As the European Union prepares for possible increases in the number of Covid-19 cases in the last months of 2022, several decisions related to the fight against Covid-19 have been taken at European level during the month of August.
The European Commission announced, on 2 August 2022, that the European Health Emergency Preparedness and Response Authority (HERA) has signed a joint procurement Framework Contract with HIPRA Human Health for the supply of up to 250 million doses of its bivalent recombinant protein vaccine PHH-1V against Covid-19 if and when it meets the conditions for conditional marketing authorisation.
Fourteen Member States are participating in this joint procurement, made possible by the Joint Procurement Agreement to Procure Medical Countermeasures against various types of transboundary health threats (C-2014/2258), which allows 36 states to participate, on a case-by-case and voluntary basis, in joint procurement of medical countermeasures. The PHH-1V vaccine is currently under rolling review by the European Medicines Agency, EMA (see EUROPE 12922/21).
The EMA also announced, on 18 August, that its Committee for Medicinal Products for Human Use (CHMP) had started the formal assessment of the Covid-19 vaccine named Skycovion, developed by SK Chemicals GmbH. The company opted for an innovative strategy: the adjuvanted vaccine contains nanoparticles incorporating elements of the SARS-CoV-2 spike protein.
Lastly, on 9 August, the European Commission announced that it had reached an agreement with Moderna to reschedule the delivery of the company’s Covid-19 vaccine to better meet the needs expressed by the states participating in the advance purchase of this vaccine. As a result of this agreement, the vaccine doses that were originally scheduled to be delivered in the summer of 2022 will be supplied in September and in the autumn and winter of 2022. These deliveries could include doses of Moderna vaccines adapted to new variants of concern should these be authorised in due course. These adapted vaccines are currently being evaluated by the EMA (see EUROPE 12975/21). At the request of some Member States, the agreement also includes a clause allowing for the delivery of an additional 15 million booster doses of the Moderna vaccine adapted to the Omicron variant of concern, should these adapted booster doses be authorised in time for use in the vaccination campaigns of these states.
The European Commission announced on 13 May that it had entered into a similar agreement with Pfizer-BioNTech (see EUROPE12952/24). (Original version in French by Emilie Vanderhulst)