DOH: Sputnik V vax maker must report adverse effects to FDA

Gamaleya, the manufacturer of Russian COVID-19 vaccine Sputnik V, has the responsibility of reporting any adverse effects of the its doses to the Philippine Food and Drug Administration (FDA), the Department of Health said Saturday.

Health Undersecretary Maria Rosario Vergeire made the remark during the Laging Handa briefing, amid Brazil's move to stop its importation due to "critical issues" surrounding the vaccine's efficacy. 

“Kung sakaling may ibang mga makikita around the globe about this, the manufacturers of Sputnik V has that responsibility to the Philippine government to submit to us these kinds of findings,” Vergeire said.

(In case they found adverse effects around the globe, the manufacturers of Sputnik V has that responsibility to the Philippine government to submit to us these kinds of findings.)

“Sa ngayon po, wala pa po tayong  natatanggap na ganito at tsaka ang pinalabas sa Brazil is based on their evaluation and just their initial conclusions” (For now, we have not received any reports on the findings in Brazil), she added.

Vergeire said the Philippines will continue the use of the Russian vaccine as the FDA has already approved its emergency use authorization

Earlier, vaccine czar Carlito Galvez Jr. said the Philippine government will rely on official medical reports to determine if there is a need to further study Russian-made Sputnik V anti-COVID vaccine amid reports of its efficacy and safety in Brazil.

Last Monday, the  Brazilian health regulator's technical staff recommended against approving imports of the Russian-made Sputnik V COVID-19 vaccine requested by governors battling against a deadly second wave of the virus.

The recommendations by Anvisa's technical staff will be taken into account by the regulator's board, which will announce its decision later on Monday. Anvisa had previously said there were "critical issues" surrounding the vaccine's effectiveness and safety that needed clarifying.

The first 15,000 doses of Sputnik V were supposed to arrive in the Philippine last Wednesday but due to “logistical challenges” the schedule was moved to  Saturday, May 1.

Vergeire said the first batch of Sputnik V jabs will be distributed to four big cities in Metro Manila. —LBG, GMA News