FDA Approves Updated mRNA COVID-19 Vaccines from Pfizer-BioNTech and Moderna Targeting Omicron JN.1-Derived KP.2 Variant
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On August 22 local time, Pfizer, Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) had approved the application for the COVID-19 vaccine for individuals aged 12 and above, and granted Emergency Use Authorization for individuals aged 6 months to 11 years.
On the same day, the FDA also approved the supplemental Biologics License Application (sBLA) for Moderna's Spikevax (2024-2025 formulation), with Emergency Use Authorization (EUA) similarly granted to individuals aged 6 months to 11 years. According to the U.S. FDA’s decision, Moderna's updated vaccine is expected to be available on the market within the next few days.
The new vaccine targets a variant named KP.2, which is the third-generation sub-branch of the JN.1 variant of the Omicron strain of the coronavirus. It is also a sub-branch with strong transmission advantages among the JN.1 variants.
Pfizer and BioNTech's COVID-19 vaccine is based on BioNTech's proprietary mRNA technology and was jointly developed by the two companies. Pfizer noted that the adaptation of the new COVID-19 vaccine KP.2 is based on FDA guidelines, which state that if feasible, KP.2 is the preferred JN.1 lineage strain for use in COVID-19 vaccines in the U.S. during the fall and winter of 2024-2025.
Moderna CEO Stéphane Bancel said, "COVID-19 remains a significant health risk, andRegardless of age or health condition,COVID-19"It is the main reason for hospitalization related to respiratory system diseases. Between 2023 and 2024, we saw over 600,000 people hospitalized due to COVID-19 in the United States. Timely vaccination against COVID-19 remains one of the best ways for people to protect their health and prevent severe illness," "We appreciate the timely review by the U.S. FDA and encourage individuals to discuss with their healthcare providers about receiving the updated COVID-19 vaccine alongside the flu vaccine this fall."
Regarding the recent surge in COVID-19 cases in the United States, the U.S. Centers for Disease Control and Prevention (CDC) stated in its latest update this month: "COVID-19 activity continues to increase in many parts of the United States, with positivity rates for COVID-19 tests, emergency department visits, and hospitalizations related to COVID-19 still on the rise, particularly among adults aged 65 and older and children under the age of 2."
Some experts claim that the rapid outbreak of the epidemic in the U.S. this time was caused by declining immunity and new variants. Currently, the KP.3.1.1 strain accounts for 37% of cases, triple what it was a month ago. It is a branch of the JN.1 strain targeted by Novavax's vaccine and both are versions of the Omicron variant. However, this expedited approval did not authorize Novavax's updated vaccine targeting the JN.1 strain.
The dominant strain in the recent U.S. outbreak is not the strain targeted by the updated Pfizer and Moderna vaccines. However, Pfizer and Moderna claim that their vaccine targeting KP.2 can elicit a stronger immune response and also combat other circulating JN.1 sub-lineages, such as KP.3 and LB.1.
References
FDA Official Website:
1、https://www.drugs.com/newdrugs/moderna-receives-u-s-fda-approval-updated-covid-19-vaccine-targeting-kp-2-variant-sars-cov-2-6358.html
2、https://www.drugs.com/newdrugs/pfizer-biontech-receive-u-s-fda-approval-authorization-omicron-kp-2-adapted-covid-19-vaccine-6359.html
