Halting of AstraZeneca jab as cases rise in Europe threatens vaccine programme
But the EMA remains convinced that the vaccine’s benefits ‘in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects’
Rome/Munich/Moscow — Europe’s slow vaccination push has sunk further into disarray after some of the biggest countries suspended AstraZeneca’s shot to explore its effects, compounding a crisis of confidence around a promising path out of the pandemic.
Germany, France and Italy decided on Monday in a co-ordinated step to suspend the use of the vaccine. Now the EU’s vaccine rollout hangs partly on the findings by the European Medicines Agency, which plans to decide on the next steps on Thursday. Concerns surrounding the shot are also likely to dominate a video conference by EU health ministers slated for later on Tuesday.
“In order to maintain trust in the vaccine, we have to give our experts in Germany and in the EU the time to evaluate the most recent occurrence,” German health minister Jens Spahn told reporters in Berlin after announcing the step. “This decision is professional, not political.”
While the move is temporary and precautionary pending the EMA’s assessment, it risks further damaging the public perception of a vaccine already plagued by a flawed trial, production shortfalls and a public spat with officials in Brussels accusing the company of violating its contractual supply obligations.
The dispute contrasts with AstraZeneca’s positive run in the UK, where Prime Minister Boris Johnson is championing a rapid vaccination push and continues to deem the shot safe to use.
The drastic response to possible side-effects puts additional pressure on countries at a time parts of Europe fall back into lockdowns. Italy has reintroduced harsher measures, and parts of Germany have also seen an increase in infections, prompting some medical experts to demand a tightening of the restrictions from which Europe’s largest economy was just starting to emerge.
After Denmark became one of the first countries in the region to suspend the AstraZeneca shot, the EMA said on March 11 that the number of clots in vaccinated people was no higher than the number seen in the general population — totalling 30 cases among five-million people who had received the vaccine.
While Astra has revised its delivery schedule multiple times, it has remained an important cornerstone of the region’s early inoculation push. The company is planning to deliver 40-million doses in the first quarter down from a planned 100-million.
The EU is expecting to receive almost 400-million vaccine doses in total in the second quarter, with the biggest number coming from Pfizer and BioNTech. Another 640-million shots are lined up for the third quarter. The commission has committed to immunising 70% of adults by the end of September.
“A longer review or a permanent ban would deal a more serious blow to the EU’s vaccination programme,” Eurasia Group analyst Federico Santi wrote in a note. “It could mean the EU may not achieve a level of vaccinations consistent with a meaningful easing of restrictions in many member states until the end of the second quarter, rather than mid-spring, as we are currently expecting.”
Even before the suspension, the UK-based company’s shot, jointly developed with the University of Oxford, had grappled with production delays, which the company attributed in part to typical teething issues of a new product. As a result, Cambridge-based Astra will only be able to deliver about 100-million doses to the EU in the first half of 2021, it said last week, 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.
Responding to the suspensions, AstraZeneca said it was working with national health authorities and European officials.
“Around 17-million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca said in a statement.
The halt, which also extends to countries including Spain, stopped health workers in their tracks. It blocked 35 vaccination centres in Rome and its Lazio region, including one which Prime Minister Mario Draghi visited last week at Fiumicino airport, said health councillor Alessio D’Amato. More than 7,000 text messages were sent to people cancelling their Tuesday appointments, D’Amato added.
Shortly after the governments announced the suspensions, the EMA stuck to its view that the vaccine’s benefits “in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects”.
In the UK, Johnson also defended the vaccine. He said on Monday that the UK’s Medicines and Healthcare products Regulatory Agency was “one of the toughest and most experienced regulators in the world” and sees “no reason at all” to discontinue its use. The tally of people who have received their first dose has passed 26-million in the country.
Anthony Harnden, the deputy chair of the UK’s joint committee on vaccination and immunisation, told the BBC that about 3,000 blood clots a month were common in the general population of the country, and that such a diagnosis was bound to happen simultaneously with the vaccination, rather than being caused by it.
In Germany, Spahn cited seven instances of clotting in the country from a pool of more than 1.6-million people who had been given the shot.
The low number prompted Karl Lauterbach, a health expert for the ruling Social Democrats, to criticise the suspension. Instead, a review of side effects without actually halting the campaign would have been preferable, particularly as cases begin mounting again in Germany, he said on Twitter.
AstraZeneca’s vaccine is one of four that have been approved in the EU, alongside shots from Pfizer and BioNTech, Moderna and Johnson & Johnson. With supplies from J&J yet to arrive and doses of Moderna limited, that means the bulk of immunisation in many countries will now be conducted with Pfizer-BioNTech. The two partners have promised to ship at least 500-million doses to the bloc in 2021, with an option for an additional 100-million doses.
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