FDA still waiting for Sinovac data

February 22, 2021

MANILA, Philippines — There is still no emergency use authorization (EUA) for China’s Sinovac Biotech with two days left prior to the expected arrival of the COVID vaccines.

In a radio interview yesterday, Food and Drug Administration (FDA) director general Eric Domingo stressed the importance of being extra careful in issuing an EUA, saying “we don’t want to have problems later on when the product is already here and are allowed to be used.”

Until this time, Domingo said the FDA is still waiting for additional information from the Sinovac manufacturer due to the absence of a published data in a medical journal.

“We are still asking for some clarification on their findings in their studies. We cannot overlook these data and forego analysis,” he explained. “This is especially true with Sinovac as they have not published their data (in a) peer-reviewed journal, so we need to complete the evaluation.”

The Chinese government has agreed to donate 600,000 doses of Sinovac vaccines, which are scheduled to arrive on Feb. 23. However, since the FDA is yet to issue an EUA for Sinovac after the application was filed last Jan. 13, this, too, might face a delay.

Also yesterday, Domingo reported that the US-based drugmaker Moderna has already expressed its intent to file for an EUA in the Philippines.

“They said they are just completing the applications and that they will file soon. It would be easy to review their data because they have already been evaluated in the US. Therefore, our own experts need not repeat some of the clarificatory questions,” he said, adding that Moderna is unlikely to have difficulty in securing the EUA.

Meanwhile, Foreign Affairs Secretary Teodoro Locsin Jr. yesterday said Russia’s Sputnik V should already be approved.

“No need to see it first by visiting Russia. None of you speak Russian or know any advanced science. If advanced countries okay a vaccine it should be good to go in a country like ours,” Locsin tweeted.

Noting that The Lancet review is definitive, Locsin said he was turning every stone to get Sputnik V to the country and that it is the vaccine that he will trust his life with.

Sputnik V’s efficacy in fighting COVID-19 was validated by internationally peer-reviewed data published in The Lancet.

In an interim analysis of a Phase 3 clinical trial, Sputnik V showed strong efficacy, immunogenicity and safety results. Efficacy of Sputnik V against COVID-19 was reported at 91.6 percent.  –  Pia Lee-Brago, Delon Porcalla

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