Vax makers starting to apply for full authorization of their Covid-19 vaccines—DOH

Coronavirus vaccines have been prepared for distribution at a vaccination site in Manila on May 18, 2021. (Ali Vicoy/Manila Bulletin)

The Department of Health (DOH) said that aside from Janssen–some vaccine manufacturers have also started applying for a Certificate of Product Registration (CPR) for their respective Covid-19 vaccines.

“Meron pa rin ilang (There are some) manufacturers which already have submitted but we cannot disclose to you yet kasi (because) they are still to complete their applications. Basta, rest assured na isa-isa nag-aaply ang ating mga manufacturers for their CPRs (Rest assured that manufacturers are starting to apply for a CPR),” said DOH Officer-in-Charge Maria Rosario Vergeire in a press briefing in San Mateo, Rizal on Tuesday, Dec. 20.

“As to the number of those which have applied, hindi ko ma disclose sa inyo (I cannot disclose yet) but what I can say would be it is not more than five. So meron na tayo (we already have),” she added.

Last August, the DOH reported that the CPR application of Janssen is being reviewed by the Food and Drug Administration (FDA).

READ: FDA reviewing Janssen’s CPR application—DOH

“Yung sa (Regarding) Janssen, it is still under review. Wala pa ho tayong may CPR dito sa ating bansa (There remains no CPR among them in the our country),” said Vergeire.

To note, a CPR is being issued by the FDA to manufacturers to allow the market and selling of their products commercially.

Vergeire said that it takes a couple months before the FDA can conclude its evaluation for a CPR application.

“May timeline naman kasi ang Food and Drug Administration na (The Food and Drug Administration has a timeline) for every new applications for Certificates of Product Registration ----because of the tediousness of the scientific evaluation for this, they have this timeline of I think, kung hindi ako nagkakamali (if I’m not mistaken)-- 270 days,” said Vergeire.

The DOH urged other vaccine manufacturers to already apply for a CPR of their Covid-19 vaccines.

“Hinihikayat pa rin natin yung ibang mga manufacturers that they apply already at para po maka move forward na tayo (We are still encouraging the other manufacturers to apply already so that we can move forward) and we can have our CPRs for our Covid-19 vaccines,” said Vergeire.

“Hopefully, ang ating goal ay as soon as possible ay makapag CPR tayo para hindi na under emergency use authority ang mga ginagamit nating bakuna (Hopefully, our goal is that as soon as possible we can issue a CPR so that the vaccines we use are no longer under emergency use authority),” she said.

To recall, the Covid-19 vaccines that have granted an emergency use authorization in the country are Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik, Janssen, Moderna, Sinopharm, Covovax, and Covaxin.