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Home Brussels Comms crisis: Regulators fail to assuage concerns over Oxford/AstraZeneca vaccine
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Comms crisis: Regulators fail to assuage concerns over Oxford/AstraZeneca vaccine

by editorApril 7, 2021April 8, 2021
April 7, 2021April 8, 2021

At overlapping press conferences Wednesday, regulators in London and Amsterdam repeatedly told people the Oxford/AstraZeneca vaccine is safe and vital to fight the coronavirus.

But instead of alleviating concerns over a potential link to fatal blood clots, the effort only fueled confusion.

While the latest assessments by the EU and the U.K. medicines regulators reached the same conclusion — that there is a potential link between the vaccine and blood clotting disorders, but that it is extremely rare and that the drug continues to remain licensed for all adults — the messages delivered appeared contradictory.

In London, officials recommended that anyone 30 years old or younger in the U.K. should be offered another vaccine whenever possible. In Amsterdam, the European Medicines Agency added blood clots to the list of the vaccine’s rare side effects and left countries to make their own restrictions. 

For a fight in which clear, coherent communication is half the battle, it was a comms nightmare. 

“Getting an AZ jab tomorrow,” Zsolt Sandor, a shop assistant from Hungary, tweeted after the two announcements. “I’m 38 and confused.” 

Both sets of regulators presented their recommendations as a matter of relative harm, and for most people the equation is a no-brainer. “Every day COVID is still causing thousands of deaths across the EU,” EMA Executive Director Emer Cooke told a press conference. “This vaccine has proven to be highly effective … it is saving lives.”

But scientists in the U.K., where community coronavirus rates are low, said the benefit of administering the vaccine to people 30 years or younger — who are unlikely to suffer badly from the virus — ceases to outweigh the risk of a potentially fatal blood clot, and people should be offered an alternative vaccine.

For many EU countries lagging far behind the U.K.’s vaccination rate and facing high coronavirus rates, the balance is trickier: They need the vaccines — especially as many banked heavily on using the Oxford/AstraZeneca vaccine — but many also have high vaccine hesitancy rates.

The EU’s attempt to inject a confidence boost was followed immediately by countries signaling the exact opposite. Belgium said it would stop giving the Oxford/AstraZeneca vaccine to people under age 56 for the next four weeks, joining a host of countries including Germany and France that already halted it for people under a certain age. Spain and Italy indicated they would follow.

In Britain, commentators voiced immediate concerns about the potential impact on vaccine uptake.

“I’m concerned that this statement by the [U.K. regulator] will lead to a lack of confidence in the AstraZeneca jab, which frankly will be devastating on the ground as this is the jab that is going out at the moment,” former Conservative leader Iain Duncan Smith told POLITICO. “This is going to be a real blow to people taking the vaccine.”

PR panic

For the U.K., the week marked a departure from what has until now been a remarkably clear communications drive on immunization.

On Monday night, Channel 4 News raised the alarm with a report that the Medicines and Healthcare products Regulatory Agency was preparing to restrict the use of Oxford/AstraZeneca in younger people. In response, the regulator issued a statement simply telling Britons to wait and see. 

When the regulator eventually moved to make a public statement Wednesday, the live televised press conference started shortly after a previously scheduled announcement by the EMA — resulting in the spectacle of two agencies issuing apparently divergent advice at the same time.

A Whitehall official said the U.K. government had been aware since at least Wednesday morning that its own statement was likely to clash with that of the EU’s but dismissed the idea that it would have any bearing on how advice was received.

Former Tory leader Duncan Smith said the lack of cross-Channel coordination had made things worse. “I’m sorry they have chosen to do it like this and that the two of them couldn’t have got together to decide together what they said. Now you’ve got a mixed message coming out which is going to confuse people.”

The delivery and the content of the U.K. announcement caused immediate consternation in a country that has come to see its vaccine rollout program as a source of national pride after many earlier missteps in handling the pandemic.

The U.K. has administered at least one vaccine dose to more than 46 percent of the population, to great envy among EU countries.

Vaccine hesitancy in the U.K. has been low overall but with higher levels among young women, and health officials are concerned about how the change in advice will affect take-up.

Prime Minister Boris Johnson responded to the announcement with an effort to reassure the public: “This vaccine is safe, effective and has already saved thousands of lives — and the vast majority of people should continue to take it when offered,” he wrote on Twitter.

Keir Starmer, the opposition Labour leader, set party politics aside to drive home the message, adding: “My first dose was AstraZeneca and I look forward to getting my second dose when it is offered.”

Privately, ministers and their advisers acknowledge that tweets and a mid-afternoon press conference are not enough to get the message out and plans for a new public information campaign are under discussion. 

On the EU side, the communication chaos hit Tuesday when the head of the EMA’s vaccine strategy, Marco Cavaleri, gave an interview to Italian newspaper il Messaggero previewing Wednesday’s announcement. The EMA said at the time that its assessment was ongoing.

In France, a country of longstanding vaccine hesitancy, Le Monde reported Tuesday that about 30 percent of doctor’s appointments for the Oxford/AstraZeneca vaccine were canceled during the first week of April. 

Political decisions 

Ultimately, the EU regulator’s role is advisory and national governments are responsible for making their own decisions about how the Oxford/AstraZeneca vaccine should be used.

“How vaccines are used and deployed by different member states, of course, is going to be impacted by the availability of vaccines, by the local infection rates, by hospital capacity, by who’s already been vaccinated,” said Peter Arlett, the head of data analytics and methods task force at the EMA. “These decisions will be driven by all of those factors put together.”

Directly after the EMA’s announcement, Health Commissioner Stella Kyriakides urged EU countries to coordinate their recommendations at an informal videoconference.

“Decisions on national vaccination campaigns, who to vaccinate with what vaccine, are always yours, but it is essential that we follow a coordinated European approach: An approach which does not confuse citizens, and that does not fuel vaccine hesitancy, because it is based on science,” Kyriakides said.

Belgian health ministers had seemingly already made up their minds. Earlier Wednesday, Belgian media reported they had agreed to temporarily restrict the use of the Oxford/AstraZeneca vaccine to people either over 55 or 60 depending on the agency’s findings. Shortly after the announcement, the government set the new age limit of 56 for four weeks. 

In a press conference late Wednesday, the head of Italy’s health council, Franco Locatelli said the health ministry is recommending “preferential usage” of the vaccine in people over 60. Those who had already been administered one dose of the Oxford/AstraZeneca shot would, however, receive a second dose.

In Spain, regional leaders meeting Wednesday night agreed the vaccine should only be given to people aged 60-64, and possibly those over 65 too pending further review.

For some, the problem of divergence stems from the EU regulator’s sluggishness. Concerns about links to blood clots began appearing in early March.

Peter Liese, a German MEP who is the European People’s Party’s health spokesperson in the European Parliament, called the announcement from the EMA “overdue” and said that “experts in several member states have acted faster and more consequently here.”

Emilio Casalicchio, Helen Collis, Ashleigh Furlong, Carlo Martuscelli and Cristina Gallardo contributed reporting.

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