NMDA Journal Winter 2020-21

nmdental.org 9 continues on page 10  Fighting COVID-19 Through Operation Warp Speed HHS Secretary Alex Azar and Defense Secre- tary Mark Esper (he was fired in November and Christopher Miller replaced him) oversee OWS with Dr. Moncef Slaoui as the chief advi- sor and General Gustave F. Perna as the chief operating officer. OperationWarp Speed Funded Programs The first program funded in March was ($456 million) for Johnson & Johnson’s (Jans- sen) candidate vaccine. Phase 1 clinical trials began in Belgium in July. Janssen’s phase 3 clinical trials with 60,000 volunteers enrolled in 215 clinical research sites interna- tionally began in September. Then in August, Johnson & Johnson (Janssen) was given another $1 billion for the manufactur- ing and delivery of 100 million doses of its recombinant adenovirus technology, AdVac, which was used to develop and manufacture with BARDA support, Janssen’s Ebola vaccine for the 2018–20 outbreak in the Congo and Rwanda. In April, Moderna received $483 million for its candidate vaccine, which began Phase 1 tri- als in March. This agreement awarded $472 million in July to include late-stage clinical development including an expanded Phase 3 study of its mRNA vaccine which began in July. In August, another $1.5 billion was awarded for the manufacturing and delivery of the vaccine, mRNA-1273, co-developed with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. BARDA has supported the Phase 2 and 3 clini- cal trials. The Phase 3 trial, which began in July, was the first US government-funded COVID-19 trial. In November, they announced that their candidate vaccine is 94 percent effective. FDA has reported that they would be willing to accept a vaccine that was at least 50 percent effective. The company received FDA Emergency Use Authorization, EUA, in December. AstraZeneca/Oxford University was funded $1.2 billion in May, which began Phase 3 clinical tri- als in late August. The agreement makes 300 million doses of the vaccine available in the US. In October, a cocktail of two monoclonal anti- bodies called AZD7442, delivered IM, is devel- oped to use on those who have compromised immune function, over 80 years old and/or undergoingmedical treatments that preclude them from receiving a COVID-19 vaccine. In July, Regeneron’s COVID-19 investigation anti-viral antibody treatment, REGEN-COV2, was funded $450 million for manufacturing so that doses of medicine will be packaged and ready to ship immediately if clinical trials are successful with FDA approval. In November, the company announced that trials indicate a 70 percent efficacy with FDA approval in December. Novavax received $1.6 billion to manufacture its vaccine candidate in which the US govern- ment own 100 million doses after its FDA approval. Pfizer was awarded $1.95 billion in July for manufacturing and distribution of 100 million doses of their vaccine candidate. Phase 3 trials began in July and Pfizer will deliver its product after FDA EUA (Emergency Use Authorization) approval. Pfizer announced in November that its mRNA vaccine is 90 percent effective with FDA EUA approval in December. In July, Sanofi and GlaxoSmithKline received $2 billion for the development, clinical trials and manufacturing of its adjuvanted vac- cine. If FDA approves, the US will own 100 mil- lion doses for its vaccination campaign. In late August, use of Convalescent Plasma (containing antibodies that will attack the coronavirus) was issued a FDA EUA. The Plasma will lessen the severity or shorten the length of the illness in hospitalized patients administered by local health care providers. Eli Lilly and Company agreed to $375million for the government to purchase the first doses of bamlanivimab, LY-CoV555, amonoclonal anti- body therapeutic for outpatient care which was in Phase 3 trial at the inception of the agreement. FDA did approve it in November. Manufacturing capacity is currently being advanced through government investment for companies Johnson & Johnson, Moderna, and AstraZeneca, in March, April, and May respectively. In June, Emergent BioSolutions was task ordered using Emergent’s BARDA-supported Center for Innovation in Advanced Department in Manu- facturing (CIADM) to advance manufacturing capabilities and capacity for a potential COVID vaccine and therapeutics worth $628 million. At the end of July, Texas A&M University and FUJIFILM were task ordered worth $265 mil- lion to advance domestic manufacturing capabilities and capacity for a potential vac- cine using another BARDA-supported CIADM. In August, Grand River Aseptic Manufactur- ing Inc. (GRAM) was awarded a $160 million firm-fixed-price contact for domestic aseptic fill and finish manufacturing capacity for vac- cines and therapeutics. In October, Cytiva agreed to expand its man- ufacturing capacity for $31 million to produce liquid and dry powder cell media, cell culture buffers, mixers bags, and XDR bioreactors. This expansion will help Cytiva respond to the demand for COVID-19, supplying con- sumables and hardware products without impacting current manufacturing output. DoD with CDC and other parts of HHS are coordinating supply, production and distri- butions of the vaccines partnering with the private sector. In May, Apiject was awarded a $138 million contract to provide 100 million prefilled syringes by year end. Themost promising candidates will go through large-scale randomized trials. When they receive FDA approval, there will be a lot of shots given across the country.