Bavarian Nordic Drops COVID Booster After Poor Phase III Results
01 Sep 2023
VaccinePhase 3Drug ApprovalEmergency Use AuthorizationClinical Result
Pictured: Syringe drawing up drug from vial/iStock, Kuzmik_A
Bavarian Nordic is dropping its experimental, Phase III COVID-19 booster after clinical data showed limited effectiveness against new and emerging variants of concern.
The Danish company announced that despite its COVID booster ABNCov2 demonstrating non-inferior levels of neutralizing antibodies as compared to Pfizer’s Comirnaty against the SARS-CoV-2 variant, the original COVID virus, the company would nevertheless not be pursuing commercialization of the vaccine.
“In a follow-up analysis, when looking at this more distant variant, the levels of neutralizing antibodies induced by ABNCoV2 were lower than those stimulated by the non-adapted Wuhan-based Comirnaty, and fewer people had detectable antibodies following ABNCoV2 (64%) versus Comirnaty (85%),” the company said.
The booster’s commercial viability was called into question because the new variants, such as XBB.1.5, are now the primary variants of concern. Bavarian Nordic said that the data “support the current position of many of the regulators (e.g. FDA, EMA and WHO) that request variant-specific COVID vaccines that will likely have to be adapted each year like flu vaccines,” and that “unfortunately, ABNCoV2 cannot be readily adapted within the seasonal timeframe and as such ABNCoV2 no longer represents a commercial opportunity for Bavarian Nordic.”
The capsid virus-like particle (cVLP) platform-based vaccine may have proven a commercial dead-end for the company, but Bavarian Nordic isn’t giving up on the platform itself. Though it is “not suitable for quick adaptations to emerging variants,” the company noted, “the data generated in the overall development of ABNCoV2 may support the use of the cVLP platform in future pandemics, and the company will discuss with the authorities how best to leverage the learnings from this development program.”
The news comes amid a push from other vaccine makers looking to get their boosters ready in time for the fall vaccination season. Reuters reported Friday that Pfizer’s updated vaccine targeting the XBB.1.5 variant, Comirnaty, has just been approved by the EU, the third such adapted shot to be adopted there.
Similarly, Novavax has been pinning its future hopes on an updated COVID vaccine, which has shown promising results against the XBB.1.5 variant as well as the emerging XBB.1.16.6 variant. The company’s vaccine was never approved or authorized by the FDA, instead only being authorized for emergency use well after Pfizer and Moderna were able to largely corner the market.
The two COVID-19 mainstays have also been adapting to the new variants. Both Pfizer and Moderna announced that their respective updated vaccines are showing responsiveness to the new variants, as they gear up for the fall vaccination season.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
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