Moderna to File for Approval of Its COVID-19 Vaccine With US and EU Regulators

By Tom Ozimek

Biotech firm Moderna said it will on Monday file requests with both U.S. and European regulators for approval of its COVID-19 vaccine, which clinical trials show is “generally well tolerated” and no serious safety concerns have been identified.

“Moderna plans today to request EUA (Emergency Use Authorization) from the U.S. FDA (Food and Drug Administration),” the company said in a statement, adding it would also “apply for a conditional marketing authorization with the European Medicines Agency (EMA).”

Moderna also announced plans to submit for emergency use listing of its vaccine with the World Health Organization (WHO), although it did not specify when that filing would take place.

Vaccinations could take place as early as 24 hours following approval, Moderna CEO Stephane Bancel said on CNBC’s “Squawk Box” on Monday.

The announcement follows an efficacy review of the Moderna vaccine, called mRNA-1273, which showed an efficacy rate of 94.1 percent, based on an analysis of 196 cases.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told Politico that the 94.1 percent efficacy rate is a “best estimate” and that, due to statistical uncertainty, the efficacy could be around 87 percent.

A secondary analysis of the vaccine’s use in 30 patients suffering from severe CCP (Chinese Communist Party) virus infection showed a 100 percent efficacy rate.

“It looks like in the trial we’ve been 100 percent effective at preventing severe COVID-19, which is really what’s driving the burden of disease in hospitals and ultimately straining our public health systems,” Dr. Stephen Hoge, the president of Moderna, told NPR.

A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against COVID-19, in Cambridge, Mass., on May 18, 2020. (Brian Snyder/Reuters)

Moderna’s vaccine, like the one developed by Pfizer/BioNTech, uses a new technology to trigger an immune response known as synthetic messenger RNA, allowing it to be produced at scale much more quickly than traditional vaccines. Moderna estimates it will be able to make 20 million doses by the end of the year in the United States and is on track to manufacture between 500 million and 1 billion doses for global distribution in 2021.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.

Moderna also said it plans to submit data from its clinical trial study to a peer-reviewed publication.

Pfizer and BioNTech, meanwhile, said in a statement they expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. Their vaccine, called BNT162b2, demonstrated an efficacy rate of 95 percent, with no serious safety concerns observed to date, according to the companies.

“We could be seeing both of these vaccines out and getting into people’s arms before Christmas,” Health Secretary Alex Azar said on “CBS This Morning” on Monday.

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