Bavarian Nordic to test its Covid-19 booster against Pfizer/BioNTech shot in pivotal study
As Bavarian Nordic has made strides recently to beef up its smallpox vaccine manufacturing in the wake of new monkeypox cases, the company is also getting ready to evaluate its Covid-19 booster in a pivotal study. And it’s going after one of the heavyweights.
The Copenhagen-based company announced Thursday morning it will be pitting its Covid-19 booster shot against Pfizer and BioNTech’s booster, redesigning its Phase III study to include the comparator. Bavarian Nordic said the change will not impact its data readout timeline, expected before the end of the year.
If all goes well, Bavarian Nordic hopes to attain approval in 2023, though it didn’t specify where.
It’s not yet clear where the company sees its advantages over the already-authorized Pfizer/BioNTech booster, but the comparator addition represents one of the challenges next-generation Covid-19 vaccine developers will face. The Pfizer booster is already one of the most widely used around the world, making it a practical choice to compare.
But that’s also millions of people who have already received a booster shot who now may not be eligible for a Bavarian Nordic booster. There are a handful of countries who have authorized second boosters for some parts of their populations as well, but Pfizer, Moderna and AstraZeneca continue to have the market advantage.
Bavarian Nordic may also face vaccine hesitancy, as only about 47% of people in the US have received their first booster shot per CDC data, despite the booster being authorized for the general population since last November. There have also been reports of low- and middle-income countries returning their donated Covid-19 shots after being unable to distribute them all.
Nevertheless, Bavarian Nordic and regulatory agencies believe this comparator approach is the best path forward to get more boosters out there. It’s an approach that may soon see much wider uptake, as earlier this week another Covid-19 booster developer, Clover Biopharmaceuticals, announced it would measure its own experimental shot against the Pfizer, AstraZeneca and Sinovac boosters.
Thursday’s news comes after Bavarian Nordic signed multiple contracts with world governments to provide supplies of its smallpox vaccine as monkeypox cases rise. Earlier this week, the EU ordered 110,000 doses of the smallpox shot — which helps defend against monkeypox as well — on top of 500,000 shots sold to BARDA last week.
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