FDA confirms: Sinopharm finally applies for emergency use of its COVID-19 vaccines

ABS-CBN News

Posted at Mar 02 2021 01:10 PM | Updated as of Mar 02 2021 01:28 PM

MANILA — The Food and Drug Administration on Tuesday confirmed that China state-owned Sinopharm has finally applied for emergency use authorization of its COVID-19 vaccines in the Philippines. 

“An online application was filed yesterday afternoon and the FDA is checking the contents of the submission now,” FDA Director General Eric Domingo told ABS-CBN News.

Domingo has yet to respond if the submission included interim results for the vaccine’s Phase III clinical trials, which is crucial in determining the safety and efficacy of a vaccine for emergency use.

Currently, only Pfizer, AstraZeneca and Sinovac have approved EUAs in the Philippines. The first batch of COVID-19 vaccines received by the country this week was from Sinovac.

Domingo could not give any further details on the Sinopharm submission, except that like in the case of Sinovac, they cannot guarantee a 21-day evaluation period.

This is because Sinopharm and Sinovac, which is a private company from China, do not have emergency use authorizations from a so-called Stringent Regulatory Authority (SRA). They are also not included in the World Health Organization’s emergency use listing unlike Pfizer and AstraZeneca. 

Having an EUA from an SRA, which is recognized by the WHO, can expedite a company’s application within 21 days, as what happened to Pfizer and AstraZeneca.

Sinovac, on the other hand, took more than a month before it was approved, also because it was not able to immediately submit its Phase III clinical trial data.

There have been conflicting reports on whether Sinopharm has submitted its EUA request to the Philippines.

Presidential Spokesperson Harry Roque on Monday morning said Sinopharm’s application was already submitted but Domingo said Monday afternoon that they have not received any. He also could not check their online submissions because the FDA main office was closed due to a local holiday.

By Tuesday morning, DOH spokesperson Maria Rosario Vergeire said that there still is no application from Sinopharm, which turned out to be not true.

Sinopharm’s vaccine is said to have a 79% efficacy rate against COVID-19.

While China donated 600,000 doses from Sinovac, the Presidential Security Group (PSG) is expecting 10,000 doses from Sinopharm though a compassionate special permit. 

Sinopharm was supposedly the smuggled vaccine used by the PSG to inoculate its members despite the country not yet having approved COVID-19 vaccines at that time.

It is also the brand reportedly used by columnist Ramon Tulfo to have himself inoculated ahead of the government’s immunization campaign.

Roque on Monday mentioned that he personally believes that the compassionate use permit for Sinopharm might have the effect of covering “what happened earlier” with the PSG.

The FDA on Tuesday admitted that it is facing a blank wall in its investigation on PSG’s illegal inoculation since they are “not getting any information.”

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