FDA Authorizes Coronavirus Booster Shots for All Adults

FDA Authorizes Coronavirus Booster Shots for All Adults

The U.S. Food and Drug Administration today announced that it has issued a marketing authorization for the use of Coronavirine, a new flu vaccine, in adults and pediatric patients 12 years and older. This new Coronavirus booster shot is an improvement over the currently available seasonal flu vaccine because it now protects against Coronavirus Type B (MRSA), the most frequently acquired infection associated with MRSA.

Health professionals have raised concerns about the effectiveness of the current seasonal flu vaccine in preventing the transmission of MRSA. In March, CDC reported that the flu season was a particularly severe one. In fact, influenza and other respiratory illness caused by MRSA may occur in an estimated 98,000 people each year in the United States, of which 50,000 to 100,000 individuals may need hospitalization.

“Coronavirus vaccination, particularly during the upcoming influenza season, provides adults an option to provide protection against this serious and difficult-to-treat infection,” said Thomas J. Farley, M.D., commissioner of the FDA. “Because influenza remains one of the leading causes of serious illness and death in the United States, vaccination remains the most effective way to protect individuals from influenza.”

The FDA tested Coronavirine against an FDA-approved vaccine, namely, the CDC-approved FluMist(R) product. This study indicated that Coronavirine was safe and well tolerated, and that the vaccine was capable of meeting its primary endpoint, namely, protection against three separate strains of influenza that were considered the influenza “hot zones” for the 2017-2018 season. Also, it reduced the amount of bacteria present in nasal secretions among vaccinated adults by 50 to 80 percent.

“This public health decision underscores the importance of taking a comprehensive approach to the public health threats of the rise of resistant pathogens and flu,” said Mark Pletcher, M.D., acting director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Improved protection against influenza is another step toward creating a vaccine system that can effectively protect individuals from the flu, however, it is important to keep in mind that this is a first step in a multi-step process.”

According to current FDA data, there are about 1.9 million cases of severe respiratory illness, approximately 74,000 of which require hospitalization, each year in the United States. These illnesses and hospitalizations can lead to death. In a 2012 CDC study, it was estimated that the annual rate of mortality due to respiratory illness caused by MRSA was approximately 1.4 percent per year, which amounts to approximately 1,500 deaths annually in the United States.

Although not included in the current vaccine, the FDA recommends that every adult receive the recommended annual flu vaccine. In addition, there are no established rules or protocols for a vaccine to be approved for a disease that it is not specifically intended to prevent. The next step will be for the FDA to conduct additional trials to test the safety and efficacy of Coronavirine in older people to ensure that it is protective against STING or simple Staphylococcus aureus.

To obtain this product, consumers should visit https://www.fda.gov/Drugs/DrugSafety/DrugSafetySafety/ucm656358.htm.

Coronavirine contains particles of Glucocel(R) 16m(R), an irradiated virus that originates from the Glucocel Type I strain of coronavirus found in three U.S. Centers for Disease Control and Prevention-identified flu “hot zones”: Panama, South Korea and Vietnam. Coronavirine was licensed by the FDA for use in patients age 12 and older.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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