- Coronavirus vaccine developers working with the U.S. government are churning out doses of their experimental shots en masse, shifting to commercial production before clinical testing is complete in an effort to meet ambitious timelines for widespread distribution and vaccination.
- "All six of the vaccines we're working with are in industrial-scale manufacturing now," Health and Human Services Secretary Alex Azar said in a Thursday interview on Fox Business. "We literally have millions of doses of vaccine already."
- Vaccines developed by Pfizer and Moderna are the furthest along in testing, with first results expected in October and November, respectively. Moderna has said it will have produced 20 million doses, enough for 10 million people, by the end of the year, while planning documents from the Centers for Disease Control and Prevention suggest Pfizer could have between 20 and 30 million doses manufactured by then.
For drugmakers, manufacturing vaccines at scale before they are proven in testing is a notable departure from the regular order of business.
Typically, small batches of an experimental shot will be produced as clinical studies advance in stages from smaller to larger trials. Only after many studies have been successfully run will drugmakers switch over to commercial production ahead of a potential approval.
During the COVID-19 pandemic, however, development and manufacturing has advanced in parallel, a risk that's largely been eased by billions of dollars in funding from the U.S. government. Awards doled out through the Trump administration's Operation Warp Speed initiative have totaled more than $11 billion between the six most advanced vaccine makers.
The administration is currently planning for a vaccine to either be authorized or approved this fall, with vaccinations of high-risk groups to come before any successful shot is rolled out more widely. Speaking Thursday, Azar said he expects 100 million vaccine doses to be ready for distribution by the end of December — a number significantly higher than the 40 to 50 million Pfizer and Moderna are likely to have produced.
AstraZeneca, developing a shot from the University of Oxford, has also advanced far in both testing and manufacturing, but the company's U.S. study is currently on hold due to a safety review.
Azar's timelines for wider distribution also appear to conflict with estimates given by other government officials. While the health secretary predicted there will be enough vaccine for all Americans by the end of March or early April, the administration's chief vaccine advisor, Moncef Slaoui, has written that only as many as 300 million doses would be ready by mid-2021.
The most advanced vaccines, including Pfizer's and Moderna's, must be given as two shots, meaning 300 million doses would only cover about half the U.S. population.
All of this planning assumes late-stage trials will show at least one, and potentially several, vaccines to be both safe and effective — an outcome that's far from guaranteed. Early trials run by Moderna, Pfizer, AstraZeneca and Novavax have shown their respective vaccines to be generally tolerable and capable of producing an immune response. Whether that protects against either COVID-19 or coronavirus infection isn't known.
And, as AstraZeneca's recent safety stumble has shown, the large trials now being run could show signs of an unexpected or dangerous side effect that earlier testing didn't reveal.
In addition to Moderna, Pfizer, AstraZeneca and Novavax, Operation Warp Speed is working with Johnson & Johnson, partners Sanofi and GlaxoSmithKline, and Merck & Co. J&J's this week began a late-stage study of its shot, while Sanofi and GSK are in Phase 1 tests of theirs.
Merck has a vaccine in testing, but not the one that the U.S. government has funded.