Monday , June 21 2021

Europe expected to place export restrictions on vaccines amid shortage fears

The move comes as a war of words with AstraZeneca over expected delays in delivery of its coronavirus vaccine to the bloc continues to make headlines.

The European Union’s medicines regulator is expected on Friday to recommend use of the Oxford/AstraZeneca Covid-19 vaccine among its 27 member states.

It’s not yet known whether the European Medicines Agency will recommend it for all adults or only people aged under 65. Germany’s vaccine commission on Thursday advised giving it only to people aged 18 to 64, citing insufficient data on its efficacy in those aged 65 and older.

However, the head of Germany’s vaccine regulator said Friday that Germany expects the European Union’s medicines regulator to approve AstraZeneca’s vaccine without age restrictions.

“The essential bases have been created for a recommendation for approval without age limit,” Klaus Cichutek said during a briefing in Berlin, cautioning however that data is weaker on the vaccine’s effects on older age groups.

The decision will come against a backdrop of mounting concern over the pace of the vaccine rollout in the bloc. EU countries including Germany are running low on vaccines, compounded by the AstraZeneca vaccine shortfall and Pfizer slowing EU deliveries of the vaccine it developed with BioNTech while a manufacturing facility was upgraded.
German officials say AstraZeneca vaccine shouldn't be given to over-65s, citing lack of data

The European Commission’s chief spokesman, Eric Mamer, said Thursday that the body would decide the following day on a “transparency and authorization mechanism for the export of vaccines” from the EU amid concern that supplies are going elsewhere.

Two EU officials said it was not an export ban, but rather that companies wanting to export coronavirus vaccines from the bloc would need to notify the national governments and wait for authorization.

“Any exporting company would send into the national authorities their plan (as to) what to export, when, to whom and so on, and what amount, and the national authorities will then be allowed to check that, and to give an authorization or a refusal,” one EU official told reporters.

“That of course has to happen very quickly, so it’s a question not of weeks, but the question of hours,” the official added.

“We are not proposing to impose an export ban, what we want to do is to monitor how the funds that we paid from the EU budget have been used and how the advanced purchase agreements that we concluded with pharmaceutical companies, are producing vaccines for our citizens,” a second official said.

Redacted contract

In a letter to several European leaders on Thursday, European Council President Charles Michel said he “welcomed” the European Commission’s proposal.

Michel added that if “no satisfactory solution” was found with vaccine manufacturers to resolve the supply issue, the EU should “make use of all legal means and enforcement measures at our disposal.”

The new mechanism would not affect humanitarian aid or COVAX, the global initiative aiming to distribute some 2 billion vaccines to poorer countries.

Europe has a vaccine shortage. So why is it fighting with AstraZeneca? Europe has a vaccine shortage. So why is it fighting with AstraZeneca?

EU officials said Monday they had been told by AstraZeneca that the company could not deliver as many doses as the EU expected because of production challenges — upending the bloc’s vaccination plans.

The European Commission, which ordered 400 million doses on behalf of EU member states and is poised to start rolling them out across the bloc, said the delay was unacceptable, and the drugmaker must find a way to increase supply.

As the dispute continued to play out Friday, the European Commission published on its website the redacted contract signed with AstraZeneca for the purchase of its vaccine for all the EU member states.

The EU had asked AstraZeneca to publish the contract, signed on August 27, following the company’s announcement of delays and reductions in the delivery of the vaccine to the bloc.

The details of the vaccine delivery schedule have been redacted from the published document.

Earlier this week, Belgian authorities conducted an inspection of AstraZeneca’s Belgian site — at the request of the European Commission — to ensure that the delay in the delivery of the vaccines was “indeed due to a production problem at the Belgian site.”

Efficacy question

Although the European Medicines Agency is expected to issue its approval for the AstraZeneca vaccine without age restrictions, this will likely not be the case for the German vaccine commission STIKO.

“We do not expect unrestricted approval [in Germany],” Health Minister Jens Spahn said Friday at a briefing alongside the head of Germany’s vaccine regulator. “There is not sufficient data for that. There is not sufficient data for the elderly.

Novavax says Covid-19 vaccine is 89% effective in UK trial, but less so in South AfricaNovavax says Covid-19 vaccine is 89% effective in UK trial, but less so in South Africa

While the AstraZeneca vaccine may not be authorized in Germany for use in people aged over 65, Spahn said Friday that the government is still aiming to vaccinate all people over the age of 80 by the end of the first quarter of 2021.

The United Kingdom, whose regulator approved the Oxford/AstraZeneca vaccine on December 30, has been administering doses to people older than 65 for nearly a month.
In its report, UK regulator MHRA said there was “limited information available on efficacy in participants aged 65 or over, although there is nothing to suggest lack of protection.”

Responding to the German announcement, MHRA Chief Executive Dr. June Raine said “current evidence does not suggest any lack of protection against Covid-19 in people aged 65 or over.”

“The data we have shows that the vaccine produces a strong immune response in the over-65s. More data is continually becoming available for this age group and our Public Assessment Report, available on our website, will be updated to reflect this,” her statement added.

CNN’s Nadine Schmidt, Claudia Otto, Chris Liakos and Tara John contributed to this report.

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