Top Saudi official issued death threat against UN's Khashoggi investigator


Senior official twice threatened to have Agnès Callamard ‘taken care of’ in meeting with UN colleagues in Geneva in January 2020

The UN special rapporteur on extrajudicial killings, Agnès Callamard: ‘Those threats don’t work on me. It didn’t stop me from acting in a way which I think is the right thing to do.’ 

Photograph: Fabrice Coffrini/AFP via Getty


Stephanie Kirchgaessner in Washington
@skirchy THE GUARDIAN

Tue 23 Mar 2021 

A senior Saudi official issued what was perceived to be a death threat against the independent United Nations investigator, Agnès Callamard, after her investigation into the murder of journalist Jamal Khashoggi.

In an interview with the Guardian, the outgoing special rapporteur for extrajudicial killings said that a UN colleague alerted her in January 2020 that a senior Saudi official had twice threatened in a meeting with other senior UN officials in Geneva that month to have Callamard “taken care of” if she was not reined in by the UN.


'The EU did not rise to the challenge': UN special rapporteur on Europe's failure to fill human rights void

Asked how the comment was perceived by her Geneva-based colleagues, Callamard said: “A death threat. That was how it was understood.”

Callamard, a French national and human rights expert who will this month take on her new post as secretary general of Amnesty International, was the first official to publicly investigate and publish a detailed report into the 2018 murder of Khashoggi, a prominent former insider who used his column at the Washington Post to write critically about the Saudi government.

Callamard’s 100-page report, published in June 2019, concluded that there was “credible evidence” that the Saudi crown prince, Mohammed bin Salman, and other senior Saudi officials were liable for the killing, and called the murder an “international crime”. The Biden administration has since released its own unclassified report, which concluded that Prince Mohammed had approved the murder. The Saudi government has denied the killing, which occurred in the Saudi consulate in Istanbul, was ordered by the future king.

The Guardian independently corroborated Callamard’s account of the January 2020 episode.

The alleged threats were made, she said, at a “high-level” meeting between Geneva-based Saudi diplomats, visiting Saudi officials and UN officials in Geneva. During the exchange, Callamard was told, they criticised her work on the Khashoggi murder, registering their anger about her investigation and her conclusions. The Saudi officials also raised baseless allegations that she had received money from Qatar – a frequent refrain against critics of the Saudi government.

Callamard said one of the visiting senior Saudi officials is then alleged to have said that he had received phone calls from individuals who were prepared to “take care of her”.

Callamard’s report said there was ‘credible evidence’ that Crown Prince Mohammed bin Salman and other senior Saudi officials were liable for Jamal Khashoggi’s killing. Photograph: Reuters

 

When UN officials expressed alarm, other Saudis who were present sought to reassure them that the comment ought not to be taken seriously. The Saudi group then left the room but, Callamard was told, the visiting senior Saudi official stayed behind, and repeated the alleged threat to the remaining UN officials in the room.

Specifically, the visiting Saudi official said he knew people who had offered to “take care of the issue if you don’t”.

“It was reported to me at the time and it was one occasion where the United Nations was actually very strong on that issue. People that were present, and also subsequently, made it clear to the Saudi delegation that this was absolutely inappropriate and that there was an expectation that this should not go further,” Callamard said.

While Callamard has in the past discussed the threats she has faced in her work as a special rapporteur, including by the Philippine president, Rodrigo Duterte, details of the alleged Saudi threat are being revealed in the Guardian for the first time.

The development will probably bolster the view of human rights experts that Saudi Arabia’s government has acted with impunity in the wake of Khashoggi’s 2018 murder, including through arbitrary arrests of critics of the prince, as well as his potential political rivals.

The Saudi government did not respond to emailed requests for comment, which the Guardian sent to the Saudi foreign ministry, the Saudi embassy in London and the Saudi embassy in Washington.

“You know, those threats don’t work on me. Well, I don’t want to call for more threats. But I have to do what I have to do. It didn’t stop me from acting in a way which I think is the right thing to do,” Callamard said.

Cern experiment hints at new force of nature

MAGICK BY ANY OTHER NAME
IT'S A QUANTUM UNIVERSE ANYTHING CAN HAPPEN

Experts reveal ‘cautious excitement’ over unstable particles that fail to decay as standard model suggests

Ian Sample Science editor 

THE GUARDIAN
@iansample
Tue 23 Mar 2021 

Scientists at the Large Hadron Collider near Geneva have spotted an unusual signal in their data that may be the first hint of a new kind of physics.

The LHCb collaboration, one of four main teams at the LHC, analysed 10 years of data on how unstable particles called B mesons, created momentarily in the vast machine, decayed into more familiar matter such as electrons.

