Moderna Inc on Tuesday applied for US approval for its COVID-19 booster vaccine against the Omicron BA.4 and BA.5 subvariants, and said if approved it would be ready to deliver doses in September.

Its application to the US Food and Drug Administration (FDA) is based on preclinical data for a so-called bivalent dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain.

Moderna said mid- to late-stage trials of the vaccine are underway.

The presentation also includes clinical trial data for Omicron’s BA.1 divalent enhancer, which was approved in Britain last week.

Moderna’s announcement comes a day after rival Pfizer Inc and German partner BioNTech applied to the US for approval of their vaccine booster, reengineered to target the Omicron BA.4/BA.5 subvariants.

Pfizer’s app is intended for emergency use by people aged 12 and over, while Moderna has requested approval for use by people aged 18 and over.

Pfizer said the doses would be ready to ship immediately after regulatory approval.

Moderna is also ramping up production of the BA.4 and BA.5 vaccines to be ready for delivery next month.

Countries including the United States, Great Britain and EU members are preparing for vaccination campaigns in the autumn season to protect against future surges.

In June, the FDA asked vaccine makers to adjust shots for the two dominant subvariants and said it would not require studies testing the shots in humans for approval, similar to how annual flu vaccine changes are handled.

In human and preclinical testing, Moderna’s two booster shots against BA.1, as well as the BA.4 and BA.5 subvariants, demonstrated strong neutralizing activity compared to the booster against the original strain of the coronavirus, the company said.

Source by [author_name]

Previous articleCKay makes exciting music announcements
Next articleGCSE results will reflect the different effects of the pandemic, the headteachers’ union says | GCSE