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Monday, December 09, 2019 {{ new Date().getDay() }}

Tag: pfizer vaccine

When Only Veterinary Science Will Do

You know things are off the wall when even the FDA can't keep a straight face. What could the U.S. Food and Drug Administration say to Americans who refuse to get a coronavirus vaccine administered by medical professionals but instead go to a livestock supply house for a drug designed to deworm horses and cows? Ivermectin in big animal doses can easily make a human sick and possibly dead.

The FDA did issue a warning for people using ivermectin to prevent or treat the virus. But it also playfully tweeted: "You are not a horse. You are not a cow."

Some might deem it inappropriate to apply humor to a matter attached to serious health consequences. Some anti-vaxxers of the right-wing persuasion may accuse intellectual elites of looking down on them. They're not wrong, but average functional folk are also rubbing their eyes in disbelief.

The only logical explanations are stupidity, mental disability, and terminal ignorance. That Sen. Ron Johnson has endorsed use of ivermectin for early treatment of COVID-19 does not change the explanation.

After the FDA gave full approval to the Pfizer-BioNTech vaccine, Johnson issued the following statement: "Our federal health agencies have not been forthright with the public about how these life altering decisions have been made or what science and data they are based upon. ... The American people deserve full and accurate information so that they make up their own minds regarding vaccination."

I understand little about aeronautics, but I get onto jet planes anyway because I know credentialed engineers have overseen the building of a safe aircraft. I don't feel I have to study the "science and data" of flight, because I know that experts are on the case.

Now you see people on TV, not all right-wingers, say they won't get the shot until they've researched the evidence on the vaccine. Some look like they couldn't operate a toaster, but if they want to examine the science and data, there are scholarly papers on the virus and its spread at their disposal, courtesy of the National Academy of Sciences. (Surely, they know all about interquartile ranges.)

Likewise, I could devote a decade to studying how those planes get off the ground before boarding one, but I'll pass.

A feed store in Las Vegas that ran out of ivermectin has posted a sign saying it will not sell it to customers who can't produce a picture of them with their horse.

Shelly Smith, manager of V&V Tack and Feed, recalled a man telling her that his wife wanted him on the "ivermectin plan." She told him that it was not safe to take, to which he said, "Well, we've been taking it, and my only side effect is I can't see in the morning." Smith said she responded, "That's a big side effect, so, I mean, you probably shouldn't take it."

Confusing matters, ivermectin in far smaller doses has been used to treat certain parasitic infections in humans. Rest assured, however, that reputable doctors are not prescribing horse paste to human patients.

Resistance to vaccines designed for humans and openness to horse meds seems especially acute in so-called conservative parts of the country. The anti-vaccine hordes of the right seem to be charging unarmed into the reality of a well-equipped and heartless virus. It's a free country, right?

Fifty years from now, documentaries about the COVID-19 crisis may relieve the grimness with a short section about the run on horse meds set to playful music. The associated tragedies will probably be forgotten, mainly because they were self-inflicted.

What can you do about people who choose veterinary medicine over the human kind? Nothing, really.

Follow Froma Harrop on Twitter @FromaHarrop. She can be reached at fharrop@gmail.com. To find out more about Froma Harrop and read features by other Creators writers and cartoonists, visit the Creators webpage at www.creators.com

U.S. Will Donate 500 Million Pfizer Vaccine Doses To Poorer Countries

By Trevor Hunnicutt and Carl O'Donnell WASHINGTON (Reuters) -The Biden administration plans to donate 500 million Pfizer coronavirus vaccine doses to nearly 100 countries over the next two years, three sources familiar with the matter told Reuters on Wednesday. The United States is likely to distribute 200 million shots this year and another 300 million in the first half of next year to 92 lower-income countries and the African Union, they said. The donations will go through the COVAX vaccine program that distributes COVID-19 shots to low- and middle-income countries. The program is led by the...

Corruption? Why Operation Warp Speed Didn’t Provide Enough Vaccine Doses

Reprinted with permission from Daily Kos

Operation Warp Speed was designed to promote the rapid development of vaccines to fight COVID-19, to secure enough of that vaccine to treat Americans in danger, and to distribute the vaccine rapidly. If the pandemic itself had been met by a coordinated national strategy—one with unified, appropriate restrictions and a network of testing and case tracing—the goals of Operation Warp Speed might have been achievable. But since Donald Trump deliberately allowed the pandemic to run rampant, it was likely impossible from the outset for any response to be adequate.

Still, Operation Warp Speed has fumbled badly on every point. When it comes to the logistics that Trump bragged about for months, the general in charge has already admitted failure. But it's those two other goals—promoting vaccine development and securing an adequate supply for the nation—where Operation Warp Speed really stumbled. And that failure goes back to a pair of decisions that were made early on, which are translating into hundreds of millions of missing doses now.

The biggest investment that Operation Warp Speed made was for a COVID-19 vaccine with one real distinction: It doesn't work.

