
Moderna seeks FDA authorisation for fourth COVID-19 jab for adults
pharmafile | March 18, 2022 | News story | Medical Communications |
Moderna has requested an EUA from the FDA for a fourth dose of its COVID-19 vaccine, as a booster for people 18 and over.
As it stands, a single booster dose of Moderna’s mRNA vaccine is authorised for emergency use in addition of its two-dose vaccine. The request comes two days after Pfizer and its collaborator BioNTech requested federal permission to provide an additional booster dose of their COVID-19 vaccine Comirnaty to people 65 and older.
Moderna said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention, along with medical providers, to determine the “appropriate use” of a second booster dose. The request is based partly on recently published data from the US and Israel, following the emergence of the omicron variant.
The FDA has not said how long it will take to review either request.
The company did not specify what the US and Israeli data showed, but Israel approved a fourth COVID-19 jab for vulnerable people over the age of 18 in January 2022. A study of more than one million Israelis over 60 showed that those who got a fourth dose of the Pfizer-BioNTech vaccine were half as likely to become infected and four-times less likely to become seriously ill than those who had only three shots. However, this has not yet been peer-reviewed.
The FDA has not said how long it will take to review either request.
Lina Adams






