The US government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, and the European Medicines Agency (EMA) has approved a new manufacturing site for the vaccine. Moderna has also formed pacts with the United Arab Emirates (UAE) and Saudi Arabia for distribution and commercialization and provided an update on regulatory filings in Switzerland.

US

The US government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, which includes an option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline. This brings the US government’s confirmed order commitment to 500 million doses, including 110 million doses expected to be delivered in the fourth quarter of 2021 and 90 million expected to be delivered in the first quarter of 2022. As of June 14, 2021, Moderna had supplied 217 million released doses of the vaccine to the US government.

EU

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has approved a new manufacturing site for the production of the finished product of Moderna’s COVID-19 vaccine. The site is operated by Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products and is located in Monts, France. The CHMP’s recommendation does not require a further decision by the  European Commission, and the site in Monts can become operational immediately (as reported on June 11, 2021).

The CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing.

As of June 4, 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US, Moderna’s site in Norwood, Massachusetts, and Lonza’s site in Portsmouth, New Hampshire, were approved by the CHMP. These approvals are expected to allow the production of an additional one to two million vials of ready-to-use vaccine to the EU every month.

UAE and Saudi Arabia

Moderna and Magenta Investments, part of an investment and industrial conglomerate in the UAE, have entered into a new agreement to distribute Moderna’s COVID-19 vaccine and updated variant booster candidates, once authorized, in the UAE in 2021 and 2022.

Additionally, Moderna and Tabuk Pharmaceutical Manufacturing Company, a subsidiary of Astra Industrial Group, a Saudi Arabia-based pharmaceutical company, have entered into an agreement to commercialize Moderna’s COVID-19 vaccine and future variant-specific booster candidates in Saudi Arabia. Under the agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the COVID-19 vaccine in Saudi Arabia. The agreement also gives Tabuk the possibility to discuss opportunities to distribute other Moderna mRNA products if authorized in the future.

Switzerland

Moderna has submitted an authorization application to Swissmedic, the national pharmaceutical regulatory agency in Switzerland, for use of its COVID-19 vaccine in adolescents. It had earlier submitted applications for use in adolescents in the US and the European Union.

Source: Moderna (US), Moderna (UAE), Moderna (Saudi Arabia) Moderna (Switzerland) and the European Medicines Agency