September 4, 2020

Top health officials say a coronavirus vaccine by November is 'extremely unlikely'

Daily Briefing

    Amid continued skepticism over whether FDA is facing political pressure to authorize a coronavirus vaccine before the upcoming presidential election, several top health care officials have voiced confidence that the agency won't authorize a vaccine without adequate data showing it's effective and safe—and have expressed doubt that a vaccine will be ready by November.

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    The officials' comments come as the United States as of Friday morning reported a total of 6,167,400 cases of the novel coronavirus virus since the country's epidemic began—up from 6,129,400 cases reported as of Thursday morning.

    Data from the New York Times shows that the average daily numbers of newly reported coronavirus cases increased over the past 14 days in Guam and 18 states: Alabama, Iowa, Kansas, Kentucky, Maine, Minnesota, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, and West Virginia.

    The Times' data also shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in Washington, D.C., and 21 states: Alaska, Arkansas, Colorado, Connecticut, Delaware, Hawaii, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, New Jersey, New Mexico, New York, Rhode Island, Tennessee, Utah, Vermont, Virginia, and Wisconsin.

    In addition, the Times' data shows that Puerto Rico, the U.S. Virgin Islands, and 11 states saw their average daily numbers of newly confirmed coronavirus cases decrease over the past 14 days: Arizona, California, Florida, Georgia, Idaho, Mississippi, Nevada, Oregon, Texas, Washington, and Wyoming.

    U.S. officials as of Friday morning also had reported a total of 186,718 deaths linked to the coronavirus since the country's epidemic began—up from 185,638 deaths reported as of Thursday morning.

    According to the Times' data, 10 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Alabama, Arkansas, Colorado, Georgia, Hawaii, Kansas, Kentucky, Montana, Virginia, and West Virginia.

    Officials say coronavirus vaccine likely will be ready this year—but not by November (and not because of political pressure)

    As the coronavirus continues to spread throughout America and related deaths continue to rise, researchers are scrambling to develop a vaccine against the virus, with some companies already conducting late-stage trials on coronavirus vaccine candidates. Some Trump administration officials have said the United States could have an authorized coronavirus vaccine by the end of this year or sooner, and CDC earlier this week directed states to have plans in place for distributing a coronavirus vaccine by Nov. 1. Further, FDA Commissioner Stephen Hahn recently said the agency could authorize use of a coronavirus vaccine candidate before Phase 3 clinical trials are completed.

    Those comments have sparked concerns among some public health experts that FDA is facing political pressure to approve a coronavirus vaccine before the upcoming presidential election. And public opinion reflects those worries, with a recent STAT News/Harris Poll finding that 78% of respondents said they were worried the approval process for a coronavirus vaccine is being driven more by politics than science.

    However, HHS Secretary Alex Azar and White House spokesperson Kayleigh McEnany on Thursday separately said the Trump administration is not pressuring federal regulators to approve a coronavirus vaccine before the general election. "Any vaccine that comes out is going to meet FDA's gold standards for authorization or licensure," Azar said during in an interview with "CBS This Morning."

    Several top health care officials in recent days have echoed those claims—and even raised doubts about whether a coronavirus vaccine will be available before November.

    For instance—Moncef Slaoui, the chief adviser for the Trump administration's Operation Warp Speed initiative, which is working to speed up development of a vaccine against the novel coronavirus—during an interview with NPR on Thursday said he believes it is "extremely unlikely" that a coronavirus vaccine will be available by the end of October, though it's "not impossible."

    Slaoui explained that "[t]here is a very, very low chance that the [clinical] trials [on coronavirus vaccine candidates] that are running as we speak" could have data ready before the end of October that would allow FDA to authorize a vaccine. As such, Slaoui said states should use the guidance CDC issued on how to prepare to distribute a vaccine, in case an inoculation is ready earlier than expected. "It would be irresponsible not to be ready if that was the case," Slaoui said.

    Separately, during an interview with ScienceInsider  on Thursday, Slaoui said he won't be influenced by political pressure to accelerate authorization of a coronavirus vaccine. "The science is what is going to guide us. And the science is what our team is focused on and will be judged by. And at the end of the day, the facts and the data will be made available to everyone who wants to look at them and will be transparent," he said.

    Slaoui added that he "would immediately resign if there is undue interference in this process."

    Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during an interview with CNN on Thursday similarly said it is "conceivable" that a coronavirus vaccine will be ready in October, but he believes it's more likely that a vaccine will be available in November or December—though those are only "guesstimates."

    Fauci added that, whenever FDA does authorize a vaccine for use, that decision will be based on data from clinical trials that is also reviewed by independent groups—and it won't be due to political pressure. "I'm pretty sure it's going to be the case that a vaccine would not be approved for the American public unless it was indeed both safe and effective. … If that's the case … I would not hesitate for a moment to take the vaccine myself and recommend it for my family," Fauci said.

    Further, Albert Bourla—CEO of Pfizer, which currently is conducting Phase 3 clinical trials on a coronavirus vaccine candidate—said he does not plan to seek FDA's authorization of the experimental vaccine unless the company has adequate data showing the candidate is safe and effective.

    "We will never submit for authorization or approval any vaccine before we feel that it is safe and effective," he said.

    During a Q&A with the International Federation of Pharmaceutical Manufacturers & Associations, Bourla said Pfizer currently has enrolled 23,000 volunteers in a Phase 3 clinical trial, which began in July, for the company's vaccine candidate, and the company plans to enroll at least 30,000 volunteers in total.

    "We expect by the end of October, we should have enough [data] ... to say whether the product works or not," he said. "Our Phase 3 study will be the only one that will allow us to say if we have a safe and effective vaccine. If we don't have results from a Phase 3 study, we would not submit" (New York Times [1], 9/4; Silva, NPR, 9/3; Cohen, Science Magazine, 9/3; Reimann, Forbes, 9/3; Lovelace [1], CNBC, 9/3; Stelloh/Allen, NBC News, 9/3; Axelrod, The Hill, 9/3; Forgey, Politico, 9/3; Lambert/Shalal, Reuters, 9/3; Dall, CIDRAP News, 9/3; Lovelace [2], CNBC, 9/3; New York Times [2], 9/4).

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