Moderna Files with FDA for Vaccine EUA

01.12.2020 - On Nov. 30, US biotech Moderna became the second Covid-19 vaccine maker to apply to the Food and Drug Administration to grant an Emergency Use Authorization (EUA) for its coronavirus vaccine. The filing follows that of the Pfizer-BioNTech team on Nov. 20.

Moderna’s application for the EUA, several hundred pages long, will include data from its Phase 3 study of 30,000 people. The application will also include several thousand pages of additional data. The company said it will also seek marketing authorization from the EU, Canada, Britain, Israel and Singapore.

Both the Moderna and Pfizer/BioNTech applications will be examined by the FDA’s expert advisory panel, possibly at its Dec. 17 meeting. While recent reports have suggested the green light could take several weeks, there is a certain amount of pressure to speed up the process. In a US interview, Moderna CEO Stéphane Bancel said he expected a decision within 24 to 72 hours.

Moderna as well as Pfizer and BioNTech have said they plan to roll out the first doses in the US during December. Priority will likely be given to front-line healthcare workers and other essential workers, such as police. Germany’s health minister Jens Spahn said he also expects an EU rollout this month.

Each of the two companies, both with a candidate based on mRNA, reported efficacy levels of around 95% for their vaccines and no serious side effects.

The AstraZeneca/Oxford University duo, which reported average efficacy of 70% for its viral vector candidate in two separate tests, has hinted that it may apply to the FDA for an EUA soon. Many commentators have said data from these trials is not sufficiently conclusive, however.

The US government has agreed to buy vaccines from both Moderna and Pfizer and provide them to the public free of charge. The country’s Biomedical Advanced Research and Development Authority (BARDA) has pledged support of $955 million to Moderna’s related vaccine R&D and also committed to buy 100 million doses for a price of around $1.5 billion.

Pfizer as yet has accepted no direct aid for the Covid vaccine from Washington, although it is a member of the US government’s Warp Speed vaccine initiative. BioNTech has received aid from the EU to support R&D.

Moderna last week finalized a deal with the EU to supply 160 million doses of its vaccine, bringing the total pledge to the 27-member bloc to more than 2 billion doses, according to Reuters figures. Earlier in November, the EU accepted Moderna's candidate for rolling review based on the results of its Phase 3 trial.

Author: Dede Williams, Freelance Journalist