Previous vaccine trials conducted by CoVPN and its collaborators at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), as well as others, demonstrated the power of antibody markers in Moderna’s mRNA and Johnson & Johnson’s Ad26 vaccines.
Now, the same has been shown for Novavax’s COVID-19 vaccine candidate, and Gilbert and colleagues believe it could have a profound impact on the supply of future vaccines and boosters. An FDA advisory committee voted 21-0 on June 7 to recommend that FDA authorize the vaccine, but it is still under review. Outside the U.S., Novavax’s COVID vaccine has an emergency-use listing by the World Health Organization, is conditionally authorized by the European Commission and has approval or emergency-use authorization in more than 40 countries.
Gilbert notes that an FDA advisory meeting on June 28 will discuss recommendations about potential vaccine strain changes for new vaccines to be deployed in the fall, when another COVID surge is expected.
With fall just around the corner, vaccine manufacturers could be challenged to make enough vaccines to meet national and global supply needs, he points out. Adding new options from manufacturers of recombinant protein vaccines could help prevent potential shortages.
Currently approved COVID vaccines use the original ancestral strain, and their protection level has diminished over time as variants have emerged that are increasingly able to evade vaccine antibodies, Gilbert explains.
“These new correlates results provide important context for the upcoming FDA discussion, as they support use of an antibody marker for guiding strain-selection decisions for recombinant protein vaccines to bolster the supply of COVID vaccines,” he says.