Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports that the European Commission (EC), Health Canada, the pharmaceutical regulatory body of Canada, and Israel’s Ministry of Health (MoH) have granted authorization to its COVID-19 vaccine, now named COVID-19 Vaccine Moderna (formerly named mRNA-1273).

These authorizations follows authorization for emergency use by the US Food and Drug Administration in December 2020, which now makes four regulatory bodies authorizing the vaccine. Additional authorizations are currently under review in Singapore, Switzerland and the UK.

EU

On January 6, 2021, the EC granted a conditional marketing authorization for Moderna’s COVID-19 vaccine and now allows vaccination programs using the Moderna vaccine to be rolled out across the European Union (EU). The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the vaccine in individuals 18 years of age and older.

On December 18, the EMA exercised its option to increase its confirmed order commitment by 80 million doses of the vaccine to bring its confirmed order commitment to 160 million doses. The first deliveries of the vaccine to European countries from Moderna’s dedicated non-US supply chain are expected to begin next week (as reported on January 6, 2021).

Canada

Late last month (on December 23, 2020), Health Canada has authorized Moderna’s COVID-19 vaccine for people 18 years of age and older under an interim order. The is based on a rolling review of data from a Phase III study involving 30,000 participants.

In early December 2020, the Canadian government exercised its option to increase its confirmed order commitment of the vaccine by 20 million doses to bring its confirmed order commitment to 40 million doses.

Israel

On January 4, 2021, Israel’s MoH gave authorization to import Moderna’s vaccine in Israel. The MoH has secured 6 million doses of the vaccine to supply the vaccine in Israel. First deliveries are expected to begin shortly (as reported on January 4, 2020).

Global manufacturing and supply

Moderna reports it is increasing its base-case global production estimate of its COVID-19 vaccine from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021.

The company said it expects about 100 million doses to be available in the US by the end of the first quarter of 2021, with 200 million doses in total available by the end of the second quarter of 2021. Moderna reported that approximately 18 million doses have been supplied to the US government ;to date (as reported on January 4, 2020).

Moderna is partnered with Lonza for production inside and outside the US. Fill-finish services are provided by Catalent in the US, and by Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, and Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, outside the US. The US government has agreed to purchase 200 million doses of the vaccine with options for potential purchase of 300 million additional doses. The Canadian government has agreed to purchase 40 million doses.

In addition, Moderna is engaged in discussions with the government of South Korea to potentially provide 40 million or more doses of the vaccine. Under the proposed agreement, distribution would begin in the second quarter of 2021.

Phase III results

Moderna reported positive interim safety and primary efficacy results from the Phase III trial of its vaccine that showed vaccine efficacy of 94.1% against COVID-19. The Phase III study enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

The Phase III study is ongoing and will continue to follow participants for two years. Moderna is also conducting a Phase II/III study of the vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

Source: Moderna (EU), Moderna (Canada),  Moderna (Israel), Moderna (supply), Modera (South Korea), and Moderna (Phase III results)