America will have enough Pfizer and Moderna doses to cover all comers eventually, but not yet. So the FDA's extremely controversial decision to pause Johnson & Johnson vaccines while regulators look into an extremely rare potential side effect is having an inevitable immediate impact: Fewer shots going into arms. Reading some of the resulting anecdotes in the New York Times and elsewhere is deeply frustrating, particularly if one comes down on the 'harmful overreaction' side of the ledger, as I do. Painful, real consequences:
The student union had been converted into a vaccination center. The doses had arrived on campus. The first appointments were minutes away. Then, at 7:23 a.m. on Tuesday, news of the pause in Johnson & Johnson vaccinations reached Youngstown State University. “We were ready to go,” said Shannon Tirone, an associate vice president at the university, in eastern Ohio, who instead started calling students to tell them they would not be able to get the vaccine after all. Similar scenes played out across the country as the abrupt halt in the use of the Johnson & Johnson vaccine because of concerns about potential blood clots upended plans to vaccinate some of the country’s hardest-to-reach populations. In California, mobile vaccine clinics in rural areas were canceled. In Chicago, vaccination events for restaurant employees and aviation workers were postponed indefinitely. And at colleges in Ohio, New York and Tennessee, where the one-dose vaccine offered a chance to quickly inoculate students before they left campus for the summer, appointments were called off en masse.
...In some places, there was no immediate alternative. In Aurora, Ill., a mass vaccination clinic planned for Tuesday was called off, leaving 1,000 patients without appointments. In Riverside County, Calif., mobile clinics that had planned to vaccinate about 400 people in less populous areas on Tuesday were canceled. And in rural Jefferson County, in southeast Iowa, a Johnson & Johnson clinic targeting manufacturing workers was scrapped at the last minute. “It was so heartbreaking to me,” said Christine Estle, the county’s public health nurse administrator, who said she and her colleagues had encouraged the roughly 140 people scheduled to attend to make appointments at local pharmacies or hospitals. The Johnson & Johnson vaccine had long been seen as a key to the country’s vaccination effort because it requires only one shot, unlike the two-dose Moderna and Pfizer regimens, and because it can be stored more easily. In cities around the country, public health experts had begun using the vaccine in places where hesitancy about one shot — much less two — is high. “A lot of our more creative planning has been with J&J,” [an official] said. “People who have a lot of barriers to get vaccinated, a single-dose vaccine can be very good.”
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President Biden downplayed the impact of this move, framing Pfizer and Moderna as "unquestionable" alternatives:
President Biden on Johnson & Johnson vaccine: "There is enough vaccine that is basically 100 unquestionable for every single solitary American." pic.twitter.com/KKrNo3njTz
— CSPAN (@cspan) April 13, 2021
But do six potentially linked cases out of nearly seven million people render J&J "questionable"? Part of the problem is that the negative headlines about one vaccine are stirring doubts among vaccine-hesitant Americans about the safety of other shots, too. What might they have missed in those trials? It's critical to underscore that the thorough and rigorous vetting process for these vaccines determined that all three available options are safe and overwhelmingly (though not 100 percent) effective, which they are. Yanking J&J out of the rotation, even temporarily, is both slowing down immunization progress and almost certainly nudging untold numbers of hesitant would-be recipients into the 'no thanks' column. Dr. Manny Alvarez appeared on my show yesterday and blasted the FDA's decision, using blunt language:
I asked @drmannyonFOX about the FDA’s Johnson & Johnson ‘pause’ over a vanishingly rare possible side effect. He absolutely unloaded. “Moronic...criminal:” https://t.co/8mw5wrSrPi
— Guy Benson (@guypbenson) April 13, 2021
Other doctors, including Anthony Fauci, are defending the move as unfortunate but necessary -- with Fauci refusing to say definitively whether J&J will ever return to the market at all (Alvarez predicted it will, in a matter of days). But this doctor's 'keep perspective' tweet got me thinking:
3 key points for folks recently vaccinated with J&J
— Ashish K. Jha, MD, MPH (@ashishkjha) April 13, 2021
1. your risk of getting hit by lightning this year > your risk of developing blood clot from vaccine
2. Don't ignore a new severe headache, abd pain, or shortness of breath
3. Enjoy being vaccinated against a deadly disease
To me, the most compelling argument in favor of the FDA making their choice was that not announcing the possible side effect, after it was brought to their attention, could have been leaked and framed as a confidence-destroying government cover-up. So why not seek some middle ground, which would acknowledge the issue without taking the drastic and attention-grabbing step of a nationwide pause? The tweet above hints at one such course of action -- making the public aware of exceptionally rare potential side-effects, especially among women within an age range, disclosing additional research into the matter, and allowing J&J jabs to continue apace for anyone who wants them. Allahpundit offers another sensible spin on a similar idea:
Given how few are known so far, you’re left to wonder why they didn’t quietly start investigating without pausing the vaccine and then proceed to ordering a pause if the investigation revealed an alarming prevalence. Although you know what doctors would say to that. What would happen to public trust if it leaked that the CDC or FDA was secretly looking into rare blood clots caused by J&J’s vaccine and hadn’t immediately told Americans about it? Anti-vaxxers would have a field day. What they could have done and I think should have done was reveal the blood clot data publicly ASAP but not pause distribution of the vaccine. Leave it up to each individual to decide whether to proceed with their J&J dose or to switch to Pfizer or Moderna. “We believe the incidence of these clots is very rare but we’re investigating and will update the public as soon as we know more,” the FDA might have said. They might even have recommended that women under 50 avoid J&J for now, until science has a better handle on the situation. I saw numerous people on social media today who were scheduled to get the Johnson & Johnson vaccine in the next few days furious at having had their appointments canceled. Plenty of Americans would have gone through with it despite today’s news. They should have been given the opportunity.
A Twitter buddy was one of those Americans who was very eager to get his J&J shot, only to have his scheduled appointment axed:
i'm going to bed pic.twitter.com/Nk840Hoht8
— Noam Blum ?? (@neontaster) April 14, 2021
Vaccine demand is plateauing and falling in some places, though (pre-J&J announcement) hesitancy has fallen. This development came at a bad time. I'll leave you with another doctor scolding stats guru Nate Silver, who has been torching the FDA's move, from the standpoint of risk assessment and harm to public confidence:
With all due respect to @NateSilver538, he is not an expert on the psychology of vaccine confidence. He is a poll aggregator and political pundit. He is not an infectious disease specialist, epidemiologist, vaccinologist, virologist, immunologist, or behavioral scientist. pic.twitter.com/HBrI6zj9aa
— Céline Gounder, MD, ScM, FIDSA (@celinegounder) April 14, 2021
With all due respect, is she an expert on the psychology of vaccine confidence? I am certainly not, but as I said yesterday, I remember what happened in Europe last month, under similar circumstances:
European confidence in AstraZeneca vaccine safety sinks after blood clot scare (changes in last 2/3 weeks)
— YouGov (@YouGov) March 22, 2021
???? safe 23% (-10) / unsafe 61% (+18)
???? safe 36% (-18) / unsafe 43% (+27)
???? safe 32% (-11) / unsafe 55% (+15)
???? safe 38% (-21) / unsafe 52% (+27)https://t.co/yI5SNGwLay pic.twitter.com/le8HXJvCXf
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