Inside Medicine. What Are You Seeing?

A lot of our patients have pre-existing conditions, which is why there is still a relatively high number of vaccinated people who died (heart, cancer, transplant, along with the many other etiologies, but we do lots of cardiac, transplant and cancer care in particular)

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We have a chart comparing risk of disease in our vaccinated versus unvaccinated employees (medical/religious exemptions), showing vaccine effectiveness in one defined group. Let me see if I can find it.

Have you cut the vaccinated data by which of the 3 vaccines the patient had received, and/or how far back they had their second shot (or first for JNJ)?

No, I don’t think there’s the manpower to do that right now. Maybe when the numbers start to come down unfortunately.

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Out of curiosity, do you verify that people who said they were vaccinated actually were? If so, how?

Ever since I read about the charges against some people in NY who were selling vax cards AND entering the data into the state database, I’ve wondered just how reliable our vax data is.

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Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern, including in a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC) and in a separate recent publication by the U.S. Centers for Disease Control and Prevention (CDC).

Additionally, the Company shared a new analysis of follow-up through 1 year in the Phase 3 COVE study suggesting a lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after first dose) compared to participants vaccinated last year (median 13 months after first dose). Manuscripts summarizing both findings have been posted to preprint servers and will be submitted for peer-reviewed publication.

“It is promising to see clinical and real-world evidence adding to the growing body of data on the effectiveness of the Moderna COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection. We hope these findings are helpful as health authorities and regulators continue to assess strategies for ending this pandemic.”

Emphasis added by me. I hope the CDC and FDA pay attention to these studies regarding booster timing. The good news I took from this study is that protection seems relatively good even 13 months post vaccination with moderna.

Breakthrough cases doubled from 88 (8 months post vaccination) per thousand to 162 per thousand once you are 13 months post vaccination.

Recent data published by the U.S. CDC2 examined vaccine efficacy across nine states based on 32,867 medical encounters including 14,636 hospitalizations between June and August 2021, during the time when the Delta variant became predominant in the United States. In the analysis, the Moderna COVID-19 vaccine efficacy against COVID-19 urgent care or emergency visit was 92% (95% CI: 89-93%) and against hospitalization was 95% (95% CI: 92-97%) at a median of 96 and 106 days respectively after vaccination. Across all age groups, vaccine efficacy was reported to be significantly higher among Moderna vaccine recipients than other COVID-19 vaccines.

The goal of the analysis is to quantify the impact of waning immunity in the face of the Delta surge in the United States. The analysis compared participants initially randomized to mRNA-1273 (vaccinated from July-October 2020; n=14,746; median follow-up of 13 months since first dose) against participants initially randomized to placebo who were crossed over and vaccinated following Emergency Use Authorization (vaccinated from December 2020-March 2021; n=11,431; median follow-up of 8 months since first dose).

In the analysis, 88 breakthrough cases of COVID-19 occurred in the more recently vaccinated group (49.0 cases per 1000 person-years) compared to 162 cases in the group vaccinated last year (77.1 cases per 1000 person-years). The reduction in incidence rates for participants vaccinated more recently compared to participants vaccinated last year was 36% (95% CI: 17-52%). A Cox proportional hazards model showed similar results after adjusting for age and risk factors for severe COVID-19. Fortunately, only 19 severe cases were observed. While not significant, there was a numerical trend towards a lower rate of severe cases in the group vaccinated more recently (3.3 per 1000 person-years) compared to the group vaccinated last year (6.2 per 1000 person-years).

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Our hospital system has fully vaccinated over 1 million people. If they are not in our database, then we check the federal database.

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Data from Israel regarding Pfizer booster out today in NEJM. Essentially, the booster shot decreased the likelihood of breakthrough infection tenfold, and of serious illness twenty-fold. And that’s not Moderna, just Pfizer.

Also, we’re seeing positive flu tests in the Northeast. I have a feeling that it’s going to be an extraordinarily early flu season. How widespread it is will depend upon masking, hand washing, and how early we can ramp up administration of flu shots (which I don’t see happening).

