EU regulators ‘worried’ member states undermined AZ vaccine

European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. 

Several European countries, including Germany, France, Italy and Spain have suspended use of the vaccine, pending the conclusion of an ongoing review by safety experts from the European Medicines Agency.

That review is due to conclude on Thursday afternoon, when the Pharmaceutical Risk Assessment Committee (PRAC) will present findings of its investigation into whether there is a causal link between the vaccine and blood clots.

But the advice from the EMA in the meantime is to continue using the vaccine given the health risk posed by COVID-19, with the EU’s top regulators maintaining that the benefits of the vaccine outweigh the risks.

Already the data suggest the rates of blood clotting incidence in the population are below those expected in the overall population.

The question of whether there is a global increase in risk of blood clots can be easily answered with the real-world population data that the regulator has been gathering, coupled with the pharmacological profile of the drug.

What could be harder to define is whether there is a link between the vaccine and a very rare condition called cerebral venous sinus thrombosis (CVST), which was behind a decision by the German regulator to suspend the vaccine.

In a statement yesterday experts from Germany’s Paul Ehrlich Institute said they “now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a deficiency of blood platelets (thrombocytopenia) and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine AstraZeneca”.

However the institute gave no further data about how many cases were involved.

Politically motivated?

Journalists attending an urgent press conference called by the EMA to discuss the process posed questions about whether the decisions were politically motivated.

There have been concerns about political interference in the vaccine roll-out ever since the EU attempted to tighten exports because of lower than expected productivity at AstraZeneca’s vaccine manufacturing network in Europe.

The combative stance taken by the EU led some to suggest it is diverting attention from criticism of a much slower-than-expected rollout of vaccines, a process which is being managed centrally by the Commission, and by some member states including Germany.

That week the German newspaper Handelsblatt wrongly reported that the AZ vaccine was barely effective in older people – an article that has been discredited, with the single source it was based on misinterpreting trial data.

The EMA is not prepared to discuss numbers of cases, although in the press conference executive director Emer Cooke said that data was coming in from different regulators all the time.

But Cooke was clear with her messaging that the EMA considers the AstraZeneca shot to be safe and effective unless the data say otherwise.

This led journalists to ask why national regulators had decided to suspend vaccination campaigns, contrary to the advice issued by the EMA.

Cooke said this was there prerogative, but added: “I have to stress that trust in safety and efficacy of the vaccines we have authorised is paramount. We have to maintain trust based on a proper scientific evaluation.

“We are worried that there may be an effect on the trust of the vaccines, our job is to make sure the products are safe and can be trusted by the European citizens.”

Questioned about whether there was a political campaign to undermine trust in the vaccine, Cooke added: “I want to put on record that our evaluation is guided by science and independence and nothing but.”

Reading between the lines, the most likely outcome in the event of a causal link between the vaccine and CVST is an update to the vaccine’s label, particularly if there is a sub-population of people who are most at risk.

Peter Arlett, head of the EMA’s pharmacovigilance and epidemiology department, said: “If the conclusion is towards a causal association there will be a consideration if there are features of the individuals that may have put them at risk.

“If there is a causal association that gives an opportunity to reduce risk. But there are a lot of ‘if’s’ in that sentence.”

 

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