Moderna and Pfizer/BioNTech Announce FDA Approval of XBB.1.5-Targeted mRNA COVID-19 Vaccines

September 11, 2023，Moderna、Pfizer、BioNTech simultaneouslyAnnouncement: XBB.1.5 COVID-19 mRNA Vaccine Receives FDA Approval; Preclinical Studies Show Both Vaccines Are Effective Against XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris) Variants.

Moderna Announces FDA Approval of Spikevax® for Supplemental Biologics License Application (sBLA) in Individuals 12 Years and Older; Emergency Use Authorization (EUA) Granted for Moderna COVID-19 Vaccine in Children Aged 6 Months to 11 Years. Moderna’s latest COVID-19 vaccine includes the spike protein targeting the XBB.1.5 sublineage of SARS-CoV-2, aiding in the prevention of COVID-19 in individuals aged 6 months and above. Following the FDA's decision, Moderna will begin shipping doses to vaccination sites across the United States, with updated vaccines expected to be available in the coming days.

In June 2023, the U.S. FDA recommended that COVID-19 vaccines should be updated to a monovalent XBB.1.5 component for the 2023-2024 vaccination season. At the VRBPAC meeting in June, clinical data submitted by Moderna showed that its updated vaccine elicited a strong immune response against multiple XBB subvariants, including XBB.1.5 and XBB.1.16. In August this year, Moderna released additional clinical trial data indicating that its updated COVID-19 vaccine triggered immune responses against EG.5 and FL.1.5.1 in humans, which are currently the dominant strains in the United States.

Over the more than 10 years since its establishment, Moderna has transformed from a research-stage company in the messenger RNA (mRNA) field into an enterprise with a diversified clinical vaccine and therapeutic product portfolio encompassing seven modalities. It possesses an extensive intellectual property portfolio and integrated manufacturing facilities that enable rapid clinical and large-scale commercial production. Moderna maintains alliances with a wide range of government and commercial partners both in China and internationally, which makes it possible to pursue groundbreaking science and achieve rapid manufacturing scale-up.

BioNTech announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for COMIRNATY 2023-2024 formulation for individuals aged 12 years and older, and granted Emergency Use Authorization for individuals aged 6 months to 11 years for the company's Omicron.n XBB.1.5 COVID-19Vaccine. This season's vaccine provides a single dose for most individuals aged 5 years and above. Children under 5 who have not yet completed a three-dose series with previous COVID-19 vaccine formulations may be eligible for an additional dose of this season's vaccine.

BioNTech is a next-generation immunotherapy company dedicated to developing new treatments for cancer and other serious diseases. The company leverages a broad computational discovery and therapeutic drug platform to rapidly develop novel biopharmaceuticals. Its extensive portfolio of oncology candidates includes personalized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T-cell therapies, several protein-based therapies including bispecific immune checkpoint modulators, targeted cancer antibodies, antibody-drug conjugate (ADC) therapies, and small molecules. Based on its deep expertise in mRNA vaccine development and internal manufacturing capabilities, BioNTech and its partners are advancing multiple mRNA vaccine candidates for a range of infectious diseases, as well as its diversified oncology pipeline.

Source:

1.Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine (modernatx.com)

2.Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine | BioNTech