PH awaits clinical trial protocol for Sputnik V COVID-19 vaccine from Russia

by Betheena Unite

The Department of Health said it is now waiting for the clinical trial protocol for the coronavirus disease (COVID-19) vaccine Sputnik V from Russia before it starts its evaluation for the conduct of clinical trials in the Philippines.

The country and the Russian Embassy recently discussed the regulatory process and the conduct of a clinical trial for Sputnik V, which is scheduled to start soon, Health Undersecretary Maria Rosario Vergeire said.

“One of our requests to them is the clinical trial protocol that we are waiting for before our vaccine experts panel starts its study for the conduct of clinical trial for Sputnik V,” Vergeire said.

“Nagkaroon ng magandang (There was a good) response and they committed to us that they will follow up so the clinical trial protocol will immediately be submitted to the Philippines so that we can start the evaluation by our vaccine experts panel,” Vergeire added.

The regulatory process of the Russian-developed vaccine is also included in the discussion, the Health official furthered.

It was disclosed that the Food and Drug Administration (FDA) also committed to shorten the process from vaccine experts panel review to ethical clearance to FDA review and evaluation.

From 55 days, the FDA committed to reduce the process to about 43 days maximum once the requirements are complete.

“We offered them (Russian Embassy) if we can do parallel, meaning they give us the documents needed to be studied by the vaccine experts panel so that when the formal protocol for this clinical trial is submitted, we can already start the regulatory process,” Vergeire said.

The undersecretary said the meeting with the Russian Embassy “went well.”

“Nasabi natin yung mga need natin na matanggap na (we were able to tell them what we need) so we can already start with the process of regulation and start the clinical trial the soonest time possible,” Vergeire said.

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