EMA Advises Against Vaccine Authorizations, Side Deals by EU Members

EU member states increasingly frustrated with the speed of vaccine rollouts are going it alone through separate authorizations and side deals for vaccines from Russia and China.

Russia’s Sputnik V vaccine, which is still under review by the European Medicines Agency (EMA), has already been authorized in Hungary and Slovakia (DID, March 5), and the Czech Republic is expected to follow their lead.

EMA officials are calling on EU member states to hold off on approving the Sputnik vaccine until the agency has reviewed all the supporting data. But the Russian government, which is using the vaccine to boost the country’s international image, has called for an apology, arguing that Sputnik V has been shown to be both safe and effective and should already have been approved.

Russia has just struck a deal with the Italian-Swiss drugmaker Adienne to manufacture Sputnik V in Italy, its first such contract in the EU, signaling Italy’s willingness to work with the vaccine developed by Russia’s Gamaleya Research Institute.  

Other EU members are looking to China. Poland is reportedly in talks to secure vaccine doses and China has already sent 550,000 doses of its Sinopharm vaccine to Hungary.

Austria and Denmark have also announced that they are no longer relying solely on the European Commission’s vaccine contracts and are collaborating with Israel to develop the next generation of vaccines  to combat viral variants, (DID, March 3)

The European Commission acknowledges that EU member states can grant their own emergency authorizations but warns that the individual nations will assume full liability for those vaccines. — Jason Scott