Bavarian Nordic's COVID shot vanquished by variant vulnerability as phase 3 data reveal flaw
01 Sep 2023
VaccinePhase 3Phase 2Clinical Result
Preview
Source: FierceBiotech
Bavarian Nordic’s candidate appears to be less effective against the omicron XBB.1.5 subvariant than the original version of Pfizer's Comirnaty.
Bavarian Nordic’s vision of ending the COVID-19 vaccine adaptation cycle is over. The Danish drugmaker found its phase 3 trial data support the need for variant-specific vaccines and, because its shot cannot be adapted quickly, has accepted the candidate “no longer represents a commercial opportunity.”
Copenhagen, Denmark-based Bavarian Nordic was a late entrant to the COVID-19 vaccineCOVID-19 vaccine race, picking up the right to a capsid viruslike particle candidate in July 2020 and, after initially aiming to win approval in 12 to 18 months, pivoting to a plan focused on boosters. As Moderna and Pfizer sewed up that market, Bavarian Nordic clung to evidence its candidate could provide broader, more durable protection.
The phase 3 data torpedoed Bavarian Nordic’s plans. The study met its primary objective—noninferiority to Pfizer and BioNTech's Comirnaty in terms of neutralizing antibodies against the original SARS-CoV-2 virus—but the changes to the pathogen since it emerged in 2019 meant the variant data would be key to commercial success.
Bavarian Nordic’s variant analysis suggests that, rather than providing broader protection, its candidate is less effective against the omicron XBB.1.5 subvariant than the original version of Comirnaty. While 85% of the recipients of Comirnaty had detectable antibodies against XBB.1.5, only 64% of their counterparts who received Bavarian Nordic’s candidate, ABNCoV2, had detectable antibodies.
“These data support the current position of many of the regulators that request variant-specific COVID vaccines that will likely have to be adapted each year like flu vaccines,” Bavarian Nordic said in a statement. “Unfortunately, ABNCoV2 cannot be readily adapted within the seasonal timeframe and as such ABNCoV2 no longer represents a commercial opportunity for Bavarian Nordic.”
The company will run a six-month follow-up analysis to evaluate the durability of the responses. Bavarian Nordic said that, if the analysis confirms the phase 2 data, it may show ABNCoV2 has an advantage over Comirnaty.
While that advantage would mean little in the context of COVID-19, Bavarian Nordic said the program may support the use of its vaccine platform in future pandemics. The company plans to talk to regulators about “how best to leverage the learnings from this development program.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Drugs
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.