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November 10, 2021

Coronavirus company news summary – Pfizer, BioNTech seek FDA approval for Covid-19 booster use in all adults – Moderna seeks expansion of EU CMA for Covid-19 vaccine in children

By Darcy Jimenez

Pfizer and BioNTech have sought authorisation from the US Food and Drug Administration (FDA) for use of Covid-19 vaccine booster shots in all individuals aged 18 years and above, Reuters has reported. Initially, when the companies sought authorisation for all adults, an FDA advisory panel rejected the request, citing lack of evidence. The FDA then authorised the use of booster shot in September for individuals aged 65 years and above and those at increased risk of infection due to workplace exposure. Meanwhile, Pfizer sought approval from the Japanese health ministry for Covid-19 vaccine use in children aged between five and 11 years.

Moderna has sought an expansion of the Conditional Marketing Authorisation (CMA) from the European Medicines Agency for its Covid-19 vaccine in children aged between six and 11 years. The filing is based on positive data from Phase II/III KidCOVE clinical trial of the vaccine in children of the same age group. Findings showed that two 50μg doses of shot were well tolerated and offered strong neutralising antibody titers.

AstraZeneca has announced plans to set up a vaccines unit to accommodate its Covid-19 vaccines and antibody therapies. AstraZeneca Europe and Canada executive vice-president Iskra Reic will lead the division, which will focus on research and development as well as production. A company spokesperson said: “The team will be dedicated to our Covid-19 vaccine, our long-acting antibody combination and our developmental vaccine addressing multiple variants of concern.”

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