Wednesday, March 31, 2021

Newest Emergent BioSolutions excuse on its Covid vaccine delay

This article does not make sense to me, but I am reproducing tonight's NYT story below. If the quality control issues are still being sorted out, then the "conflation" of two vaccine ingredients is not the whole story of the plant's problems.

FDA knew there were problems a month ago, when it withheld the EUA for vaccine made here. I guess this story perhaps came out now, the night of March 31, because until just a few days ago, J and J had promised to meet its 20 million dose quota by the end of the month.

But there is another unanswered question. How did FDA allow Emergent to ship its vaccine out to Indiana in bulk for bottling, when it knew there were problems at the plant? Based on what happened at the time of the Gulf War, once unauthorized product is allowed to be shipped off premises, it could wind up in the arms of the unsuspecting. All vaccine product made by Emergent needs to be accounted for, immediately, both bulk and bottled.

I could have predicted there would be delays. Emergent's Modus Operandi is to plead manufacturing problems and demand extra money to fix them, which as a sole source supplier, it always got. Read the old Congressional hearings on the anthrax vaccine. Here's one. A commitment to quality would lose them money. And when you are making vaccines under an EUA, you have no liability.

And don't forgot, Emergent has contracts to product 9 different medical products in response to Covid. Nine. Lobbying pays.

UPDATE: The 4/1/21 Associated Press article on Emergent.

Workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines’ ingredients several weeks ago, ruining up to 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.

The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca. Federal officials attributed the mistake to human error.

The mixup has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions’ work to avoid further quality lapses.

The mistake is a major embarrassment for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program.

It does not affect Johnson & Johnson doses that are currently being delivered and used nationwide. All those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.

But all further shipments of the Johnson & Johnson vaccine — projected to total tens of millions of doses in the next month — were supposed to come from the massive Baltimore plant.

Those shipments are now in question while the quality control issues are sorted out, according to people familiar with the matter..Federal officials still expect to have enough doses to meet President Biden’s commitment to provide enough vaccine by the end of May to immunize every adult. The two other federally authorized manufacturers, Pfizer-BioNTech and Moderna, are continuing to deliver as expected.

Pfizer is shipping its doses ahead of schedule, and Moderna is on the verge of winning approval to deliver vials of vaccine packed with up to 15 doses instead of 10, further boosting the nation’s stock.

Monday, March 29, 2021

Science article on AZ vaccine-associated thrombosis--reposted with formatting changes due to it exceeding the page width for Safari

A rare clotting disorder may cloud the world’s hopes for AstraZeneca’s COVID-19 vaccine

By Kai Kupferschmidt, Gretchen VogelMar. 27, 2021 , 10:20 AM

In the tumultuous rollout of AstraZeneca’s COVID-19 vaccine, all eyes this week were on the United States, where the company had a highly public communication breakdown over the vaccine’s efficacy with an expert panel overseeing a large study in the Americas. But on the other side of the Atlantic Ocean, the vaccine faces new concerns about safety as an explanation gains ground for the unusual strokes and clotting disorders recorded in at least 30 recipients.

Many European countries suspended use of AstraZeneca’s vaccine earlier this month following initial reports of the symptoms, which have led to at least 15 deaths. Most resumed vaccinations after the European Medicines Agency (EMA) recommended doing so on 18 March, saying the benefits of the vaccine outweigh any risks. EMA is continuing to investigate the matter and will convene a wide-ranging committee of experts on 29 March.

Now, a group of researchers led by German clotting specialist Andreas Greinacher of the University of Greifswald says the highly unusual combination of symptoms—widespread blood clots and a low platelet count, sometimes with bleeding—resembles a rare side effect of the blood thinner heparin called heparin-induced thrombocytopenia (HIT).

The scientists, who first described their findings during a 19 March press conference, recommend a way to test for and treat the disorder and say this can help ease worries about the vaccine. “We know what to do: how to diagnose it, and how to treat it,” says Greinacher, who calls the syndrome vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). Greinacher has posted a manuscript on the preprint server Research Square.

Even if Greinacher’s mechanism isn’t the whole story, multiple researchers told Science they were convinced the vaccine was causing the rare set of symptoms. If that turns out to be true, it could have major consequences for the vaccine, which is one of the cornerstones of the World Health Organization’s push to immunize the world. AstraZeneca is working with partners around the globe to make and distribute billions of doses in low- and middle-income countries, which might have a harder time identifying and treating rare side effects.

