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August 24, 2021

Coronavirus company news summary – Pfizer/BioNTech’s Comirnaty receives first full FDA approval – Valneva starts UK rolling submission for Covid-19 vaccine candidate

By Chris Lo

Pfizer and BioNTech have received the first full approval for a Covid-19 vaccine from the US Food and Drug Administration (FDA), which authorised the companies’ Comirnaty vaccine for the prevention of Covid-19 in people aged 16 years and above. The vaccine will continue to be available under emergency use authorization for adolescents aged 12 to 15 years. Meanwhile, the UK Government has agreed to procure 35 million additional doses of Comirnaty, to be supplied from the second half of 2022.

Valneva has started a rolling submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the initial approval of its whole virus, inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001. The company expects approval before the end of 2021, contingent on positive results from the ongoing Phase III Cov-Compare clinical trial and regulatory review. To date, the UK has ordered 100 million VLA2001 doses for delivery this year and next year.

Bavarian Nordic has signed a funding agreement valued at up to $126m (DKK800m) with the Danish Ministry of Health to support the development of its Covid-19 vaccine candidate, ABNCoV2. The funds are intended to help move the vaccine’s development towards regulatory approval as a booster jab. The agreement follows the launch of a Phase II trial of ABNCoV2 as a booster vaccine for people with prior SARS-CoV-2 infection or vaccination.

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