FDA clears Novavax Covid-19 vaccine for emergency use in 12-17 year olds

In this age group, “overall, the clinical efficacy of the vaccine is around 80%,” said Silvia Taylor, senior vice president of corporate affairs for Novavax. The vaccine has shown an overall efficacy of 90% in adults.

Novavax announced in early July that its vaccine showed a “broad” immune response to currently circulating variants, including the Omicron BA.4 and BA.5 subvariants.

“One of the things that we think makes our vaccine unique is that we’re actually seeing a very good immune response against variants with our prototype vaccine. And so if you think about the vaccine we already have cleared and which we’re now talking about being cleared for adolescents, we’re actually seeing a good immune response against variants, including Omicron, including BA.1 and BA.5,” Taylor said.

Protein-based vaccines use a more traditional approach than mRNA vaccines, teaching the immune system to recognize the small, modified pieces of virus that the vaccine targets. In this case, that means fragments of the coronavirus spike protein. The vaccine was created from a genetic sequence of the original strain of the coronavirus.

This technology is also used for vaccines against diseases such as hepatitis B and whooping cough.

Taylor told CNN that the availability of a protein-based coronavirus vaccine helps give teens more options.

About 60% – or 15.2 million – of all 12 to 17 year olds in the United States are fully vaccinated against Covid-19, according to the United States Centers for Disease Control and Preventionfrom Friday.

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

Next, Novavax plans to have trial data on the use of the vaccine in children under 12 years of age.

“We recently started a trial which we call Hummingbird, which is a phase 2b/3 trial, and which is going to be an efficacy and efficacy trial and also clearly looking at safety, and which will have three age cohorts “, Taylor says, referring to groups of children ages 6 to 11, 2 to 5, and 6 months to 23 months.

“The first cohort of children, this trial has already started, and it’s for children ages 6 to 11,” Taylor said. “We expect these results in early 2023.”

Novavax is working on an updated version of its vaccine that specifically targets the Omicron coronavirus variant and its subvariants — and the company could seek approval later this year, she said.

“Our intention is to seek authorization for a bivalent form of vaccine containing BA.5 in the fourth quarter of this year,” Taylor said.

“This matches the approach taken by other manufacturers,” she said. “We would submit this for formal clearance for EUA, just as we have done for other indications to the US FDA.”

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