Europe is relying heavily on the vaccine as well; the European Union bought 400 million doses. The company’s failure to deliver on time has delayed vaccine rollouts on the continent, and now dented confidence is exacerbating the delays. And even if the risk is very low, it may make sense to use the vaccine only in those who also stand to gain the most from it: elderly people at high risk of dying from COVID-19. Several European countries have started to do this. The situation has scientists walking a tightrope: They want to make the medical profession aware of their concerns without sowing panic.

But Greinacher’s hypothesis is being taken seriously. Two German medical societies put out press releases lauding him for solving the issue. In the Netherlands, the Dutch Internal Medicine Society urged internists to be aware of the symptoms and the recommended course of action. The United Kingdom has officially reported only five cases—despite administering 11 million doses of the AstraZeneca vaccine—but the British Society for Haematology has urged its members to be aware of “an important and emerging area of haemostasis and thrombosis practice” and to report any possible cases. The Australian Technical Advisory Group on Immunisation has recommended against giving any COVID-19 vaccine to people with a history of HIT.

It is not yet clear how the vaccine could trigger VIPIT, and not everyone thinks the case is closed. “It’s intriguing, but I am not entirely convinced,” says Robert Brodsky, a hematologist at Johns Hopkins University. AstraZeneca, meanwhile, has not directly responded to the reports of the rare constellation of symptoms except to say that they did not appear in any of the company’s clinical trials.

“People are absolutely working like crazy behind the scenes to provide more clarity,” says Saskia Middeldorp, a vascular internist at Radboud University Medical Center, who disagreed with the temporary halt of the vaccine because she says the benefits clearly outweigh the risks.

A “very striking” disorder

The VIPIT story began on 27 February, when Sabine Eichinger, a hematologist at the Medical University of Vienna, was confronted with an unusual patient. A 49-year-old nurse had sought help at a local hospital the day before, suffering from nausea and stomach discomfort, and was transferred to Eichinger’s hospital. She had a low platelet count and computed tomography scans found thromboses—blood clots—in the veins in her abdomen and later in arteries as well. “There was little we could do at this stage,” Eichinger says. The patient died the next day.

The combination of low platelet count, or thrombocytopenia, and clots kept Eichinger thinking, however. “It’s very striking,” she says. Platelets, also known as thrombocytes, help form blood clots, so low levels usually lead to bleeding, not clotting. “You would think that low platelets and thromboses are opposites really.” One condition where they occur together is called disseminated intravascular coagulation, when severe infection, injury, or cancer trigger clotting so widespread it uses up all the platelets, “but she had none of these things,” Eichinger says.

The unusual combination also appears in HIT, which can occur in patients given heparin as a drug. Heparin binds to a protein called platelet factor 4 (PF4), forming a complex. For reasons that aren’t understood, some people produce antibodies against the complex, setting off an out-of-control clotting reaction. Eichinger’s patient had not received heparin, but she had gotten a shot of the AstraZeneca vaccine 5 days before her symptoms began. “I thought maybe this is some kind of immune reaction,” Eichinger says.

She reached out to Greinacher, who had studied HIT for decades. “Then things started happening thick and fast,” she says, as multiple countries responded to reports of clotting by suspending use of the AstraZeneca vaccine.

Greinacher says he contacted other colleagues who had studied HIT in Canada and Germany and asked the Paul Ehrlich Institute (PEI), which oversees vaccine safety in Germany, whether they had seen any cases. They had. PEI recommended Germany pause use of the vaccine as well and asked Greinacher to help investigate. He soon received blood samples from eight additional patients. All had both low platelets and unusual clotting, he says. In four samples, the researchers also found evidence for antibodies against PF4, a hallmark of HIT. He and his colleagues are now checking whether other vaccine recipients and former COVID-19 patients have similar antibodies.

People are absolutely working like crazy behind the scenes to provide more clarity.

Saskia Middeldorp, Radboud University Medical Center

Brodsky says it isn’t clear whether VIPIT explains all of the cases. He agrees that the PF4 antibodies and the clotting seen in patients resemble HIT, but the link has not been proved, he says: “I’m convinced that these patients have platelet factor 4 antibodies, at least four of them. But I’m not convinced that those … antibodies are explaining the thrombocytopenia or the clotting.”

