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.

https://newsinfo.inquirer.net/1805329/2-more-firms-seek-fda-nod-on-covid-19-vaccines

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