Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has entered into separate agreements with Gavi, a global vaccine alliance, to supply up to 500 million doses of its COVID-19 vaccine and, up to 14 million to the Swiss government of its booster vaccines. The company also provided an update of its COVID-19 booster vaccine candidates.

Supply pact with Gavi

In its pact with Gavi, Moderna has agreed to supply up to 500 million doses of its COVID-19 vaccine to low- and middle-income countries.

This agreement covers the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries. Moderna is in discussions to allocate and supply to self-financing participants in the future. COVAX is a global initiative co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines.

The supply agreement includes an initial 34 million doses to be delivered in the fourth quarter of 2021. Additionally, through this agreement, on behalf of the COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in participating countries, including lower-income countries, Gavi also retains the option to procure 466 million additional doses in 2022.

Late last month, WHO issued an emergency use listing (EUL) for Moderna’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. An EUL is a prerequisite to supply vaccines to the COVAX Facility. The EUL process assesses health products during public health emergencies with the goal of making medicines, vaccines, and/or diagnostics available to address the emergency.

The EUL also allows many countries around the world to expedite their own regulatory approval processes to import and administer a vaccine. It also enables UNICEF and the Pan American Health Organization Revolving Fund to acquire the vaccine for distribution to countries in need.

Supply pact with Swiss government

Separately, Moderna announced a new supply agreement with the Swiss federal government for 7 million doses of COVID-19 booster vaccines in 2022, with an additional option for another 7 million doses for delivery during the second half of 2022 or first quarter of 2023.

Purchases under this agreement are subject to regulatory approval of the booster vaccine candidate. The new agreement follows two earlier agreements between the Swiss government and Moderna to supply a total of 13.5 million doses of its COVID-19 vaccine. The vaccine was authorized by Swiss regulatory authorities in January (January 2021).

Update on booster vaccines

Moderna also reported initial data from a Phase II study that showed that a single 50-µg dose of of its original COVID-19 vaccine (mRNA-1273) or mRNA-1273.351 (a booster candidate based on the B.1.351 variant first identified in South Africa) given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).

Evaluation of a multivalent vaccine booster candidate, mRNA-1273.211, which combines into a single vaccine a 50-50 mix of mRNA-1273, Moderna’s authorized vaccine, and mRNA-1273.351, its booster candidate against the South African strain, is ongoing, and data are expected shortly (as reported on May 5, 2021). The company is also evaluating a 50-µg booster dose of mRNA-1273.

Source: Moderna (Gavi), Moderna (Switzerland), Moderna (WHO), and Moderna (booster)