Disarray: CDC and FDA tell White House to put most booster shots on hold for now

AP Photo/Evan Vucci

Wasn’t it literally yesterday that the most famous scientist in America told us it may be that three shots is the proper regimen for durable immunity against COVID instead of two?

That is, that we shouldn’t necessarily think of the third shot as a “booster” so much as an integral part of protecting oneself from the coronavirus?

Why was Fauci out in front of the public talking up three shots when, it turns out, the public health bureaucracy isn’t sold on the idea yet?

More to the point, why has the president been hyping September 20 as the start date for third doses among the general public if his own science advisors hadn’t signed off on that?

If you missed it on Wednesday, read Jazz’s post about two key FDA vaccine regulators who’ve apparently resigned in protest over the administration’s decision to push boosters before the agency felt comfortable doing so. Trump was lambasted during his presidency for politicizing science, creating an opening for Biden to pledge on the campaign trail that the science would always determine the policy in his administration. Less than eight months removed from Inauguration Day, he’s now had two scientists quit because he neglected to keep that pledge. And somehow his most high-profile advisor, Fauci, was left to talk up third doses at a televised briefing just 24 hours before the FDA and CDC told the White House privately to slow down.

Why aren’t these people on the same page? Why did Biden publicly set a September 20 date for boosters if the scientists weren’t ready for that?

Top federal health officials have told the White House to scale back a plan to offer coronavirus booster shots to the general public later this month, saying that regulators need more time to collect and review all the necessary data, according to people familiar with the discussion.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their agencies may be able to determine in the coming weeks whether to recommend boosters only for recipients of the Pfizer-BioNTech vaccine — and possibly just some of them to start…

Among the reasons for delaying is that regulators need more time to decide the proper dosage for a possible third Moderna shot. The company’s application asking the F.D.A. to authorize a booster shot contains insufficient data, one federal official familiar with the process said. Other data expected from Johnson & Johnson has not been delivered.

Nor has the raw data that the F.D.A. has been seeking from Israel, which is already giving boosters to everyone 12 and older. Israeli officials say their data shows that the potency of Pfizer’s vaccine wanes over time against severe disease and hospitalization, but that a third shot bolsters protection significantly. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.

The vaccinated are risk-averse by definition when it comes to COVID. Many of them are following the news about breakthrough infections domestically and some are keeping up on the terrible wave that highly vaccinated Israel is enduring. Israel is the canary in the coal line for America, in fact, since they’re using the same vaccines we are and following the same dosing regimen. They’ve already authorized boosters for everyone, with apparent success:

Meanwhile, risk-aversion among the vaccinated here at home is almost certainly damaging the economy:

I wonder how much the administration’s dumb chatter about boosters has fed that aversion to risk, leading some vaccinated to calculate that they should isolate short-term since they’ll soon be eligible for a third dose, at which point it’ll be “safe” to be out and about again. There’s no way to know how people will react to the coming news that boosters are postponed and may not be distributed at all. Will some of the vaxxed lie their way into getting third doses anyway by telling pharmacists that they’re unvaccinated and would like their “first” dose? How many will decide that it’s “safe” to socialize immediately if the FDA and CDC declare that they aren’t sure that boosters are needed versus how many will decide to isolate indefinitely, until boosters are finally approved?

And how will public distrust of federal health agencies influence the reaction? It would be easier to applaud the FDA and CDC for wanting to slow down and be rigorous about the science if they’d had a record of moving efficiently on other needed health measures during the pandemic. But they’ve always seemed to move more slowly than the urgency of the situation warrants. They took too long this spring on urging the vaccinated to unmask, too long on ending the six-foot rule in schools, too long on fully approving Pfizer’s vaccine, and are currently taking too long to authorize the vaccines for kids with the new school year having already begun. A winter wave of COVID is impending and seniors will need to be protected. Are they going to drag their feet on boosters too such that some elderly people end up dying before they can get their third dose?

I’m tempted to say “Let’s just follow Israel’s lead” but that gets to another problem with the FDA and CDC. Why are we so dependent on Israel for crucial data in the middle of a pandemic?

If they need more time to assess whether third doses are causing unexpected side effects, fair enough. But if they’re holding back because they’ve concluded that a third dose provides some extra protection against COVID but not “enough,” why not dispense the doses anyway? Even if third doses don’t do much to add to the vaccinated’s protection from severe illness, reducing their ability to get infected and to pass the virus to others will save lives this winter and reduce the total number of hospitalizations, which will be important to making sure that people with health emergencies can get the care they need.

Here’s Scott Gottlieb warning that the next big Delta wave is coming to the northeast soon. If you’re a senior citizen there, good luck with the two doses you’ve already had.