COVID Transmissions for 11-3-2021
Let's get those 5-11 year olds vaccinated!
Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.
It has been 717 days since the first documented human case of COVID-19. In 717, the Umayyad Caliphate began the Siege of Constantinople, a watershed event in both Arab and Byzantine history. During the sea battle component of this conflict, the Byzantines deployed the weapon known as Greek Fire, which destroyed many of the Caliphate’s ships.
Today we’ll discuss the vaccine for young children, as well as a data integrity issue reported for the trial of the adult Pfizer vaccine—and why you don’t need to worry about it in terms of the vaccine’s efficacy.
Bolded terms are linked to the running newsletter glossary.
As of today, I’ve edited down some of the standard text (like what appears below this line) to help shorten the newsletter.
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Now, let’s talk COVID.
CDC recommends Pfizer vaccine for 5-11 year old children
In a unanimous vote followed by the endorsement of the CDC director, the US CDC has now recommended the use of the vaccine in 5-11 year old children. It’s time to get out there and get vaccinated (in accordance with labeling).
I was interested to see this, which points out why there is a clear and compelling argument for vaccination of children against COVID-19:
As you can see there, there are several diseases for which we currently have vaccines approved in young children that killed fewer children over periods of years than COVID-19 has killed in just the last year. The need to protect young children from COVID-19 is obvious from this, and prompts the CDC to act.
One thing I would really like to see, now that this has happened, is news organizations leaving behind their practice of reporting % vaccinated adults in US states as though this is meaningful information. The whole population matters for COVID-19 control, and by leaving children 5-11 (and 12-18, for whom vaccination was already approved months ago) out of the vaccine uptake numbers, we fool ourselves into thinking we have better vaccine uptake than we really do. Everyone, including the newly approved 5-11 year old group, needs to be considered here.
If you have children in this age group please talk to their pediatrician about vaccination—against COVID-19, and also against other deadly diseases.
Potential issues with data integrity in a small portion of Pfizer vaccine trial sites
I’m bringing this up because I expect the story to be weaponized. The British medical journal now known only as The BMJ has run a news piece revealing internal research integrity issues with one Contract Research Organization (CRO) that ran 3 of the total 153 sites in the Pfizer vaccine trial: https://www.bmj.com/content/375/bmj.n2635
Of 44,000 participants in the trial, this story applies to just the approximately 1000 participants at the 3 sites being run by the CRO, Ventavia. The issues are, relatively, low-risk, indicating that proper data auditing practices were not followed, patient interactions were mishandled, and some patients may have been unblinded to what arm of the trial they were in.
These accusations are concerning, at least somewhat, and I don’t see Ventavia recovering from them if they turn out to be true. They were reported to the FDA, and hopefully that agency will fully audit Ventavia and get to the bottom of whatever impacts it might have had.
That said, the number of patients at these sites is very small compared to the wider trial, and I doubt this had a meaningful impact on the overwhelmingly positive results. The reason I am sharing it is because I expect this story to be weaponized by antivaccine groups to claim that the entire trial has issues. It’s clear that this is not the case.
The data problems in question occurred for a subset of patients in at these sites, and the absolute maximum number of patients affected is less than 2.5% of the overall trial population. It is certainly lower than that, but that is the upper bound. There is no reason based on this to doubt the safety or efficacy of Pfizer’s vaccine. I can be relatively confident in this, because the Pfizer vaccine has since had numerous real-world studies conducted where it has performed admirably and within the expectations set by this trial.
There is a story here about a bad contractor impacting a small percentage of the data collected in a massive trial. That story is concerning and should be followed up. But it doesn’t impact what we know about the vaccine—that it is safe and effective.
What am I doing to cope with the pandemic? This:
Voting!
I went to vote yesterday. It’s an “off year,” but there are no real off years. It’s important to vote every year. It is how you have a say in your government.
Carl shared the following:
Good morning.
You say, "Only people who had previous infection without any vaccination, or who had vaccination without any previous infection, were included in the two respective arms." I presume that is really "... who had vaccination without KNOWN previous infection ..." Did the authors take that into account? There are known to be many asymptomatic or nearly asymptomatic infections.
David Gorksi wrote this morning about how the Orthodox Jewish community in New York (and apparently only in New York) continues to be victimized by antivaxxers.
https://sciencebasedmedicine.org/antivaxxers-are-targeting-orthodox-jews
My reply:
According to the methods section of the paper, the criterion was no prior documented infection. There is some chance that undetected past infections were included, but these would be in the minority and I don't think would have a huge impact on the results.
I have, unfortunately, seen these things about the ultra-Orthodox community. Unfortunately with so little emphasis placed on secular scientific education in those communities, they become easier targets for antivax charlatans. It's really a shame.
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No corrections since last issue.
See you all next time. And don’t forget to share the newsletter if you liked it.
Always,
JS