PH rollout of Sputnik V jabs on despite Brazil rejection

MANILA – Sputnik V vaccine’s Philippine rollout will push through as planned despite Brazil’s import ban on the Russian shots.

Department of Health Undersecretary Maria Rosario Vergeire said on Saturday the jabs have been declared safe for public use by the Food and Drug Administration (FDA).

“Kailangan pong maintindihan ng ating mga kababayan na ang Sputnik V po ay nabigyan na ng Emergency Use Authorization ng ating Food and Drug Administration so ibig sabihin napag-aralan na po iyong dossier ng Sputnik V at nakita naman na katanggap-tanggap at ligtas ito para sa ating mga kababayan (The public must understand that Sputnik V has an EUA granted by the FDA, which means they already studied the vaccine’s dossier and saw that it’s acceptable and safe for public use),” she said in the Laging Handa briefing.

Brazil’s National Health Surveillance Agency (Anvisa) earlier rejected importing Sputnik V, saying the data it evaluated “shows the presence of replicating virus.”

Vergeire said the country will reevaluate should the manufacturers of Sputnik V submit additional documents related to Brazil’s findings.

“Kung sakali pong may ibang mga makikita (Should they see other findings) around the globe about this, the manufacturer of Sputnik V has that responsibility to the Philippine government to submit to us these kinds of findings,” she said.

“Sa ngayon po, wala pa naman tayong natatanggap na ganito at saka iyang ipinalabas po diyan sa Brazil, dito po is based on their evaluation and these are just initial conclusions. (At present, there’s no such findings and that the one reported in Brazil is based on their evaluations and these are just initial conclusions),” she added.

The initial batch of 15,000 doses of Sputnik V vaccines arrived Saturday afternoon via a Qatar Airways flight from Moscow via Doha.

Taguig City, Manila, Muntinlupa, Makati, and Parañaque will get 3,000 doses each for the pilot rollout while the remaining 485,000 doses of the Russian jabs are expected next week.

In a statement, Gamaleya Research Institute said the Brazilian regulator’s decision “contradicts an earlier decision by Brazil’s Ministry of Science, Technology and Innovation, which recognized the Sputnik V vaccine as safe and permitted its production in Brazil.”

“The Sputnik V team has addressed the technical issues raised by Anvisa board members during the meeting on April 26 to demonstrate that these allegations have no scientific grounds and cannot be treated seriously in the scientific community and among international regulators,” it said.

It also said there is “strict quality control” in all Sputnik V production sites as it confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced earlier.

“Existing quality controls ensure that no RCA can exist in Sputnik V vaccine,” it said.

“The quality and safety of Sputnik V are, among other things, assured by the fact that, unlike other vaccines, it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration. This purification technology helps to obtain a highly purified product that goes through mandatory quality control, including control for RCA or any additives presence,” the statement added.

The Sputnik V manufacturer also emphasized that “only E1 and E3 type non-replicating adenoviral vectors, which are harmless for the human body, are used in the Sputnik V vaccine production.