Moderna Submits FDA Application for Omicron BA.4/BA.5 Bivalent COVID-19 Booster Vaccine

Intelligent Finance APP learned that Moderna (MRNA.US) submitted an authorization application to the FDA on Tuesday for its Omicron BA.4 and BA.5 bivalent COVID-19 vaccine booster, and stated that if approved, delivery would begin in September.

The application is based on preclinical data of the bivalent dose, which includes the major BA.4/BA.5 variants and the original coronavirus strain. Moderna stated that the mid-to-late stage trials of the vaccine are currently underway. The submission also includes clinical trial data of its Omicron BA.1-targeted bivalent vaccine, which was approved last week in the UK for adult booster vaccinations.

On Monday, Pfizer (PFE.US) and BioNTech (BNTX.US) submitted an authorization application to the FDA regarding the reformulated Omicron BA.4/BA.5 bivalent COVID-19 vaccine booster. Pfizer stated that it would be ready to ship immediately after regulatory approval. Countries including the UK, the US, and EU member states have been preparing for fall vaccination campaigns to prevent a surge in cases.

In this application, the Pfizer vaccine is applicable to individuals aged 12 and above, while the Moderna vaccine is suitable for those aged 18 and above.

Moderna stated that the booster shots targeting BA.1 as well as BA.4 and BA.5 subvariants showed strong neutralizing activity in experimental results compared to the booster shots targeting the original coronavirus strain.