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October 8, 2021

Sanofi reports positive data from study of flu shot with Covid booster 

The study evaluated the safety and immunogenicity of a 100µg dose of a Covid-19 booster given along with the influenza vaccine.

Sanofi has reported positive interim data from a descriptive study of its Fluzone High-Dose Quadrivalent vaccine with Moderna’s experimental Covid-19 booster vaccine.

Findings showed that administering the vaccines at the same time offered immunogenicity responses and a safety and tolerability profile in line with those observed when they are given separately.

An influenza vaccine, Fluzone High-Dose Quadrivalent is approved for use in adults aged 65 and above in the US and Canada.

It is licenced as Efluelda in Europe for use in adults aged 60 and above.

Funded by Sanofi, the study is being conducted in the US in collaboration with Moderna and the US Biomedical Advanced Research and Development Authority (BARDA).

The study is currently following up the subjects for six months for safety.

It comprised nearly 300 subjects aged 65 years and above who were already inoculated with two doses of Moderna’s vaccine as the primary vaccination a minimum of five months before recruitment.

The study analysed the safety and immunogenicity of 100µg dose of Covid-19 booster shot administered with the influenza vaccine in these subjects.

Sanofi Vaccines North America medical head Dr Michael Greenberg said: “This season, more than ever, it is critical to help protect the older adults, who are at especially high risk for both severe Covid-19 and complications from influenza, which can include heart attacks and strokes.

“These positive results could facilitate the implementation of Northern Hemisphere influenza and Covid-19 booster vaccination campaigns, especially in this high-risk population.”

The company expects to report the complete data from the study later this year.

Fluzone High-Dose is the only influenza vaccine to offer a decline in disease-associated complications including hospitalisations due to cardiovascular events and pneumonia, over ten successive seasons in over 34 million individuals aged 65 and above, Sanofi noted.

Last month, Moderna commenced its submission to the US Food and Drug Administration for the assessment of a booster shot of its Covid-19 vaccine, mRNA-1273, at the 50µg dose level.

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