Did the FDA just make another bad call about boosters???

Last update: Saturday 8/6/22 

The FDA recently announced its recommendation that second booster shots for those under 50 be postponed until autumn. So you ask yourself, why might this be a bad call, and if so, why would it be "another" bad call? When did the FDA make a previous bad call about boosters? ... Ahhhhhh, dear reader, your last question suggests that you are well under 65. As a really old guy, well over 65, the editor of this blog takes every bad policy call by any of our esteemed pandemic managers very personally, because every bad call gives the virus another chance to kill him. That's why he recalls every bad policy as clearly as anyone who ever had a near death experience can recall that experience. So hop into his Way-Back machine as he drives you back to the summer of 2021, the summer of mega breakthroughs at the beach, and the summer wherein we lost our innocence while confronting the declining effectiveness of our highly effective vaccines.

• "Summer boosters for people under 50 shelved in favor of updated boosters in the fall", Rob Stein, NPR, 7/28/22

Fundamental facts of the pandemic. 

Wile reading this note, please keep the following facts in mind: 

• COVID-19 rarely kills children, but its lethality increases with the age of its potential victims. 
• Month after month throughout the pandemic, 70 to 80 percent of all COVID deaths have been 65+, even though this age group is less than 20 percent of the total U.S population. 
• During the Omicron surge early in 2022 and thereafter, the COVID death share for the 65+ group has exceeded 80 percent

The FDA's booster call in 2021

Now let's recall the booster events that started last summer as reported by articles in the major media. Although the editor's points are fully explored in the articles, the headlines capture the gist of what's reported in the articles; so readers should feel free to skim the headlines and read the articles when they have more time.

1) July 4th breakthrough cases 

In a sudden explosion of breakthrough cases in the Provincetown, Massachusetts beach resort during the July 4th holiday celebrations, over 700 vaccinated visitors were infected by the newly dominant Delta variant. Most of these vaccinations had to have occurred between April and June, so most vaccinations had to be, at most, two months old.

• "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  
•  "‘It’s Nowhere Near Over’: A Beach Town’s Gust of Freedom, Then a U-turn", Ellen Barry and Beth Treffeisen, NY Times, 8/1/2

Delta was not only more  transmissible than the original variants; it was far more lethal; but no one died. Primary dose vaccinations still protected their recipients from severe illness and death. More correctly, primary doses still protected younger recipients because common sense suggests that the vast majority of the adult revelers in Provincetown were in the younger age groups, i.e., in their 20s, 30s, and 40s.

 2) Discovery of waning effectiveness of primary doses against infection

A few weeks later, the CDC data indicated that vaccines might lose their effectiveness against infection after five or six months. If so, the most endangered persons would be those who were most threatened by infections, i.e., those who were oldest and those who were immunocompromised. But direct evidence of the waning effectiveness of our vaccines' capacity to protect these groups against severe illness and death did not exist. 

• "Vaccine Effectiveness Against Infection May Wane, C.D.C. Studies Find", Apoorva Mandavilli, NY Times, 8/18/21

3) To boost or not to boost ...

There was no consensus among medical experts that booster shots were justified by the limited data available. But this did not deter President Biden from announcing his intention to make booster shots available to most people as soon as possible.

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

Two key FDA vaccine regulators resigned shortly thereafter to protest the president's interference in the science-based process of determining the advisability of boosters

• "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 

The FDA soon authorized Pfizer booster boosters for older and/or immunocompromised recipients; but it also advised shots for younger persons whose jobs exposed them to heightened risks for becoming infected.

• "F.D.A. Authorizes Pfizer Booster Shots for Older and At-Risk Americans", Noah Weiland and Sharon LaFraniere, NY Times, 9/22/21

The CDC's advisory panel of experts disagreed with the FDA. They only authorized Pfizer boosters for persons who wee older and/or immunocompromised. 

• "Federal Panel Recommends Booster Shots, Opening New Campaign Against the Virus", Apoorva Mandavilli and Benjamin Mueller, NY Times, 9/23/22 ...Note: Lousy headline; the "federal panel "is the CDC's advisory committee

Rather than present the public with a CDC recommendation that was not consistent with the recommendation from the FDA, the CDC Director overrode the recommendation of the CDC's expert advisors by also proposing that persons at risk be eligible for Pfizer boosters.

• "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  

The following article discusses the ongoing lack of consensus among medical experts as to the advisability of booster shots for recipients who were neither older nor immunocompromised

• "Are Vaccine Boosters Widely Needed? Some Federal Advisers Have Misgivings.", Apoorva Mandavilli, NY Times, 10/25/21 

In the following weeks, the FDA recommended boosters for Moderna and Johnson & Johnson boosters, and then recommended boosters for all adults. The CDC rapidly concurred with each FDA approval

• "F.D.A. Authorizes Coronavirus Booster Shots for All Adults",  Sharon LaFraniere and Noah Weiland, NY Times, 11/19/21
• "C.D.C. Endorses Covid Vaccine Booster Shots for All Adults", Apoorva Mandavilli, NY Times, 11/19/21

4) So who was right? The FDA's experts or the CDC's experts?

A CDC report published in February 2022 showed that the only age group that derived substantial benefit from boosters while Delta was dominant in the last half of 2021 were older recipients.

• "Younger Americans Benefited Less From Booster Shots Than Older People", Apoorva Mandavilli,  NY Times, 2/4/22 ... Note: Article states that "The data run only through the end of December, when the Omicron surge had just begun."  

This blog editor's analysis of subsequent CDC data found that this pattern continued under Omicron in 2022. See links to "related notes" at the bottom of this page. 

Question: Why all the concern about boosters now? 

Answer: Our current boosters still protect against severe illness and death, especially for those in the oldest age groups, but provide little or no protection against infection or reinfection. Moreover, each infection/reinfection imposes risks of long COVID. Hopefully, the new boosters that the FDA is asking us to wait for will greatly reduce every recipient's chances of becoming infected or reinfected by all variants and sub-variants of Omicron.

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Links to related notes on this blog:  

• "How well have our vaccines protected the oldest members of our society against COVID?", Latest update: 6/11/22
  
  
• "Our pandemic of the elderly -- dead unvaccinated, dead vaccinated, and dead boosted", Latest update: 7/21/22