Sen. Kamala Harris suggested Saturday that she might refuse a vaccination for Covid-19 because “I would not trust Donald Trump.” My father, 96, feels the same way about Gerald Ford. “No way,” he says when I tell him I hope he gets the new shot as soon as it’s available. “I got the swine flu vaccine in 1976. I was in bed for three days, and my memory hasn’t been the same since.”
That fiasco has fueled many anti-vaxxers since. More than 40 million people received a rushed, flawed vaccine against a virus that never emerged, and at least 500 cases of the paralyzing Guillain-Barré syndrome were linked to it, along with thousands of cases of other unreported symptoms like my father’s.
This time at least the epidemic—and the need for a vaccine—is real. Of the more than 30 vaccines currently in clinical trials for Covid-19, three are in Phase 3, the final stage before approval, in the Trump administration’s Operation Warp Speed. Factories are gearing up, and distributions centers have been instructed to be in place by Nov. 1. That’s a good move even if the vaccine isn’t ready to distribute by then. The last thing we need right now is a bureaucratic delay.
The leading vaccine candidates—from BioNTech/
Moderna, and Oxford/
—have all cleared early safety trials and shown a robust immune response. What remains to be seen is how safe and effective a vaccine will be when 15,000 volunteers receive it in Phase 3, vs. the response of 15,000 who receive a placebo. Anthony Fauci, longtime director of the National Institute of Allergy and Infectious Diseases, told me in an interview last week that the ultimate decision will be made based on whether a safe vaccine offers actual protection against this coronavirus.
According to Dr. Fauci, the Data Safety Monitoring Board could use this information to reach a decision even before the completion of the trials: “If you get a number of events, namely infections, and your trial happens to be focused in an area where you have it and you reach the predetermined number of events, you could get an answer before the trial is officially over.”
The FDA could approve it conditionally, using an emergency use authorization. “That’s the reason why you have data and safety monitoring boards. They intermittently look at the data for adverse events . . . and for data that is for efficacy. . . . Is it conceivable that you could get an answer in October? The answer is certainly. I think its unlikely, but I think we can get it.”
Once we have a vaccine, the next challenge will be getting people to take it. This will involve considerable community engagement, outreach and transparency on the science, especially given the distrust of vaccines in some segments of society—apparently now including the Democratic presidential ticket.
I will try to convince my patients to overcome their fear and help them to recognize that the dangerous virus should be scarier than the vaccine. That’s the only way to beat Covid-19.
Dr. Siegel is a clinical professor of medicine and medical director of Doctor Radio at NYU Langone Health and a medical correspondent for Fox News.
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Appeared in the September 8, 2020, print edition.
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