Printed in January 2021 Issue
The U.S. United States Department of Defense (DOD) awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine. The manufacturing will be handled in Cambridge, Massachusetts and is expected to be fulfilled by June 30, 2021.
Moderna’s vaccine has been granted emergency use authorization (EUA) in the U.S. and in Canada. The EUA was granted by the FDA on December 18 for individuals 18 years of age and older. Health Canada granted authorization on December 23. The Canadian authorization came under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and was based on a rolling review of data that started on October 12. It included data from the Phase III COVE trial of 30,000 volunteers.
Earlier in December, the Canadian government exercised its option to increase its confirmed order of the vaccine by 20 million doses, bringing the total commitment to 40 million doses.
The European Commission (EC) has secured 160 million doses of Moderna’s vaccine, although the European medicines Agency (EMA) has yet to authorize the vaccine for use in the European Union. A meeting of the EMA’s Committee for Human Medicines (CHMP) is scheduled for January 6, 2021.
The UK government has received a commitment for seven million doses of the Moderna vaccine, 40 million of the Pfizer-BioNTech vaccine, and 100 million doses of the AstraZeneca-University of Oxford vaccine. The Pfizer-BioNTech vaccine is already being distributed in the UK and the U.S. Expectations are that the AstraZeneca-Oxford vaccine will be authorized in the UK on January 4, although there is as yet no indications when or if it will be authorized in the U.S. As of this date, U.S.-based clinical trials of the AstraZeneca-Oxford vaccine have not yet been completely enrolled.
The AstraZeneca-Oxford vaccine was delayed in the U.S. after a clinical hold was placed on the trial after a UK patient suffered a severe reaction, transverse myelitis, a partial paralysis of the spine, that may have been caused by the vaccine. Although the trials restarted after a few days in the UK and other countries, it was delayed for a number of weeks while the FDA evaluated it. There have also been confounding results in the trials, with 1800 participants accidentally receiving a half-dose of the first injection and that group reporting an efficacy of 90%, compared to about 62% in the regular doses. Researchers do not yet understand the disparity.
In the U.S., Moderna has committed to 200 million doses—not including the additional 100 million for the DOD. The company reported on December 11 that the U.S. government had exercised its option to acquire an additional 100 million doses of the vaccine, bringing it up to 200 million. About 20 million are expected to be delivered by the end of this week with the rest available in the first quarter of 2021. The second half of the 200 million will be delivered in the second quarter of 2021.