AstraZeneca’s EU Covid-19 vaccine disaster deepens on clots, nationalism
An AstraZeneca spokesman said the approval timing is in line with original plans and hasn’t had any impact on EU deliveries
AstraZeneca Plc’s European vaccine nightmare is worsening, with a number of countries halting shots over safety fears as further delivery delays prompt governments around the world to hoard doses they’ve already got.At least 10 countries including Italy and Norway reacted after Austria, and later Denmark, raised concerns over the possible side effects from two batches. While Europe’s medicines regulator said there was no indication of issues, it led to a spate of suspensions stretching as far as Thailand.
The health scare emerged against a backdrop of further supply woes. The drugmaker’s efforts to make up for the European Union shortfall by sourcing shots elsewhere have hit a wall as governments around the world protect their own supplies. The US rebuffed pressure to share doses and is holding on to its Astra stockpile, even though the shot isn’t yet authorized for use there.
The drama keeps Astra at the center of a political storm in Europe, weeks after manufacturing issues first put the two sides into conflict. Meanwhile, the EU is falling further behind the UK and the US in vaccinations, creating a political crisis for the bloc’s leaders.
In addition to low yields producing less vaccine than planned, one plant in the Netherlands is still awaiting regulatory approval to deploy doses. The site, owned by the manufacturer Halix, is making the vaccine drug substance for Astra and forms part of both the EU and U.K. supply chains.
An Astra spokesman said the approval timing is in line with original plans and hasn’t had any impact on EU deliveries. Halix didn’t respond to a request for comment outside of normal business hours.
But the various issues mean Astra will only be able to deliver about 100 million doses to the EU in the first half of the year, it said Friday, about a third of the number originally planned. Thirty million doses are due to be delivered by the end of this quarter, with the rest coming in the next three months.
Italy has already responded with direct action, making use of a new EU measure to stop Astra from shipping some doses to Australia. Prime Minister Mario Draghi hinted on Friday that he’ll do that again if he has to.
“The European Union has taken clear commitments with pharmaceutical companies and we expect they will be respected,” Draghi said. “We have taken some strong decisions against companies which have delayed the deliveries and we will continue to do so.”
The latest developments will do little to encourage take up of the Astra vaccine in the EU, which had already encountered issues in recent weeks in light of the varying efficacy rates, potential loss of protection against new virus variants, and questions on its effectiveness in older adults. Until recently, a number of countries had restricted use of the shot to those aged under 65.
In a March 7 YouGov survey, perceptions in EU countries of the safety of the shot from Astra and the University of Oxford were lower compared with vaccines from Pfizer Inc. and partner BioNTech SE, and Moderna Inc. By contrast, Britons viewed Astra’s as the safest of the three.
The suspensions may further embed negative views, despite the guidance from the European Medicines Agency.
The number of incidents reported -- about 30 from a group of around five million -- is no greater than what would have occurred naturally in that size of population, according to regulators and scientists.
“Genuine problems with a batch are very rare and almost always relate to contamination by bacteria or physical” particles like glass detected by the manufacturer, said Stephen Evans, a professor at the London School of Hygiene & Tropical Medicine. “Pausing the use in this case is not evidence-based.”
Astra said an analysis of safety data of more than 10 million records had shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any age group, gender, batch or country.
The Astra vaccine has become an emblem for growing pandemic nationalism as countries race to inoculate populations as quickly as possible. The U.S. has already ordered nearly enough vaccines from the three manufacturers with authorization from the Food and Drug Administration to immunize its adult population twice over.
“We’re going to start off making sure Americans are taken care of, first, but we’re then going to try to help the rest of the world,” President Joe Biden said on Wednesday.
Meanwhile, back in Europe, the EU spent much of the past week in yet another war of words with the UK after it accused Britain of blocking vaccine exports. The EU itself has exported millions of doses, though it also has controls it can use to ensure drug companies honor contracts.
“I think there’s an incredible irony with the European Union complaining about other countries being protectionist,” said Mark Eccleston-Turner, a law and infectious disease specialist at Keele University in England. “At the start of this pandemic they were referring to this vaccine as a public good, and then sought to buy up as many doses as they can and put export controls” in place.