Saturday, July 31, 2021

Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021*

 *This is the published report. The New York Times, Forbes, and the Washington Post all report that there was a slide presentation at CDC that painted an even more dire picture. Dr. Walensky, CDC director briefed Congress on the internal slide presentation, but it has not been made public. NYT and WaPo have seen some of the slides. This new unpublished data is at bottom below the hash marks.


7:26 p.m. July 30.

This is the CDC report that caused the change of guidance. Excerpts:

Summary

What is added by this report?

In July 2021, following multiple large public events in a Barnstable County, Massachusetts, town, 469 COVID-19 cases were identified among Massachusetts residents who had traveled to the town during July 3–17; 346 (74%) occurred in fully vaccinated persons. Testing identified the Delta variant in 90% of specimens from 133 patients. Cycle threshold values were similar among specimens from patients who were fully vaccinated and those who were not.


What are the implications for public health practice?

Jurisdictions might consider expanded prevention strategies, including universal masking in indoor public settings, particularly for large public gatherings that include travelers from many areas with differing levels of SARS-CoV-2 transmission.

...

During July 2021, 469 cases of COVID-19 associated with multiple summer events and large public gatherings in a town in Barnstable County, Massachusetts, were identified among Massachusetts residents; vaccination coverage among eligible Massachusetts residents was 69%. Approximately three quarters (346; 74%) of cases occurred in fully vaccinated persons (those who had completed a 2-dose course of mRNA vaccine [Pfizer-BioNTech or Moderna] or had received a single dose of Janssen [Johnson & Johnson] vaccine ≥14 days before exposure)....Overall, 274 (79%) vaccinated patients with breakthrough infection were symptomatic.

Among five COVID-19 patients who were hospitalized, four were fully vaccinated; no deaths were reported. 

Real-time reverse transcription–polymerase chain reaction... cycle threshold...values [virus load] in specimens from 127 vaccinated persons with breakthrough cases were similar to those from 84 persons who were unvaccinated, not fully vaccinated, or whose vaccination status was unknown. The Delta variant of SARS-CoV-2 is highly transmissible; vaccination is the most important strategy to prevent severe illness and death. 

Having a "strategy" does not speak to the strategy's efficacy. I can have an excellent, truly excellent, strategy to defend against LeBron James. I'm not going to be effective. The paper addresses efficacy of the vaccination strategy at bottom.
...
By July 26, a total of 469 COVID-19 cases were identified among Massachusetts residents; dates of positive specimen collection ranged from July 6 through July 25...median age was 40 years...

Oooh.
...

Five were hospitalized; as of July 27, no deaths were reported. One hospitalized patient (age range = 50–59 years) was not vaccinated and had multiple underlying medical conditions.†† Four additional, fully vaccinated patients§§ aged 20–70 years were also hospitalized, two of whom had underlying medical conditions.

Okay, let's unpack this. The "real-time reverse threshold values" gobbledy-gook means "virus load". So, 346 fully vaccinated people were infected, 123 un-part-unk were infected; 274 of the fully vaxed-and-infected had symptoms, 127 of the fully-vaxed-and-infected had virus loads similar to 84 un-part-unk, 4 fully vaxed were made so ill that they had to be hospitalized, 1 un-partial-unk was hospitalized; none died. 

So, you are nearly three times likelier to contract Delta if you are fully vaccinated (74%) than if you aren't or are partially vaccinated (26%); almost half (46% ) of the fully-vaxed are going to get a virus load of similar heft to the un-part-unk; a higher percentage of the fully-vaxed are going to get sick (79%)! and more of the fully-vaxed (1.4%) are going get soo sick that they have to go to hospital than the un-part-unk (1.15%). Nobody, vaxed, unvaxed or in between went to funeral home (0%).

It does not follow from the data on this one outbreak that vaccination is an efficacious strategy against Delta
...
The findings in this report are subject to at least four limitations. First, data from this report are insufficient to draw conclusions about the effectiveness of COVID-19 vaccines against SARS-CoV-2, including the Delta variant, during this outbreak. 

Oomph.

As population-level vaccination coverage increases, vaccinated persons are likely to represent a larger proportion of COVID-19 cases. 


Okay, wait, wait, wait, wait, wait. The "strategy" of getting vaccinated has its most important desideratum, NOT GETTING COVID-19. The "strategy" of getting the whole country vaccinated is to decrease the total number of cases of COVID-19. How can it be that as vaccinations increase cases among the vaccinated will increase? That is complete BULLSHIT.

Second, asymptomatic breakthrough infections might be underrepresented because of detection bias.

Okay, they are grasping at straws. They are using weasel words and trying to explain away the horrifying 79% symptomatic-vaxed. Look, this is a MAJOR study on a shocking incident that received widespread popular publicity. The evidence is not anecdotal, it is very good, hard data. If the evidence had not been good enough they wouldn't have written this highly-anticipated damn paper. You can make reasonable scientific findings based on solid data like this. They made such findings. They then simultaneously gulped and shit themselves.

