America has gone from Operation Warp Speed to Biden's Snail Speed on COVID tests
The milder yet highly transmissible omicron variant may blaze a path to the end of the pandemic, but we still need help to fight it.
It was Dr. Peter Marks, head of the Center for Biologics Evaluation and Research at the FDA, who's credited with coining the apt term Operation Warp Speed. The key to this highly successful operation was to prepay drug companies for vaccines that at the time were unproven and might never see the light of day.
This, plus a multiarmed distribution plan involving the Centers for Disease Control and Prevention, the drug companies, the U.S. military, FedEx, UPS and major pharmacy chains as well as state cooperation, led to an unprecedented success story. We had the vaccines before the end of 2020, and the therapeutics and rapid tests were supposed to follow.
Operation Snail Speed
Unfortunately, what followed instead under the current president was Operation Snail Speed, with an obsessive focus on the vaccines to the exclusion of all else.
This doubling down and constant promotion of the one major tool we do have has led to a political backlash of resistance among those who don’t follow the president.
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Joe Biden's COVID-19 vaccine doctrine includes no room for immunity from an infection itself or the possibility that hybrid immunity (vaccination plus recovery from infection) might sometimes replace or delay the need for boosters.
It is also possible that healthy children will have less need for boosters because of their heightened immune response. This, despite the fact that a recent study from Arizona shows that two shots of the vaccine lowered the risk of infection in those ages 12-17 by more than 90%.
Of course this was pre-omicron, but the latest research from South Africa revealed that two doses of the Pfizer vaccine was 70% effective against severe illness and hospitalization against omicron in all ages.
Nevertheless, the Food and Drug Administration just extended approval for boosters to the 12- to 15-year-old category, even to those at very low risk of a serious case.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccine Advisory Committee, wrote to me in an email that he was concerned his committee did not meet to discuss the pros and cons of this booster extension.
“I think it would have been valuable for the American public to have heard a discussion about the pros and cons of that recommendation," he wrote. "I see it as a lost opportunity.”
Dr. Marc Siegel: Stop shaming people over masks. Focus on COVID vaccines and testing.
Dr. Cody Meissner, head of pediatric infectious diseases at Tufts University and also a member of the FDA advisory committee on vaccines, emailed me that “it may turn out that (omicron) is a relatively mild illness in most people that still confers protection against delta.”
Inavailability of at-home tests
With all this focus on vaccines, testing and therapeutics have taken a backseat. Many home tests, including Abbott’s BinaxNow, Quidel and BD Veritor, received FDA emergency use authorization in late 2020 and early 2021, but many others were stalled waiting for approval.
The National Institute of Health’s Rapid Acceleration of Diagnostics initiative didn’t start until late April 2020, and two more rapid home tests produced by Roche and Siemens received emergency use authorization in late December.
Unfortunately, the tests themselves are scarce. The 500 million home tests that the administration recently promised seem like a pipe dream.
And while the administration hasn’t provided enough tests, it has increased the unwarranted demand for them by instigating fear of gatherings amid increased omicron case numbers. Who hasn’t encountered someone with omicron? Should we all be tested daily? No, we should not.
Dr. Marc Siegel: Get the shot. Wear a mask. Don't get sick and die because you're stubborn.
When it comes to therapeutics, the Biden team’s results are even more anemic. Paxlovid, Pfizer’s new protease inhibitor wonder drug, has been approved but is scarce.
Ditto monoclonal antibodies, the synthetic neutralizing antibodies that have been so helpful in patients at high risk of complications or hospitalization. Omicron is most susceptible to sotrovimab, made by GlaxoSmithKline, but in most states it is almost impossible to find.
The milder yet highly transmissible omicron variant may blaze a path to the end of the pandemic, but we still need help to fight it. Vaccines and boosters are a major weapon when applied appropriately, and it is good to see that 62% of Americans are now fully vaccinated.
But we have more work to do. And the Biden team's emphasis on vaccines to the exclusion of other tools isn’t bringing us to where we need to go.
Dr. Marc Siegel, a member of Paste BN's Board of Contributors and a Fox News medical correspondent, is a professor of medicine and medical director of Doctor Radio at NYU Langone Health. His latest book, "COVID: the Politics of Fear and the Power of Science," was published last fall. Follow him on Twitter: @DrMarcSiegel