Michael Minasi / KUT
Moderna is seeking approval for a fourth COVID-19 vaccination shot pending a grant for emergency food from the Food and Drug Administration, the company announced Thursday.
If approved, this will be the second booster shot that Moderna has sent out to people aged 18 and up.
The request to include adults over the age of 18 was made to provide flexibility to the US 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 … “the company said in a statement.
The decision to request an additional dose stemmed from data in the US and Israel on the effects of the Omicron variant, the statement said.
The first dose, which was administered as a pair, was approved by the FDA during emergency use in December 2020, while Modern’s first booster shot was approved for emergency use in November 2021.
The FDA fully approved Moderna’s existing COVID-19 vaccine doses in January.
Dr. Eric Topol, founder and CEO of Scripps Research Translational Institutetold NPR’s Rob Stein that there is enough evidence to move forward with another booster dose.
“We have to get on with this because [there] is a large group of people who have lost their protection against serious illness from Omicron and future variants, “he said.
However, some experts are not sold on the need for another dose right now.
“I think you want really convincing evidence that another booster was necessary and beneficial, and we just do not have that,” said Dr. Jesse Goodman, a former FDA chief researcher. “I do not think we know a booster will ultimately not be required, but we are just not there yet.”
Drugmakers Moderna and Pfizer-BioNTech require two initial doses and then a third shot to protect against COVID-19. Earlier this week, Pfizer and BioNTech sought FDA approval for another booster shot for people 65 and older.