Two new applications—one for monovalent and the other for bivalent vaccines—are pending with the Food and Drug Administration (FDA) for their commercial use against COVID-19, according to Director General Samuel Zacate.
The FDA chief, however, did not elaborate. So far, only Pfizer’s bivalent vaccine under the brand name Comirnaty Original/Omicron BA.4-5 was given the certificate of product registration, a license issued by the FDA for the commercial distribution and sale of a medical device.
The FDA is hoping Pfizer can finally bring in commercial batches of bivalent vaccine Tozinameran Famtozinameran by the end of this month or in August, Zacate said.
The jabs may be sold to consumers 12 years old and above and administered by a medical professional as a booster shot. —Kathleen de Villa
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