The Food and Drug Administration (FDA) has made an unexpected decision to prioritize the development of a new Covid-19 vaccine targeting the KP.2 variant. This comes despite the agency's own committee of experts recommending the JN.1 variant just a week prior.
The decision was influenced by increasing Covid-19 cases in some regions of the United States. Dr. Peter Marks, head of the FDA’s vaccine regulations department, emphasized the need for the 'freshest' vaccine available, drawing an analogy to purchasing fresh milk. The KP.2 variant now represents 22.5% of new Covid-19 cases in the US, with its sister variant, KP.3, accounting for 25%.
Following the decision, the FDA has directed Pfizer and Moderna, both of which use mRNA technology, to expedite the production of vaccines targeting KP.2. Novavax, which employs a protein-based vaccine approach that requires longer manufacturing times, indicated it might only manage a JN.1 vaccine in time for the fall.
The FDA's announcement underscores a significant shift in strategy, as this marks the third revision of Covid-19 vaccines to combat evolving strains. The new vaccine rollout is expected as part of a nationwide vaccination campaign this autumn, akin to the annual updates for flu vaccines.
Data presented during the advisory committee meeting indicated that a JN.1 vaccine would produce higher antibody levels against circulating strains than the current XBB.1.5 targeted vaccine, which is no longer in circulation. However, the FDA assessed that the current dominance of KP.2 warranted a change in strategy.
In Italy, despite a slight increase in Covid cases, hospitalization rates remain stable. Weekly monitoring by the ISS and the Ministry of Health reported around 1800 new cases, a minor rise from the previous week. The occupancy rates of hospital beds and intensive care units also remained unchanged.
- The occupancy of beds in the medical area in Italy was 1.0% as of June 12, 2024, stable compared to the previous week. Similarly, intensive care bed occupancy was 0.3%.
- The FDA's ongoing monitoring and flexible adaptation to emerging strains reflect a broader and more dynamic approach to dealing with the Covid-19 pandemic. The quick pivot to KP.2 aims to enhance the effectiveness of the nation’s immunization strategy.
- The Centers for Disease Control and Prevention (CDC) will later determine the recommendations on who should receive the updated vaccine. This decision will follow a meeting of their advisory committee expected later this month.