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.
, 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,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.
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
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Moderna files for FDA approval of updated Covid vaccine for fallModerna said the submission is based on the FDA's recommendation that vaccine makers update their jabs to target omicron subvariant XBB.1.5.
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Moderna seeks US FDA authorization for updated COVID vaccineModerna said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant.
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FDA to test labeling changes by adding nutrition information to front of food packagesNutrition labels on the front of food packages would have the intention of helping people with less nutritional knowledge identify foods that would be part of a healthy eating pattern, the FDA said.
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FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the USU.S. regulators have sent warning letters to dozens of retailers selling fruity disposable e-cigarettes, including the current best-selling brand, Elf Bar
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FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the USU.S. regulators have sent warning letters to dozens of retailers selling fruity disposable e-cigarettes, including the current best-selling brand, Elf Bar. The action Thursday is the Food and Drug Administration's latest attempt to crack down on illegal disposable vapes that have poured into U.S. stores in recent years. The FDA has tried for years to regulate the multibillion-dollar vaping industry. But new illegal products continue to launch. A new separate government report finds there are now 269 different e-cigarette brands sold in the U.S. Elf Bar was the best-selling disposable brand. It comes in fruit and candy flavors that regulators say appeal to underage users.
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FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in U.S.It’s the latest attempt by regulators to crack down on illegal disposable vapes that have poured into U.S. stores in recent years.
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