Moderna could ship its COVID-19 vaccine as soon as December if regulatory approval is granted this month. The company has already initiated the rolling regulatory approval process with Health Canada and intends to seek prequalification and/or emergency use listing with the World Health Organization. The Canadian vaccine supply will be sourced from Moderna's European production capacity with its strategic manufacturing partner in Switzerland, Lonza, and its fill/finish partner in Spain, ROVI.

On November 30, Moderna announced the primary efficacy analysis of its phase III study of mRNA-1273, indicating a 94.1% efficacy rate.

Moderna's COVID-19 vaccine demonstrates durable immunity in early clinical trial
Moderna published interim data from a National Institutes of Health-led phase I study of its messenger RNA (mRNA)-1273 COVID-19 vaccine on December 3...

FDA sets advisory meeting date to discuss Moderna COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for December 17...

Moderna to file COVID-19 vaccine EUA request
Moderna said it plans to request on November 30 an emergency use authorization (EUA) from the U.S. Food and Drug Administration and conditional marketing...

Moderna expands COVID-19 vaccine supply agreement with U.K.
Moderna has announced a supply agreement with the U.K. government for an additional 2 million doses of messenger RNA (mRNA)-1273, the company's...

EC secures 80M doses of Moderna COVID-19 vaccine
Moderna has announced that the European Commission (EC) has agreed to secure 80 million doses of its COVID-19 vaccine messenger RNA (mRNA)-1273.