Treatable condition

Greinacher agrees on the need for more data. But he says it’s crucial to alert doctors to the potential complication. When recognized in time, HIT can be treated with immunoglobulins—nonspecific antibodies from blood donors—that help put the brakes on platelet activation. Nonheparin blood thinners can help dissolve the clots. VIPIT should be treated in a similar way, he says. In at least one case, Greinacher says, a doctor sought the group’s advice and the patient recovered. The German Society for the Study of Thrombosis and Hemostasis, of which Greinacher is a member, has issued a set of recommendations for diagnosing and treating VIPIT. Greinacher says he has also been in touch with safety representatives at AstraZeneca.

Nigel Key, a hematologist at the University of North Carolina, Chapel Hill, agrees on the need to alert doctors. “Maybe it is too much to expect at this point that there would be a very detailed molecular mechanism,” he says, but the advice to physicians who may encounter patients is crucial.

Brodsky and Key say the cases are striking enough that they probably represent a real side effect. “I think the vaccine is mostly safe. I think the benefits probably outweigh the risk for a general population,” Brodsky says. “But these cases raise concern that this vaccine is potentially life-threatening in a small subset of patients.”

Scientists are now scrambling to understand how big that subset is and who’s in it. So far, most cases have been observed in women under age 65. But that could be because of the vaccinated population: Many countries initially used AstraZeneca only in people younger than 65 because early clinical trials included few older recipients. That meant the vaccine was used in priority groups such as health care workers and teachers, a majority of whom are women. In Norway, for example, 78% of the AstraZeneca doses went to women, says Sara Viksmoen Watle, chief physician at the Norway Institute of Public Health. The United Kingdom, however, used the vaccine first in older people, which may explain why fewer unusual clotting events have been spotted there.

Data from Norway—whose extensive health registries make this type of research easier—suggest previous COVID-19 infection does not predispose vaccinees to a severe reaction, Watle says. Alerting clinicians will help ensure that fewer cases are missed for analysis, Key says. A global database of cases may be helpful, too.

Many countries are, for now, accepting the risk that the AstraZeneca vaccine may carry, but several have restricted its use to people who are at the highest risk of dying from COVID-19: those ages 55 or older in France, 65 or older in Sweden and Finland, and 70 or older in Iceland. That approach makes sense, says Sandra Ciesek, a virologist at Goethe University, Frankfurt. “The argument I keep hearing is that the risk-benefit ratio is still positive. But we do not have just one vaccine, we have several. So, restricting the AstraZeneca vaccine to older people makes sense to me, and it does not waste any doses.”

Denmark and Norway are waiting for more data. Norway, which has administered the AstraZeneca vaccine to 130,000 people under age 65, has reported five patients who had low platelets, hemorrhage, and widespread thromboses, three of whom died. That’s about one case in 25,000 vaccinees, “a high number with a very critical outcome in previously healthy, young individuals,” Watle says. The country hopes to make a decision on the vaccine within 3 weeks. It can afford to hold off: COVID-19 cases are relatively low and AstraZeneca is delivering so few doses that the extended pause won’t make a big difference in the short term.

Middeldorp says she expects more clarity after Monday’s meeting of EMA’s expert group, which includes clotting experts, neurologists, virologists, immunologists, and epidemiologists. The agency says it will issue an update on the vaccine during the next meeting of its safety committee, being held from 6 to 9 April. Ideally, that meeting will help clarify how frequently the condition occurs and whether the risk varies by age or sex, Middeldorp says. The world needs AstraZeneca’s vaccine, she says—but that means it is crucial to fully understand its benefits and its risks.

Why? This will be another Living List. Please send additions.

1. Why did all of the vaccines chosen for Operation Warp Speed use novel technologies, unused in any routine vaccines? (Yes, a new Ebola vaccine uses an adenovirus vector, and a resurfaced military-only adenovirus vaccine uses one too--but that's all.) Why wasn't a method with a proven track record chosen for the largest vaccine program in the history of the world?

2. Why did all 4 of the initial vaccines selected for development in Operation Warp Speed (Moderna, Pfizer, J and J/Janssen and Astra-Zeneca) rely on using RNA or DNA?

3. Why did all 4 vaccines rely on the "S" or Spike protein as their only antigen, despite accumulating evidence that multiple segments on it might stimulate autoimmunity? And despite evidence that the spike protein itself explained some or most of Covid's toxic effects on human tissues?

