The much-celebrated impact of full F.D.A. approval - new mandates from the military, colleges, companies, local governments - has a flip side: The months-long wait to reach this point has almost certainly cost American lives. 🧵
FDA officials have suggested that they had no choice to move as cautiously as they did. But that's not the case. They did have a choice. They picked caution.
There are two basic ways to see that the F.D.A. could have acted more quickly than it did:
1) The agency has acknowledged that it moved more quickly in this case than normal. A typical vaccine approval process takes between 8-12 months; this one was 3.5 months.
There is nothing magical about 3.5 months, however. Once the FDA had departed from its usual process, it could have done so more aggressively. Some experts have been urging that. No White House official or member of Congress was standing in the way of an expedited process.
FDA leaders long ago made up their minds about the substance here. Commissioner Woodcock said *three months ago* that the vaccines “have met our high standards for quality, safety and effectiveness.”
The wait for full approval was more about process than science.
2) American history is rich with examples of government officials doing what the FDA decided not to do in this case: overhaul their process in a time of crisis.
Such as:
- FDR risking confrontation with the courts to fight the Depression
- FDR and corporate America building war ships, plan es and bombs faster than almost anyone had thought possible
- The Bernanke Fed pushing the legal envelope during the 2007-9 financial crisis.
During normal times, taking the cautious route and following procedural precedent tends to make sense. It minimizes chaos and mistakes.
But a national emergency can change the equation.
In an emergency — like a depression, a war or a pandemic — government leaders will sometimes decide that the abstract benefits of bureaucratic continuity are smaller than the concrete benefits of preventing a depression, winning a war or saving lives.
The FDA decided not to do so, and its leaders still have not explained why they believed the benefits of their approach outweighed the costs.
I'd be genuinely curious to hear the FDA leaders make that case. The wait for full approval probably cost hundreds, if not thousands, of U.S. lives. (About 1,000 people are now dying daily from Covid.)
What's the other side of the ledger look like? (Fin)
In California, Covid caseloads and hospitalizations, which were already well below the national average, have been falling for about two weeks….
… If anything, statewide comparisons understate the power of the vaccines; every state, including California, has areas with relatively low vaccination rates. When you instead look at California on a county basis, the picture is striking….
Check out the strong relationship between vaccination and hospitalization rates in California’s countries. nytimes.com/2021/09/15/bri…
Should people who got a J&J shot be getting a follow-up shot from Moderna or Pfizer?
🧵
From the start, J.&J.’s single-shot vaccine has appeared to be less effective than the two-shot vaccines from Moderna and Pfizer. The J.&J. shot still provides good protection against serious illness, but not as much as the others. And the Delta variant may be widening the gap.
Federal officials have suggested they are likely to approve a booster shot for J.&.J recipients eventually. But any approval seems to be weeks away, if not months.
The current Covid situation is grim: very high caseloads, full ICUs, more than 1,500 deaths a day.
Amid this grimness, there are three reasons for some hope:
🧵
1. The vaccines continue to be highly effective against serious illness.
Seattle - a highly vaccinated place - is telling. Over the past *month*, the death rate for fully vaccinated people has been about 1 in 100,000, and the hospitalization rate has been 5 in 100,000.
2. The Delta surge has led to more aggressive actions on vaccine mandates. And vaccine mandates tend to make a big difference.
The Delta variant is clearly more contagious than earlier Covid. But does Delta also cause more severe illness in the average person who's infected?
1. We don't yet know. 2. The evidence so far suggests Delta is similarly severe - maybe a little more, maybe a little less.
🧵
This question is especially relevant to kids and vaccinated adults. In both, earlier versions of Covid were overwhelmingly mild. If Delta is not more severe, then that's still true.
If Delta is more severe, it calls for a much more cautious approach.
What are the reasons to think - tentatively, until we get more evidence - that Delta is not fundamentally different in severity from earlier versions?
In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern.
🧵
* After Delta took hold last winter in India, caseloads there rose sharply for slightly more than two months before plummeting at a nearly identical rate.
* In Britain, caseloads rose for almost exactly two months before peaking in July.
* In Indonesia, Thailand, France, Spain and several other countries, the Delta surge also lasted somewhere between 1.5 and 2.5 months.
* In the U.S. states where Delta first caused caseloads to rise, the cycle already appears to be on its downside....
A lot of commentary presumes that there was a clean solution for the U.S., if only Biden (and, to a lesser extent, Trump) had executed it. The commentary never quite spells out what the solution was, though.
There is a reason for that: A clean solution probably did not exist.
The fundamental choice, as @helenecooper says, was between a permanent, low-level U.S. war in Afghanistan — a version of what McCain once called a 100-year war — and a messy exit.
“It was always going to be an ugly pullout," Helene says.