(UPDATED) The Food and Drug Administration (FDA) on Friday, March 19, 2021, granted emergency use authorization (EUA) for Sputnik V, the vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology against coronavirus disease 2019 (Covid-19).
Sputnik V is the fourth Covid-19 vaccine allowed for emergency use in the Philippines, after those of Pfizer-BioNTech, AstraZeneca-Oxford and Sinovac.
FDA, which regulates health products in the country, is recommending Sputnik V for individuals 18 years old and older.
It is administered in two doses 21 days apart, and requires storage of -18 degrees Celsius and below.
As of March 15, FDA records showed that Sputnik V demonstrated 91.6 percent overall efficacy against symptomatic Covid-19 21 days after the first dose.
It also showed 100 percent efficacy against moderate and severe forms of Covid-19.
FDA Director General Eric Domingo, in a virtual press briefing on Friday, said the Gamaleya vaccine was approved after “rigorous and thorough review by the regulatory and medical experts of the currently available published and unpublished data.”
“It was decided that all conditions for an EUA were present and that the benefit of using the vaccine outweighs the known and potential risks,” he said.
Adverse events
The Department of Health (DOH) listed common local adverse events after inoculation with Sputnik V as pain at the injection site, hyperthermia and swelling.
Systemic reactions may include hyperthermia, headache, asthenia, muscle/joint pain, malaise, sore throat, diarrhea, rhinorrhea, loss of appetite, pain in the oropharynx, nasal congestion, colds, sneezing and cough.
No serious adverse events were reported during its Phase 3 clinical trials, which enrolled 21,977 participants, according to the DOH.
The local distributor of Sputnik V, Philippine Archipelago International Trading Corporation, will supply the vaccine only to emergency response stakeholders, namely by the DOH and National Task Force Against Covid-19, Domingo said.
Kirill Dmitriev, CEO of Russian Direct Investment Fund, said the Philippines was among the first to show interest in Sputnik V.
"Philippines is one of the most populated nations in the Southeast Asia. Diversification of the national vaccine portfolio through registration of Sputnik V provides people of the Philippines with access to one of the best vaccines, which is already saving lives around the world," he said in a statement.
Sputnik V has also been approved for emergency use in 51 other countries.
Dmitriev said a dose of Sputnik V is priced at less than $10.
Other vaccines
Meanwhile, the FDA is still evaluating the application of Bharat Biotech from India for an EUA in the Philippines.
Bharat Biotech, which developed Covaxin, filed its application on January 22 and submitted Phase 3 clinical trials data on March 9, Domingo said.
Clinical trials in the Philippines are also ongoing for vaccines developed by Clover Pharmaceuticals, Janssen Pharmaceuticals (Johnson & Johnson) and Sinovac Life Sciences.
An EUA allows the use of a vaccine under development during a public health emergency such as the Covid-19 pandemic. Vaccines with EUA are still not allowed for commercial use.
“We have not issued any certificate of product registration for any Covid-19 vaccine so no Covid-19 vaccine can be sold in the market commercially,” Domingo said.
As of March 19, the Philippines has received donations of 600,000 doses of the Sinovac vaccine from China and 525,600 doses of the AstraZeneca vaccine from the Covax facility.
Vaccine czar Carlito Galvez Jr. recently announced that he has signed a supply agreement for 30 million doses of the Novavax vaccine to be manufactured by Serum Institute of India.
The Philippines is also programmed to receive from the Covax facility an additional 4.05 million doses of the AstraZeneca vaccine and 117,000 doses of the Pfizer-BioNTech vaccine.
These will be on top of the additional 1.4 million Sinovac vaccines that are expected to arrive in a few weeks, the 13 million doses covered by a supply agreement with Moderna, and the 17 million doses procured through tripartite deals with AstraZeneca and local government units.
The government aims to vaccinate up to 70 million Filipinos, including 24.5 million individuals in Priority Group A, in 2021. Since these vaccines, except the single-dose vaccine from Janssen, require two doses, the government needs to procure up to 140 million doses for 2021 alone. (Marites Villamor-Ilano with a report from HDT / SunStar Philippines)