The Food and Drug Administration (FDA), a US agency similar to Anvisa, has authorized the emergency use of Novavax’s Covid-19 vaccine in adolescents. This is the fourth coronavirus vaccine available in the United States and, unlike the others, uses protein-based technology.
The immunizer was authorized for use in adults in July. It will now also be available with two doses for teens aged 12 to 17.
In this age group, “overall, the clinical efficacy of the vaccine is around 80%,” said Silvia Taylor, senior vice president of global corporate affairs at Novavax. The vaccine showed 90% overall efficacy in adults.
Novavax announced in early July that the vaccine shows a “broad” immune response to currently circulating variants, including the Omicron subvariants BA.4 and BA.5.
“One of the things that we believe makes our vaccine unique is that we actually see a very good immune response against variants. So if you think about the vaccine that we’ve already authorized and that we’re talking about now that will be authorized for teenagers, we actually see a good immune response against 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 small, modified parts of the virus that the vaccine targets. The immunizer was created from a genetic sequence of the original strain of the coronavirus. The technology is also used for vaccines for diseases such as hepatitis B and whooping cough.
Taylor said to CNN that having a protein-based coronavirus vaccine available helps give teens more options.
About 60% — or 15.2 million — of all 12- to 17-year-olds in the U.S. are fully vaccinated against Covid-19, according to the U.S. Centers for Disease Control and Prevention.
“We fundamentally believe that people want a choice in the vaccines they can get for themselves, and especially in this population that we’re talking about for children,” Taylor said. “So we think that this kind of reassuring technology that is understood, combined with the high levels of efficacy and the well-tolerated safety profile, could help increase the number of vaccinations in children.”
With the approval of emergency use in teens, Novavax now plans to have trial data on vaccine use among children under 12.
“We recently started a trial that we’re calling ‘Hummingbird,’ which is a Phase 2b/3 study of effectiveness, and it’s also clearly looking at safety, and it will have three age cuts,” Taylor said, referring to groups of children aged 6 to 11 years, 2 to 5 years and 6 months to 23 months.
“In the first group of children, this experiment has already started, and this is for children aged 6 to 11 years old,” Taylor said. “We expect these results in early 2023.”
Novavax is working on an updated version of its vaccine that specifically targets the Ômicron variant and its subvariants – the company may apply for authorization later this year.
“Our intention is to apply for authorization of a bivalent BA.5-containing form of a vaccine in the fourth quarter of this year,” Taylor said.
“This is consistent with the approach that other manufacturers are taking,” he added.
Source: CNN Brasil
