Regulatory Focus™ > News Articles > 2020 > 11 > Moderna files COVID vaccine EUA; adcomm set for 17 December

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Posted 30 November 2020 | By Kari Oakes 

Moderna files COVID vaccine EUA; adcomm set for 17 December

2727 The pharmaceutical company Moderna has filed an emergency use authorization request with the US Food and Drug Administration (FDA) for the coronavirus vaccine the firm co-developed with the National Institutes of Health (NIH). 

The company's vaccine against COVID-19 will be considered at a 17 December meeting of the FDA's Vaccines and Related Biological Products Advisory Committee. Announcing the meeting, FDA Commissioner Stephen Hahn, MD, said that the advisory committee's external medical, scientific and public health experts will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission."

Like the upcoming 10 December VRBPAC meeting to consider the Pfizer/BioNTech COVID-19 vaccine, the meeting for Moderna’s candidate will be streamed live on Facebook, YouTube, and Twitter in addition to the usual FDA-hosted live webcast. RELATED: Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December, Regulatory Focus 20 November 2020)

“We will file today for an emergency use authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe,” said Moderna’s CEO Stéphane Bancel in a 30 November press announcement. Moderna said that it is concurrently seeking a conditional marketing authorization from the European Medicines Agency (EMA), which has already been conducting a rolling review of Moderna’s mRNA-1273 messenger RNA vaccine.
Rolling reviews of mRNA-1273 are also underway by regulatory authorities in Canada, Switzerland, the United Kingdom, Israel and Singapore; Moderna is also seeking prequalification or emergency use listing, as deemed appropriate, from the World Health Organization.
Today’s announcement accompanied the release of some of the efficacy data from the completed Phase 3 COVE study that enrolled over 30,000 US participants. The final efficacy data fall in line with those from an interim analysis; Phase 3 data showed vaccine efficacy of 94.1%. Of 196 cases of COVID-19 among study participants, 185 occurred in the placebo group. Thirty severe COVID-19 cases occurred, all among placebo recipients. One participant who receive placebo died from COVID-19-related causes.
“Efficacy was consistent across age, race and ethnicity, and gender demographics,” according to the Moderna press release, which noted that of the 196 participants who developed COVID-19, 33 were aged 65 years and up, and 42 were from diverse communities. (RELATED: NIH director: Efficacy for co-developed Moderna vaccine nears 95%, Regulatory Focus 16 November 2020)
No new safety signals were identified between the interim analysis and the completion of the Phase 3 trial, said Moderna. Such adverse reactions as fatigue, myalgia, arthralgia, headaches, and injection sites reacitons were more common after the second dose of the two-dose sequence.
Full phase 3 clinical trial data for mRNA-1273 are being prepared for submission to a peer-reviewed publication, said Moderna.
Moderna conducted early development work for the vaccine in collaboration with the Vaccine Research Center at NIH’s National Institute for Allergies and Infectious Diseases. Moderna has participated in the US government’s Operation Warp Speed vaccine accelerator and has received nearly $1 billion in additional federal funding from the Department of Health and Human Service’s Biomedical Advanced Research and Development Agency (BARDA).  

Moderna press release


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Tags: coronavirus, EMA, FDA, US

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