Russia pauses approval of combined AstraZeneca/Sputnik V vaccine trial, requests data

MOSCOW (Reuters) -The Russian health ministry’s ethical committee has declined to approve clinical trials in Russia combining a British shot from AstraZeneca and Oxford University with Russia’s Sputnik V vaccine, an AstraZeneca official told Reuters on Friday.

Irina Panarina, AstraZeneca general director in Russia and Eurasia, said the decision did not mean that the trials would never be approved or were definitively prohibited.

Before the committee’s decision she said that AstraZeneca had received questions about the trials from the health ministry and was now preparing a response to them, which would be sent next week.

Human trials of a COVID-19 vaccine combining the AstraZeneca/Oxford shot with Sputnik V had been approved in Azerbaijan, the United Arab Emirates and Belarus, said Panarina.

Russia’s health ministry said that the ethical committee made the decision due to the lack of some documents and information required for drawing conclusions on the efficacy and safety of the combined vaccine.

Once the new data is provided, the ethical committee and one more health ministry institution will examine it and decide on the possibility of the trial, the ministry added.

Both AstraZeneca/Oxford and Sputnik V vaccines involve two doses, an initial shot and a booster.

Sputnik, however, uses different viral vectors for its two shots.

In the trials, participants would first receive the AstraZeneca vaccine and then the first Sputnik V shot 29 days later.

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