Moderna Inc has applied to the US Food and Drug Administration (FDA) for authorisation of a second COVID-19 booster shot for adults 18 and older.
This would be Moderna’s second booster shot for people 18 and up, if approved.
The move comes in the wake of Pfizer Inc (NYSE:PFE) (Pfizer Inc (NYSE:PFE)) and German biotech partner BioNTech SE seeking an emergency use application by the US FDA for a second COVID-19 booster shot for people 65 and older.
“The request to include adults over 18 years of age was made to provide flexibility for 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…” Moderna said in a statement.
Data from the US and Israel on the effects of the Omicron variant led to the decision to request an additional dose, the company added.
Research published in the New England Journal of Medicine determined that a fourth dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine was safe and significantly boosted antibody levels.
Some countries have already begun offering fourth doses of COVID-19 vaccines due to fears over a new outbreak of the virus.
In the United States, fourth vaccine doses are authorised only for people with weakened immune systems.
CDC data shows that vaccine efficacy decreases over time and a third shot helps restore it, but it hasn’t released comprehensive age and health data to support this claim.
