Malacañang said that the Russian coronavirus (COVID-19) vaccine Sputnik V will soon be issued an emergency use authorization (EUA) by the local Food and Drug Administration (FDA).
Presidential Spokesman Harry Roque made the statement as the country continues to negotiate with pharmaceutical companies in efforts to acquire more supplies of COVID-19 vaccines.
In his presser on Monday, Roque said that the Gamaleya Research Institute from Russia has finished submitting all the necessary requirements for the EUA of Sputnik V.
“Natapos na rin ang pagsusumite ng lahat ng dokumento ng Sputnik V so inaasahan po natin anytime now na ang Sputnik V ay baka mabigyan na rin ng EUA (All the required documents for Sputnik V has been submitted so we can expect that it will be granted the EUA anytime now),” he said.
FDA Director-General Rolando Enrique Domingo said that Gamaleya Research Institute has invited the FDA to an on-site inspection of its manufacturing plant after its failure to submit a Certificate of Good Manufacturing Practice.
He added that a group of FDA inspectors headed to Russia on March 15 to finalize its assessment on Sputnik V vaccine’s EUA.
Sputnik V was the first COVID-19 vaccine offered to the Philippines in August last year. To show his gratitude, President Duterte expressed his willingness to be the first person in the Philippines to receive the said vaccine.
However. Malacañang explained that an expert panel review from the Philippines will first have to review the results of the first and second phases of the clinical trials of the Russian vaccine.
The original target for Sputnik V was to be registered with the local FDA by April 2021 and the President may only get its vaccine by May 1 at the earliest.
The Philippines has rolled out its vaccination program against COVID-19 with the CoronaVac vaccine from China and the AstraZeneca vaccine from the COVAX Facility. The vaccines are intended for healthcare workers only.