The Food and Drug Administration gave emergency use authorization on Tuesday to Novavax’s new Covid vaccine designed to target the coronavirus’ dominant XBB sublineage, which is fueling a spike in cases, hospitalizations and deaths across the country.
At $130 a dose, the vaccine was approved for those 12 years and older—for those already vaccinated with any vaccine, one dose can be given at least two months after a person’s last Covid shot, and two doses administered three months apart can be given to the unvaccinated.
Novavax’s approval follows the approval of Moderna and Pfizer-BioNTech’s monovalent vaccines targeting new coronavirus variant, which were also given emergency use authorization last month by the FDA for those six months and older.
This comes after the agency encouraged Moderna, Pfizer and Novavax to create new monovalent vaccines that target the XBB lineage, which makes up the majority of the variants circulating in the U.S.
The Novavax vaccine received approval from an advisory committee of the Centers for Disease Control and Prevention last month, though it still awaits approval from the agency’s director.
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Though most insurance companies are expected to cover the cost of Covid boosters, the CDC’s Bridge Program is set to launch this fall, providing Covid vaccine coverage to the uninsured.
Covid-related deaths and hospitalizations have increased since the start of the summer and are expected to keep rising as fall and winter kick into gear. Deaths increased by 8% between September 17 and September 23, and hospitalizations stood at 19,079 during this period, according to the CDC’s most recent data. EG.5, or the “Eris” variant—part of the XBB lineage—is the dominant strain in the U.S., making up 29.4% of all cases between September 17 and September 30. As of June, the XBB omicron subvariants made up 95% of all Covid cases in the U.S., according to an FDA report. The existing bivalent boosters offer about 50% protection against XBB variants in most adults and about 33% protection in those 65 years and older, according to a January study conducted by the CDC. Moderna said its new booster may be effective at protecting against the Eris variant, Novavax said its shot provided a broad immune response against Eris in small animals and Pfizer reported its new shot protected against the variant when tested on mice. Because the current bivalent boosters don’t specifically protect against XBB, some experts recommend waiting until the new monovalent boosters release before getting an updated shot.
An earlier round of updated Covid boosters provided additional protection against previous variants, but only 17% of the U.S. has received at least one booster.
A new Covid variant called BA.2.86, or “Pirola,” is a descendant of the BA sublineage and has begun circulating in the U.S. Although there aren’t enough cases for it to appear on the CDC’s variant tracker, the World Health Organization has labeled it as a variant under monitoring. This is because Pirola has 36 more mutation spikes than XBB.1.5—the dominant strain in the U.S. earlier this year—and 34 additional mutations compared to BA.2. Pirola isn’t a descendant of the XBB sublineages, so there may be concern they won’t protect against Pirola. However, Moderna said Wednesday its new booster provided an 8.7-fold increase in neutralizing antibodies against Pirola in its clinical trial.