FDA Expected to Expedite Approval Process: Updated COVID-19 Vaccines Could Be Approved This Week

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FDA Expected to Expedite Approval Process: Updated COVID-19 Vaccines Could Be Approved This Week

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FDA Expected to Expedite Approval Process: Updated COVID-19 Vaccines Could Be Approved This Week

The U.S. Food and Drug Administration (FDA) is expected to approve a new batch of updated COVID-19 vaccines as early as this week, aimed at combating the largest summer surge of the virus seen in the U.S. in the past two years.

The FDA is likely to approve updated mRNA vaccines developed by Pfizer/BioNTech and Moderna, targeting the KP.2 variant. However, it remains unclear whether Novavax’s protein-based vaccine will also receive regulatory approval, as it is still under FDA review.

This anticipated approval comes weeks ahead of last year’s vaccine approval on September 11, marking a significant acceleration in the FDA’s approval process. The new vaccines are based on a recommendation from June to adjust the monovalent COVID-19 vaccines to target the Omicron JN.1 variant.

Dr. Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, emphasized the urgency of addressing the current surge in cases. Despite having recently received last season’s vaccine to boost his immunity, he plans to wait four months before getting the updated vaccine, in line with health officials’ recommendations.

According to data from the Centers for Disease Control and Prevention (CDC), levels of SARS-CoV-2 detected in wastewater across the country are at a “very high” level, marking the peak of summer outbreaks in the U.S. since July 2022.

The current virus outbreak is driven by waning immunity and the emergence of new variants. The KP.3.1.1 strain, which now accounts for 37% of cases, has tripled in prevalence over the past month. It is a subvariant of the Omicron JN.1 strain, the target of Novavax’s vaccine, and both are versions of the Omicron variant.

In June, the FDA recommended vaccine manufacturers develop monovalent COVID-19 vaccines adjusted for the Omicron JN.1 variant for the upcoming fall immunization campaign. The expected approval this week reflects a faster authorization process by the FDA, which previously approved a batch of COVID-19 vaccines adjusted for the Omicron XBB.1.5 variant in September 2023.

The CDC recommends that everyone aged six months and older receive the latest COVID-19 vaccine and flu vaccine this year. An FDA spokesperson mentioned that while the agency cannot comment on the timing of product applications, it anticipates timely action to authorize or approve the updated COVID-19 vaccines for release this fall.

Both Pfizer and Moderna have stated that they have ample supplies of the new COVID-19 vaccines and will begin shipping them immediately upon approval, with availability in stores expected within days. In contrast, Novavax’s protein-based vaccine takes longer to produce than mRNA vaccines. Company executives told investors last week that they expect their updated vaccine to reach warehouses this month and be ready for distribution once authorized.

FDA Expected to Expedite Approval Process: Updated COVID-19 Vaccines Could Be Approved This Week

(source:internet, reference only)

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