The European Commission granted yesterday evening a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by AstraZeneca, the third COVID-19 vaccine authorised in the EU.
This authorisation follows a positive scientific recommendationon Friday (29 January) based on an assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.
“Securing safe vaccines for Europeans is our utmost priority,” said European President Ursula von der Leyen. “With the AstraZeneca vaccine now authorized, 400 million additional doses will be available in Europe. I expect the company to deliver these doses as agreed, so that Europeans can be vaccinated as soon as possible.”
“We will continue doing all we can to secure more vaccines for Europeans, our neighbours and our partners worldwide.”
The authorisation was giving without any reservations despite concerns that the AstraZeneca vaccine might be less effective among elderly people. According to EMA, there are not yet enough test results to determine a protection level for the group of people over 55. However, “based on what we know of other vaccines and the current test results, we expect protection in this target group as well,” it said.
While the Commission authorised the use of the AstraZeneca vaccine, it continues to be suspicious of the company and the way how it respects the advance purchase agreement it signed with the Commission and the delivery agreements with the member states.
After a hectic week with talks with the company, the Commission also put into place a special transparency and authorisation mechanismfor exports of COVID-19 vaccines. An implementing regulation was adopted in record speed yesterday and will enter into force immediately.
EU has invested up to €2,9 billion in its advance purchase agreements with the vaccine producers and want to protect its investment.
“For the best part of the last year we worked hard to get Advance Purchase Agreements with vaccine producers to bring vaccines to the citizens, in Europe and beyond,” explained Stella Kyriakides, Commissioner for Health and Food Safety.
“We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised. We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens. We are accountable towards the European citizens and taxpayers – that is a key principle for us.”
According to the Commission, the mechanism is nor targeting any vaccine producer or any other country and its sole purpose is to enable to it monitor exports of vaccines from Europe and ensure that that they are not done in breach of the agreements signed with the producers.
“We invested money in them and don’t want to waste one single day,” Kyrikiades added. Valdis Dombrovskis, Executive Vice-President and Commissioner for Trade Valdis Dombrovskis, said that, “We had no choice but to act in a race against the clock.”
The mechanism includes a wide range of exemptions to fully honour EU’s humanitarian aid commitments, protect vaccines deliveries to its neighbourhood, and to countries in need covered by the international COVAX-facility aiming at providing vaccines to low-income countries.
A Commission official clarified yesterday that the candidate countries, the countries in EU’s southern and eastern neighbourhood and the EFTA countries (Iceland, Liechtenstein, Norway and Switzerland) are exempted. The United Kingdom does not fall into this category after Brexit and is not exempted.
The Commission underlines that the mechanism is not an export ban and is not targeting any specific country. It will be activated when a vaccine producer wants to export vaccines to non-exempted countries. In such a case, the Commission will issue a binding decision based on the opinion of the member states. The official did not foresee any disagreement between the Commission and the member states.