New Study on Vaccinated vs non Vaccinated Shedding

1,917 Views | 5 Replies | Last: 3 yr ago by Jabin
Layne Staley
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AG
https://www.medrxiv.org/content/10.1101/2021.07.31.21261387v4.full.pdf

little significance in the data between the two group. only difference was one had the vaccine and the other didn't.

I wonder when the longer term safety data will start rolling in.
TXTransplant
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As someone who used to write and review articles for data-based scientific journals, this one is terrible. It really shouldn't pass the peer-review process without major edits.

With that said, I'm not going to question the validity of the data. We will assume that it's correct. However, reading the article as it's written, I see a few flaws.

1) n is only 699. It's 310 for vaccinated individuals and 389 for unvaccinated. That is a very small sample set.

2) Based on what is written in paragraph 2 under "Main text" they pretty much only tested SYMPTOMATIC vaccinated people.

From that paragraph (emphasis is my own): "Infectious virus was detected in the sole specimen tested from an asymptomatic fully vaccinated individual. Although few asymptomatic individuals were sampled, these results indicate that even asymptomatic, fully vaccinated people might shed infectious virus."

Of course symptomatic people are going to shed virus, vaccinated or not. They are drawing the conclusion that even asymptomatic fully vaccinated people might shed the virus based on ONE data point.

In Figure C, it shows that there were 24 asymptomatic unvaccinated people and 11 asymptomatic vaccinated people. That contradicts the paragraph that I quoted, but it's still a pitifully small sample set. And I think the difference is that the n=1 data point is from the subset that was determined to be infectious. So, only one asymptomatic vaccinated person had enough virus in the sample to be deemed "infectious". All the rest of the "infectious" samples came from symptomatic vaccinated individuals.

133 unvaccinated and 74 vaccinated subjects had "unknown symptom status". To me, that's not acceptable considering how small this sample set is.

They conclude: "Vaccinated and unvaccinated persons should get tested when symptomatic or after close contact with someone with suspected or confirmed COVID-19."

Did it really take 15 PhDs, MDs, and DVMs to reach that conclusion???

Regardless, this article is a great example of why peer review is SO important. Note the disclaimer in the header on every page stating that this has NOT been peer-reviewed.

I'm curious to hear what others who have a background in writing and reviewing peer-reviewed literature have to say about this.

I reviewed the article pretty quickly, so if I missed or misunderstood something, please point it out.
Get Off My Lawn
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The data which would really interest me is likely unethical to produce and therefore difficult to procure: exclusively vaccinated individuals who then get infected with a full dose of the actual virus (enough to expect infection to take hold) and then get monitored for symptoms, viral shedding, etc. for the subsequent weeks.

I'm not sure how you get clean data on the leakiness without manufacturing the conditions, and this researcher appears to have done the next best thing: finding active leaks in the wild by grabbing symptomatic cases of both types.

I get why researchers are being relegated to functioning as analysts in their quest to create valuable data, but a controlled experiment is a cornerstone of modern research and it's unfortunate that we're relegated to passive observational data due to the nature of the problem at hand.
TXTransplant
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I think the closest you could get to that data is to monitor health care workers who come into contact with covid patients on a daily basis. But, even then, they are wearing PPE and taking extra precautions to prevent transmission.

You are correct in observing that this data is hard to come by.

I really have no issue with the data itself in this article. What I do have issues with is the weak (and pretty obvious) conclusion that was drawn, and the fact that the article doesn't more specifically point out that the majority of the test subjects were symptomatic.

That's my issue with all of the papers and data that are coming out right now. The "average Joe" has unprecedented access to the information but really doesn't have much experience interpreting and understanding the information.

So, in my mind the ethical and moral obligations of the authors to make sure that they are explaining the data and their conclusions as clearly, accurately, and objectively as possible is more important than ever.

Peer-review keeps authors accountable for preparing a good article instead of just being lazy in an attempt get something (anything) published. It also helps prevent them from overstating or extrapolating their conclusions beyond what the data truly shows (on a statistically significant level) just to get clicks and citations.
TXTransplant
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https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02183-8/fulltext

This study doesn't completely fill in the gaps, but it does have a much larger sample set (n = 3,436,957) and the study ran from Dec 14, 2020 to Aug 8, 2021, so it does attempt to measure effectiveness over time.

From the data/results: 184,041 participants contracted covid and 12,130 ended up in the hospital.

Over the entire study period, fully vaccinated individuals had an adjusted vaccine effectiveness of 73% (95% CI 7274) against SARS-CoV-2 infections and 90% (8992) against COVID-19-related hospital admissions (appendix pp 67). Stratified by age group, the vaccine effectiveness against infection of those who were fully vaccinated was 91% (95% CI 8893) for those aged 1215 years and 61% (5765) for those aged 65 years and older (appendix p 6). The age stratified vaccine effectiveness against hospital admissions was 92% (95% CI 8895) for those aged 1644 years, and 86% (8288) for those aged 65 years and older (appendix p 6).

Vaccine effectiveness against infection for the fully vaccinated decreased with increasing time since vaccination, declining from 88% (95% CI 8689) during the first month after full vaccination to 47% (4351) after 5 months (157 days after second dose, p<00001; figure 2A; appendix p 9). Individuals aged 65 years and older had a vaccine effectiveness of 80% (95% CI 7385) within 1 month after being fully vaccinated, decreasing to 43% (3054; p<00001) at 5 months after full vaccination (figure 2A; appendix p 9). Among fully vaccinated individuals of all ages, overall adjusted vaccine effectiveness estimates for COVID-19 hospital admissions were 87% (95% CI 8291) within 1 month after being fully vaccinated, and 88% (8292) at 5 months after full vaccination, showing no significant waning (p=080; figure 2B; appendix pp 910).

Overall vaccine effectiveness against infection with the delta variant for the fully vaccinated was 75% (95% CI 7178), while overall vaccine effectiveness for other variants was 91% (8892; appendix pp 910). Estimates against both delta and other variants were high within 1 month after full vaccination (vaccine effectiveness against delta 93% [95% CI 8597] vs other variants 97% [9599]; p=029). At 4 months after full vaccination, vaccine effectiveness against delta infections declined to 53% (95% CI 3965) and vaccine effectiveness against other variants declined to 67% (4580; p=025).

Bold emphasis added. There is a lot to unpack in this article, but the data is a much better set for drawing conclusions from.
Get Off My Lawn
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A back-brief to check comprehension: once you're 5+ months out from vaccine, chances of contracting Covid drop to pretty near a coin flip, but the chance of it being severe enough to get hospitalized remains low.
Jabin
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It seems that the study linked by TxTransplant considered the Pfizer vaccine only, correct? If so, it would not be valid to extrapolate from it to all vaccines. It's my impression that the Moderna vaccine has proven to be more robust over time than the Pfizer.
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