Trump-haters are so determined to defeat the president that they're opposing emergency authorization of a COVID-19 vaccine. What a callous disregard for human life. Without a vaccine, another 100,000 fatalities are expected by year's end, according to Washington University epidemiologists. On Friday, Food and Drug Commissioner Stephen Hahn ignited a firestorm when he said the FDA might grant emergency use authorization to one of the COVID-19 vaccines this fall, if clinical trial results indicate it's safe and effective.
Emergency use authorization would allow the vaccine to be rushed to frontline health care workers, cancer patients, first-responders, mass transit workers and the elderly. But only those who want it. It's voluntary, just like "right to try." Full-fledged FDA approval will take months longer, and most Americans won't be able to stop in a drug store to get vaccinated until mid-2021.
Emergency use authorization is customarily granted when early results are so promising that waiting would amount to a cruel disregard for the lives that could be saved. The European Union and the United Kingdom also have announced they're considering emergency or conditional approval.
Joe Biden accuses Donald Trump of meddling in vaccine development rather than leaving it to the experts. Truth is, Trump is revolutionizing how vaccines are developed for this pandemic and future ones. He learned what not to do from the pathetic performance of the Obama-Biden administration when the H1N1 virus, also called the swine flu, struck in 2009.
The first victim was a 23-month-old Texas baby who died in April 2009.
The Obama administration promised to develop and manufacture 100 million vaccine doses by October, but came up with only 11 million, due to a flawed plan and bungled manufacturing. As the delay dragged on, infections tripled to 60 million.
Trump isn't risking failure. Instead of relying on one vaccine production method, like Obama did, Trump's Operation Warp Speed has eight companies working on vaccines based on four different scientific platforms. Each company recruits 30,000 volunteers, administers the shots and waits to see if these vaccinated volunteers are significantly less likely to contract COVID-19 than unvaccinated people. The first trials, run by Pfizer, Moderna and AstraZeneca, are expected to finish in December.
Formal approval will be in the hands of Vaccine and Related Biological
Products Advisory Committee experts drawn from industry and academia. They meet publicly, examine the data, vote and make a recommendation to the FDA. It often takes months.
But even for emergency use authorization, that committee will be consulted, explains Peter Marks, who runs FDA vaccine approval.
Hahn insists emergency use hinges on data, not politics, but anti-Trumpers accuse him of trying to boost Trump's reelection chances. These are the same voices that bash hydroxychloroquine, attack emergency use of Remdesivir, and wish failure on whatever breakthrough could stop the COVID-19 carnage.
Highly respected Anthony Fauci is another matter. His caveats are being touted by the anti-Trumpers. But parse his words. Fauci says, "The one thing you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy." Hahn has already confirmed emergency use depends on that signal of efficacy. If it's powerful, then waiting for all 30,000 results would cost too many lives.
Fauci also worries granting emergency use for one vaccine would make it harder to recruit volunteers for other vaccine candidates, because
everyone will want the real deal. Sorry, but that's bureaucratic thinking at its worst. Tell that to a nurse treating COVID-19 patients and desperate for protection.
Meanwhile, Biden announced that if the virus continues, then he'll consider locking down the country again.
Americans have suffered enough from lockdowns.
Trump's idea is better: "We will achieve a victory over the virus by
unleashing American scientific genius." In short, a safe vaccine developed at warp speed. The naysayers need to get out of the way.
Betsy McCaughey a former lieutenant governor of New York
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