As most trusted medicines regulators, joined by the World Health Organization, continue to insist that the Oxford/AstraZeneca vaccine is safe and that its benefits far outweigh the risks, its suspension across much of Europe appears to be colliding with expert opinion.
Some U.K. critics are therefore concluding that the suspension must be political — otherwise, the logic doesn’t stand.
But criticism also came from some voices in Brussels. The European Commission’s Sylvain Giraud of DG Sante tweeted on Tuesday: “What is the point to have scientific institutions like [European Medicines Agency] and WHO if decisions on vaccines are taken on political grounds?”
“Resisting scientists’ advice now seem to be seen as a good point for politicians,” he added.
It’s the second time numerous EU countries have diverged with the European Medicines Agency over the Oxford/AstraZeneca vaccine.
After the EU approved the jab in January, many countries — including Germany, Italy, Ireland, the Netherlands, France, Sweden and Poland — restricted its use to younger adults on grounds that data on older people was limited at the time. Those decisions went against the EMA, which concluded that the vaccine was safe and effective for all people over 18.
And now, as many EU countries temporarily suspend vaccinations with the jab — including the Netherlands, Ireland, Slovenia, Sweden, Portugal, Latvia, Austria and Lithuania — scientists in the U.K. are also questioning the logic.
Simon Clarke, a microbiologist at the University of Reading, said it’s “reckless” to stop administering the vaccine.
“I keep hearing the phrase ‘abundance of caution’ being used in reference to countries pausing rollout of the Oxford vaccine,” he told the Daily Mail. “But is it really caution?”
“This is a very odd story,” said Peter Openshaw, professor of experimental medicine of the Imperial College London, speaking to BBC Radio 4. “It really is a completely one-sided argument statistically that we need to be vaccinating, and … it’s a disaster for the vaccination uptake in Europe, which is already on slightly unsteady ground in some countries.”
The EU’s ambassador to the U.K., João Vale de Almeida, defended the calls as national decisions taken by individual governments, as opposed to an EU-wide decision.
“When doubts appear … the principle of precaution prevails,” he told the BBC.
To Openshaw, the decision partly stems from a concern for being blamed if policymakers got it wrong. Regulators, he told the BBC, “are afraid of not making that decision to pause, on the basis they might be in some way thought culpable if they didn’t.”
That said, not all medicines regulators have aligned with their politicians. In Germany and Denmark, where fatal cases of blood clots have been detected, the medicines regulators have been clear that the suspension is their expert advice, as a precaution, while further investigations continue.
In an interview with the German newspaper Die Welt Thursday morning, Klaus Cichutek, head of the Paul Ehrlich Institute — the government body that recommended the suspension — explained that the decision was purely scientific.
There were “six cases of sinus vein thrombosis in women between the ages of around 20 and 50 years,” he told Welt. “Two of them tragically fatal. There is another case of cerebral hemorrhage with thrombosis in a man.”
The institute’s analysis found that the number of these cases, out of around 1.5 million vaccinations, was above average in the population without vaccination, he explained.
Initial talks with experts concluded “it cannot be ruled out that the vaccine is responsible,” he said. “However, the judgment has not yet been made.”
In Italy, however, the medicines regulator has emphasized the safety of the vaccine and pointed the finger at politicians for halting its vaccination program.
“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations … to put them on hold in order to carry out checks,” said Nicola Magrini, director general of Italy’s medicines authority AIFA, as reported by Reuters. “The choice is a political one.”
Italy followed Germany’s decision after Prime Minister Mario Draghi spoke on the phone with German Chancellor Angela Merkel on Monday, after which he realized Italy “cannot wait any longer,” according to la Repubblica.
At the same time, Italian Health Minister Roberto Speranza was in talks with the health ministers of Germany, France and Spain, who all decided on the precautionary suspension pending the EMA’s final response.
Meanwhile, the EMA’s executive director, Emer Cooke, met with EU health ministers Tuesday to update them on her drug safety committee’s analysis. The EMA is scheduled to issue its findings on the AstraZeneca situation on Thursday.
Cooke also appeared at a press conference Tuesday, noting that the EMA is discussing each reported event, case by case, to see if there’s any causal relationship between the vaccine and what she termed “very rare thromboembolic events.” Batches of vaccines are being investigated as part of the assessment, she said, adding that health events are also being reported from numerous batches.
Asked whether any of the thromboembolic events were timed around the BioNTech/Pfizer vaccine as well, Cooke said the agency is looking “at adverse events associated with all vaccines.”
“At the moment the current focus … is the AstraZeneca [vaccine], but we have looked at the background rates for all the vaccines currently in circulation” she explained. “It looks like there are similar numbers coming in, across the world, but that is something that will have to be evaluated by our committee.”
As for countries’ decisions to suspend the vaccine, she said they were taken “in the context of the information that is available at the national level, and it is the country’s prerogative to do so.”
Meanwhile, U.K. Prime Minister Boris Johnson has sought to reassure the British public. The U.K.’s medicines regulator sees “no reason at all to discontinue the vaccination program, for either of the vaccines that we’re currently using,” he said, underlining that the U.K. has one of the “toughest and most experienced” drugs regulators in the world.