The mathematical framework that underpins scientists’ understanding of the subatomic world, known as the standard model of particle physics, firmly maintains that the particles should break down into products that include electrons at exactly the same rate as they do into products that include a heavier cousin of the electron, a particle called a muon.

A man rides his bicycle along the beam line of the Large Hadron Collider.

Photograph: Valentin Flauraud/AFP via Getty Images

But results released by Cern on Tuesday suggest that something unusual is happening. The B mesons are not decaying in the way the model says they should: instead of producing electrons and muons at the same rate, nature appears to favour the route that ends with electrons.

“We would expect this particle to decay into the final state containing electrons and the final state containing muons at the same rate as each other,” said Prof Chris Parkes, an experimental particle physicist at the University of Manchester and spokesperson for the LHCb collaboration. “What we have is an intriguing hint that maybe these two processes don’t happen at the same rate, but it’s not conclusive.”

In physics parlance, the result has a significance of 3.1 sigma, meaning the chance of it being a fluke is about one in 1,000. While that may sound convincing evidence, particle physicists tend not to claim a new discovery until a result reaches a significance of five sigma, where the chance of it being a statistical quirk are reduced to one in a few million.

“It’s an intriguing hint, but we have seen sigmas come and go before. It happens surprisingly frequently,” Parkes said.

The standard model of particle physics describes the particles and forces that govern the subatomic world. Constructed over the past half century, it defines how elementary particles called quarks build protons and neutrons inside atomic nuclei, and how these, usually combined with electrons, make up all known matter. The model also explains three of the four fundamental forces of nature: electromagnetism; the strong force, which holds atomic nuclei together; and the weak force which causes nuclear reactions in the sun.

But the standard model does not describe everything. It does not explain the fourth force, gravity, and perhaps more strikingly, says nothing about the 95% of the universe that physicists believe is not constructed from normal matter.

Much of the cosmos, they believe, consists of dark energy, a force that appears to be driving the expansion of the universe, and dark matter, a mysterious substance that seems to hold the cosmic web of matter in place like an invisible skeleton.

 ONCE UPON A TIME IT WAS KNOWN AS AETHER TO SCIENTISTS 

AND MYSTICS  LA REVUE GAUCHE - Left Comment: Search results for ETHER 

“If it turns out, with extra analysis of additional processes, that we were able to confirm this, it would be extremely exciting,” Parkes said. It would mean there is something wrong with the standard model and that we require something extra in our fundamental theory of particle physics to explain how this would happen.”

Despite the uncertainties over this particular result, Parkes said when combined with other results on B mesons, the case for something unusual happening became more convincing.

“I would say there is cautious excitement. We’re intrigued because not only is this result quite significant, it fits the pattern of some previous results from LHCb and other experiments worldwide,” he said.

Ben Allanach, a professor of theoretical physics at the University of Cambridge, agrees that taken together with other findings, the latest LHCb result is exciting. “I really think this will turn into something,” he said.

If the result turns out to be true, it could be explained by so-far hypothetical particles called Z primes or leptoquarks that bring new forces to bear on other particles.

“There could be a new quantum force that makes the B mesons break up into muons at the wrong rate. It’s sticking them together and stopping them decaying into muons at the rate we’d expect,” Allanach said. “This force could help explain the peculiar pattern of different matter particles’ masses.”

B mesons contain elementary particles called beauty quarks, also know as bottom quarks.

Scientists will collect more data from the LHC and other experiments around the world, such as Belle II in Japan, in the hope of confirming what is happening.

#MONOPOLYCAPITALISM

Authors fear the worst if Penguin owner takes over Simon & Schuster

Analysis: if Bertelsmann, owner of Penguin Random House, buys US publisher, writers expect smaller deals and less choice for readers

UK watchdog investigates Penguin owner’s Simon & Schuster takeover

FREEDOM OF THE PRESS BELONGS TO THOSE WHO OWN ONE

AJ LEIBLING

If Bertelsmann does buy Simon & Schuster, authors will have one less publisher to sell new books to, creating downward pressure on advances. 

Photograph: Alamy

Alison Flood
Mon 22 Mar 2021 THE GUARDIAN

Jokes circulated online when, in 2013, Penguin and Random House merged: would the new mega-publisher, which became the world’s biggest trade publishing group, be known as Random Penguin? Penguin House? Now, as the prosaically named Penguin Random House’s parent company Bertelsmann’s $2.17bn acquisition of Simon & Schuster comes under scrutiny in the UK, the jokes are fewer and further between.

