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UK's MHRA begins rolling review of Moderna’s coronavirus vaccine

MHRA will accept and consider new evidence as it becomes available

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun a rolling review of Moderna’s mRNA-based COVID-19 vaccine.

The vaccine candidate, mRNA-1273, will be reviewed on a rolling basis, meaning that the MHRA will begin an independent assessment of the vaccine using information submitted by Moderna.

The MHRA will then accept and consider new evidence when it becomes available until the application is sufficient to warrant authorisation of the shot.

Last week, Moderna completed enrolment of its late-stage phase 3 trial testing mRNA-1273 in 30,000 participants.

According to the company, 25,654 participants have now received their second vaccination with the vaccine candidate in the phase 3 COVE study.

Moderna’s COVID-19 vaccine entered phase 3 in record time, with the US National Institutes of Health (NIH) partnered study launching in July.

The primary endpoint of the COVE study is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

Results from an interim analysis of the phase 1 study of mRNA-1273, published in July, demonstrated that participants who received two doses of the vaccine had rapid and strong immune responses against SARS-CoV-2, the novel virus which causes COVID-19.

“This phase 1 data demonstrates that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly supports the choice of 100 µg in a prime and boost regimen as the optimal dose for the phase 3 study,” said Tal Zaks, chief medical officer of Moderna.

The clinical development of mRNA-1273 is being carried out in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID). Moderna was selected by the US government for their ‘Operation Warp Speed’ initiative for the development of a successful COVID-19 vaccine.

Moderna’s chief executive officer Stéphane Bancel said last week that he expects interim results from the company’s COVID-19 vaccine trial in November, according to the Wall Street Journal.

Bancel also added that the vaccine candidate could be granted an emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) in December, assuming that the data from its phase 3 trial is positive.

Article by
Lucy Parsons

29th October 2020

From: Regulatory



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