DOST welcomes FDA's approval of Sputnik V for emergency use
The Department of Science and Technology (DOST) welcomed Friday, March 19, the decision of Food and Drug Administration (FDA) to grant emergency use authorization (EUA) to Sputnik V, the coronavirus disease (COVID-19) vaccine developed Russian drugmaker Gamaleya Research Institute.
DOST Secretary Fortunato “Boy” T. de la Peña expressed elation over the FDA’s EUA grant to the Sputnik V Gam-Cov-Vac COVID-19 vaccine manufactured by Gamaleya National Center of Epidemiology and Microbiology.
"I am happy that DOST has been of assistance in our government’s overall effort in having more types of COVID-19 vaccines accessible for our people.Our bilateral agreements on science and technology, our Vaccine Expert Panel evaluation, our guidance on independent vaccine clinical trials and our support for Philippine participation in the Covax Facility have been of help,” he told the Manila Bulletin in a Viber message.
"Our close coordination with our FDA has also been of help in the processes involved. We are now looking forward to the WHO Vaccine Solidarity Trials where the Philippines will be one of the implementors,” de la Peña added.
The DOST chairs the Task Group on Vaccine Evaluation and Selection (TG VES).
In a statement, the DOST's Office of the Undersecretary for Research and Development (OUSECRD) took note of the FDA’s move, describing it as "a development as the country now has an additional approved vaccine in its portfolio for the National COVID-19 Vaccination Program.”
Undersecretary for Research and Development Rowena Cristina Guevara, who leads the TG-VES, noted that the agency’s Vaccine Expert Panel (VEP) has reviewed the initial clinical trial data of Sputnik V, which served as one of the bases for the FDA’s approval of the vaccine’s EUA application.
"As early as August 2020, the DOST-led TG VES has been in contact with Gamaleya and RDIF (Russian Direct Investment Fund), through the assistance of both the Department of Foreign Affairs (DFA) and the Embassy of the Russian Federation in the Philippines, in terms of COVID-19 vaccine development, and more recently, in Gamaleya’s submission of the required documents to FDA for their EUA application,” she said.
The OUSECRD cited that the non-replicating viral vector COVID-19 vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology through the support of RDIF. It is authorized for limited use among Filipino individuals aged 18 and above, it added.
Both Gamaleya and RDIF were identified by DOST as "one of its bilateral partners for the possible conduct of vaccine clinical trials in the Philippines,” the DOST-OUSECRD said.