Authors have made it abundantly clear that they fear the fallout if the deal goes ahead. When it was first announced last November, the Authors Guild in the US was quick to register its objections. The acquisition, which would bring heavyweight S&S authors including Hillary Clinton, John Irving, Stephen King and Bob Woodward under the PRH umbrella in the US, would “creat[e] a huge imbalance in the US publishing industry”, it warned, calling on the US justice department to step in.

The Authors’ Guild’s UK equivalent, the Society of Authors, followed suit last month, urging the Competition and Markets Authority to take a look at a deal, which it warned could have “a generally anti-competitive effect on prices

 for consumers and significantly adverse contractual terms for authors”.

The Authors Guild believes the combined Penguin Random House Simon & Schuster would account for approximately 35% of all book units sold in the US; Bertelsmann argues that it would be less than 20% in the US, and that the deal is therefore approvable.

THE GUILDS ARE NOT THE WRITERS UNIONS, WHICH WERE NOT CONTACTED NOR ARE THEY WRITERS ONLY DEFENSE THEY 

HAVE PEN AS WELL, NOT ATTRIBUTED IN THIS ARTICLE

For the publishers, the increased size would give them extra clout in their all-important dealings with behemoth Amazon, and with other book shop chains. But, for authors, reducing the so-called “big five” publishers in the US to four would cut down their options, giving them fewer bidders for their manuscripts, thus driving down advances and making it harder for them to negotiate better deals.

The effect would be similarly profound in the UK, argues the Society of Authors, even though S&S is the ninth largest publisher in the UK in 2019, according to sales monitor Nielsen BookScan, with sales of £27m, compared with Penguin Random House’s £346m.

The UK competition watchdog has listened and is investigating; all eyes will now be on the US.

Environmental group adds 3 vegetables to its annual Dirty Dozen list

Susan Selasky
Detroit Free Press

Since 2004, the Environmental Working Group (EWG) has released an annual list of fruits and vegetables the group calls the Dirty Dozen, because they're deemed to contain the most pesticides. But there are a few surprises to this year's list.

While kale has been alone in the No. 3 spot since 2019 — the first time it made the list in 10 years — the group added mustard greens and collard greens alongside it. All three are known to be low in calories, high in fiber and have antioxidant qualities. Strawberries are No. 1 and spinach comes in at No. 2 on the list.

More: Worried about your fruits and vegetables? Here's how to wash them

Bell peppers, tested for the first time since 2012, and hot peppers (chile peppers), came in at No. 10, knocking tomatoes to the No. 11 spot.

EWG's yearly Shopper’s Guide to Pesticides in Produce is based on test data from the U.S. Department of Agriculture (USDA). The group identified, according to a news release, which fresh fruits and vegetables contain the most and the least amount of pesticide residue. 

You can find the list at www.ewg.org

Among the findings, the EWG cited included:

70% of nonorganic fresh produce sold in the U.S. had pesticides.

20 different pesticides were found in a single sample of the three leafy greens in the No. 3 spot.

115 pesticides — the highest amount — were found on bell peppers.

“Whether organic or conventionally grown, fruits and vegetables are critical components of a healthy diet,” said EWG toxicologist Thomas Galligan in a news release. “We urge consumers who are concerned about their pesticide intake to consider, when possible, purchasing organically grown versions of the foods on EWG’s Dirty Dozen, or conventional produce from our Clean Fifteen.”

Eat your veggies

The annual report is not without controversy.

What’s important to note is that dietitians and health experts recommend that the overall goal is for Americans to increase their consumption of fruits and vegetables for a healthy, well-balanced diet.


SPECIAL INTEREST OPPOSITION
The Alliance for Food and Farming (AFF), AGRABUSINESS LOBBY

strong opponents of EWG's annual list, says it shows a negative impact  on fruit and vegetable consumption  

 

WHICH IS COMPLETE BS EWG HAS NO SUCH POWER PR OR ACTIVIST AFF ON THE OTHER HAND HAS AN OVERSIZED ABILITY TO COUNTER EWG AND AS USUAL WITH CORPORATE SHILLS THEY BLAME CITIZEN ACTIVISTS FOR THE FAILURES IN THEIR INDUSTRY  

 “Last year, the Environmental Working Group (EWG) faced significant criticism from the nutrition community for inaccurately escalating and perpetuating consumer safety fears about these healthy foods as our world was locking down due to the pandemic,” Teresa Thorne, Executive Director of the AFF said in a news release. “EWG continues to dismiss the needs of consumers and disrespect farmers by choosing to inaccurately disparage the very foods health experts agree we should eat more of every day to improve immune function, prevent diseases and increase lifespan.”

