The United States Food and Drug Administration approved new vaccines from Pfizer and Moderna as hospitalizations are rising due to COVID-19 cases.
The Monday approval was focused on updated COVID-19 vaccines from the pharmaceutical companies and put them on track to get to residents in the next few days. The new shots targeted the Omicron variant XBB.1.5 and were approved for use on people aged 12 or older. The new vaccines were also authorized for emergency use for children aged six months up to 11 years old.
FDA Approves New COVID-19 Vaccines
Despite the authorization, the new vaccines from the two leading pharmaceutical companies will not be available to Americans immediately. An advisory panel of the Centers for Disease Control and Prevention (CDC) is set to meet on Tuesday to vote on a recommendation for using the new shots.
After the health agency's director signs off on the recommendations, the new vaccines will be administered at pharmacies, health clinics, and other vaccine distribution sites across the United States, as per CNBC.
In August, United States President Joe Biden's administration said it was expecting new single-strain vaccines from Pfizer, Moderna, and Novavax that target the XBB.1.5 variant to be available to the general public in mid-September.
On Monday, the FDA did not announce a decision regarding an updated COVID-19 shot from Novavax. However, the pharmaceutical company said in a statement that the agency was still reviewing its vaccine candidate. On the same day, Novavax shares closed nearly 13% lower following the approval of the other updated shots.
The pharmaceutical company's vaccine uses protein-based technology, a decades-old method deployed in routine vaccinations against hepatitis B and shingles. On the other hand, Pfizer and Moderna's vaccines use messenger RNA, which teaches cells how to make proteins that trigger an immune response against the coronavirus.
Rise in Coronavirus Cases
In a statement, top FDA scientist Dr. Peter Marks said that the public can be assured that Pfizer and Moderna's new and updated vaccines have already met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality, according to Reuters.
CDC Director Mandy Cohen's endorsement is expected to come in the next few days and is set to clear the way for the new vaccines. The official said that she expects the jabs to roll out in September.
The authorization of the FDA follows a late summer rise in COVID-19 cases at a time when the new EG.5 subvariant of Omicron, nicknamed Eris, started spreading rapidly across the nation and other countries. Scientists also raised concerns about the highly mutated BA.2.86 subvariant detected in several countries worldwide.
With the rise of COVID-19 cases, the trifecta of preventive measures could portend the first winter of the decade without a crush of patients that is overwhelming some hospitals. However, a healthier winter is somewhat difficult to achieve as only 20% of adults in the US got the COVID-19 vaccine in the past year, said the New York Times.
