Moderna Applies for Full ‘Biologics License’ Approval of Its COVID-19 Vaccine

June 2, 2021 Updated: June 2, 2021

Moderna applied for a so-called “biologics license” for its COVID-19 vaccine on June 1, a step up from its current emergency-use authorization, which would open the shot to interstate commerce and allow the drugmaker to market it directly to consumers.

The company’s mRNA vaccine was approved for emergency use by the Food and Drug Administration (FDA) in December under a mechanism that facilitates the availability and use of medical countermeasures during public health emergencies.

Moderna’s vaccine received a nod for emergency use in people aged 18 and older amid the pandemic on the basis of safety data from a large clinical trial involving about 30,000 people. The trial showed a 94.1 percent reduction in the number of symptomatic COVID-19 cases in people who had received the vaccine, compared to people who received dummy injections.

Moderna said it would continue to submit trial data “on a rolling basis over the coming weeks with a request for a Priority Review,” an accelerated process that could cut the 10-month standard review down to six months.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stéphane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

To date, over 55 million Americans have been fully vaccinated with Moderna’s two-dose vaccine, according to the Centers for Disease Control and Prevention, with a total of just over 125 million doses administered.

Approval of a biologics license will allow Moderna to keep its vaccine on the market once the public health emergency is over, and will allow the company to advertise its product to the public, which isn’t permitted under emergency use.

Moderna is the second company to seek a biologics license for its COVID-19 vaccine, with Pfizer and partner BioNTech announcing on May 7 that they had initiated the process and were similarly seeking to fast-track full approval under a priority review.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans in collaboration with the U.S. government,” Albert Bourla, chairman and CEO of Pfizer, said in a statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

Also on June 1, the National Institutes of Health (NIH) announced the start of a clinical trial of adults fully vaccinated against COVID-19 receiving vaccine booster shots, to inform public policy decisions around booster shot safety, scheduling, and efficacy.

The study seeks to determine the safety and immunogenicity of mixed booster regimens against the CCP virus and emerging variants.

The three COVID-19 vaccines currently available in the United States are those made by Johnson & Johnson, Moderna, and Pfizer-BioNTech.

“Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus,” National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said in a statement.

“The results of this trial are intended to inform public health policy decisions on the potential use of mixed vaccine schedules should booster doses be indicated.”

The NIH said initial trial results are expected by late summer.

Isabel Van Brugen and Reuters contributed to this report.

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