THE Department of Health yesterday said several manufacturers of COVID-19 vaccines have begun applying for a certificate of product registration (CPR) with the Food and Drug Administration.
All seven COVID-19 vaccines available in the country are using emergency use authorizations from the FDA. These are Pfizer, AstraZeneca, Sinovac, Sputnik V/Sputnik Light, Janssen, Moderna, and Sinopharm.
A CPR is needed for the manufacturers to market, import, export, sell, offer to sell, distribute, transfer, promote, and advertise a health product.
Health Undersecretary Maria Rosario Vergeire said government has received CPR applications from “not more than five” companies.
“As to the number of those of which have applied, I cannot say the exact number but what I can say would be is that it is not more than five,” she said in a press conference,
“One by one, our vaccine manufacturers have started applying for their CPRs,” she added.
Vergeire said that out of the current applicants, only Janssen has completed requirements for the CPR application. She said Janssen’s application, which was submitted two months ago, is projected to be concluded after nine months.
“Because of the tediousness of the scientific evaluation for this, the FDA has this timeline of, I think, 270 days. This is how long a new product is being evaluated,” she said.
Meanwhile, the Alliance of Health Workers (AHW) urged the DOH to first use all COVID-19 vaccines in its stockpile before pushing for the procurement of the bivalent doses, or the “newer generation” vaccines.
The DOH is in negotiations with Pfizer and Moderna over the procurement of the bivalent vaccines against COVID-19.
The bivalent COVID-19 vaccines are also known as the Omicron-specific jabs.
The DOH gave the assurance that the monovalent vaccines will not be disregarded despite the arrival of its bivalent counterparts.
“Our objective remains to be to use up all our current stocks of monovalent vaccines,” Vergeire said.
She also said the decision to purchase bivalent vaccines is based on its potential benefits, and not just to pile up stocks.
“We are procuring these vaccines because it was found, based on evidence, that the bivalent vaccines can address both the original strain of the virus and subvariants of Omicron,” she said.
“We want to buy these bivalent vaccines because there is evidence that it can add better protection, especially to our vulnerable sector, like the elderly and those with comorbidities,” she added.
