June 23, 2023 – Moderna has applied for FDA approval of a new COVID-19 vaccine targeting the predominant strain of the virus called XBB.1.5. The company said it is prepared to roll out the shot this fall.
Currently, the XBB lineage of the virus accounts for 95% of all cases, including 27% of cases being XBB.1.5, and 20% of cases being XBB.1.16, according to the CDC’s variant tracker.
In a news release, the company said on Thursday that the new formulation has “a robust immune response,” but did not provide further details about 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 provide a new version of the COVID vaccine for the fall based on a task force’s recommendation for a formulation targeting XBB subvariants. This will be the first of what is expected to be an annual updated COVID vaccine, similar to how the flu vaccine is updated annually.
Moderna said the most common side effects of the new version of its vaccine were injection site pain, headache, fatigue, muscle pain, and chills.
In the past week, 6,649 people were hospitalized in the U.S. for COVID-19, which is a nearly 8% decrease from the week prior. There were 409 COVID deaths last week, measuring a 9% one-week increase. Public health officials are gaging how widespread and harmful the virus is through hospitalization and death rates. During the pandemic’s height, the number of weekly deaths reached 26,000 in January 2021. The CDC now also reports COVID deaths in relation to all other causes of death in the U.S. Last week, COVID deaths made up 1.2% of all U.S. deaths.
It’s unclear what the demand will be for the new version of the vaccine. Just 17% of people in the U.S. chose to get the most recent booster, which was called bivalent because it targeted the original virus as well as Omicron strains, according to CDC data.