Sputnik-V gets EUA

THE government may start negotiating with Russia’s Gamaleya Institute for a possible multi-billion procurement deal as the Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for its Sputnik V coronavirus vaccine.

With the FDA’s decision to grant Gamaleya Institute EUA, Sputnik V vaccine thus becomes the fourth to be granted emergency approval in the Philippines amid another round of sharp surge in the daily recorded infection of COVID-19.

FDA Director General Eric Domingo said the vaccine has satisfied all conditions that would merit an EUA, adding that the Russian-made vaccine underwent rigorous review of late-stage trial data. Domingo hinted at a conclusion – benefits overweighing potential risks.

“The known and potential benefits of the Gamaleya Sputnik V vaccine, when used to prevent COVID-19, outweigh the known and potential risks of said vaccine as of date,” Domingo said.

As such, the government is expecting the arrival of an initial batch of two million doses of the vaccine this April.

In a separate statement, vaccine czar Carlito Galvez said the government had been waiting on the necessary EUA so that deals to purchase about 10 million doses could move forward.

To date, the country’s stockpile of 1.125 million doses of donated vaccines supplied by the World Health Organization’s COVAX global facility has already been farmed out. However, the national government has only managed to inoculate 240,297 healthcare workers.

With infections soaring faster than levels seen during the Philippines’ last deadly surge in cases from July to August 2020, experts have also underscored the urgent need to not only vaccinate all health workers, but scale up vaccinations to cover as many Filipinos as quickly as possible.

Peer-reviewed analysis of trial data showed that Russia’s Sputnik V vaccine is safe, demonstrated nearly 92 percent efficacy against symptomatic cases of COVID-19, and provided complete protection against moderate to severe cases. Russian scientists have also said that a trial in Russia testing the effectiveness of revaccination with the Sputnik V shot to protect against new mutations of the coronavirus was producing “strong results.”

Since the last peak in cases observed in 2020, the Philippines has reported the presence of more infectious variants first found in the United Kingdom, South Africa, and Brazil. On March 13, the Philippines also reported detecting a variant of the virus that contained mutations found in other variants of concern, though health officials said the variant was still considered to be under investigation.

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