MANILA (2nd UPDATE) - The Philippines on Friday issued emergency use authorization for Russia's Sputnik V vaccine, the fourth COVID-19 jab to be green-lighted in the country.
Late-stage trial results showed the vaccine was 91.6 percent effective in preventing the disease, Food and Drug Administration director-general Eric Domingo told reporters in a press briefing.
The efficacy rate of the vaccine, which comes in a 2-dose regimen administered 3 weeks apart, is consistent among all age groups 18 and older, he added.
"Based on the totality of evidence available to date, including data from adequate and well-known controlled trials, it is reasonable to believe that the Gamaleya National Center of Epidemiology and Microbiology Sputnik V Gam-Cov-Vac COVID-19 vaccine may be effective to prevent COVID-19," Domingo said.
The potential benefits of the Sputnik V vaccine, he noted, also outweigh the known and potential risks of the Russian-developed shots.
"The adverse events reported were mostly mild and transient, similar to common vaccine reactions. No specific safety concerns were identified," Domingo said.
The Philippines will start negotiating a supply deal for Sputnik doses next Tuesday, said vaccine "czar" Secretary Carlito Galvez.
"Ang initial request po namin is kung puwedeng makapag-deliver sila ng more or less 3 million doses this coming April, May," he said.
(Our initial request is that they deliver more or less 3 million doses this coming April, May.)
Authorities will also try to convince their Russian counterparts to allow Philippine local governments to procure Sputnik jabs, said Galvez.
The Gamaleya Institute applied for emergency use of its experimental vaccine on Jan. 7. It later submitted results of its Phase 3 trials on Jan. 21.
It marks the fourth vaccine to obtain regulatory approval in the Philippines after Pfizer-BioNTech on Jan. 14, AstraZeneca-Oxford on Jan. 28 and Sinovac on Feb. 22.
Courtesy of DOH
Domingo said the Philippine Archipelago International Trading Corp. should supply the vaccine to emergency response stakeholders.
The jabs, which are stored at -18 degree Celsius and below, shall be administered to healthy individuals aged 18 years and older.
"The good with the Sputnik V vaccine is that 25 percent of trial participants actually have comorbids [but] they also did quite well with the vaccine," he said.
Domingo reiterated that the EUA was not a marketing authorization or a certificate of product registration. "Hence, this EUA cannot be used as an authorization to market the vaccine commercially," he added.
Russia approved the vaccine in August before its large-scale trial began, saying it was the first country to do so for a COVID-19 shot. It named it Sputnik V, in homage to the world’s first satellite, launched by the Soviet Union.
Small numbers of frontline health workers began receiving it soon after and a large-scale roll out started in December, though access was limited to those in specific professions, such as teachers, medical workers and journalists. In January, the vaccine was offered to all Russians.
In February, Galvez said the Philippines was planning to buy 20 million doses of the Sputnik V vaccine.
He had said the initial delivery of the vaccines was set in April if regulators authorized it for emergency use.
The Philippines rolled out its COVID-19 inoculation drive on March 1, much later than other countries.
To date, nearly 241,000 out of 1.7 million health-care workers have been vaccinated. The country aims to vaccinate 70 million or two-thirds of its population by yearend to achieve herd immunity.
- With a report from Reuters
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