As Britain administers the world’s first non-clinical trial doses of the Pfizer-BioNTech COVID-19 vaccine, President Trump signed an executive order earlier today demanding pharmaceutical companies prioritize U.S. patients when distributing doses.
“We must ensure that Americans have priority access to COVID-19 vaccines developed in the United States or procured by the United States Government,” the order reads. After American needs are met by the “free” vaccine, “it is in the interest of the United States to facilitate international access to United States Government COVID-19 Vaccines.”
The administration’s plans to mobilize the Department of Defense in tandem with the Department of Health and Human Services to aid in efficient distribution.
President Trump also threatened to invoke the National Defense Production Act if drug manufacturers fail to provide an adequate supply of the vaccine. “If necessary, we’ll invoke the Defense Production Act, but we don’t think it will be necessary,” the President said at a Tuesday press conference.
Activating the NDPA grants the federal government a special priority status with all orders and contracts, and gives the administrations the authority to force drug companies to increase production. It could also be used to halt the export of any vaccine produced domestically, establishing a federal government monopsony on the vaccine market.
The FDA is expected to grant emergency use authorization to the American drug manufacturer Pfizer as early as Thursday for their mRNA based vaccine. An FDA hearing for Moderna, using a similar technology, is scheduled for the 17th. Both vaccines have shown to be 95% effective in clinical trials, outshining all competitors.
During the summer, the administration ordered 100 million doses of the two-dose vaccine from both Pfizer and Moderna, with the option to purchase an additional 500 million and 400 million doses, respectively. The initial purchase from Pfizer would vaccinate up to 50 million Americans. The two manufacturers are expected to produce a total of 2.3 billion doses by the end of 2021.
The U.S. would need more than 600 million doses to inoculate every American. According to the NY Times, the Pfizer deal “was one of six contracts that the Trump administration signed with vaccine makers in a strategy intended to hedge its bets and maximize the chances of success.” Contracts were formed over the summer, well before results of each trial were made public and Pfizer emerged as the first company to seek FDA approval.
If Moderna’s vaccine is approved, the two companies are expected to produce enough doses “to vaccinate about 22.5 million people before the end of the year.”
Pfizer also scaled back their initial production estimates from 100 million by the end of December to 50 million doses. Novavax, Johnson & Johnson, and Sanofi, three of the six Operation Warpspeed participants, do not have an estimate on when they’ll complete clinical trials.
The U.S. secured 300 million doses of AstraZeneca’s vaccine back in May. The British company is expected to seek emergency use from the FDA as early as late January. Unlike Moderna and Pfizer, AstraZeneca’s vaccine can be kept in standard refrigerators, making it the easiest of the big 3 to transport and store.