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US as Failed State: Covid Booster Shot Mess

Summary:
It should come as no surprise that the US is regularly exposed as being incapable of managing its way out of a paper bag. We had the early 2020 Covid test kit fiasco, which never really ended. Even though it was obvious that Delta was coming, the US is already experiencing test shortages, with Covid infections set to worsen as schools open. And that’s before getting to inexcusable data failures, like trying to shift vaccine complaints to VSafe, which was impossibly buggy, and being late with updates to VAERS (and having non-medical admins reject physician reports for arbitrary reasons) and refusing to track breakthrough cases among the vaccinated. And now that the CDC has reversed itself, it’s not clear what the follow through is like on the state and county level. And the list goes on…the

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It should come as no surprise that the US is regularly exposed as being incapable of managing its way out of a paper bag. We had the early 2020 Covid test kit fiasco, which never really ended. Even though it was obvious that Delta was coming, the US is already experiencing test shortages, with Covid infections set to worsen as schools open. And that’s before getting to inexcusable data failures, like trying to shift vaccine complaints to VSafe, which was impossibly buggy, and being late with updates to VAERS (and having non-medical admins reject physician reports for arbitrary reasons) and refusing to track breakthrough cases among the vaccinated. And now that the CDC has reversed itself, it’s not clear what the follow through is like on the state and county level.

And the list goes on…the CDC not admitting error, such as admitting that surfaces aren’t enough of a Covid vector worth worrying about, leading schools to engage in hygiene theater when case counts rise, and refusing to admit to aerosol transmission or the merits of a layered defense, except in the bowels of its site, leading school administrators to neglect ventilation as a Covid defense.

With this history, it’s rich to see CDC and Biden Administration defenders act as if they were all set to offer boosters this fall, when their shambolic messaging and actions scream otherwise.

Let’s start with the fact that the US officialdom was loath to admit that boosters would be necessary even though coronavirus infections do not confer long-lived immunity and the Covid vaccine was also not expected to be sterilizing. Mind you, the vaccine-makers themselves were signaling otherwise; recall the Pfizer news release that its shots conferred “up to” six months of immunity. By contrast, to the extent the likes of the sainted Dr. Fauci mentioned boosters, it was to suggest that they might need to be annual, like for the flu.

And how can we be sure that was an after the fact thought? The CDC vaccination cards. They were never intended to prove vaccination status to third parties or track vaccine history. They were envisioned more like dentist appointment card, to remind those in a two-shot regime when to come in for their second installment.

The fact that the CDC has no idea who got vaccinated and when is now allowing anyone so minded to get another shot, irrespective of when they had their last one and what type it was.

The sudden rush to ready a third round of mRNA shots, and then not be deliver on the changed messaging, is more proof of an inability to plan and execute, or alternatively, of caring more about optics than results.

First is the elephant in the room of not knowing if another round right now is such a hot idea given Delta. The press has admittedly done a fine job of burying the top level protest resignations at the FDA over the booster blitz:

And to be clear, the “politics” are declining vaccine efficacy against Delta, particularly of the supposed gold standard vaccine Pfizer, as confirmed by data from Israel, Mayo, and Imperial College. Israel, which is close to a Pfizer monoculture, is in the midst of a new infection wave and has responded by launching a new round of vaccinations, starting with the elderly and immunocompromised.

By contrast, AstraZeneca itself is pushing back against another round of vaccinations in the UK, except for high risk groups. From the Daily Mail:

And the heads of AstraZeneca have warned that booster jabs may not be needed for everyone in Britain, and a rush to roll it out nationwide risks putting additional strain on the NHS.

Pascal Soriot, chief executive of the company, said the UK remains ‘a few weeks away’ from being able to make a decision on pushing a vaccine booster programme across the country.

Writing in the Telegraph, Mr Soriot, along with Executive Vice President of BioPharmaceuticals R&D, Sir Mene Pangalos, warned that moving ‘too quickly’ to boost the whole adult population would deprive scientists of insights into the effectiveness of two vaccine doses.

On the one hand, it’s revealing, and not a good way, to see drug company execs admit that they are conducting experiments on the public at large, without the normal consents and controls. But on the other, they are saying flat out that they don’t have any evidentiary ground for seeing another round of shots as beneficial right now.