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Flu activity has been elevated for the last 6 weeks in the US, which is early, similar to what we saw with RSV earlier this summer. Some areas are seeing a greater number of cases than others, but the percentage of flu healthcare visits has been higher in total each of the last 6 weeks than any week in last year’s flu season.

https://gis.cdc.gov/grasp/fluview/fluportaldashboard.html

Many insurance companies aren’t paying for flu shots until Sept 28, so a curious mismatch and poor policy there.

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Checked with someone. Almost all of our patients have had the Pfizer vaccine, so little Moderna to compare with. But a cursory review was done and there didn’t appear to be any difference in antibody production between the two.

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Also, re the Mu variant, we’ve seen that variant since May, get about 1 a week. 99.97% is Delta. The little Mu we’ve seen is not concerning given the level of Delta.

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Thanks. It will be interesting how this all shakes out, and the outcome of today’s FDA meeting where they are reviewing the Pfizer booster/third shot data.

A Delaware study showed Moderna had the fewest breakthrough cases, but all three vaccines are doing remarkably well. Moderna vaccine had lowest rate of COVID-19 breakthrough cases in Delaware

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my Boss had Pfizer and was fully vaccinated by Feb. We have a business trip coming up so he got his antibodies check and had none. He is cancelling the trip. He is not immunocompromised. Its possible he has all that other stuff (T cell, B cell, etc), but to him, he feels like his immunity has waned and needs a booster.

Yes, if he/she got Covid now they would be considered a breakthrough case. But that term is misleading.

Interesting. My own health care provider’s website doesn’t have me down as being vaxxed (or H). We both got ours at CVS. Now I’m wondering if we’re even in the federal database.

Between that and the people charged for putting unvaxxed people into NY’s database, I still wonder just how accurate things are. Were they the only ones or are there others who just haven’t been caught, and if so, how many others?

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DH told me that he combed through one of the Israeli studies on the need for boosters. They were comparing people vaccinated six months ago to people vaccinated recently. (But the people vaccinated six months ago were mostly 65+, and at risk. Those vaccinated more recently were young and healthy.) The first group had more Covid infections, therefore, they concluded that vaccine efficiency is waning.

The two groups should be matched, either:

  1. Young people vaccinated six months ago with young people vaccinated more recently, or
  2. Older people vaccinated six months ago with older people vaccinated more recently.
    When the Israeli data is analyzed with matched groups, there is no statistically significant difference in rates of infection.

This is a caution that it takes training, knowledge of study design, understanding of statistics, and more to evaluate and interpret research studies. We have journalists with no science background, politicians, and lay people on Twitter telling us what they mean.

Our government has already paid for and promised boosters. We don’t seem to be able to figure out a way to get the 80 million shots that are out there to people overseas who have not had any. I guess we should put them in arms before they expire, but we shouldn’t pretend we are “following the science” because we don’t have the data to support this.

If we need to buy time for the elderly and immune-compromised, we do have data for monoclonals, and they have been approved for preventative use. They are very effective at keeping people out of the hospital. If immune systems did not mount a robust response to the first two vaccine doses, are we sure that they will respond to a third?

I wish we had a national health system so we could study these questions ourselves, and I wish we could gather and scrutinize more data before making these decisions.

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I wish we had more time, too, but that doesn’t help the hospitals that are overwhelmed today and the ICU beds that are already filled. Most vaccine efficacy against viruses does indeed wane over time, so it occuring in this instance isn’t surprising but rather expected.

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Hospitals are overwhelmed with the unvaccinated. How does a third shot to the fully vaccinated help?

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Anything that keeps breakthru cases out of the hospital helps. Those cases are likely to be older or weaker to begin with, hence the importance of the booster for them. Also Healthcare, first responders, and other essential workers whose services are stretched very thin already, and whose services we will lose completely in a breakthru case.

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My friend with RA got a third shot and her antibodies went from roughly 250 to 2500.

My doc wants me to get one. I don’t know why I am waiting! The safety data for 3rd shots has come out so that is reassuring.

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