4. Why have government and industry authorized and unleashed 340 different lab tests for Covid in the US, only one of which has been FDA-approved, and none of which are reliably accurate?

5. Why are government and many experts lying about the fact that recovered people should be vaccinated, when vaccinating them puts them at higher risk of immune adverse reactions?

6. Why are government and experts lying to claim that vaccine-induced immunity will be stronger, more robust and long-lasting than natural immunity, when this is an outright falsehood for which there is zero evidence? Unless they have lied that the mRNA and DNA will be destroyed in hours or a few days, and instead the vaccinated will become long-term Spike factories?

7. Why do governments and experts contradict the last lie with another lie, which claims that new variants will escape natural and vaccine-induced immunity, so that we can expect more shots every 6-12 months in future, tweaked to the current variants?

8. Why don't they tell the truth, that variants with multiple spike mutations can defeat the current vaccines, but are much less likely to defeat natural immunity, which depends on many other immune epitopes, not just the spike.

9. Why do leaders like Angela Merkel repeat in unison, "[We] will not be able to rest easy until the entire world receives access to ample supplies of vaccines against the coronavirus," Most of Africa had a tiny fraction of the deaths seen in the Western Hemisphere and Europe. Why do they need supplies of vaccine? Why do these otherwise heartless leaders want so badly to share their vaccines?

Why do they flip-flop back and forth about how the vaccines will or won't protect against viral variants? For example, the NY Times: As Virus Variants Spread, 'No One is Safe Until Everyone is Safe.'

Here is more of the same propaganda: "Unless we vaccinate the world, we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them."

—Gregg Gonsalves, Yale University

Well, if we vaccinate the whole world, even children for whom the vaccine is unnecessary, what about all the cats, ferrets, minks and mice that are still susceptible? There is no possibility of "zero covid" --like the flu, this virus will be with us until it decides to leave. We cannot disappear it. Yet the meme persists.

10. Why, if our world leaders actually cared about saving lives, have they so aggressively suppressed HCQ and ivermectin for early, effective Covid treatment? Note that the EMA advised against ivermectin one week ago, as the FDA did in February--neither actually explaining what evidence they reviewed and how they drew their conclusion.

11. Why don't they tell the truth, that Vitamin D deficiency is a major risk factor for serious illness? And that a few pennies' worth of oral vitamin D taken weekly or even monthly is probably your best insurance from dying from Covid? (The UK has started prescribing Vitamin D for high-risk individuals.)

12. Why are outlets like the Washington Post publishing lies like "Vaccine passports have little to do with international travel " when several airlines are already trialing them?

13. Why is it so important to roll out vaccine passports when no standards for them even exist yet, and the privacy issue is a real problem? They were voted in by the European Parliament one week ago, and have been rolled out in Israel and NY state (the Excelsior pass) for events.

14. Why do officials claim these passports will be 'free,' when the cost to build, provide interoperability and maintain the new systems will be many billions of taxpayer dollars?

15. Why are the US, Israel and western Europe rushing to duplicate the practices of the Nazis (Your papers please!")?

16. Why did FDA permit the vaccine companies to design their clinical trials with loose criteria to identify cases (1 or 2 mild symptoms and a positive PCR test, which used an excessive cycle threshold of 40, leading to false positives)?

17. Why did FDA then allow the trials to essentially stop as soon as the vaccines received an EUA: which is when FDA approved the companies' request to offer vaccine to all the placebo subjects, thus making it impossible to obtain long-term safety data using the placebo group for comparison?

18. Why has the FDA allowed numerous entities and so-called fact-checking sites to claim the current Covid vaccines, issued under EUA, are "safe and effective" or "approved" when they do not meet either standard, and it is FDA's responsibility to quash such false claims immediately?

19. Why, over the past several weeks, have the FDA, the EMA and now the WHO issued warning against the use of ivermectin for Covid, when the scientific evidence is overwhelmingly in favor of its considerable benefits? Here is a brief summary of the extensive data (for all the Covid drugs) that can be found at c19study.com. Below is a compilation of studies on ivermectin:

	Improvement	Studies	Authors	Patients
Early treatment	80% [59‑91%]	17	161	1,856
Late treatment	50% [34‑62%]	20	146	6,885
Prophylaxis	89% [78‑94%]	12	77	7,011
Mortality	76% [58‑86%]	18	155	7,267
RCTs only	70% [54‑80%]	26	225	3,686
All studies	72% [64‑79%]	49	384	15,752

20. Why did the clinical trials for all the Covid vaccines fail to

include pregnant women, yet pregnant women are being

encouraged to be vaccinated, despite many case reports of

miscarriages following vaccinations?

