Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) announced that it has initiated rolling submission for a biologics license application (BLA) with the FDA seeking approval/licensure of its COVID-19 vaccine, mRNA-1273, in adults. The company will continue to submit data from ongoing clinical and other studies to support the BLA and plans to request the FDA for a priority review of the regulatory application.
Please note that mRNA-1273 is currently available under emergency use authorization (“EUA”) in the United States. The vaccine has also received similar emergency/conditional/temporary authorization in multiple countries. An EUA means authorization for a particular product remains in effect for as long as public health emergency lasts. A potential approval to the BLA for mRNA-1273 will allow Moderna continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering infection cases. Please note that none of the available COVID-19 vaccines have received an approval so far.
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) initiated rolling submission for a BLA seeking approval for their mRNA-based COVID-19 vaccine, BNT162b2.
Meanwhile, Moderna is also focusing on increasing its manufacturing capacity for its COVID-19 vaccine as well as for investigational booster doses.
The company announced a new agreement with its existing Switzerland-based partner, Lonza, for supply of drug substance for an additional 300 million doses of its updated booster variant vaccine candidate annually, following a potential authorization. Moderna has also signed a similar agreement with Spain-based ROVI for another 300 million doses of booster vaccine.
The company has also signed several fill/finish agreements with multiple companies to support manufacturing services and supply packaging for COVID-19 vaccine. It signed an agreement for similar services with
Thermo Fisher Scientific ( TMO Quick Quote TMO - Free Report) to support the production of hundreds of millions of doses that will start in the third quarter of 2021.
Moderna’s stock has gained 76.7% in the year so far against the
industry's decline of 4.1%. Image Source: Zacks Investment Research
We remind investors that mRNA-1273 achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study evaluating it in adult patients. Meanwhile, the vaccine achieved 100% efficacy in
adolescent patients in a phase II/III study. Another phase II/III study is evaluating mRNA-1273 in in children aged six months to less than 12 years.
The company is also developing booster
vaccine candidates targeting different variants of coronavirus and a refrigeration-stable COVID-19 vaccine candidate, mRNA-1283, to facilitate easier distribution and administration. Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see
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