Currently, five vaccines, approved by the European regulator, benefit from a marketing authorization (AMM): mRNA vaccines from Pfizer-BioNTech and Moderna, those with “viral vector” from AstraZeneca and Janssen (laboratory Johnson & Johnson) and, since December 20, the protein-based product from Novavax. The latter has not yet been authorized in France.
The European Medicines Agency (EMA) examines applications for other vaccines in a flow-through process known as “rolling reviews”. The data is sent as the work progresses and is analyzed in real time. These ongoing reviews continue until sufficient evidence is available for a formal application for marketing authorization. Four vaccines are examined in this context by the EMA:
• The Russian vaccine Sputnik V has been examined by the EMA since March 4, 2021. It is a “viral vector” vaccine, like those of AstraZeneca and Janssen. It has already been authorized in more than 70 countries, according to the Covid-19 Vaccine Tracker platform (in English), including Russia, Argentina, Venezuela, Libya or Serbia. In the European Union, only two countries have given the green light to this vaccine, Hungary and Slovakia. The latter gave it up.
• The Chinese Sinovac vaccine has been the subject of a review procedure by the European regulator since May 4. It uses the classic inactivated virus technique, which consists of injecting all or part of it after having subjected it to a treatment rendering it harmless. This vaccine is authorized in nearly 50 countries, still according to Covid-19 Vaccine Tracker, including China, Chile, Brazil, the Philippines, Ukraine and Turkey.
• the French vaccine from Sanofi Pasteur, developed in partnership with the British GSK (for the adjuvant), has been examined by the EMA since July 20. It is a vaccine “Sub-unit”, made from proteins that trigger an immune response. For the moment, tests are still in progress and it is therefore not authorized in any country. However, the EU has already placed a pre-order, in September 2020, for the purchase of 300 million doses.
• Valneva’s Franco-Austrian vaccine has been examined by the EMA since December 2. It is an “inactivated virus” vaccine, like the Sinovac vaccine, a more traditional technique used by most childhood or influenza vaccines. Also called VLA2001, this vaccine is not currently in use anywhere in the world, but the European Commission has already signed an agreement with Valneva for an order of up to 60 million doses, delivered by 2023.
Evaluation German vaccine from CureVac, started in February, ended in October at the request of its manufacturer, who explained that he was focusing on other vaccine projects against Covid-19. The vaccine being evaluated was based on messenger RNA technology. In November 2020, the European Union had placed a pre-order for the purchase of 225 million doses, with an option for 180 million additional doses. But the first tests had given disappointing results.