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Key Points

  • The CDC has asked states to ready facilities to distribute a coronavirus vaccine by Nov. 1.
  • Dr. Anthony Fauci said at a health conference that it’s more likely a vaccine will be ready by “the end of the year.”
  • Drug companies Moderna and Pfizer are racing to complete patient enrollment for their late-stage vaccine trials by the end of September.
Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, arrives to testify before the House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C., July 31, 2020. (Image by Kevin Dietsch/Pool/Reuters)
Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, arrives to testify before the House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C., July 31, 2020. (Image by Kevin Dietsch/Pool/Reuters)

White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won’t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

At a health conference, Fauci said it’s more likely a vaccine will be ready by “the end of the year” as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

It’s unlikely we’ll have a definitive answer” by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about,” Trump told reporters.

Infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics, not science.

The CDC has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1, just two days before the election. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible.

Earlier Tuesday, nine drugmakers released a public letter pledging to “uphold the integrity of the scientific process” as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines.

We saw it critical to come out and reiterate our commitment,” Pfizer CEO Albert Bourla told NBC’s “TODAY” on Tuesday. “We will develop our product, develop our vaccine using the highest ethical standards.”

On Thursday, Health and Human Services Secretary Alex Azar also tried to alleviate concerns about the review process, insisting the government’s Nov. 1 deadline for states is not linked to the presidential election.

It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on “CBS This Morning.” “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”

Dr. Moncef Slaoui, who is leading the Trump administration’s Operation War Speed initiative, told NPR a vaccine ready for public distribution in November is “extremely unlikely.”

The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC. Hahn said the FDA wouldn’t authorize a vaccine that’s not safe, even if it is fairly effective.

Fauci said Tuesday the trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of medical experts who observe patient safety and treatment data. He added he “wouldn’t be surprised” if the U.S. had more than one vaccine.

In the meantime, he said, the U.S. coronavirus response still needs to improve.

He called the coronavirus outbreak in the U.S. a “mixed bag” as new cases fall in the southern region of the country and cases surge in states such as Montana, the Dakotas, Michigan, Minnesota and Iowa.

When you look at the country as a whole, we need to be doing much better than we’re doing,” he told told PBS’ Judy Woodruff at the conference.
 
 
Berkeley Lovelace Jr / CNBC Reporter Author:
Berkeley Lovelace Jr. is a health-care reporter for CNBC.com, mainly covering pharmaceuticals and regulatory action out of the U.S. Department of Health and Human Services. He’s also the host of “Healthy Returns,” a weekly health-care newsletter. Follow him on Twitter @BerkeleyJr.

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