A Bumbling Biden Fails the Monkeypox Test Would he have handled Covid better than Trump? A different outbreak gives ample reason for doubt.By Allysia Finley

https://www.wsj.com/articles/a-bumbling-biden-fails-the-monkeypox-test-covid-trump-vaccines-jynneos-stockpile-rct-doses-smallpox-medicine-public-health-treatment-11661108794?mod=opinion_lead_pos5

Donald Trump was unlucky that a once-in-a-century pandemic struck in his re-election year. And Joe Biden is lucky that the current monkeypox outbreak is relatively mild. But his administration’s bumbling response belies Mr. Biden’s 2020 argument that he would have handled Covid better.

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. The federal government began to support the development of Bavarian Nordic’s Jynneos vaccine. In 2017 the Trump administration awarded Bavarian a 10-year contract for freeze-dried vaccines, giving the U.S. rights to an estimated 13 million doses. The Food and Drug Administration approved the vaccine in 2019, and the Trump administration in 2020 ordered 1.4 million doses in case of emergency.

So when the first monkeypox cases popped up in mid-May, the U.S. had the benefit of scientific knowledge, experience and a ready-made vaccine. The Centers for Disease Control and Prevention has reported 14,115 cases nationwide as of Aug. 18, probably an underestimate since the virus can look similar to other diseases. No deaths have been reported in the U.S. But Biden officials’ inept response has made the outbreak far worse than it might have been.

On May 22, four days after the first case was identified, Mr. Biden said monkeypox was “something that everybody should be concerned about,” although reports indicated that the virus was mainly spreading among gay men.

Officials then rushed to tamp down a brewing panic. “This is a virus we understand,” White House Covid response coordinator Ashish Jha said. “We have vaccines against it. We have treatments against it. It’s not as contagious as Covid. So I am confident we’re going be able to keep our arms around it.”

At the time the government had a mere 2,400 usable doses of Jynneos in its Strategic National Stockpile—enough to inoculate 1,200 people. Bavarian was storing another 372,000 finished doses in Denmark, but they wouldn’t arrive for weeks. Demand for vaccines quickly outstripped supply.

The other doses the government had ordered earlier were filled at Bavarian’s new “fill and finish” factory in Denmark, which had been operating since early 2021. But the FDA didn’t certify the facility until July 27, meaning that those doses couldn’t be distributed. As cases mounted, the administration ordered millions more doses in late June and July but they too couldn’t be delivered until later this year or next.

To stretch the government supply, the FDA this month approved a new method for injecting vaccines in the upper skin layer, which would allow each single-dose vial to be split into five doses. Bavarian CEO Paul Chaplin warned officials in a letter that there was “very limited safety data available” to support this method, and local officials complained that healthcare workers weren’t trained in it. Nevertheless, administration officials last week told states they would send them more doses only if they adopt this protocol.

Making matters worse, doses were misdirected because the administration used antiquated computer systems to distribute them to states, which couldn’t track the shipments. “Our response is completely inefficient and breaking the back of state and local responders,” Claire Hannan, executive director of the Association of Immunization Managers, told the New York Times.

Meantime, some 1.7 million courses of the smallpox antiviral treatment, which could help patients, sit in Washington’s stockpile. European regulators have approved the drug to treat monkeypox, but the FDA hasn’t, and the CDC is restricting access by requiring doctors to complete mounds of paperwork to prescribe it.

The reason? Government officials explained in the New England Journal of Medicine last week that the National Institutes of Health wants to conduct a randomized controlled trial. Expanding access to the antiviral could make this harder to do—why risk getting a placebo when your physician can prescribe the real thing?—but a trial could take years at the NIH’s snail speed. The Trump administration was criticized for authorizing convalescent plasma as a Covid treatment without evidence from randomized trials, but tens of thousands of patients probably benefited from access to it.

The Biden administration’s haphazard monkeypox response may cause hundreds of thousands of Americans to suffer needlessly. Why should we think Mr. Biden would have done any better with Covid?

 

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