Old movies about boosters, science, and judgement calls ... with a 2nd P.S.

Last update: Sunday 4/3/22 

The challenge posed by the sudden emergence of the Delta variant in the summer of 2021 was met by the Biden administration's full-throated call for booster shots for everyone. Unfortunately, the administration announced this objective before the advisory committees of the FDA and the CDC had determined that this change in policy was justified by the science. Indeed, two high level experts at the FDA resigned in protest.

Last year's confusion
The following bullets provide links to articles that reported these events. The first two describe the stunning mega-cluster of Delta breakthrough cases that erupted in Provincetown, MA, a resort beach community, over the course of the July 4th holiday weekend.

• "C.D.C. Internal Report Calls Delta Variant as Contagious as Chickenpox", Apoorva Mandavilli, NY Times, 7/30/21
   
• "Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021", CDC, 7/30/21 

The next article reports the Biden administration's announcement of its intentions to provide booster shots for everyone and the support this initiative received from the heads of the FDA and the CDC ... prior to this proposal being reviewed by the FDA and CDC advisory committees.

•  "U.S. to Advise Boosters for Most Americans 8 Months After Vaccination", Apoorva Mandavilli, NY Times, 8/16/21

The president's announcement was quickly followed by two top level resignations from the FDA in protest.

• "Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial Period", Noah Weiland and Sharon LaFraniere, NY Times, 8/31/21 
• "Health Officials Advise White House to Scale Back Booster Plan for Now", Sharon LaFraniere and Noah Weilan, NY Times, 9/3/21 

Then came a genteel scrum between the FDA's advisory committee and the CDC's advisory committee wherein the FDA committee recommended that all workers on the pandemic's front lines receive booster shots vs. the subsequent CDC committee's recommendation that only at-risk for health and older persons receive booster shots.

• "F.D.A. Authorizes Pfizer Booster Shots for Older and At-Risk Americans", Noah Weiland and Sharon LaFraniere, NY Times, 9/22/21  
•  "Here is who voted on which booster-shot policies the C.D.C. should adopt.", Dan Levin, NY Times, 9/23/21

Initial resolution

This untenable conflict was quickly resolved by the decision of the CDC's Director to override the recommendation of the CDC's committee. She determined that the CDC would provide the same guidance as the FDA, i.e., support booster shots for front line workers as well as for the elderly and and at-risk. Her unexpected decision ended the scrum, but did not end the division of opinion within the expert community.

•  "C.D.C. Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk", Apoorva Mandavilli and Benjamin Mueller, NY Times, 9/24/21   

Final resolution

The division of opinion persisted until the sudden emergence of the super contagious Omicron variant, whose first case in the U.S. was detected in early December 2020. Whereas Delta generated a substantial number of breakthrough cases, under Omicron breakthroughs became the norm. This combination of high transmissibility and high percentage of breakthroughs made the case for booster shots a slam dunk ... under Omicron ...

• Omicron Prompts Swift Reconsideration of Boosters Among Scientists", Apoorva Mandavilli, NY Times, 12/1/21 
  
  
• "Most Covid Infections May Soon Be Breakthroughs. Here’s What That Means.", Eleanor Cummins, NY Times, 12/19/21
  
  
• "Omicron will infect ‘just about everybody,’ Fauci says", Andrew Jeong and Ellen Francis, Washington Post, 1/12/22  

Judgement Day

Nevertheless, the objections to boosters under Delta were confirmed in February, 2022, at least six weeks after Delta had faded into the bio-history books. A belated CDC report showed that booster shots while Delta was dominant provided negligible benefits to everyone except the oldest recipients ... which is what the CDC's advisory committee had affirmed.

• "Younger Americans Benefited Less From Booster Shots Than Older People", Apoorva Mandavilli, NY Times, 2/4/22 ... Note: Mostly Delta infections were analyzed, very little Omicron  

Did this mean that the CDC committee was "right" and the FDA committee was "wrong". Not really, but it did illustrate something that is very important, but often overlooked. 

Pandemic events sometimes move faster than the speed of normal science. In such cases, advisers must make judgement calls that are informed by science, but not limited to what the lagging science can confirm. Neither the experts on the FDA committee nor the experts on the CDC committee (nor the policy wonks in the Biden administration) could make a recommendation in the summer/early fall 2021  that was based on rigorous science. So the advisors had to make judgement calls, calls that would ultimately be affirmed (or contested) by subsequent events. 

In this sense the CDC made a better call than the FDA. Nevertheless, the CDC Director wisely reversed her committee's recommendation in order to minimize national confusion by aligning the CDC's guidance with the FDA's guidance because the FDA had cast its judgement first. Had the CDC committee cast the first judgement, the FDA Commissioner would have felt pressed to override his committee.

Have we seen this movie before?

Recently the Biden administration announced its intention to offer second booster shots to everyone 50 and over ... once again, before any announcements of support by the FDA and CDC advisory committees. ... Hmmmmmmmmm ... Let's hope the movie has a more credible, less confusing ending this time ... :-(

• "Biden Administration Plans to Offer Second Booster Shots to Those 50 and Up", Sharon LaFraniere, NY Times, 3/25/22

P.S. Some good news???

• "F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older", Sharon LaFraniere, NY Times,  3/29/22 ... Note: The decision also covers those  12 years and older with some immune deficiencies ... The article states that the CDC concurred with the FDA's decision, but "Neither the F.D.A. nor the C.D.C. convened its outside committee of experts to debate the new policy, sparking criticism." 

Question: Why wasn't the approval of the advisory committees required this time???

P.S #2. More confusion.
Consider the following headline and editor's note:

• "Many say they’re confused about whether, when to get second booster", Yasmeen Abutaleb and Lena H. Sun , Washington Post, 3/3/22 ... Note: The headline for this article is misleading. Its real news is that the "many" includes many clinical physicians, the healthcare professionals ordinary folk turn to for advice. The CDC/FDA merely "allowed" some people to receive second boosters; they did not "recommend" second boosters.

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Links to related notes on this blog:  

• "Strategic implications of some basic facts about the CDC", Last update: 3/19/22