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Novavax wins approval for its COVID vaccine from the FDA

Novavax cleared its COVID-19 vaccine for adolecent use in the US by FDA.

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On Friday, the FDA approved Novavax’s COVID-19 vaccine for immediate use in adolescents, making it possible to increase access to the fourth licensed vaccine in the country.

As an alternative to Pfizer and Moderna’s mRNA technology, the two-dose regimen uses protein-based technology that has been successfully applied in vaccines against other viruses.

After receiving approval from the CDC, providers can start giving the vaccine to people aged 12–17. The vaccine has already been approved for use in adults. Three weeks separate the two administrations.

As we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season, having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted, will hopefully help increase vaccination rates,” said Novavax President Stanley Erck in a statement.

Since many parents and caregivers are already familiar with protein-based vaccines from their use in other disease areas, “we hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination.”

The company claimed a primary efficacy rate of 78% in its trial of 2,247 adolescents, which persuaded the FDA to approve emergency use for adolescents.

Last year, when the Delta variant was more common in the United States, Novavax ran the trial. The White House has maintained its call for vaccination and boosters in the face of the spread of the BA.4 and BA.5 subvariants of omicron, but it is unclear how these mutations might affect the vaccine’s effectiveness.

Earlier this month, the FDA gave the go-ahead for Novavax’s vaccine for adults, and about a week later, the CDC gave their approval.

On Wednesday, White House coronavirus response coordinator Ashish Jha said that updated COVID-19 vaccine doses for everyone over the age of 12 are expected to be approved by regulators in “a few short weeks.” The two omicron subvariants in circulation will be the primary targets of the assault.

Injecting doses of the coronavirus spike protein, as in Novavax’s COVID-19 vaccine, can help humans avoid life-threatening illness.

The company uses an insect virus to produce the spike protein, which then replicates after infecting moth cells. Following replication, the manufacturer extracts and purifies the replicated spike proteins for human injection.

When compared to the cold storage conditions required by mRNA vaccines like those produced by Pfizer and Moderna, this method only requires regular refrigeration. These vaccines instruct human cells to produce the spike protein, which acts as a defense against new infections.

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