21. Why have CDC and FDA failed to share the safety data

they have from the Vaccine Safety Datalink, the Genesis database,

the V-safe data, the Defense Medical Surveillance System, the VA

database, BEST and others? Why do they pretend they cannot link

vaccinees with their medical records, when they have extensive online

data from every vaccinee, or could get it from state databases?

22. Why has CDC, with 10,000 employees and a huge budget,

not made the assessment of safety its number 1 priority, when it is

spending big to convince and coerce the entire population

to partake in a grand Covid vaccine experiment?

23. Why are we being threatened with inability to travel and enjoy

other "privileges" without vaccination and the vaccine passport?

It seems the idea is to impose both before the public realizes

that herd immunity is nearly here, the vaccines don't work well

and are much more dangerous than billed.

24. Why, if the vaccines worked well, are the vaccinated encouraged

to shun and shame the unvaccinated into participating in

the experiment?

25. Why, in the past week, has it suddenly become mainstream

to suspect the pandemic is due to a lab leak, when for the past year

this was called a conspiracy theory? (Note: I suggested a lab leak in

March 2020). What is the purpose of this change in the narrative?

26: Why did it take Congressman Grothman to introduce a Congressional

resolution affirming the important role of Vitamin D in Covid protection

(and protection from other infections)? Why are our so-called public

health agencies turning public health on its head, encouraging

useless drugs and experimenting on us, while withholding safe and

effective vitamins, OTC treatments, and suppressing the use of licensed drugs

that are highly effective for Covid?

27. Why have most Americans failed to see what is in front of their faces?

Sunday, March 28, 2021

Science magazine acknowledges the rare, serious clotting disorder occurring after Astra-Zeneca's Oxford adenovirus DNA vaccine

A man receives a dose of AstraZeneca's COVID-19 vaccine at a conference center in Rome on 24 March. Italy halted use of the vaccine on 15 March but resumed immunizations four days later.

ANTONIO MASIELLO/GETTY IMAGES

A rare clotting disorder may cloud the world's hopes for AstraZeneca's COVID-19 vaccine

By Kai Kupferschmidt, Gretchen VogelMar. 27, 2021 , 10:20 AM

In the tumultuous rollout of AstraZeneca's COVID-19 vaccine, all eyes were on the United States this week, where the company had a highly public communication breakdown over the vaccine's efficacy with an expert panel overseeing a large study in the Americas. But on the other side of the Atlantic, the vaccine faces new concerns about safety as an explanation gains ground for the unusual strokes and clotting disorders recorded in at least 30 recipients.

Many European countries suspended use of AstraZeneca’s vaccine earlier this month following initial reports of the symptoms, which have led to at least 15 deaths. Most resumed vaccinations after the European Medicines Agency (EMA) recommended doing so on 18 March, saying the benefits of the vaccine outweigh any risks. EMA is continuing to investigate the matter and will convene a wideranging committee of experts on 29 March.

The scientists, who first described their findings during a 19 March press conference, recommend a way to test for and treat the disorder and say this can help ease worries about the vaccine. “We know what to do: how to diagnose it, and how to treat it,” says Greinacher, who calls the syndrome vaccine-induced prothrombotic immune thrombocytopenia, or VIPIT. Greinacher says he has submitted a manuscript to the preprint server Research Square.

Even if Greinacher’s mechanism isn’t the whole story, multiple researchers told Science they were convinced that the vaccine was causing the rare set of symptoms. If that turns out to be true, it could have major consequences for the vaccine, which is one of the cornerstones of the World Health Organization’s push to immunize the world. AstraZeneca is working with partners around the globe to make and distribute billions of doses in low- and middle-income countries, which might have a harder time identifying and treating rare side effects.

Europe is relying heavily on the vaccine as well; the European Union bought 400 million doses. The company's failure to deliver on time has delayed vaccine rollouts on the continent, but now, dented confidence is exacerbating the delays. And even if the risk is very low, it may make sense to use the vaccine only in those who also stand to gain the most from it: elderly people at high risk of dying from COVID-19. Several European countries have started to do this. The situation has scientists walking a tightrope: They want to make the medical profession aware of their concerns without sowing panic.

