Moderna stated Thursday that it is seeking clearance for a fourth COVID-19 immunization shot, pending a request for emergency authorization usage from the Food and Drug Administration.
Moderna, a biotechnology firm, asked the Food and Drug Administration on Thursday to enable adults 18 and older to receive a second booster dose of the company’s mRNA vaccine, citing worries that the vaccinations’ immune protection wears off with time.
Pfizer and its German partner, BioNTech, applied for FDA approval for a second booster shot for those 65 and older earlier this week, but Moderna’s application is much broader.
The applications by the manufacturers of the two messenger RNA vaccines, which account for nearly all of the vaccinations distributed in the United States, are bound to exacerbate the dispute about the longevity of the coronavirus vaccines’ protection — a matter that has divided the scientific community.
Both Pfizer-BioNTech and Moderna have stated that their demands for a second booster dose are based in part on recent Israeli data showing lower vaccination efficacy during the omicron outbreak. Moderna is still undertaking clinical studies for an omicron-specific booster shot, which was initially reported by the New York Times.
Studies and real-world data demonstrate that booster protection against severe sickness and death lasts for several months but fades against infections.
In a recent interview, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said that data from the United States shows that protection against severe illness remains strong four to five months after a booster, though effectiveness drops slightly from 91 percent to 78 percent.
Moderna said in a statement on Thursday that it requested that the second booster shot be made available to all adults in order to offer the Centers for Disease Control and Prevention and clinicians greater freedom in determining whether individuals would benefit from a second dose of the vaccine.
The FDA’s decision might be made quickly if officials determine that the evidence is straightforward and does not require assessment by a panel of outside vaccine experts. After that, CDC advisers would weigh in on who should be eligible for a second booster shot, with the CDC director having the final say.
After receiving emergency use authorization in December 2020, the two-dose Moderna vaccine obtained full FDA approval for adults in January. In November, the FDA approved a booster shot of the messenger RNA vaccinations.
The business claimed in a statement that “real-world evidence continues to validate the effectiveness and excellent safety profile of the Moderna COVID-19 vaccine.”