FDA authorizes Novavax’s updated Covid vaccine targeting JN.1 strain
The Food and Drug Administration on Friday approved a bivalent Covid vaccine from Novavax, giving the shot an emergency use authorization.
The new formulation is certified for the persons with the age of 12 and over while the vaccine will be aimed at the JN. one strain of the virus.
This was so in spite of the fact that the shares of the company rose by 9 percent by the close of trading in the afternoon.
“Today’s authorization gives the American public an additional Covid-19 vaccine option,” said Peter Marks, the director of the FDA’s CBER.
The company has said the doses are expected to be ready as soon as within the end of the next one week as it responded to emailed questions.
At the beginning of this month, the health regulator endorsed the modernized Covid vaccines developed by Pfizer and Moderna to contain the hitherto unknown KP. 2 variant.
JN. 1 was the predominant strain in the United States earlier this year beginning with the week ending February 7. It is now not as sick as it once was but it is estimated that it contributes to 0. Two percent of cases over the past two weeks up to August 31, according to the Centers for Disease Control and Prevention.
The KP. 2 variant while the second variant is believed to be responsible for 3 percent of the total causes of death. 1%, with KP. 3. 1. 1 now becoming dominant at 42! 2%.
Earlier in June it had switched its strain recommendation for 2024-25 Covid shots as it called on manufacturers to alter the new vaccines to fight the KP. 2 variant, if possible other than using the JN. Earlier it wanted to reach out to only 1 lineage.
Novavax’s shot is a protein-based vaccine as opposed to the mRNA-based vaccines that are Spikevax manufactured by Moderna and Comirnaty developed by Germany’s BioNTech and American pharma major Pfizer.
Coronavirus cases, hospitalizations and death have risen in the last three months in the United States. But the public has demand of them in a much smaller fashion as compared to when the virus was in its height.
Novavax estimated total market size and sales of Covid vaccines in the US to be similar to last year, but its own sales to be higher, it stated in early May.