Tuesday, September 08, 2020

“A Very Special Day”


The question of performative language will continue to obsess us.  Just because the President says so, doesn't make it so.  A vaccine may be announced.  It will NOT be "available."

The CDC is still finalizing who will be eligible to be vaccinated first, but from meetings of its Advisory Committee on Immunization Practices, it appears front-line medical workers, first responders and people at high risk for severe disease will get first dibs.

That's the first hurdle.  The second is distribution:

Here’s how it would work: Medical offices, clinics, hospitals, pharmacies and other groups that want to vaccinate people for COVID-19 need to first enroll in the U.S. COVID-19 vaccination program They’ll sign an agreement with the CDC and prove they have the space, the necessary equipment and properly trained staff to administer the shots.

Because the requirements for storing, handling and administering the shots are so challenging, the government will prioritize getting vaccine to sites that can reach large numbers of priority populations and vaccinate lots of people quickly, CDC documents show.

When a vaccine becomes available, a vaccination site will request doses through a state agency, usually its department of public health. That’s how it was generally done during the 2009 nH1N1 influenza pandemic, said Julie Swann, a professor of industrial and systems engineering at North Carolina State University who was a science adviser to the CDC at the time.

The department of health would confirm the site was OK’d to distribute the vaccine. At that point, if vaccine supplies are limited, the state could determine how much vaccine to allocate to that specific site, perhaps less than was requested.

Next, the order will be electronically transmitted to the CDC. The CDC also could decide how many doses to allocated to a given site if vaccine supplies are limited, Moore said.

The CDC will then transmit the order to itscontracted partner McKesson, the largest pharmaceutical distribution and technology company in the United States. It already has distribution centers across the country and is building more for COVID-19.

Vaccine orders will be shipped within 24 hours of approval depending on supply, the CDC’s planning documents say.

And then there's the storage question:

Here’s where things diverge a bit. Moderna’s candidate vaccine has to be stored at minus 4 degrees Fahrenheit, but Pfizer’s requires it be stored at minus 94. If either of them are among the first vaccines available, that 90-degree difference means they must be distributed differently.

The Moderna vaccine will be stored either at the manufacturing plant or at a McKesson distribution center. When an order comes in, McKesson will ship it directly to the medical facility that ordered it, said Moore.

The Moderna vaccine comes as a frozen liquid in a 10-dose vial and contains no preservatives. It can be stored in a freezer or in its shipping container if it's replenished with dry ice, CDC documents show. It can be stored for up to two weeks at normal refrigerator temperatures (36 to 46 degrees) according to data provided by the Immunization Action Coalition. Once at room temperature it must be used within six hours.

After the vial has been punctured to take out the first dose, it is good for six hours and then must be thrown away. Because vaccine will be in short supply, especially at first, clinical sites will need to schedule patients so none is wasted.

To be effective, the Moderna requires two doses of vaccine given 28 days apart. It must be the same vaccine both times.

No word in this article what happens if you get infected inside that 28 day period. Not to mention these kinds of requirements are going to severely limit the availability of the vaccine, if it's effective.

And even if there is a vaccine, nothing changes this year:

"If you look at where we were heading into Memorial Day, relative to where we are heading into Labor Day, we have an equivalent amount, if not more infection heading into Labor Day," [Scott] Gottlieb [former FDA Comissioner]  said. At the end of May, the U.S. was diagnosing about 21,000 new coronavirus cases a day, now that rate has jumped to about 40,000 infections a day, with "about 150 tragic deaths a day," according to Gottlieb.

"And we're heading into a more difficult season, we're heading into the fall and winter, when we would expect a respiratory pathogen like the coronavirus to start spreading more aggressively than it would in the summertime," he said.

As the virus persists, American's stamina has dwindled. "People are exhausted," Gottlieb said. "People have been social distancing and wearing masks and staying home for a long period of time right now, small businesses are hurting."

"I think that people's willingness to comply with the simple things that we know can reduce spread is going to start to fray as we head into the fall and the winter," he said. "And that's another challenge, trying to keep up our vigilance at a time when we know this can spread more aggressively."

"This could run its course in 2020, and as we get into 2021, start to slow down," he said. "I think the tragic consequence of that is there's going to be a lot of death and disease along the way."
Even if Trump makes an announcement, no one will notice.  A vaccine won't make a dent in the virus this year.  There is no "October Surprise."  Trump cannot save us.  He certainly can't save himself.

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