinate populations as quickly as possible. The United States has already ordered nearly enough vaccine from the three manufacturers with the approval of the Food and Drug Administration to immunize their adult population twice.

“We’re going to start by making sure the Americans are taken care of, first, but then we’re going to try to help the rest of the world,” President Joe Biden said Wednesday.

Meanwhile, back in Europe, the EU has spent much of the past week in another war of words with the UK after accusing Britain of blocking vaccine exports. The EU itself exported millions of doses, though it also has controls it can use to ensure drug companies honor their contracts.

“I think there is an incredible irony with the European Union complaining that other countries are protectionist,” said Mark Eccleston-Turner, Law and Infectious Disease Specialist at Keele University in England. “At the start of this pandemic, they referred to this vaccine as a public good, and then sought to purchase as many doses as possible and put in place export controls.”

– With help from Tim Loh, Ian Wishart, Morten Buttler and Nikos Chrysoloras