Bivalent jabs from Pfizer approved for sale, use in PH
A 3D-printed Pfizer logo is placed near medicines from the same manufacturer in this illustration taken Sept. 29, 2021. (REUTERS FILE PHOTO)
MANILA, Philippines — The Food and Drug Administration (FDA) has given the green light to pharmaceutical giant Pfizer to sell and distribute its bivalent COVID-19 vaccines, paving the way for Filipinos to get access to the next-generation jabs even if the country’s public health emergency gets revoked.
In a statement on Monday, the FDA said it granted a certificate of product registration (CPR) for Pfizer’s Tozinameran + Famtozinameran (15 mcg/15 mcg)/0.3 ml under the brand name Comirnaty Original/Omicron BA.4-5.
The vaccine is suitable for adults and children 12 years old and above.
The CPR for Pfizer’s bivalent vaccines was given a five-year validity period, according to the FDA, “after a comprehensive evaluation process [and] extensive clinical trials … of all scientific data” provided by the drugmaker.
A CPR is a license issued by the FDA that allows medical devices, such as COVID-19 medicines and vaccines, to be distributed and sold directly to the consumer.
Article continues after this advertisement‘Crucial step’
The development comes four months after Pfizer sought regulatory approval on Feb. 23 for the commercial use of its bivalent vaccines that target the more transmissible Omicron subvariants of the novel coronavirus.
Article continues after this advertisement“This significant milestone marks a crucial step in our nation’s current challenge against the global health crisis,” the agency said.
The Inquirer asked the FDA for the estimated cost of the commercial bivalent vaccines and whether other jabs in the stockpile would still be made available to the public once the Pfizer shots reached the local market, but there was no response at press time.
In October 2022, Pfizer said it plans to charge $110 to $130 (around P6,000 to P7,200) for a dose of its COVID-19 vaccine in the United States once the US government stopped footing the bill.
The FDA also urged other vaccine makers to apply for or to complete the requirements of their own CPR applications to provide “a diverse portfolio of safe and effective options” for Filipinos.
The other COVID-19 vaccines in the government inventory are being distributed under emergency use authorization (EUA), which is issued for unregistered drugs and vaccines during a public health emergency.
But once the state of emergency is lifted, the EUA for other vaccine brands that have yet to secure a CPR shall be deemed to have lapsed, although the jabs already delivered may still be distributed by the government.
Like flu, cough, colds
On Monday, Health Secretary Teodoro Herbosa, taking his cue from the World Health Organization’s declaration of the end of the Public Health Emergency of International Concern for COVID-19 in May, said he was inclined to ask President Marcos to lift the public health emergency, as the coronavirus was now like “influenza, cough [and] colds,” or any other disease being monitored.
In August last year, the FDA formed “Task Force Edward” in order to speed up the CPR approval of COVID-19 vaccines “without compromising the efficacy, quality, and safety of the vaccines.”
Another body, dubbed “Task Force Fleming,” was created to streamline the evaluation of COVID-19 drugs.
COVID-19 infections nationwide had been on a downtrend in the last two weeks, with the latest Department of Health data showing a seven-day national average of 492 cases per day.
