FDA grants EUA to Sinovac

Published February 22, 2021, 1:58 PM

by Manila Bulletin

By LESLIE ANN G. AQUINO and GENALYN KABILING

The Food and Drug Authority (FDA) has granted Emergency Use Authority (EUA) for the coronavirus disease 2019 (COVID-19) vaccine of China’s Sinovac Biotech.

(NOEL CELIS / AFP / FILE PHOTO / MANILA BULLETIN)

FDA Director General Undersecretary Eric Domingo announced this development Monday, Feb. 22, during the Laging Handa public briefing.

“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is grating an EUA to the COVID-19 vaccine of Sinovac,” he said.

“It is decided that all conditions for an EUA are present and the benefits of using the vaccine outweigh the known and potential risks,” Domingo added.

He said interim data show that when the vaccine is used on clinically healthy members of a community aged 18 to 59 it has an efficacy rate of 65.3 to 91.2 percent.

However, he said, it has a lower efficacy rate of 50.4 percent when used on healthcare workers exposed to COVID-19.

“Therefore, it is not recommended for use in this group,” said Domingo.

He added that the vaccine recommended by experts consists of two equal standard doses of 0.5 ml each given 4 weeks apart.

Domingo, meantime, stressed that the EUA is not a marketing authorization or a Certificate of Product Registration.

“Hence, this EUA cannot be used as an authorization to market the product commercially,” he said.

The FDA had earlier granted EUA to the COVID-19 vaccines of Pfizer and AstraZeneca.

PRRD prefers Sinopharm

President Duterte will not be among the first to get the Sinovac vaccines after the country’s drug regulators advised against its use for senior citizens, Malacañang announced Monday.

Duterte, who is 75 years old, prefers instead to be vaccinated by another Chinese-made vaccine, Sinopharm, to protect against the coronavirus illness, according to Presidential spokesman Harry Roque.

“Obviously po dahil sinabi ng EUA na inisyu ng Food and Drug Administration (FDA)  na hindi muna natin gagamitin sa seniors, hindi mapapasama ang president sa mauuna (Obviously, because the EUA issued by FDA indicated it cannot be used for seniors, the President will not be among those who will get the first jabs),” Roque said during a televised press conference Monday, Feb. 22.

Asked if the President will take the other Chinese developed vaccine, Roque said: “He has said his preference is for Sinopharm.”

The FDA had earlier issued a compassionate use permit for 10,000 doses of Sinopharm vaccines supposedly intended for the Presidential Security Group (PSG) tand their families.

With the FDA approval of Sinovac, Roque said the government could soon begin the vaccination drive initially for uniformed personnel and other essential workers. He clarified that the Palace did not ask the FDA to complete its review of the Sinovac vaccine with undue haste.

“Hindi natin minadali at hindi natin napilit na gumawa ng eksperto ng desisyon na ayaw nila so tumagal ang proseso, naantala ang pagdating ng Sinovac so wala talagang nagpabilis sa proseso at nagkaroon pa ng kondisyones (We did not rush, we did not force the experts to issue a decision they don’t like. The process was prolonged, the arrival of Sinovac was delayed. It was not unnecessarily hastened and in fact, conditions were imposed),” he said.

 
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