Pfizer and German partner BioNTech said on Monday that they have applied for US authorization for a Covid-19 vaccine modified to target sub-variants of Omicron. The request to the Food and Drug Administration was for a so-called bivalent vaccine containing a dominant BA. 4 and BA. 5 variants of the virus together with the original strain of the coronavirus. It is intended for children from 12 years of age.
Moderna said mid- to late-stage testing of the vaccine is underway.The post also includes data from a clinical trial for its bivalent BA.1-targeting booster candidate Omicron, which was approved in Britain last week. Moderna’s announcement comes a day after rival Pfizer and German partner BioNTech filed for US authorization for their vaccine booster reengineered to target Omicron’s BA.4/BA.5 subvariants.
Pfizer’s app is for emergency use among 12-year-olds and older, while Moderna has applied for approval for use in people 18 and older. Pfizer said the doses will be ready to ship immediately after regulatory approval. Moderna is also ramping up production of the BA.4 and BA.5 targeted vaccine to be ready for delivery next month. Countries including the United States, Britain and the European Union are preparing for vaccination campaigns in the fall to protect against future waves.
The FDA in June asked vaccine makers to tailor vaccines to target the two dominant subvariants, and said it would not require studies testing the vaccine in humans for approval, similar to how annual flu vaccine changes are handled.In human and preclinical tests, Moderna’s two boosters against subvariants BA.1 and BA.4 and BA.5 showed strong neutralizing activity compared to a booster against the original strain of the coronavirus, the company said.
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