But Greinacher's hypothesis is being taken seriously. Two German medical societies put out press releases lauding him for solving the issue. In the Netherlands, the Dutch Internal Medicine Society urged internists to be aware of the symptoms and the recommended course of action. The United Kingdom has officially reported only 5 cases—despite administering 11 million doses of the AstraZeneca vaccine—but the British Society of Haematology has urged its members to be aware of “an important and emerging area of haemostasis and thrombosis practice” and to report any possible cases. The Australian Technical Advisory Group on Immunisation has recommended against giving any COVID-19 vaccine to people with a history of HIT.

“People are absolutely working like crazy behind the scenes to provide more clarity,” says Saskia Middeldorp, a vascular internist at Radboud University Medical Center in the Netherlands, who disagreed with the temporary halt of the vaccine because she says the benefits clearly outweigh the risks.

A 'very striking' disorder

The VIPIT story began on 27 February, when Sabine Eichinger, a hematologist at Medical University Vienna, was confronted with an unusual patient. A 49-year old nurse had sought help at a local hospital the day before, suffering from nausea and stomach discomfort, and was transferred to Eichinger’s hospital. She had a low platelet count and computed tomography scans found thromboses—blood clots—in the veins in her abdomen and later in arteries as well. “There was little we could do at this stage,” says Eichinger. The patient died the next day.

The combination of low platelet count, or thrombocytopenia, and clots kept Eichinger thinking, however. “It’s very striking,” she says. Platelets, also known as thrombocytes, help to form blood clots, so low levels usually lead to bleeding, not clotting. “You would think that low platelets and thromboses are opposites really.” One condition where they occur together is called disseminated intravascular coagulation, when severe infection, injury, or cancer trigger clotting so widespread it uses up all the platelets, “but she had none of these things,” Eichinger says.

The unusual combination also appears in HIT, which can occur in patients given heparin as a drug. Heparin binds to a protein called platelet factor 4 (PF4), forming a complex. For reasons that aren't understood, some people produce antibodies against the complex, setting off an out-of-control clotting reaction. Eichinger's patient had not received heparin, but she had gotten a shot of the AstraZeneca vaccine 5 days before her symptoms began. “I thought maybe this is some kind of immune reaction," Eichinger says.

Greinacher says he contacted other colleagues who had studied HIT in Canada and Germany and asked the Paul Ehrlich Institute (PEI), which oversees vaccine safety in Germany, if they had seen any cases. They had. PEI recommended that Germany pause use of the vaccine as well and asked Greinacher to help investigate. He soon received blood samples from eight additional patients. All had both low platelets and unusual clotting, he says. In four samples, the researchers also found evidence for antibodies against PF4, a hallmark of HIT. He and his colleagues are now checking whether other vaccine recipients and former COVID-19 patients have similar antibodies.

People are absolutely working like crazy behind the scenes to provide more clarity.
Saskia Middeldorp, Radboud University Medical Center

Brodsky says it isn’t clear whether VIPIT explains all of the cases. He agrees that the PF4 antibodies and the clotting seen in patients resemble HIT, but the link has not been proven, he says: “I’m convinced that these patients have platelet factor 4 antibodies, at least four of them. But I’m not convinced that those … antibodies are explaining the thrombocytopenia or the clotting.”

Treatable condition

Greinacher agrees on the need for more data. But he says it's crucial to alert doctors to the potential complication. When recognized in time, HIT can be treated with immunoglobulins—nonspecific antibodies from blood donors—that help put the brakes on platelet activation. Non-heparin blood thinners can help dissolve the clots. VIPIT should be treated in a similar way, he says. In at least one case, Greinacher says, a doctor sought the group’s advice and the patient recovered. The German Society for the Study of Thrombosis and Hemostasis, of which Greinacher is a member, has issued a set of recommendations for diagnosing and treating VIPIT. Greinacher says he has also been in touch with safety representatives at AstraZeneca.

Nigel Key, a hematologist at the University of North Carolina at Chapel Hill, agrees on the need to alert doctors. “Maybe it is too much to expect at this point that there would be a very detailed molecular mechanism,” he says, but the advice to physicians who may encounter patients is crucial.

