EMA ‘has received no application’ from Turkey for Turkovac, say reports

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While Turkovac, Turkey's domestic COVID-19 vaccine, has been granted emergency approval and is now administered in the country, it has also led to uncertainties as the research results pertaining to the vaccine have not yet been published in a peer-reviewed scientific journal.

As reported by Ali Gülen from daily Sözcü, an official from the European Medicines Agency (EMA) has said that "the EMA has not received an application from Turkey for the approval of the Turkovac."

According to this news report, the official has noted that "in order for the Turkovac to be approved for use against COVID-19 in the European Union (EU), an application should be submitted to the Agency."

This lack of applications to the EMA has caused concerns that the Turkovac vaccine may not enjoy worldwide validity.

The EMA statement has reportedly indicated that if an application is received, it will be published on the official website of the Agency, adding that "after an application is made for the Turkovac, a comment may be made about the vaccine and the accuracy and usability of the data from the last phase may be better understood after the related data is examined."

Lack of data on phase trials criticized

Following the Phase 1, 2 and 3 trials, the EMA starts examining vaccines for "emergency approval", which takes months. Without an approval by the EMA, the vaccine is not deemed valid in the EU countries, Switzerland, England, Ireland, Canada, the US and several other countries.

As people are required to prove vaccination in entering these countries, only the ones who have received the vaccines approved by the EMA or the US Food and Drug Administration are allowed to do so.

The Turkish Medical Association (TTB) previously asked a series of questions about Turkey's domestically produced Turkovac vaccine, which has been granted an emergency use approval by the Health Ministry's Pharmaceuticals and Medical Devices Agency (TİTCK):

• Have the results of the Phase-1, Phase-2 and Phase-3 trials been published as a publicly accessible scientific report?
• Was a report indicating that the vaccine is "safe" and "effective" issued before the Emergency Use Approval was given?
• Have the conditions of Good Manufacturing Practices (GMP) and Biosecurity Level (BSL3) ensured in the manufacturing facilities?

CLICK - Lack of scientific publications raises questions over Turkey's domestic Covid vaccine

In the face of these questions, President and ruling Justice and Development Party (AKP) Chair Recep Tayyip Erdoğan previously targeted the TTB, calling the Association "liars", "frauds" and "hustlers".

Which vaccines have received approval?

The EMA has so far announced that the vaccines of BioNTech/Pfizer, Novavax, Moderna, AstraZeneca and Johnson&Johnson have been granted emergency use approval. The applications for Russia's Sputnik V, China's Sinovac and France' Sanofi and Valneva are still pending.

While Russia and China made the applications months ago, the related process will be finalized for Turkey's Turkovac in 2023 even when it applies today. (AEK/SD)