Pfizer, Moderna, and Novavax Gear Up for XBB.1.5 Strain Targeted Vaccines as FDA AdCom Unanimously Support

Thursday, the FDA's Vaccines and Related Biological Products Advisory Committee all 21 members voted "Yes," recommending that updated monovalent COVID shots in the fall and winter targeting the XBB variants, which are now the dominant strains of the SARS-CoV-2 virus in the world.

The agency dropped the original coronavirus strain (Wuhan strain) from the formulation.

Since earlier this year, the XBB lineage has dominated infections across the United States and the world, starting with XBB.1.5 and now seemingly evolving toward XBB.1.16 and XBB.2.3.

Pfizer Inc's PFE presentation at the FDA meeting indicated that targeting a single strain of XBB would be the most effective approach based on the latest data. The pharma giant is collaborating with BioNTech SE BNTX for COVID-19 vaccines targeting XBB.1.5 strains.

In line with these findings, a panel from the World Health Organization recommended in May that vaccine manufacturers focus on developing shots for the XBB.1 strains. 

Moderna Inc MRNA also expressed its ability to supply a new vaccine later this year, supporting the WHO's recommendation.

Novavax Inc NVAX shared its plans to have a vaccine targeting the XBB.1.5 strain ready for distribution in the fall. 

In documents released this week, FDA staff reviewers said available evidence suggests this year's shots should target an XBB subvariant.

Reuters noted that if XBB.1.5 is chosen as the target for this year's campaign, it will benefit Novavax, as their protein-based vaccine takes longer to manufacture than rival mRNA-based shots. If the FDA chose a different target, Novavax could again find itself playing catch up to rivals.

The companies presented the preclinical data at the meeting.

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