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Clear link between AstraZeneca vaccine and rare blood clots in brain, EMA official tells paper

James Drew

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There is a link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in the brain but the possible causes are still unknown, a senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday (6 April), writes Giulia Segreti.

“In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily Il Messaggero when asked about the possible relation between the AstraZeneca shot and cases of brain blood clots.

Cavaleri added that the EMA would say there is a link although the regulator would not likely be in a position this week to give an indication regarding the age of individuals to whom the AstraZeneca shot should be given.

He did not provide evidence to support his comments.

AstraZeneca was not immediately available for comment. It has said previously its studies have found no higher risk of clots because of the vaccine.

The regulator has consistently said the benefits outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the AstraZeneca vaccine.

The World Health Organization has also backed the vaccine.

The EMA said last week that its review had at present not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven, but is possible and further analysis is continuing, the agency said.

A high proportion among the reported cases affected young and middle-aged women but that did not lead EMA to conclude this cohort was particularly at risk from AstraZeneca’s shot.

The EMA is expected to give an update of its investigation on Wednesday.

Some countries, including France, Germany and the Netherlands, have suspending the use of the vaccine in younger people while the investigations continue.

Scientists are exploring several possibilities that might explain the extremely rare brain blood clots that occurred in individuals in the days and weeks after receiving the AstraZeneca vaccine.

European investigators have put forward one theory that the vaccine triggers an unusual antibody in some rare cases; others are trying to understand whether the cases are linked with birth control pills.

But many scientists say there is no definitive evidence and it is not clear whether or why AstraZeneca’s vaccine would cause an issue not shared by other vaccines that target a similar part of the coronavirus.

In a separate interview, Armando Genazzani, a member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), told La Stampa daily that it was “plausible” that the blood clots were correlated to the AstraZeneca vaccine.

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Germany wants to use Regeneron's COVID-19 antibody therapy more broadly

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Germany would like to use Regeneron’s COVID-19 monoclonal antibody cocktail as a treatment for this disease more broadly but needs to finalize some details on reimbursement, Health Minister Jens Spahn said on Thursday (15 April), writes Caroline Copley.

“The drug is available in Germany, we need it much more and we want it much more and we are working on rolling it out across the nation,” he told a weekly news conference.

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President von der Leyen on developments in the Vaccines Strategy

EU Reporter Correspondent

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In a press statement on 14 April, President of the European Commission, Ursula von der Leyen, announced an agreement with BioNTech-Pfizer to accelerate the delivery of 50 million vaccine doses to the second quarter of this year, starting this month: “We are in a race against time. The faster we reach our target of having 70% of adults in the European Union vaccinated, the better chances we have of containing the virus. And the good news is: Vaccination is picking up speed across Europe! Member states have received over 126 million doses of vaccines as of yesterday (13 April). And I am happy to say that today we have reached 100 million vaccinations in the EU. This is a milestone that we can be proud of. Of these 100 million vaccinations, more than a quarter are second doses – which means that we have now more than 27 million people fully vaccinated I am pleased to announce that we have reached an agreement with BioNTech-Pfizer to, once again, speed up the delivery of vaccines. 50 million additional doses of BioNTech-Pfizer vaccines will be delivered in quarter 2 of this year, starting in April. This will bring the total doses delivered by BioNTech-Pfizer to 250 million doses in the second quarter. These doses will be distributed pro-rata to the population, among all the member states. This will substantially help consolidate the roll-out of our vaccination campaigns.” As part of preparations for the medium term, the Commission is also entering into a negotiation with BioNTech-Pfizer for a third contract, to foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023. This contract will entail that not only the production of the vaccines, but also all essential components, will be based in the EU. The President's full statement is available online in English, and French and shortly in German. You can watch it here.

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Coronavirus response: Commission proposes to exempt vital goods and services distributed by the EU from VAT in times of crisis

EU Reporter Correspondent

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The European Commission has proposed to exempt from Value Added Tax (VAT) goods and services made available by the European Commission, EU bodies and agencies to Member States and citizens during times of crisis. This responds to the experience gained  during the course of the Coronavirus pandemic. Among other things, it has shown that the VAT charged on some transactions ends up being a cost factor in procurement operations that strains limited budgets. Therefore, today'sinitiative will maximise the efficiency of EU funds used in the public interest to respond to crises, such as natural disasters and public health emergencies. It will also strengthen EU-level disaster and crisis management bodies, such as those falling under the EU's Health Union and the EU Civil Protection Mechanism.

Once in place, the new measures will allow the Commission and other EU agencies and bodies to import and purchase goods and services VAT-free when those purchases are being distributed during an emergency response in the EU. The recipients might be Member States or third parties, such as national authorities or institutions (for example, a hospital, a national health or disaster response authority). Goods and services covered under the proposed exemption include, for instance:

  • Diagnostic tests and testing materials, and laboratory equipment;
  • personal protective equipment (PPE) like gloves, respirators, masks, gowns, disinfection products and equipment;
  • tents, camp beds, clothing and food;
  • search and rescue equipment, sandbags, life jackets and inflatable boats;
  • antimicrobials and antibiotics, chemical threat antidotes, treatments for radiation injury, antitoxins, iodine tablets;
  • blood products or antibodies;
  • radiation measuring devices, and;
  • development, production and procurement of necessary products, research and innovation activities, strategic stockpiling of products; pharmaceutical licences, quarantine facilities, clinical trials, disinfection of premises, etc.

Economy Commissioner Paolo Gentiloni said: “The COVID-19 pandemic has taught us that these kinds of crises are multifaceted  and have a wide-ranging impact on our societies. A rapid and efficient response is essential, and we need to provide the best response now in order to prepare for the future. Today's proposal supports the EU's goal to react to crises and emergencies in the EU. It will also ensure that the financial impact of EU-level relief efforts to fight the pandemic and support the recovery is maximized.”

Next steps

The legislative proposal, which will amend the VAT directive, will now be submitted to the European Parliament for its opinion, and to the Council for adoption.

Member States shall adopt and publish, by 30 April 2021 the laws regulations and administrative provisions necessary to comply with this Directive. They shall apply those measures from 1 January 2021.

Background

The Coronavirus pandemic has thrown into sharp light the importance of coherent, decisive and centralised EU-level preparation and response in times of crisis. In the context of the Coronavirus pandemic, the von der Leyen Commission has already outlined plans to strengthen EU preparedness and management for cross-border health threats, and presented the building blocks of a stronger European Health Union. At the same time, the Commission has proposed to strengthen cooperation between EU Member States through the EU Civil Protection Mechanism with the aim of improving responses to future natural or man-made disasters. For instance, in the context of the new European Health Union, the Commission announced the creation of the Health Emergency Response Authority (HERA) to deploy rapidly the most advanced medical and other measures in the event of a health emergency, by covering the whole value chain from conception to distribution and use.

The EU has already taken action in the field of taxation and customs to support the fight against and the recovery from the coronavirus pandemic. In April 2020, the EU agreed to waive customs and VAT charges for imports of masks and other protective equipment needed to fight the pandemic. This waiver remains in place and plans are underway for its extension. In December 2020, EU member states agreed on new measures proposed by the Commission to allow a temporary VAT exemption for vaccines and testing kits being sold to hospitals, doctors and individuals, as well as closely related services. Under the amended Directive, member states can apply either reduced or zero rates to both vaccines and testing kits if they so choose. 

More information

Commission proposes to exempt vital goods and services distributed by the EU in times of crisis

Council directive amending Council Directive 2006/112/EC as regards exemptions on importations and on certain supplies, in respect of Union measures in the public interest

COVID-19 response in the field of taxation and customs

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