FDA authorizes Novavax Covid-19 vaccine for emergency use in ages 12-17
Novavax introduced in early July that its vaccine reveals “broad” immune response to at the moment circulating variants, together with the Omicron subvariants BA.4 and BA.5.
“One of many issues that we imagine makes our vaccine distinctive is that we really see actually good immune response in opposition to variants with our prototype vaccine. And so, if you concentrate on the vaccine that we have already got licensed that we’re speaking about now to be licensed for adolescents, we really see immune response in opposition to variants together with Omicron, together with BA.1 and BA.5,” Taylor stated.
Protein-based vaccines use a extra conventional method than mRNA vaccines, educating the immune system to acknowledge little modified items of the virus that the vaccine is focusing on. On this case, which means fragments of the coronavirus spike protein. The vaccine was created out of a genetic sequence of the unique pressure of the coronavirus.
This know-how can also be used for vaccines for situations equivalent to hepatitis B and pertussis.
Taylor advised CNN that having a protein-based coronavirus vaccine obtainable helps give adolescents extra choices.
“We imagine essentially that individuals desire a alternative within the vaccines that they are in a position to have for themselves, and particularly on this inhabitants that we’re speaking about for kids,” Taylor stated. “So, we predict that that form of reassuring know-how platform that is understood, mixed with the excessive ranges of efficacy and the well-tolerated security profile, might help enhance that vaccination quantity in kids.”
Subsequent, Novavax plans to have trial information on utilizing the vaccine amongst kids youthful than 12.
“We not too long ago initiated a trial that we’re calling Hummingbird, which is a Part 2b/3 trial, and that is going to be an effectiveness and efficacy trial and in addition clearly be security, and that may have three age cohorts,” Taylor stated, referring to teams of kids ages 6 to 11, ages 2 to five, and 6 months to 23 months.
“The primary cohort of children, that trial was already initiated, and that is for teenagers 6 to 11,” Taylor stated. “We anticipate these ends in the early a part of 2023.”
Novavax is engaged on an up to date model of its vaccine that particularly targets the Omicron coronavirus variant and its subvariants — and the corporate may file for authorization later this 12 months, she stated.
“Our intent is to file for authorization of a BA.5-containing bivalent type of a vaccine within the fourth quarter of this 12 months,” Taylor stated.
“That is in keeping with the method that different producers are following,” she stated. “We might submit that for formal authorization for EUA, identical to we did for different indications to the US FDA.”
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