Note that Israel is already planning a fourth shot, which our GM anticipated in July (“WT” = “wild type”):

When Moderna put out their preprint on the B.1.351 booster (now obsolete with the rise of B.1.617.2):

https://www.medrxiv.org/content/10.1101/2021.05.05.21256716v1

There were two concerning observations there:

1. No neutralization activity left against P.1 and B.1.351 after 6-8 months
2. The booster worked, but only increased the neutralizing titers to ~40% of what they were originally against the Wuhan variant and what they are against it when boosted.

Pfizer and Moderna have been interchangeable all throughout, they should perform the same here too….

BTW, B.1.617.2 is probably about the same as B.1.351 with the WT booster, so expect the fourth shot to be needed sooner than 6 months if it’s not B.1.617.2-specific, and it will not be. Which is probably also why there is a push, not very vocal yet, for not just a 3rd shot, but an entire new course, 3rd+4th shots.

And, as I have noted several times before, notice how even with the B.1.351 3rd hot, neutralization of B.1.351 is not the same as of WT….

Today the Financial Times reports in some detail that the Biden plan to rush out a new round of vaccinations is already going pear shaped:

The Biden administration’s plans to widely administer Covid-19 vaccine booster shots later this month have become mired in confusion over regulatory approvals, eligibility and logistics, in the latest blow to its efforts to curb the pandemic.

US health officials announced last month that they planned to start offering Americans another round of Covid jabs from September 20, following evidence that the effectiveness of some vaccines starts to wane after a few months.

But with two weeks left before that date, the planned rollout of boosters is being hampered by uncertainty over the timing and implementation of the programme, putting the administration of President Joe Biden on the defensive….

Former officials say the White House jumped the gun by announcing the September 20 date before booster shots had been approved by the US Food and Drug Administration and recommended by the Centers for Disease Control and Prevention…

The issue has caused such tension within the administration that two senior FDA officials last week announced their retirements from the organisation’s vaccine department.

Allies of Marion Gruber and Philip Krause said the two had been upset by the way in which the FDA’s role had been undermined over several months.

The FDA declined to comment on the retirements, but one former administration official said: “Those resignations were shocking. And with cases near record highs and booster shots about to be rolled out, they come at the worst possible time.”

The apparently more compliant Associated Press is in “blame Moderna” mode:

President Joe Biden’s plans to start delivery of booster shots by Sept. 20 for most Americans who received the COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said Friday.

Biden announced last month that his administration was planning for boosters to be available for all Americans who received the mRNA vaccines in an effort to provide more enduring protection against the coronavirus, pending approvals from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Those agencies, though, are awaiting critical data before signing off on the third doses, with Moderna’s vaccine increasingly seen as unlikely to make the Sept. 20 milestone…

According to one official, Moderna produced inadequate data for the FDA and CDC to approve the third dose of its vaccine, and the FDA has requested additional data that is likely to delay those boosters into October. Pfizer, which is further along in the review process, in part because of data collected from the vaccine’s use in Israel, is still expected to be approved for a third dose for all by Sept. 20.

Israel only very recently allowed people over 40 to get a third shot. Before then, injections were limited to the elderly and the immunocompromised. The elderly were not heavily represented in the original clinical trials and the immunocompromised were excluded. One wonders if the reason Marion Gruber and Philip Krause of the FDA quit was that the data Pfizer was presenting to get its third shot approved wasn’t sufficiently representative, and it would take some weeks before Israel had expanded its vaccination eligibility enough to have a broad enough population.

Curiously, these stories also fail to mention that there may be less reason to rush to shoot up Moderna recipients as urgently as Pfizer. From a CNBC write-up of the recent large-scale Mayo study:

The risk of suffering a breakthrough COVID-19 infection with the delta variant after being fully vaccinated with the Moderna vaccine may be much lower than the risk for those who received the Pfizer vaccine, according to a new Mayo Clinic study that is awaiting a full review.

The study found that in July in Florida, where COVID cases are at an all-time high and the delta variant is prevalent, the risk of a breakthrough case was 60% lower for Moderna recipients as compared to Pfizer recipients.

Similarly, in Minnesota last month, the authors found that the Moderna vaccine (also known as mRNA-1273) was 76% effective at preventing infection, but the Pfizer vaccine (known as BNT162b2) was 42% effective.

So the Administration, having put all its chips on the magic vaccines, can only double down on them and hope they work well enough (or they get lucky and contagion rates wane as the public increases its level of precautions) that infections fall off enough for them to escape blame. But the flip side is while not all that many get worked up at old people dying, even hale and hearty elderly who could well have lived a decade longer, kids perishing or suffering from Long Covid or other morbidities won’t be well tolerated. It would be better if I were wrong, but we look set to have an ugly autumn.

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