The Philippine Food and Drug Administration (FDA) has approved the application for Emergency Use Authorization (EUA) of Gamaleya Research Institute for its Sputnik V COVID-19 vaccine.
The vaccine developed by Russia is the fourth to be granted emergency approval in the Philippines, following the EUA issuance of Pfizer, AstraZeneca and Sinovac COVID-19 vaccines.
“Today, we would like to announce that after a rigorous and thorough review by the regulatory and medical experts of the currently available published and unpublished data, the FDA is granting Emergency Use Authorization to the Sputnik V Gam-Cov-Vac COVID-19 vaccine manufactured by the Gamaleya National Center of Epidemiology and Microbiology,” FDA Director General Eric Domingo confirmed in an online briefing.
He explained that the benefits of the Sputnik V vaccine outweigh the known and potential risks. The interim data from the ongoing Phase 3 trials show the Sputnik V has an efficacy rate of 91.6% in age groups 18 and older.
Based on the EUA, two equal and standard doses of Sputnik V will be administered 21 days apart for patients receiving the vaccine.
Sputnik V also requires cold storage facilities with -18 degrees Celsius temperature and below (frozen solution). Domingo said the adverse events reported were mostly mild and transient similar to common vaccine reactions.
The FDA clarified that it cannot be sold commercially in the market since the EUA is not a marketing authorization or a Certificate of Product Registration.
Fifty-one countries have already granted EUA to Gamaleya’s Sputnik V vaccine including Russia, Argentina, Bahrain, Belarus and Hungary.
Meanwhile, Domingo shared the FDA had discussions on US vaccine makers Moderna and Johnson & Johnson about the documentary requirements for emergency use authorization but it has yet to receive any applications as of this date. – Mark Fetalco
