Tag: failedstate

Bucatini Shortage

Around World War II, Carl explained, the established noodle industry (henceforth referred to as Big Pasta) was “upset” by the introduction of Nissin’s ramen noodles into the country, which were “completely out of spec” with what the United States then recognized as noodles — specifically because the ramen was being sold for a lower price and with what Carl called “lower standards” of nutrition. “They were really pressed”. That’s when the “standards of identity” were created: Big Pasta made sure that all noodles had to meet certain specifications to be considered “enriched macaroni products” and sold in the United States. As time went on, it would seem, the petty beef spun out into a juicier beef, with the main agitators of Big Pasta turning on each other. Nearly 120 years after the Macaroni and Noodle Manufacturers’s inception, that beef finally came for De Cecco. Weeks after we were first in touch, Courtney replied to tell me that De Cecco’s products were “collected as routine surveillance of imported products,” but Carl had a more intriguing theory: “It sounds as if someone was not happy with De Cecco’s product coming in and looked at it and saw that it was out of spec”. The FDA doesn’t typically go around looking. They’ve got plenty of other things to do.”

another example of the FDA being completely useless, here in the service of protectionism.

Virtual shooting drills

If you want to know what school was like in 2020, let me tell you about one moment that has stuck with me for months. One Thursday morning in October, my daughter, an eighth-grader, spent her “homeroom” period performing a school lockdown drill. She was, of course, in her own house, like all her classmates. The students watched a video on their computers about lockdown procedures, then practiced hiding under desks. And so it happened that in this, the most absurd and bewildering academic year of her life, my eighth-grader tucked herself under the table in her bedroom, to prepare for the possibility that someone might try to shoot her, someday later, at her school.

just because there’s a pandemic doesn’t mean the US can stop acting like an imbecile at every opportunity.

Dose variation

The reason we do a second vaccination is that these later doses help to solidify immune memory, in part by giving extra training to the cells that produce antibodies, a process called affinity maturation. But this process begins with the single dose, and the evidence collected between the time of the 1st and 2nd doses in 10Ks of people in the Phase 3 trials suggests that the level of affinity maturation may provide enough protection to meet the standards we have set for vaccine approval during this pandemic even without the 2nd dose. we should begin immediate single-dose trials, recruiting volunteers from low-risk populations who are 1st in line for the vaccinations.

Magical extra doses and supply chain optimization:

some of the vaccine distribution sites had access to low dead-volume syringes, syringes that leave less vaccine trapped between the plunger and needle — the “dead volume” — after a shot is given. Thus, less vaccine was wasted in the syringe and more available for putting into arms using the low dead-volume syringes.

This is quite remarkable. Increasing vaccine supply by 20% by building more factories could cost billions. We should do that, it would be worth it. But in this case, we managed to increase supply by at least 20% use a relatively inexpensive redesign of the syringe. What this indicates is the importance of thinking along the entire supply chain for opportunities for optimization.

Single-Shot and first doses first

The FDA panel voted unanimously to authorize the J&J vaccine. Good. Note, however, that the single-shot J&J vaccine is quite comparable to the first dose of the Pfizer and Moderna vaccines. Yet, few people are demanding that J&J be required to offer a second shot at all, let alone in 3-4 weeks (What about vaccine escape! How long does immunity with a single-shot last! What about the children!). It really is scandalous how these objections to a single-shot have disappeared. This is evidence of what I call magical thinking–an undue focus on the clinical trial design as having incantatory power.

Why did J&J focus on a single-shot? Was this because of “the science”, i.e. something unique about their vaccine? No. J&J focused on a single-shot vaccine for the same pragmatic reasons that I favor First Doses First.

J&J chose to begin with the single shot because the World Health Organization and other experts agreed it would be a faster, more effective tool in an emergency. (emphasis added).

Since that time, Dr Dolittle has insisted we stick to the 2 shots regime. Criminal negligence.

Fractional doses work

in an article on new vaccine boosters there is this revealing statement:

Any revised Moderna vaccine would include a lower dose than the original. The company went with a high dose in its initial vaccine to guarantee effectiveness, but the company is confident the dose can come down, reducing side effects without compromising protection.

Arrgh! Why wait for a new vaccine??? Fractional dosing now! The article also notes:

One of Moderna’s co-founders is known for his research on microneedles, tiny Band-Aid-like patches that can deliver medications without the pain of a shot. Moderna has said nothing about delivery plans, but it’s conceivable the company might try to combine the 2 technologies to provide a booster that doesn’t require an injection.

The skin is highly immunologically active so you can give lower doses with a microneedle patch. The microneedles are sometimes made from sugar and don’t hurt.

Dose stretching works extremely well

A new paper on dose-stretching makes 3 big points. First, “Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection.” Future vaccines may not have to go through lengthy clinical trials but can instead rely on these correlates of immunity.

A 50% or 25% dose of the Moderna or Pfizer vaccine looks to be more effective than the standard dose of some of the other vaccines like the AstraZeneca, J&J or Sinopharm vaccines. The point is not that these other vaccines aren’t good–they are great! The point is that by using fractional dosing we could rapidly and safely expand the number of effective doses of the Moderna and Pfizer vaccines.

Second, even if efficacy rates for fractional doses are considerably lower, dose-stretching policies are still likely to reduce infections and deaths. A 50% dose strategy reduces infections and deaths under a variety of different epidemic scenarios as long as the efficacy rate is 70% or greater.

Third, it is better to start vaccination with a less efficacious vaccine than to wait for a more efficacious vaccine. Thus, Great Britain and Canada’s policies of starting First Doses first with the AstraZeneca vaccine and then moving to second doses, perhaps with the Moderna or Pfizer vaccines is a good strategy.

Queens street vendors

With little recourse, many immigrants from Latin America — who already were among the hardest hit by the virus — have resorted to what they did back home: working as ambulantes — street vendors. But for decades, New York has capped the number of citywide street vending permits — it is currently limited to 2900 for food and 853 for vendors of general merchandise — creating a black market and making vendors vulnerable to high fines. Ambulantes are frustrated and feel that a respected way of making a living in other parts of the world is criminalized here.

it is way past time to stop this permits nonsense.

COVID-19 Will Win

Thanks to the effort of millions of people, we were close to a great success story. But because of the failures of Trump and Chauvin, of the CDC and the WHO, of public-health experts and Fox News hosts, we are, instead, likely to give up—and tolerate that 100K’s of our fellow citizens will die needless deaths.