European health ministers will discuss the future of AstraZeneca Plc’s Covid-19 vaccine after a growing number of countries suspended its use to examine side effects, potentially throwing the region’s already slow inoculation campaign further off track.
The ministers will gather virtually on Tuesday to discuss their response, ahead of the latest findings by the European Medicines Agency, the regional drugs regulator, which plans to decide on the next steps on Thursday. At stake is the future of one main building block of Europe’s vaccine push, where AstraZeneca was due to account for about a fifth of all doses in the second quarter.
“We cannot afford a single doubt over the vaccines’ efficiency,” French Industry Minister Agnes Pannier-Runacher said on France Info radio on Tuesday. The AstraZeneca CEO, Pascal Soriot, “is in the hot seat and he knows it.”
With infection numbers creeping up again in countries like Germany, the risk of further vaccine shortages will increase pressure on politicians who have been punished for a lackluster immunization program. German Chancellor Angela Merkel saw her party slump to its worst ever results in two state elections on Sunday. In France, President Emmanuel Macron is running neck and neck with his populist rival Marine Le Pen in polls for next year’s presidential election.
The European Commission is expected to tell ministers to wait until the bloc’s drugs regulator gives its verdict on Thursday and to act upon this recommendation. The Commission will also sound the alarm over millions of unused doses in member states, according to a person familiar with the matter.
The European Commission has committed to immunizing 70% of adults by the end of September, but the latest precautions could push back efforts by at least a couple of weeks and potentially longer, according to London-based research firm Airfinity Ltd. Some 30 million AstraZeneca doses are due to be delivered by the end of this quarter, with more coming in the next three months.
Even before the suspension, the U.K.-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 with 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 the year, it said last week, about a third of the number originally planned.
Questions over the safety of the AstraZeneca shot have inserted an extra dose of bitterness into the bloc’s troubled relations with the U.K. government, which has been vaunting the vaccine as a vindication of British ingenuity. Austrian Chancellor Sebastian Kurz is meeting his colleagues from six neighboring countries later on Tuesday, whose leaders have complained about an “uneven” distribution of vaccines in the EU.
Risk and Reward
While the move to suspend is temporary and precautionary pending the EMA’s assessment, it stands to further damage 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.
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 hospitalization and death, outweigh the risks of side effects.”
“A longer review or a permanent ban would deal a more serious blow to the EU’s vaccination program,” 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.”
The suspension contrasts with AstraZeneca’s positive run in the U.K., where Prime Minister Boris Johnson is championing a rapid vaccination push and continues to deem the shot safe to use.
The 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.
German Health Minister Jens Spahn told reporters in Berlin on Monday that the decision to suspend was “professional, not political.” Still, the move drew a rebuke from some other lawmakers given the low numbers of possible blood-clot findings.
AstraZeneca’s vaccine is one of four that have been approved in the EU, alongside shots from Pfizer Inc. and BioNTech SE, Moderna Inc., and Johnson & Johnson. With supplies from J&J yet to arrive and doses of Moderna limited, that means the bulk of immunizations in many countries will now be conducted with Pfizer-BioNTech.
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 — totaling 30 cases among 5 million people who had received the vaccine. Neighboring Sweden has stuck with the vaccine, with the country’s medical products agency saying the benefits of the shot outweigh its risks.
Responding to the suspensions, AstraZeneca said it’s working with national health authorities and European officials.
“Around 17 million people in the EU and U.K. 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.
Read: Astra CEO Defends Vaccine Delivery in EU Committee Grilling
Belgium and Austria said late Monday that they would continue using the Astra shot, but would keep a close watch on the situation.
“It’s a very good vaccine that protects people against this terrible disease,” Belgian Health Minister Frank Vandenbroucke said, according to Le Soir newspaper.
In the U.K., Johnson also defended the vaccine. He said Monday that the U.K. Medicines and Healthcare products Regulatory Agency is “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 chairman of the U.K.’s Joint Committee on Vaccination and Immunisation, told the BBC that about 3,000 blood clots a month are common in the general population of the country, and that such a diagnosis is bound to happen simultaneously with the vaccination, rather than being caused by it.
–With assistance from Richard Bravo, Alexei Anishchuk, Boris Groendahl, Geraldine Amiel and Nikos Chrysoloras.