Moderna starts process to obtain BLA for Covid-19 shot

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Fokusiert
© GettyImages/Fokusiert

Related tags: Vaccine, Fda, booster, variant, mRNA

Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.

The move follows similar action by Pfizer-BioNTech for their mRNA vaccine on May 7.

Stéphane Bancel, CEO of Moderna, said the company will continue to submit data from its Phase 3 study to the FDA to support the BLA on a rolling basis over the coming weeks with the biotech requesting a priority review.

Once the rolling BLA submission is complete, the FDA will notify the company as to when it is formally accepted for review.

The COVID-19 pandemic accelerated Moderna’s transition from clinical-stage biotech with unproven technology to a commercial business with a blockbuster product.

Its COVID-19 vaccine - mRNA-1273 - is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by the US biotech and investigators from the US National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.

The jab is currently available in the US under an Emergency Use Authorization (EUA), which was granted in December 2020. According to the US Centers for Disease Control and Prevention (CDC), more than 124 million doses of the US biotech’s vaccine have been administered in the US to date.

Moderna has also received emergency authorization for use of mRNA-1273 from health agencies in Canada, Israel, the EU, the UK, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea, along with an Emergency Use Listing (EUL) from the World Health Organization (WHO).

Variant specific booster vaccines

The company also reported that preclinical data on its variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication, and that a Phase 2 study to evaluate three approaches to boosting is ongoing.

Last month saw Moderna share initial data from a midphase trial of a vaccine designed to protect against B.1.351, the variant first identified in South Africa. The study found a booster shot with the variant vaccine, mRNA-1273.351, achieved higher neutralizing antibody titers against B.1.351 than a follow-up mRNA-1273 jab.

The clinical significance of the lower antibody titers achieved by first-generation COVID-19 vaccines against some variants is unclear. There is emerging real-world evidence that the ancestral strain Pfizer-BioNTech vaccine provides high levels of protection against B.1.351, contributing to skepticism in some quarters about the need for booster shots.

“We’re hearing loud and clear from the market: supply us with more mRNA vaccine for primary series and supply us with more mRNA vaccine in the future for boosters for 2022 and 2023. There is a big shift versus what the market perceived six or nine or 12 months ago, when protein vaccines or adeno vaccines were thought to be the answer to the pandemic,”​ said Bancel in May.

Related topics: Markets & Regulations, Pipelines, COVID-19

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