HHS buys $2 billion worth of Pfizer’s vaccine candidate

The Trump administration has agreed to pay Pfizer $1.95 billion for 100 million doses of the experimental coronavirus vaccine the company is developing along with German biotech company BioNTech. The deal also gives the government the right to buy another 500 million doses.

Why it matters: The federal government is betting that Pfizer and BioNTech’s vaccine will effectively stave off the coronavirus and therefore is worth buying before more definitive clinical trial data come out. The Department of Health and Human Services made a similar deal for Novavax’ vaccine.

The state of the global race for a coronavirus vaccine

Vaccines from the U.K., U.S. and China are sprinting ahead in a global race that involves at least 197 vaccine candidatesand is producing geopolitical clashes even as it promises a possible pandemic escape route.

Driving the news: The first two candidatesto reach phase three trials — one from the University of Oxford and AstraZeneca, the other from China — both appear safe and produce immune responses, according to preliminary results published today in The Lancet.

  • A vaccine from Moderna, the U.S. biotech firm, is heading into phase three trials after similarly encouraginginitial results.
  • There are at least 16 other vaccines currently in clinical trials in Australia, France, Germany, India, Russia, South Korea, the U.K., the U.S. and China, which is experimenting with a variety of vaccine types and has five candidates already in trials.

What they’re saying: Experts are increasingly confident that it’s no longer a question of if but when vaccines will be available.

  • “Absolutely, for sure, we will get more than one vaccine,” Barry Bloom, a professor of public health at Harvard, told reporters today.
  • He cautioned that it’s not yet clear which vaccines will win the race and that we won’t know how effective they are in protecting against COVID-19 — and for how long — until after phase three trials.

Pressed on when a vaccine could be approved, Bloom said that while it seemed “utterly crazy seven months ago,” January was looking increasingly realistic.

  • Richard Horton, The Lancet‘s editor-in-chief, is more cautious: “If we have a vaccine by the end of 2021, we will have done incredibly well.”
  • Zeke Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania, splits the difference: “Seven months after we got the genome, to have three vaccines in phase three is literally unprecedented. If in six to eight months we get a license, that will be, again, totally unprecedented in world history.”

But, but, but: “Getting something approved doesn’t protect you from COVID,” Emanuel warns.

  • The challenges of producing, distributing and delivering a vaccine (particularly in two doses, as the Oxford vaccine requires) around the entire world are hard to even fathom.
  • Even distributing a vaccine in one country will require an unprecedented buildup of facilities, materials (like glass vials), personnel and protocols, assuming enough people are even willing to take it.

The global picture is even murkier. Several countries and pharmaceutical companies have committed to “fair and equitable” distribution.

  • In principle, that would suggest a vulnerable front-line worker in Uganda, say, should get the vaccine before a young, healthy person in the United States.
  • In practice, well … no one really knows.

The bottom line: “It’s very fragmented, and in some ways that’s understandable,” Horton says. “But the danger of that is that many countries will lose out and only the strongest country, the country with the most money, will win.”

  • If countries hoard supplies rather than prioritizing at-risk people elsewhere, Bloom says, “that should be a cause not just of global concern but of global shame.”

For now, governments are prioritizing their own populations.

  • The Trump administration is pouring at least $3.5 billion into the development and manufacture of three leading vaccine candidates, with the promise of hundreds of millions of doses should they prove safe and effective.
  • Even as the homegrown Oxford vaccine takes a global lead, the U.K. is hedging its bets by purchasing 90 million doses being developed by German and French companies.
  • The U.K. and U.S. have both also put in large pre-orders of the Oxford vaccine, though AstraZeneca says 1 billion doses will also be manufactured in India and distributed mainly to other low- and middle-income countries.
  • The WHO and EU are attempting to create a framework for distributing the vaccine globally, though the U.S. has declined to take part.
Illustration: Eniola Odetunde/Axios

What to watch: Managing the largest vaccination project in history will clearly require global collaboration — but it’s also becoming a competition between rival powers.

  • “Six months from now, we will be in a situation where a few countries will have vaccines, and we believe those countries will be the UK, Russia, China and the US,” Kirill Dmitriev, the head of Russia’s sovereign wealth fund, told the FT.

Between the lines: Others are less certain Russia will be in that group, though Dmitriev says a vaccine bankrolled by his fund and developed by the state-run Gamaleya Institute will move into phase three trials next month.

“Basically other countries will decide, you know, which vaccine to buy … and who do you trust?”

— Kirill Dmitriev

State of play: There’s a clear lack of trust among the competitors.

  • According to the U.S, U.K. and Canada, hackers linked to Russian military intelligence have attempted to steal vaccine research in order to aid their own efforts.
  • The U.S. has also accused China of pilfering American research.
  • House Republican leader Kevin McCarthy will introduce a bill on Tuesday that would sanction foreign hackers attempting to steal U.S. vaccine research, according to a copy of the bill obtained by Axios’ Alayna Treene.

Zoom out: It will be a victory for humanity when the first coronavirus vaccines are approved. But the competition to obtain one early goes beyond national pride.

