- The U.S. government plans to pay nearly $2 billion to secure a supply of 100 million doses of an experimental coronavirus vaccine being developed by Pfizer and German drug developer BioNTech, the largest order yet in the Trump Administration's aggressive push to make a shot available to Americans by early next year.
- Pfizer and BioNTech's candidate is among the most advanced now in human testing. Results from two early studies in the U.S. and Germany showed the vaccine was generally safe and could elicit potentially protective immune responses.
- Per the agreement announced Wednesday, the U.S. government could also acquire an additional 500 million doses, although it's unclear what those would cost. The initial payment of $1.95 billion for 100 million doses suggests a per-dose price of roughly $20, which would equate to a cost of $40 per person since the vaccine is given via two shots.
Unlike other drugmakers racing to develop a coronavirus vaccine, Pfizer chose to fund clinical testing and manufacturing on its own. But the sizable purchase order from the U.S. and, earlier this week, the U.K. should help the large drugmaker recoup its investment.
Under a project dubbed "Operation Warp Speed," the Trump administration aims to have 300 million doses of a coronavirus vaccine ready for distribution by January 2021. It's an extraordinarily ambitious goal, particularly as there's no guarantee the experimental shots now in early studies will be proven safe and effective by large Phase 3 trials.
So far, the administration appears to be hedging its bets, lining up orders for some 500 million vaccine doses from AstraZeneca, Novavax and now Pfizer. Taken together, the three agreements could total as much as $4.75 billion in funding for experimental vaccines.
The deals with AstraZeneca and Novavax appear to include funding for Phase 3 testing, likely to involve 30,000 people in each trial, and related manufacturing scale-up costs. Pfizer's, by contrast, does not. The firm will only get the $1.95 billion upon delivery after an emergency authorization or approval from the Food and Drug Administration.
The U.S. government has also funded vaccine makers Moderna, Johnson & Johnson and Sanofi, although no specific supply agreement has been announced for any of those three.
Moderna's candidate is likely to be the first to begin late-stage testing in the U.S., with a Phase 3 trial slated to start on July 27. Pfizer and AstraZeneca could be close behind, however.
With encouraging Phase 1 data now in hand, Pfizer plans to begin a Phase 2b/3 study as early as this month. Should that go well, the drugmaker said it could be in a position to ask for an emergency authorization from the FDA in October.
Guidance recently issued by the regulator indicates FDA reviewers will want evidence any experimental vaccine reduces, by at least half, the risk of either coronavirus infection or developing COVID-19. Emergency authorizations, like what was granted to Gilead's COVID-19 drug remdesivir, would be considered on a case-by-case basis, the agency stated.
Like other companies, Pfizer is already manufacturing doses of its shot before there's evidence that it will work. The company expects to produce 100 million doses by the end of 2020 and as many as 1.3 billion doses through 2021.
The vaccine is given via two shots administered three weeks apart, so 100 million doses would be enough to vaccinate 50 million people.
Americans will receive the vaccine for free, according to the statement from the companies and the U.S. Department of Health and Human Services. At $20 per dose, the shot would cost modestly more than the $12 to $18 per dose the Centers for Disease Control and Prevention pays for adult influenza vaccines.
At a congressional hearing Tuesday, officials from Pfizer, Moderna and Merck & Co. said their companies would price their vaccines above the cost of production. AstraZeneca and J&J, by contrast, have said they won't profit from vaccine sales during the pandemic period.
Pfizer and BioNTech said they are in "advanced discussions" with other governments about supply of their vaccine candidate. The deal with the U.K. government, announced Monday, would reserve 30 million doses for that country.
The companies are also considering providing doses to an international supply pool set up by the World Health Organization and several of its partners.