Sinopharm seeks EUA – Malacañang
China-owned pharmaceutical company Sinopharm has applied for emergency use authorization (EUA), Malacañang announced Monday.
The Food and Drug Administration (FDA), the regulatory body in charge of reviewing applications for EUA, was apparently unaware of the firm’s move at press time, however.
“It has been filed. It has already filed with the FDA an application for EUA for Sinopharm vaccine,” Roque said in a press conference in Manila.
Roque also showed a photo of the firm’s email showing its EUA application.
Sinopharm’s vaccine, which has been approved by Beijing for general use, reportedly had a 79 percent efficacy rate based on interim Phase 3 trials.
Sought for clarification, FDA chief Eric Domingo said, “No application yet.”
The EUA granted by the FDA is needed before vaccines could be imported, purchased, and administered by the national government to the public. However, it is not a license for commercial use.
Sinopharm’s vaccine, which has been approved by Beijing for general use, reportedly had a 79 percent efficacy rate based on interim Phase 3 trials.
Roque, meanwhile, said Malacañang’s legal office has yet to conclude its review whether President Rodrigo Duterte, as Commander-in-Chief, can receive Sinopharm’s vaccine under “compassionate use license”.
FDA granted Duterte’s security detail a compassionate permit for 10,000 doses of Sinopharm vaccine last month for “one-time” use and “importation.”
“It will take around 21 days more or less for the FDA to act on the application that has been filed today. So, I don’t know when the legal opinion of the Malacañang legal office will come out on whether or not he can have his shot under the compassionate use, so whichever comes first,” he said.
It has already filed with the FDA an application for EUA for Sinopharm vaccine.
Sinopharm’s vaccine was the jab administered last year to Duterte’s security aides last year, which caught the FDA by surprise and enraged the public.
The Presidential Security Group (PSG) reportedly obtained a “donation” of Sinopharm doses and administered it among themselves in September and October, disregarding regulatory processes set by the government.
The issue prompted the FDA to conduct a probe as to how unauthorized Covid-19 vaccines arrived in the country, but the agency said its investigation has hit a blank wall after their queries went unanswered by the PSG.
Sinopharm’s Covid-19 vaccine utilizes an inactivated virus to catalyze an immune response.
Countries like the United Arab Emirates, Pakistan, Peru, Hungary, and Morocco have authorized Sinopharm’s vaccine for emergency use.
So far, only Covid-19 vaccines from Pfizer-BioNTech, AstraZeneca, and Sinovac have received an EUA in the Philippines.