Bavarian Nordic is making waves with its monkeypox vaccine, but don’t forget the company also has a COVID-19 booster shot in the works, and it’s apparently headed for a big phase 3 showdown.
The Scandinavian biotech plans to put its shot, called ABNCoV2, up against Pfizer and BioNTech’s Comirnaty in a phase 3 trial slated to start in August.
ABNCoV2 is a capsid virus-like particle vaccine, originally developed by Danish company AdaptVac, and licensed by Bavarian Nordic. The shot has previously shown it can stand up to the omicron variant and that it boosts antibodies against ancestral SARS-CoV-2 when given as a booster during phase 2 testing.
Bavarian Nordic, on the strength of that data, moved to take the shot into phase 3. But today’s update revealed a redesign for that study, which was originally vaguely worded to pit ABNCoV2 against an mRNA vaccine to show whether the investigational candidate is non-inferior to a licensed product. The trial was expected to include 4,000 people.
Many of those details are the same, but Bavarian Nordic is instead planning the trial as a comparator study against just Comirnaty. The company wants to see whether the neutralizing antibodies spurred by ABNCoV2 match the Pfizer-BioNTech product.
Bavarian Nordic said this redesign was made possible in cooperation with regulatory authorities and vaccine manufacturers.
“We are pleased to be able to run the phase 3 trial of ABNCoV2 as a double-blind, controlled study, which provides us with a more robust foundation for the regulatory process towards approval,” said Paul Chaplin, president and CEO of Bavarian Nordic.
The study will be double-blinded, meaning neither participants nor the researchers will know which jab is being administered until the trial is over. The 4,000 subjects to be enrolled must have had a primary series or a booster with a licensed vaccine. The group will be split into two, with 1,000 people randomized to receive a single dose of Bavarian Nordic’s or Pfizer-BioNTech’s shot. The remaining 3,000 participants will receive a dose of ABNCoV2.
Bavarian Nordic said the overall timeline has not changed for the planned study, even though initiation has slipped from the first half of the year to August. The company is still expecting an initial read out by the end of the year with a rolling submission to regulators to follow. Bavarian Nordic is hopeful a regulatory approval can be obtained in 2023.
Development of ABNCoV2 is being funded by the Danish government.
There's plenty of competition in the booster market, despite the dominance of Comirnaty and Moderna's rival mRNA shot Spikevax. Sanofi and GSK recently posted some data on their combined booster candidate, showing it induces a stronger response against the omicron variant than first-generation products.