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Manila Bulletin devider Philippines devider National devider Sputnik V, 2 other vaccine developers apply for possible conduct of trials here

Sputnik V, 2 other vaccine developers apply for possible conduct of trials here

Published Oct 8, 2020 01:24 pm

Three vaccine developers, including Sputnik V's, have submitted an application for the possible conduct of Phase 3 clinical trials of their vaccines in the country.

This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
(Photo by Handout / Russian Direct Investment Fund / AFP / MANILA BULLETIN)

First to submit among the three developers was the Gamaleya Research Institute of Epidemiology and Microbiology who developed the Russian vaccine Sputnik V.

Second was the Janssen Pharmaceutical Companies of Johnson & Johnson and third is the Sinovac Biotech from China.

During the “Laging Handa” press briefing Thursday, Department of Science and Technology-Philippine Council for Health Research and Development Executive director Dr. Jaime Montoya said Sinovac Biotech has submitted complete documents to the Food and Drug Administration (FDA).

For the Sputnik V, Montoya said that there is a second round of evaluation.

"May kulang pa na mga datos na hiningi ang ating vaccine expert panel so may second round ng evaluation na nangyayari ngayon (There is still data that is being acquired by our Vaccine Expert Panel so there is an ongoing second round of evaluation)," he said.

Montoya said that Janssen Pharmaceutical Companies of Johnson & Johnson have not completed their documents.

The Department of Health had earlier said all candidate vaccines must undergo a regulatory process before it can be tested in the country.

DoH Undersecretary Mario Rosario Vergerie said approval from the FDA and ethics review board must be secured first before the conduct of any vaccine trial by local or international sponsors or developers.

In an online forum last month, Jesusa Joyce Cirunay, head of the FDA Center for Drug Regulation and Research, said the approval of a trial application would normally take 45 to 60 days.

Montoya assured that once vaccines become available, likely by the first or second quarter of 2021, the country will get access to it through the Gavi COVID-19 Vaccines Global Access (COVAX) facility.

The COVAX Facility is a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide.

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