US preorders COVID-19 vaccine and antibody therapy

The US government is spending over $2 billion to preorder a vaccine and an antibody therapy for COVID-19. Money for both programs comes from the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD). The investments are part of Operation Warp Speed, the government’s plan to distribute 300 million doses of a COVID-19 vaccine by January 2021 and accelerate COVID-19 therapies.

Novavax was awarded $1.6 billion to begin manufacturing 100 million doses of the vaccine and test it in a Phase III clinical trial of up to 30,000 people this fall. The firm’s vaccine contains spike proteins of the SARS-CoV-2 virus embedded in nanoparticles. Results from the Phase I safety study are expected in late July.

Separately, in May, the Coalition for Epidemic Preparedness Innovations committed up to $388 million to Novavax, and in June the DoD signed a $70 million contract for 10 million doses of the firm’s vaccine.

The deal with Novavax is the government’s single-largest investment yet in a COVID-19 vaccine. In May, BARDA committed up to $1.2 billion for up to 300 million doses of AstraZeneca’s vaccine, to be tested in a Phase III trial in the US this summer. BARDA has also awarded $536 million to Moderna, $456 million to Johnson & Johnson, $38 million to Merck & Co. and IAVI, and $30 million to Sanofi.

On the therapeutic front, Regeneron Pharmaceuticals got $450 million to manufacture a cocktail containing two monoclonal antibodies that target the SARS-CoV-2 spike protein. BARDA previously provided Regeneron $167 million to develop the drug and begin testing its safety in clinical trials. Regeneron will now test the antibodies in advanced trials to determine if they can treat people with COVID-19 and prevent the disease in uninfected people.

The first batches of the therapy could be shipped to the government by the end of summer; it will be distributed for free if the Food and Drug Administration approves it or grants it emergency use authorization. The exact number of doses will depend on what amount of the drug is most effective. Regeneron estimates that it could supply 70,000–300,000 therapeutic doses or 420,000–1.3 million preventative doses.