FDA Authorizes Novavax Covid-19 Vaccine

|


The Novavax’s Covid-19 vaccine has been authorized for adult use. Now, the US Food and Drug Administration (FDA) has reportedly approved it for emergency use for younger adult ages 12-17.

Silvia Taylor, Novavax’s senior vice president global corporate affairs, told CNN “In this age group, overall, the clinical efficacy of the vaccine is around 80%”, whereas it had reportedly shown 90% overall efficiency in adults.

Taylor told CNN “One of the things that we believe makes our vaccine unique is that we actually see really good immune response against variants with our prototype vaccine. And so, if you think about the vaccine that we already have authorized that we’re talking about now to be authorized for adolescents, we actually see a good immune response against variants including Omicron, including BA.1 and BA.5.”

Taylor further added to CNN “We believe fundamentally that people want a choice in the vaccines that they’re able to have for themselves, and especially in this population that we’re talking about for children. So, we think that that kind of reassuring technology platform that’s understood, combined with the high levels of efficacy and the well-tolerated safety profile, can help increase that vaccination number in children.”

“Our intent is to file for authorization of a BA.5-containing bivalent form of a vaccine in the fourth quarter of this year,” Taylor said. “This is consistent with the approach that other manufacturers are following. We would submit that for formal authorization for EUA, just like we did for other indications to the US FDA.”