Russia's Gamaleya drops clinical trial application, eyes emergency approval in PH

Russia's Gamaleya Research Institute has withdrawn its application for late-stage clinical trials in the Philippines, expressing interest to instead seek emergency approval for its Sputnik V COVID-19 vaccine in the country. 

Department of Science and Technology (DOST) Undersecretary for research and development Rowena Guevara announced the development on Friday, January 8, saying Gamaleya informed them of its change in plans last January 6. 

Napakasimple ng rason nila, mag-a-apply na sila ng emergency use authorization (Their reason is very simple, they will apply for emergency use authorization),” Guevara said in a press briefing, when asked why the firm decided to drop Phase 3 clinical trials in the Philippines. 

Gamaleya’s decision to apply for emergency approval, should it be granted, would bring its vaccine to a larger number of people, as opposed to clinical trials where only a set number of individuals who volunteer to participate will receive it. 

The company had been among the first to express interest in late-stage clinical trials in the Philippines, after President Rodrigo Duterte vouched for it last August 2020 and offered to be injected with the vaccine in public.  

The company only made a partial submission for trials last December 17. Before its decision to withdraw, the country’s’ vaccine expert panel and research ethics board had been waiting for official documents to be submitted. 

With the latest development, Sinovac and Clover Biopharmaceuticals are now the only companies interested in conducting Phase 3 studies in the Philippines. Janssen Pharmaceutica was earlier given clearance for this last December 28, with trials possibly starting by the end of January.

Gamaleya's Sputnik V vaccine so far has emergency approval from Russia, Argentina, and Belarus. 

What to know about Gamaleya

Gamaleya earlier announced that its vaccine had an efficacy rate of 91.4%, though it has yet to publish its full findings in a scientific journal.

Scientists stressed the need for further follow-up as initial findings were based on an analysis of 20 COVID-19 cases found among trial patients. In contrast, results from Pfizer and Moderna were based on about 95 participants who got COVID-19. 

Last December 11, Gamaleya also joined forces with drug maker AstraZeneca, which is developing a vaccine with the University of Oxford, to study if their vaccines will deliver stronger protection when combined together. 

Last January 6, AstraZeneca applied for emergency approval of its vaccine with the Food and Drug Administration. A decision could be out in about a month’s time. – Rappler.com

Sofia Tomacruz

Sofia Tomacruz covers foreign affairs and is the lead reporter on the coronavirus pandemic. She also writes stories on the treatment of women and children. Follow her on Twitter via @sofiatomacruz. Email her at sofia.tomacruz@rappler.com.

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