It’s Baaack! FDA Approves Omicron Booster Shots Without Human Trials

After the failure of the mRNA vaccines to prevent infection and transmission of COVID-19, the U.S. Food and Drug Administration announced Wednesday it has granted emergency use authorization for boosters that target the predominant omicron variant.

The FDA said it is authorizing a “single booster dose at least two months following primary or booster vaccination.”

The “updated boosters,” the agency said in a statement, contain “two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”

The reference is to two, highly contagious major subvariants of omicron that have produced mild symptoms in most people infected with the virus, regardless of vaccination status.

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In fact, studies and real-world data indicate people who have been vaccinated for COVID-19 have a greater chance of infection, hospitalization and death.

Nevertheless, FDA Commissioner Robert Califf claimed in the statement that “the COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19.”

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” he said.

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The omicron Moderna boosters are authorized for individuals 18 years or older. The Pfizer-BioNTech doses are for those 12 years or older.

The FDA predicts the BA.4 and BA.5 subvariants will “circulate this fall and winter.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency has “worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.”

Marks was at the center of the resignations of the two top FDA scientists one year ago, Marion Gruber and Philip Krause, Politico reported. The news site cited a former FDA official who said the two officials quit because they were angered by the agency’s lack of autonomy regarding its approval of the vaccines.

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