Third, demographics of cases likely reflect those of attendees at the public gatherings, as events were marketed to adult male participants; further study is underway to identify other population characteristics among cases, such as additional demographic characteristics and underlying health conditions including immunocompromising conditions.
...
Finally, [the virus load blah blah blah] might provide a crude correlation to the amount of virus present in a sample and can also be affected by factors other than viral load.
####################################

[The slide presentation] strikes an urgent note, revealing the agency knows it must revamp its public messaging to emphasize vaccination as the best defense against a variant so contagious that it acts almost like a different novel virus, leaping from target to target more swiftly than Ebola or the common cold.

The Barnstable study alone does NOT justify "emphasize on vaccination as the best defense". The data from Barnstable show the opposite: more of the vaccinated get infected than the un-part-unk category; more of the fully vaccinated were hospitalized than the un-part-unk. On this metric the sample size may be so small as to lose significant meaning its meaning was significant enough for the published report to present them.
...
“I finished reading it significantly more concerned than when I began,” Robert Wachter, chairman of the Department of Medicine at the University of California at San Francisco, wrote in an email.

CDC scientists were so alarmed by the new research that the agency earlier this week significantly changed guidance for vaccinated people even before making new data public.

One of the slides ...estimates that there are 35,000 symptomatic infections per week among 162 million vaccinated Americans.

The document outlines “communication challenges” fueled by cases in vaccinated people, including concerns from local health departments about whether coronavirus vaccines remain effective and a “public convinced vaccines no longer work/booster doses needed.”

That is not a "communication challenge," that is a data-driven challenge. The "communication" should be plain. In the case of Barnstable, the vaccine gold standards produced 1) significantly a greater proportion of infections in the fully vaxed than in the un-part-unk 2) greater symptomatology in the fully faxed than in "other" and 3) for what it is worth four of the five incidents of hospitalization.

The presentation highlights the daunting task the CDC faces. It must continue to emphasize the proven efficacy of the vaccines at preventing severe illness and death while acknowledging milder breakthrough infections may not be so rare after all, and that vaccinated individuals are transmitting the virus. The agency must move the goal posts of success in full public view.

The Barnstable County data of the published report do NOT "emphasize the proven efficacy of the vaccines against severe illness." In fact the first "caveat" at the end of the published report notes explicitly that "data from this report are insufficient to draw conclusions about the effectiveness of COVID-19 vaccines against SARS-CoV-2, including the Delta variant, during this outbreak." [in Barnstable]. The undersigned wishes to emphasize that this is a major study with the outbreak under study chosen specifically by CDC. It has no right to hide more damning data nor to massage the Barnstable findings into something more easy to swallow by Americans. But the major caveat the undersigned wishes to add is "during this outbreak." This is a major study--but of only one outbreak. Others may soften the gut punch of the Barnstable published report, although the slide presentation in this post addendum is worse, not better.

The CDC declined to comment.

...“Waiting even days to publish the data could result in needless suffering and as public health professionals we cannot accept that.”

...Matthew Seeger, a risk communication expert at Wayne State University in Detroit, said...Because public health officials had emphasized the great efficacy of the vaccines, the realization that they aren’t perfect may feel like a betrayal.

“We’ve done a great job of telling the public these are miracle vaccines,” Seeger said. “We have probably fallen a little into the trap of over-reassurance"...

The CDC’s revised mask guidance stops short of what the internal document calls for. “Given higher transmissibility and current vaccine coverage, universal masking is essential to reduce transmission of the Delta variant,” it states.

Leveling with the public should not be a "communications challenge." Neither should shielding more ominous data from the public.

The [slide presentation] includes CDC data from studies showing that the vaccines are not as effective in immunocompromised patients and nursing home residents, raising the possibility that some at-risk individuals will need an additional vaccine dose.
...
The agency faced criticism from outside experts this week when it changed the mask guidance without releasing the data, a move that violated scientific norms, said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center at the University of Pennsylvania.

“You don’t, when you’re a public health official, want to be saying, ‘Trust us, we know, we can’t tell you how,’” Jamieson said. “The scientific norm suggests that when you make a statement based on science, you show the science. … And the second mistake is they do not appear to be candid about the extent to which breakthroughs are yielding hospitalizations.”
...
Walter A. Orenstein, associate director of the Emory Vaccine Center, said he was struck by data showing that vaccinated people who became infected with delta shed just as much virus as those who were not vaccinated. The slide references an outbreak in Barnstable County, Mass., where vaccinated and unvaccinated people shed nearly identical amounts of virus.

“I think this is very important in changing things,” Orenstein said.

A person working in partnership with the CDC on investigations of the delta variant, who spoke on the condition of anonymity because they were not authorized to speak, said the data came from a July 4 outbreak in Provincetown, Mass. Genetic analysis of the outbreak showed that people who were vaccinated were transmitting the virus to other vaccinated people. The person said the data was “deeply disconcerting” and a “canary in the coal mine” for scientists who had seen the data.

“I think the central issue is that vaccinated people are probably involved to a substantial extent in the transmission of delta,” Jeffrey Shaman, a Columbia University epidemiologist, wrote in an email after reviewing the CDC slides.