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June 11, 2021

Coronavirus company news summary – Moderna submits EUA request to FDA for use of Covid-19 vaccine in adolescents – US to donate 500 million Pfizer/BioNTech vaccines to low-income countries

By Chris Lo

Moderna has submitted an emergency use authorisation (EUA) request to the US Food and Drug Administration (FDA) for its Covid-19 vaccine in adolescents in the US. The company has already filed EUA requests with the European Medicines Agency (EMA) and Health Canada and is expected to do the same with other regulatory agencies worldwide to approve its vaccine for this age group.

Pfizer and BioNTech will be providing 500 million doses of their Covid-19 vaccine to the US government at a not-for-profit price, to be distributed to lower-income countries and related organisations. Around 200 million doses will be offered in 2021, while the remaining 300 million doses will be provided in the first half of 2022. The vaccines will be donated to at least 100 low- and lower middle-income countries including those in the African Union, and the partners will work with the COVAX facility to ensure efficient and equitable distribution.

The US FDA has authorised the shelf life extension of the Johnson & Johnson single-shot Covid-19 vaccine from three months to four and a half months. The decision was made based on data received from ongoing stability assessment studies, which found the vaccine to be stable at four and a half months when refrigerated at 2-8°C. J&J’s Phase III ENSEMBLE study has found the single-shot Covid-19 vaccine to be effective against prevalent Covid-19 variants of concern.

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