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DISINFO: EU normally imposes tight regulation but not on the untested Pfizer/BioNTech vaccine

DISINFORMATION CASE DETAILS

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coronavirus vaccination EU regulations European Union Information war

DISINFO: EU normally imposes tight regulation but not on the untested Pfizer/BioNTech vaccine

SUMMARY

The more surprising is that Pfizer, which lacks experience in the field of vaccine manufacturing, insisted that the agreement with the European Medicines Agency should not hold it responsible for the complications of using its vaccine, which is strange because European authorities usually impose tight control on drug manufacturers.

RESPONSE

Recurring pro-Kremlin disinformation narrative about vaccination.

Pfizer does not lack expertise in vaccine development. Pfizer has been involved in the commercial production of vaccines since the early 1900s and was has received several awards until today.

The European Medicines Agency has authorised the Pfizer-BioNTech coronavirus vaccine, granting it “a conditional marketing authorisation” with “all the safeguards, controls and obligations this entails”.

Conditional marketing authorisation is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic. And in line with the EU’s safety monitoring plan for COVID-19 vaccines, Pfizer-BioNTech vaccine will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.

Exemption from civil liability is known under conditional marketing. This was the only answer for maintaining the speed and scale of development and rollout of the vaccines. Under the current circumstances, EU member states' governments were focusing on trying to save as many lives as possible during the pandemic. The European Commission said: “it needed to act as quickly as possible while safeguarding patient safety”.

Read more cases that claim that the West wants to discredit Sputnik-V vaccine, or that EU prohibits countries from saving its citizens from COVID-19, and that the reasons for the West's criticism of Sputnik-V vaccine are political, or that ugly commercial interests are behind the criticism of the Russian COVID-19 vaccine, or that WHO confirms the "Sputnik-V" vaccine is safe and effective, or even that people shouldn’t trust the Moderna vaccine, and that NATO has a policy of discrediting “Sputnik-V”.

Disclaimer

Cases in the EUvsDisinfo database focus on messages in the international information space that are identified as providing a partial, distorted, or false depiction of reality and spread key pro-Kremlin messages. This does not necessarily imply, however, that a given outlet is linked to the Kremlin or editorially pro-Kremlin, or that it has intentionally sought to disinform. EUvsDisinfo publications do not represent an official EU position, as the information and opinions expressed are based on media reporting and analysis of the East Stratcom Task Force.

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