Wednesday, April 21, 2021

Not Surprising -- In The Least -- But Disgusting, Just The Same...


[Back to the power alley, here:] I think it best to chalk this one up to. . . monumental idiocy, at every level of the Tangerine administration's political appointees. It could well be graft and corruption -- but it is equally likely that these morons didn't understand -- and didn't bother to learn -- what it takes to get an entirely new injection device through FDA, and approved, in the United States.

That seems the Occam's Razor answer. . . but damn, is this ever frustrating. Of course, Pfizer and Moderna would not want to use a third party's novel injection device, for the first time, on such a mission critical global pandemic vaccination roll-out, as the logistics alone are daunting: keep the vaccine stock at deep freeze temps until just before dosing, and then (somehow?!) tranfer it to an eye-dropper single use squeezer, with a needle on the end?! All I can say is. . . WTAF, Trump? Read this, in full:

. . .A year after a Connecticut company was awarded almost $1.3 billion in federal loans and contracts to supply an essential syringe for the Covid-19 vaccine rollout, no syringes have been made. The syringe hasn't received even the first of a series of approvals it needs from the federal government before it can be manufactured, and a factory promising 650 jobs remains unbuilt.

ApiJect Systems Corp. positioned itself as the company that would make the difference between a stumbling rollout and delivery of lifesaving vaccines. . . .

According to ApiJect, two vaccine makers have requested FDA approval to use its syringe with their products, but neither federal regulators nor any of the vaccine makers would confirm any approval requests. ApiJect didn't provide the names.

ApiJect's plant is supposed to be built in an industrial park in North Carolina, but Morgan Weston, a spokesperson for the foundation that runs the park, said that the plant hasn't been built and that "they have not moved their operation in on any level. . . ."

The Trump administration also approved a Defense Production Act loan for ApiJect of up to $590 million. In all, the administration awarded the company nearly $1.3 billion in loans and contracts last year. In addition to the Defense Production Act loan, there was a Department of Health and Human Services contract at the end of January worth up to $453 million, just as the pandemic was emerging, and then a Defense Department contract in May worth up to $251 million.

When the Pentagon announced the ApiJect contract, it said the contract would "enable the manufacture of more than 100 million prefilled syringes for distribution across the United States by year-end 2020. . . ."


Yes, this guy Walker, above should give back whatever funds he still has from the federal sources, and Jefferies should offer rescission to all the would be investors.

That is so, because at the most basic, common sense, practical level, no one will use these things -- from a plant that no ground is broken upon, from an FDA filing that doesn't yet exist. . . from an untested tech device. . . using precious, hard to transport vaccine stock that no US company wants to allow into the ApiJect squeeze bottles. In a word -- I N S A N E.

Update -- for its part, ApiJect now says by press release it only got about $150 million. Gee that makes me feel so. . . much better. NOT. The essential truth of the reporting is that a novel, not FDA filed (let alone approved) injector makes ZERO public health sense, in arresting a lethal global pandemic -- where speed to market, and reliability are the absolute "must haves". None.

Who are these. . . jokers?!

नमस्ते

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