Novavax, Inc. has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17.
"We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19," said Gregory M. Glenn, M.D., President, Research and Development, Novavax. "The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population."
All PREVENT-19 trial participants aged 12 through 17 are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.
Findings from the pediatric expansion of the PREVENT-19 pivotal Phase 3 trial were announced in February.
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