Metro Manila (CNN Philippines, April 14) — The Food and Drug Administration said there are still no reported adverse events in countries using the Sputnik V COVID-19 vaccine.
This, as the Philippine government finalizes the procurement of 20 million doses from the vaccine manufacturer, Russian firm Gamaleya.
“So far sa ibang countries wala pa namang nakikitang signals or red flag,” FDA Director General Eric Domingo said Wednesday. “Kapag dumating dito iyan magiging strict din naman ang ating monitoring but until maumpisahan natin yan, we’ll keep getting information from the other countries who are using it.”
[Translation: So far in other countries they have not reported signals or red flags. Once they arrive in the country we will be strict in monitoring, but until we start its use, we’ll keep getting information from the other countries who are using it.]
The country has already received some three million doses of COVID-19 vaccines from by China and the World Health Organization-led COVAX facility. It has also secured additional supply from Sinovac, AstraZeneca, Moderna, and Novavax, while other negotiations are still being finalized.
For Sputnik V, the government is expected to soon sign the supply agreement.
The regulator earlier granted Emergency Use Authorization (EUA) for Sputnik V, and the initial shipment of 20,000 doses is expected to arrive this week.
The FDA said the vaccine can only be administered to clinically health individuals aged 18 and above. Analysis of its Phase 3 clinical trails also showed it had an efficacy of 91.6% after two doses, according to the report published in the scientific journal The Lancet.
Moreover, 25% of those who participated in the trial have comorbidities but responded well to the vaccine.
Meanwhile, Domingo said the FDA will soon issue new guidelines on AstraZeneca, after its use on those below 60 years old was temporarily halted over reports of blood clotting following vaccination.
The agency is also looking into the same reports of blood clotting allegedly due to Janssen’s COVID-19 vaccine, he added. The vaccine expert panel is still reviewing Janssen’s EUA application. Domingo said a recommendation is expected on Thursday.
The EUA application for COVAXIN from India-based firm Bharat Biotech is also still being reviewed, according to Domingo.