Trump introduced former GlaxoSmithKline executive Moncef Slaoui as the head scientist for Operation Warp Speed. On the surface, it didn't seem a bad choice. After all, GlaxoSmithKline had been involved in the development of 14 vaccines over the previous decade. Slaoui certainly had experience with both the science and the scientists involved in many of the efforts. And many of those involved were also familiar with Slaoui.

Some organizations, like Pfizer, did not approach Operation Warp Speed for funding. It wasn't until July that the government made a deal with Pfizer. That deal was an advance purchase order to secure 100 million doses (enough for 50 million people) of the vaccine developed by German firm BioNTech and manufactured by Pfizer when it became available. If Pfizer didn't deliver, they didn't get paid.

On the other hand, Operation Warp Speed provided $456 million in advance funding for Johnson & Johnson's vaccine, up to $483 million for Moderna, $1.2 billion for AstraZeneca's vaccine, $1.6 billion for Novavax, and $2.1 billion for a vaccine to be developed by Sanofi and GlaxoSmithKline. Most of these development deals came with advance arrangements to secure doses from the manufacturers, including 300 million doses of the AstraZeneca vaccine, 100 million doses of Novavax, and 100 million doses from Sanofi/GlaxoSmithKline.

In essence, Slaoui developed a strategy that was "don't put all your eggs in one basket," which may seem wise except that the way in which it was implemented actually required that every single egg remain intact for the program to work adequately. None of the manufacturers could deliver their full number of doses until well into 2021. What Operation Warp Speed had created was a situation where unless every vaccine was a winner, there were guaranteed to be vaccine shortages lasting for months.

This could have been remedied. Early on it was clear that some vaccines were moving through the pipeline more quickly than others and demonstrating better results in Phase One and Two trials. But Operation Warp Speed failed to adjust its targets to obtain more doses of those vaccines. Most notably, when given a chance to purchase another 100 million doses of the Pfizer vaccine, Slaoui passed. He justified this decision by saying that other vaccines on the way, such as the one from AstraZeneca, were going to be much easier to distribute than the Pfizer/BioNTech offering, which requires deep cold storage.

That might be fine if the AstraZeneca vaccine was available. But it's not. AstraZeneca's Phase Three testing was marred by manufacturing issues that meant not every participant got the same amount of vaccine in an initial dose. This was further complicated by results suggesting that volunteers who got less vaccine actually had a better resistance to COVID-19. Sorting out the AstraZeneca data is expected to take some time, and though the company has moved for approval in the U.K., any approval from the FDA is likely weeks away at best. Additionally, AstraZeneca's vaccine results indicate that it's considerably less effective than the offerings from either Pfizer or Moderna. A 70 percent effective vaccine would be good in most cases—but not when a 95 percent effective vaccine is also out there.

The U.S. has now announced that it has secured 100 million more doses of the Pfizer vaccine. However, these will be delivered in late spring after Pfizer has delivered the 200 million doses already ordered by nations that purchased earlier.

The bet on AstraZeneca and pass on Pfizer was one of two huge decisions that make everything done by Operation Warp Speed seem more suspect. The other was the huge investment in the Sanofi/GlaxoSmithKline vaccine candidate. There are very good reasons to be suspicious of this action. Slaoui is not just a former GlaxoSmithKline executive, he is still sitting on $10 million in GlaxoSmithKline stock—which he has refused to sell. "I won't leave those shares," said Slaoui, "because that's my retirement." Of course, no one was asking him to surrender it for free. Slaoui recently sold $12 million in other stock, but apparently feels that $22 million is inadequate to fund his retirement.

Slaoui's relationship with GlaxoSmithKline is looming especially large after results that were reported back on Dec. 11. As Stat News reported, the vaccine that got the largest up-front payment from Operation Warp Speed has the singular distinction of flunking out in Phase Two testing. The Sanofi/GlaxoSmithKline vaccine failed to produce the level of immune response thought to be necessary for protection of older patients. This means the manufacturers are going back to square one. Any vaccine that results from this effort will not be available before the second half of 2021—at the earliest.

The biggest order Operation Warp Speed placed was for the AstraZeneca vaccine. The biggest investment it made was in the GlaxoSmithKline vaccine. Both of those have turned out to be very bad bets, and the way that these deals were structured guarantee that Americans will not have adequate vaccine supplies for months.

Was there a clear alternative? Of course: Put in an advance order to all of the manufacturers that was enough to secure vaccine for the entire nation if delivered by early 2021. The worst thing that could have happened in that case was that the nation spent a few billion on extra vaccine—vaccine that could still be sold or given to others around the world. The worst thing that could happen without such a deal … is what's happening.

Most States Are Unprepared To Distribute Pfizer Covid-19 Vaccine

Reprinted with permission from ProPublica

As the first coronavirus vaccine takes a major stride toward approval, state governments' distribution plans show many are not ready to deliver the shots.

The challenge is especially steep in rural areas, many of which are contending with a surge of infections, meaning that access to the first batch of COVID-19 vaccines may be limited by geography.

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