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43 araw clinical studies ng Sputnik V — DOH

INAASAHANG 43-araw ang itatakbo ng pag-aaral ng local experts sa mga dokumento ng Russia kaugnay ng bakuna laban sa CoVid-9 na Sputnik V, ayon sa Department of Health (DOH).

 

Ibig sabihin, mas mabilis ang magiging daloy ng proseso nito kompara sa 55 araw na naunang napag-usapan ng sub-technical working group on vaccines na pinamumunuan ng Department of Science and Technology (DOST).

 

“According naman sa pag-uusap namin ng sub-technical working group ng vaccine development, dati we were pegging na 55 days ang ating span of time from vaccine expert panel’s review to ethical clearance, to FDA’s review or evaluation bago natin mailabas ang evaluation,” ani Health Undersecretary Maria Rosario Vergeire

 

“Pero the FDA has committed to shorten the process, so we are now looking about 43 days. Ito na ‘yung maximum natin,” aniya.

 

Noong Biyernes, nagpulong ang mga opisyal ng Filipinas at Russian Embassy. Sa naturang pulong, inalam ng Russia ang clinical trial protocol ng estado at humingi ng timeline ng proseso bago magawa ang target na trial.

 

Ayon kay Vergeire, mas mabilis pa sa 43 araw ang magiging proseso kung agad makokompleto ng Russia ang submission sa kanila ng mga dokumento.

 

“We also offered to them kung puwede na tayo gumawa ng parallel. Ibig sabihin ibigay n’yo na sa amin ang mga dokumentong kailangan naming pag-aralan para sa vaccine experts panel, so that kapag nagsa-submit na sila ng formal na protocol for this clinical trial mauumpisahan namin ang regulatory process… they committed that they will be responding immediately.”

(CYNTHIA MARTIN)

 

Krystall Herbal Products and FGO Branches

About Cynthia Martin

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