Sinopharm vaccine to undergo regular FDA process despite WHO approval –DOH

China-owned pharmaceutical company Sinopharm’s COVID-19 vaccine would still need to undergo the usual regulatory process despite its recent World Health Organization’s emergency use listing (EUL), the Department of Health said Saturday.

“Ito'y malaking tulong dahil na-review na siya ng mga eksperto ng WHO. So pagpasok dito [sa bansa], regular process pa rin. Although siyempre malaking karagdagan sa credibility nu’ng nakapagbigay ang WHO ng EUL para sa bakunang ito,” Health Undersecretary Maria Rosario Vergeire said during Laging Handa briefing.

(This will be a big help because the vaccine was reviewed by WHO experts. When it enters the country, the regular process will still be followed. Of course, we also see additional credibility on the vaccine after the WHO granted it with an EUL.)

The usual regulatory procedure will ensure that Sinopharm could be granted with Emergency Use Authorization (EUA), Vergeire added.

In light of WHO's approval, Health Secretary Francisco Duque III, also on Saturday, said he has already given instructions to file for an emergency use authorization for the donated China-made vaccines.

"On Monday, I have already instructed the Public Health Services Office of the DOH to file with DFA for issuance of an emergency use authorization for the Sinopharm donated vaccines," he said.

The World Health Organization on Friday approved the Sinopharm Covid-19 vaccine for emergency use -- the first Chinese jab to receive the WHO's green light.

The WHO had given emergency use approval to the vaccines being made by Pfizer-BioNTech, Moderna, Johnson and Johnson, and the AstraZeneca jab being produced at separate sites in India and in South Korea.

In the Philippines, about two to three companies have asked the FDA to grant the Sinopharm vaccine an ergency use authorization.

But the companies have yet to submit the requirements for the EUA.

President Rodrigo Duterte and his bodyguards were inoculated with the Chinese-made vaccine under a compassionate use authority for the Sinopharm vaccine, which had been donated to the Presidential Security Group. — DVM/MDM, GMA News