"The groundwork of all happiness is health." - Leigh Hunt

Moderna asks FDA to approve XBB COVID vaccine

June 23, 2023 – Moderna has filed an application with the FDA for approval of a brand new COVID-19 vaccine targeting the predominant virus strain called XBB.1.5. The company said it's able to bring the shot to market this fall.

Currently, 95% of all cases are of the XBB lineage of the virus, of which 27% are XBB.1.5 and 20% are XBB.1.16, in keeping with the CDC. Variant tracker.

In a Press releaseThe company said Thursday that the brand new formulation produced “a robust immune response,” but didn't provide further details on the vaccine's effectiveness in trials.

Moderna and fellow vaccine makers Pfizer and Novavax began developing the XBB.1.5 formulations a month and a half ago. CNBC reported.

Last week, the FDA asked manufacturers to offer a new edition of the COVID vaccine for the autumn, based on a task force advice for a formulation that targets XBB subvariants. This will likely be the primary of what are expected to be annually updated COVID vaccines, just like how the flu vaccine is updated annually.

According to Moderna, essentially the most common unwanted effects of the new edition of its vaccine are pain on the injection site, headache, fatigue, muscle aches and chills.

Last week, 6,649 people were hospitalized for COVID-19 within the U.S., down nearly 8% from the previous week. Last week, there have been 409 COVID deaths, up 9% in a single week. Public health officials use hospitalization and death rates to measure how widespread and harmful the virus is. At the peak of the pandemic, weekly deaths reached 26,000 in January 2021. The CDC also now reports COVID deaths relative to all other causes of death within the U.S. Last week, COVID deaths accounted for 1.2% of all U.S. deaths.

It is unclear how much demand there will likely be for the new edition of the vaccine. Only 17% of individuals within the U.S. opted for the most recent booster shot, which was called bivalent since it fought each the unique virus and omicron strains, in keeping with CDC data.