Moderna to file for emergency use authorization in U.S. and EU

Moderna to file for emergency use authorization in U.S. and EU

HIGHLIGHTS

  • Moderna Inc. becomes the second major vaccine candidate to file for an Emergency Use Authorization (EUA) in the United States and European Union.
  • Moderna’s primary efficacy analysis of the Phase 3 COVE study found the vaccine has an effectivity of 94.1% for COVID-19 and has 100% efficacy over the severe forms of COVID-19.
  • The EUA application means the regulators will now scrutinize the phase III trial data of the mRNA-based vaccine and give a green light for widespread distribution.
  • “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

KOLKATA (India) — American pharma giant Moderna Inc. becomes the second major vaccine candidate to file for an Emergency Use Authorization (EUA) in the United States and European Union, the company confirmed the news in a statement.

The announcement comes shortly after Moderna’s primary efficacy analysis of the Phase 3 COVE study found the vaccine has an effectivity of 94.1% for COVID-19 and has 100% efficacy over the severe forms of COVID-19.

The Primary analysis drew conclusions from a trial on 196 people. 185 cases of COVID-19 were observed in the placebo group while the group jabbed with Moderna’s vaccine had 11 cases.

A secondary end-point of the primary analysis took note of severe COVID. It found the placebo group had 30 severe cases and none in the mRNA-1273 vaccine group, Moderna said in a release.

Moderna’s interim analysis of the Phase 3 study involved 30,000 volunteers. At that time the efficacy was slightly higher at a little over 95%.

The EUA application means the regulators will now scrutinize the phase III trial data of the mRNA-based vaccine and give a green light for widespread distribution if deemed applicable for mass use.

Meanwhile, EUA application by another major vaccine candidate, also American, is on the way. A Wall Street Journal report, citing familiar sources, said Pfizer has already started distributing its vaccine to key locations.

United Airlines Holdings Inc. reportedly began distributing Pfizer’s COVID-19 vaccine the pharma giant developed with German partner BioNTech to key locations, to keep an edge should EUA is approved.

While the primary analysis of Moderna’s large-scale trial has come out promising, even after the vaccine is approved (if), their Phase 3 COVI study will be extended months of median follow-up post-vaccination as required by the U.S. FDA for Emergency Use Authorization (EUA).

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

“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.”

Vaccine candidates from Pfizer, AstraZeneca, and Moderna are the forerunners in the highly anticipated wait for a federally-approved COVID-19 vaccine, which is being hailed as the key to stop the pandemic.

Moderna has contract with the UK government for supplying 2 million additional doses of their mRNA-based vaccine, securing a gross total of 7 million doses from the vaccine-maker.

NOTE: the story has been edited to correct an error that said Moderna has already filed for the EUA, whereas it is due for Monday.

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