COVID-19

PH eyes clinical trials for Russian COVID-19 vaccine as safety concerns raised

Sofia Tomacruz

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PH eyes clinical trials for Russian COVID-19 vaccine as safety concerns raised
The Department of Health assures the public that Russia's COVID-19 vaccine will be subject to a rigorous review and regulatory protocols before possible use in the Philippines

Philippine officials are eyeing to participate in Phase 3 clinical trials for Russia’s COVID-19 vaccine.

The vaccine was touted by Russian President Vladimir Putin as “quite effective,” but scientists worldwide have raised concerns over its safety. 

Health Undersecretary Maria Rosario Vergeire said on Wednesday, August 12, that the Philippines’ vaccine expert panel led by the Department of Science and Technology would meet with the Gamaleya Research Institute of Epidemiology and Microbiology within the day.

Gamaleya, part of Russia’s health ministry, had developed the vaccine in coordination with the country’s defense ministry.

“Ang pag-uusapan ngayon (What will be discussed) with the Department of Science and Technology is how we can possibly have the clinical trial here also in the Philippines,” Vergeire told reporters in a briefing.

Why it matters

Talks on possible Phase 3 clinical trials come as scientists around the world are skeptical about Russia’s claim that it has developed a COVID-19 vaccine proven to be both safe and effective.

Experts pointed to the lack of published and transparent scientific data on the vaccine’s supposed efficacy. 

Questions over the vaccine called Sputnik V largely revolve around the rush to declare it ready for use despite the lack of Phase 3 testing. As the last stage in clinical trials, the step is crucial as it involves thousands of participants over several months to determine if a vaccine produces immunity as well as any significant side effects.

Among the experts who raised concerns over the vaccine was renowned US National Institute of Allergy and Infectious Diseases Director Anthony Fauci, who “seriously doubts” the Sputnik V vaccine meets these standards. 

“Having a vaccine…and proving that a vaccine is safe and effective are two different things,” said Fauci in a National Geographic discussion moderated by ABC News’ Deborah Roberts. 

“I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that,” he added. 

The World Health Organization has also yet to give the vaccine its stamp of approval, which would require a “rigorous review and assessment of all the required safety and efficacy data.” 

Balancing risks

Despite this, President Rodrigo Duterte said the Philippines is moving forward and discussing specifics such as the possible number of doses to be allocated for the country.

Vergeire, however, tempered expectations and sought to assure the public that vaccines to be used in the Philippines will still be subject to health safety and regulatory procedures.

“Even if it went through regulatory procedures in Russia, when it arrives in the Philippines, it will still go through our own procedures. It’s different when it arrives here in the country,” she said in a mix of English and Filipino. 

“This would be a critical study and review…so we are sure [of the vaccine]…. We’ll study the dossier [on the vaccine] and review these allegations…and what the findings were during different phases of [clinical] trials,” she added. – Rappler.com

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Sofia Tomacruz

Sofia Tomacruz covers defense and foreign affairs. Follow her on Twitter via @sofiatomacruz.