Experts from the European Medicines Agency (EMA) are due to visit Russia this week for an inspection of the Sputnik V vaccine against covid-19, which is currently being evaluated as an alternative by countries in the European Union (EU) to speed up the vaccination program.
The European agency will inspect the Russian facilities responsible for the production of Sputnik V, already in use in Hungary. If those vaccinated are given the green light, overcoming mistrust of Europeans should be a challenge. According to the EMA, the agency is required by law to verify that manufacturers of medicines for which marketing authorization is sought in the EU comply with good manufacturing practice. The EMA had already announced an inspection of the vaccine production sites in March. Clinics where Sputnik V has been clinically tested will also be visited. The agency does not intend to publish the results of its inspection until it has analyzed the marketing authorization application for Sputnik V in the EU. The EMA also avoided saying exactly when European inspectors would visit Russia. The Russian side had given April 10 as the date. Within the EU, compliance with drug manufacturing standards is monitored by national regulators and the EMA coordinates this work. Outside the EU, an inspection can only be left out if it has already been carried out within the past two or three years, says the EMA.
Mistrust in the EU
Distrust of the Russian vaccine in the EU is high. Recently, on March 17, five MEPs sent a letter to the EMA, stressing that Russia has repeatedly shown itself “more than willing to politicize and falsify medical and scientific data on a very professional scale and at large-scale when they serve political purposes “.