Moderna Just Made This Major Update for Vaccinated People
The pharmaceutical company is looking to make big changes.
With boosters first approved in fall 2021, it's been some time since many of us got our third shot. Thankfully, COVID has shown a clear decline in the U.S. over the last month. According to the Centers for Disease Control and Prevention (CDC), infections have fallen by more than 28 percent in the last week alone, and hospitalizations were also down by over 27 percent in the same time. But the virus is unpredictable, and there are some signs that a new variant could upend progress. Now, vaccine manufacturers like Moderna are preparing for that possibility.
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On March 17, Moderna announced that it has submitted a request to the U.S. Food and Drug Administration (FDA), asking the agency to amend its emergency-use authorization (EUA) to allow a fourth shot of its COVID vaccine (mRNA-1273) for any vaccinated adults 18 years or older. According to a statement from the pharmaceutical company, its request covers a second booster for all adults regardless of what vaccine they received for their first.
"This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron," Moderna said in its statement.
Pfizer also recently asked the FDA to expand its EUA to allow for another booster on March 15, although its submission only requests that the amendment covers adults over the age of 65. But Moderna doesn't necessarily expect that its submission will translate into an additional shot for all adults immediately.
"The request to include adults over 18 years of age was made to provide flexibility for the U.S. Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities," the company explained.
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Despite both Moderna and Pfizer pushing for a fourth dose approval, health officials are divided on the need for second boosters—much like they initially were for boosters in general. "I'm a strong proponent of giving a second booster now," Peter J. Hotez, PhD, a vaccine expert at the Baylor College of Medicine in Houston, told The New York Times on March 18. "It's clear that protection is waning now pretty quickly a few months after your third dose. So it's short-lived. The hope is that a second booster would restore it."
But experts like Jesse L. Goodman, MD, a former chief scientist for the FDA, question just how much this waning protection is affecting the risk of hospitalization and death, which the first booster shot had "made a huge difference" in bolstering protection against, as Hotez noted.
"While protection is waning against mild infections, without more information we do not yet know to what extent, if any, protection is waning against severe disease," Goodman told The New York Times, adding that it is also not clear "to what degree and for how long another booster might help."
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