  • Vaccines will save countless lives, drive economic recoveries, and could provide rare opportunities to generate goodwill and influence abroad.
  • “There’s a huge soft power advantage to the U.S. ensuring that other countries can get the vaccine and protect themselves,” Emanuel says. The same would, of course, be true for China.

The bottom line: The race is on, but it won’t end when the first vaccine is approved.

World-leading Oxford coronavirus vaccine produces immune response

A coronavirus vaccine from Oxford University and AstraZeneca, perhaps the most promising candidate currently in development, appears to be safe and produces an immune response, according to preliminary findings published in The Lancet.

Why it matters: The race is on to get a vaccine approved and into circulation. A separate report published today finds that a Chinese candidate also produces an immune response, while American biotech firm Moderna revealed last week that its candidate produces a strong immune response.

State of play: The Oxford vaccine is in phase three trials, the last step before possible approval. According to the Economist, it could be cleared for emergency use as early as October.

  • Moderna’s vaccine is moving into phase three now, while another candidate from Pfizer is believed to be relatively close behind.
  • China has at least six candidates currently in trials, one of which is in phase three.
  • Russia says a candidate from its state-run Gamaleya Institute will enter phase three trials next month.
  • According to the Milken Institute’s tracker, there are 197 candidate vaccines in development, 19 of which are in some stage of clinical trials.

What to watch: While it seems increasingly likely that a vaccine will be available by early next year — the timeline suggested by Anthony Fauci — it remains unclear who will get it first.

  • The U.K. announced today that it had bought up millions of doses not only of the Oxford vaccine, but of candidates from France and Germany.
  • That’s another sign that this could play out as a bidding war, rather than the sort of equitable distribution European leaders have discussed.
  • President Trump, meanwhile, has at times described the vaccine race in America First terms. The U.S. is pouring billions of dollars into developing and manufacturing vaccines and expects to claim millions of doses if and when they are approved.

The states where face coverings are mandatory

Ohio Gov. Mike DeWine issued a mandatory mask order for people out in public, effective at 6 p.m. Thursday.

The big picture: 30 states, in addition to the District of Columbia, have issued some form of mask mandate as new infectionssurge across the country. Minnesota Gov. Tim Walz is also expected to issue an order Wednesday afternoon, the Star Tribune reports. 

Why it matters: Face masks are essential to slowing the coronavirus’ spread, but they have become politicized in recent months. 

States/territories that are mandating facial coverings in public:

  1. Alabama
  2. Arkansas
  3. California
  4. Colorado
  5. Connecticut
  6. Delaware
  7. District of Columbia
  8. Hawaii
  9. Illinois
  10. Kansas
  11. Kentucky
  12. Louisiana
  13. Maine
  14. Maryland
  15. Massachusetts
  16. Michigan
  17. Minnesota
  18. Montana
  19. Nevada
  20. New Jersey
  21. New Mexico
  22. New York
  23. North Carolina
  24. Ohio
  25. Oregon
  26. Pennsylvania
  27. Rhode Island
  28. Texas
  29. Virginia
  30. Washington
  31. West Virginia

Of note: Some city and local governments such as Phoenix and Jacksonville have enacted mandates as well. Other states have rules for people in certain situations, such as taking public transit or entering grocery stores.

We’re still in the early stages of the vaccine race

New clinical trial data from two experimental coronavirus vaccines — one from Oxford University and AstraZeneca in the United Kingdom, and the other from CanSino Biologics in China — are providing cautious optimism in the race to combat the pandemic.

The big picture: Science has never moved this fast to develop a vaccine. And researchers are still several months away from a clearer idea of whether the leading candidates help people generate robust immune responses to this virus.

Driving the news: The Oxford and CanSino vaccines didn’t lead to any severe adverse reactions or hospitalizations, according to the results released yesterday.

  • Safety — not efficacy — was the main thing these studies were supposed to be testing. And they performed well enough to move on to further trials.
  • Competing candidates from Modernaand Pfizer/BioNTech have also performed well in safety trials.

Yes, but: Future trials will be the ones that tell us whether any of these potential vaccines actually trigger patients’ immune systems to respond to the virus.

  • In the results released yesterday, Oxford researchers gave their vaccine to 543 people but only tested 35 for “neutralizing antibodies.” A separate, nonrandomized group of 10 people got a booster dose of the Oxford vaccine a month after the initial dose.
  • Preliminary antibody responses from CanSino’s vaccine were “disappointing” to several experts.

“It’s a lot of hype,” said Paul Offit, a physician and vaccine expert at Children’s Hospital of Philadelphia. “It’s just trying to read the tea leaves of what will be a large phase three trial.”

The bottom line: There are 23 coronavirus vaccines in clinical testing right now, according to the World Health Organization. 

  • We now have data on the first four, but the studies mostly are confirming that the vaccines aren’t severely harmful and that large-scale studies are warranted — not that they definitely work yet.
  • “It is good and hopeful news indeed, but we’ll only know when the large trials are done,” tweeted Robert Califf, a former FDA commissioner under Barack Obama.

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