Scientists are now scrambling to understand how big that subset is and who's in it. So far, most cases have been observed in women under 65. But that could be because of the vaccinated population: Many countries initially used AstraZeneca only in people under 65 because early clinical trials included few older recipients. That meant the vaccine was used in priority groups such as health care workers and teachers, a majority of whom are women. In Norway, for example, 78% of the AstraZeneca doses went to women, says Sara Viksmoen Watle, chief physician at the Norway Institute of Public Health. The United Kingdom, however, used the vaccine first in older people, which may explain why fewer unusual clotting events have been spotted there.

Data from Norway—whose extensive health registries make this type of research easier—suggests previous COVID-19 infection does not predispose vaccinees to a severe reaction, Watle says. Alerting clinicians will help ensure that fewer cases are missed for analysis, Key says. A global database of cases may be helpful too.

Many countries are, for now, accept the risk that the AstraZeneca may carry, but several have restricted its use to people who are at the highest risk of dying from COVID-19: those aged 55 or older in France, 65 or older in Sweden and Finland, and 70 or older in Iceland. That approach makes sense, says Sandra Ciesek, a virologist at Goethe University Frankfurt. “The argument I keep hearing is that the risk-benefit ratio is still positive. But we do not have just one vaccine, we have several. So restricting the AstraZeneca vaccine to older people makes sense to me, and it does not waste any doses.”

Denmark and Norway are waiting for more data. Norway, which has administered the AstraZeneca vaccine to 130,000 people under 65, has reported five patients who had low platelets, hemorrhage, and widespread thromboses, three of whom died. That's about one case in 25,000 vaccinees, "a high number with a very critical outcome in previously healthy, young individuals,” says Watle. The country hopes to make a decision on the vaccine within 3 weeks. It can afford to hold off: COVID-19 cases are relatively low and AstraZeneca is delivering so few doses that the extended pause won't make a big difference in the short-term.

Middeldorp says she expects more clarity after Monday's meeting of EMA's expert group, which includes clotting experts, neurologists, virologists, immunologists and epidemiologists. The agency says it will issue an update on the vaccine during the next meeting of its safety committee, being held from 6 to 9 April. Ideally that meeting will help clarify how frequently the condition occurs and whether the risk varies by age or sex, Middeldorp says. The world needs AstraZeneca's vaccine, she says—but that means it is crucial to fully understand its benefits and its risks.

The "dangerous Covid variants" story is hogwash, as I have told you. Its only purpose is to instill fear/Lockdown Skeptics

The following article is from Lockdown Skeptics:

This morning I wrote that despite the British Covid variant – supposedly much more deadly and contagious – being dominant in the UK since December, positive cases peaked 10 days before the January lockdown, and instead of a Christmas surge, infections plummeted in January and also failed to spike in schools when they reopened in March. In Denmark, too, the dominance of the British variant in January and February was marked not by a new surge in positive cases but precipitous decline, confounding predictions.

Now we have two more places that show the Kent variant is failing to live up to the hype. The table below from the U.S. Centers for Disease Control shows that as of February 27th, Florida was the state with the highest prevalence of the British variant (B.1.1.7) at 13.2%, and Texas comes in third at 7.1%.

These are also two of the most open states. Florida ended its restrictions in September and did not reimpose them in the winter, while Texas removed its remaining ones back at the start of March. So, for the past month neither has had any restrictions at all, let alone a lockdown “tough enough” to hold back the British variant. And what do we see? No new surge at all. The reopening in Texas even saw positive cases decline to their lowest level since last spring.

This isn’t modelling or prediction. It is cold, hard data on what happens when a state opens up or stays open for the winter. It is therefore also solid proof that restrictions are not needed to “control” the coronavirus. We already knew that from Sweden in the spring. Now we know it from Florida in the winter, and Texas, which is near the bottom of the pack when it comes to vaccinations, shows us what we can expect when we open up, British variant or no British variant.

Of course, there will still be new outbreaks of COVID-19, as some countries in Europe are currently experiencing. But how much more proof do governments and their scientists need that the threat is manifestly manageable without unprecedented restrictions on liberty, the efficacy of which is anyway unproven?

Kent Covid – not so much a tiger as a pussycat.

By Will Jones / 27 March 2021 • 16.21

Wednesday, March 31, 2021

Monday, March 29, 2021

Sunday, March 28, 2021

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A 'very striking' disorder

Treatable condition