- The European Medicines Agency (EMA) on Monday (12 September) recommended the authorisation of an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2 as a booster shot.
- Subsequently, CHMP looked at the available data on Comirnaty and its adapted vaccines, including the recently authorised adapted vaccine Comirnaty Original/Omicron BA.1 as well as investigational vaccines against other variants of concern.
- On 31 August, the US Food and Drug Administration (FDA) amended the emergency use authorisations of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine targeting the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
EMA recommends booster vaccine targeting COVID-19 subvariants for approval