They also point out that the USDA's Pesticide Data Program report finds that 99% of samples tested fell below the safety standards set by the Environmental Protection Agency. Additionally, more than 40% of produce tested had no detectable pesticide residue.

Only one in 10 Americans eat enough fruits and vegetables daily, according to the Centers for Disease Control and Prevention. The CDC recommends that adults eat 1½-2 cups of fruit and 2-3 cups of vegetables per day.

The AFF also points to studies that found eating five servings of fruits and vegetables a day, may reduce the risk for certain diseases. Another Tufts University study found that prescribing fruits and vegetables would prevent nearly 2 million cardiovascular events such as heart attacks, 350,000 deaths and cut health care costs by $40 billion.

The AFF finds that the EWG's Dirty Dozen list creates fear and disparages consumers from buying — organic or not.

“With only one in 10 Americans eating enough fruits and vegetables each day, we should be promoting consumption to enhance immune function and prevent illness, not discouraging it with tactics like the Dirty Dozen list,” Thorne added.

STRAIGHT FROM THEIR PRESS RELEASE. 

 Alliance for Food and Farming: “Dirty Dozen” List Scientifically Unsupportable, Hurts Consumers | Business | Maryville Daily Forum (maryvilleforum.com)

Alliance for Food and Farming launches #NoMoreDirtyDozen | The Packer

MORE SPACE THAN GIVEN TO EWG 

THIS IS FROM THE FP FOOD WRITER 

CAN WE SAY CORPORATE SHILLING 

IN THE FOOD SECTION

 

I AM SHOCKED SHOCKED I SAY

  

 

THIS IS ALL SHE WROTE ON THE EWG

Alexis Temkin, Ph.D., EWG toxicologist, says the group advises that eating a diet that is high in fruit and vegetables, organic or conventional and including frozen and canned, should be a priority.

"There is increasing evidence that low dose chronic exposure to mixture of pesticides may have adverse effects on human health, particularly during sensitive windows of development like pregnancy and childhood," Temkin said in an email to the Free Press.

EWG said it is aware that access and being able to afford organic is not always an option. That is why, they said, the group created its "Clean 15" shoppers guide.

While the EWG's list is based on USDA data, most pesticide residues detected fall within established government levels.

Along with the Dirty Dozen list, EWG releases its list of fruits and vegetables that contain the least amount of pesticides. At the top of that list is the beloved avocado. Also, on the list are asparagus, cabbage, and cauliflower — all known as nutritional all-stars.

     MORE CORPORATE SHILLING IN THE FOOD SECTION

To help consumers the AFF provides an easy-to-use risk at safefruitsandveggies.com showing how many servings of a specific fruit or vegetable one would have to eat without any effect on the highest amount of pesticide residue the USDA recorded.

With bell peppers that would be 196 servings for a woman in one day.

To handle fruits and vegetables safely, the FDA recommends washing them before eating or using.

I HAVE WORKED WITH EWG IN THE PAST IN A PROFESSIONAL CAPICITY WHEN I WAS EPSB CUSTODIAL CONSULTANT AND FOUND THEM CREDIBLE IT IS A FACT THAT CONCENTRATIONS OF PESTICIDES STAY IN YOUR BODY THEY ARE ALL (HERBICIDES,PESTICIDES, TOXIC CHEMICALS, ETC.)FOREVER CHEMICALS

EWG's list of most contaminated fruits and vegetables
Strawberries
Spinach
Kale, collard and mustard greens
Nectarines
Apples
Grapes
Cherries
Peaches
Pears
Bell and hot peppers
Celery
Tomatoes  

EWG's Clean 15
Avocados
Sweet corn*
Pineapple
Onions
Papaya*
Sweet peas (frozen)
Eggplant
Asparagus
Broccoli
Cabbage
Kiwi
Cauliflower
Mushrooms
Honeydew melon
Cantaloupe

VULCAN PORN REDUX

Soaring through Iceland’s Fagradalsfjall volcano

Watch this amazing footage of a drone flying right through an erupting volcano in Iceland

By James Vincent Mar 22, 2021


Last Friday, the Fagradalsfjall volcano near Iceland’s capital of Reykjavik began erupting for the first time in 800 years after the island nation was hit by thousands of small earthquakes. Thankfully, the eruption was small and has not put anyone in danger. Instead, it’s gifted the world with some awe-inspiring views of lava flowing from the ground.



The sight has been best captured by Icelandic drone pilot Bjorn Steinbekk, who took the straightforward approach of flying right through the eruption. We spotted the footage from Steinbekk (above) via Twitter, and it seems he flew several sorties through the airborne lava — a daring feat that makes us wonder how his drone survived the high temperatures.

If the eruption of Fagradalsfjall looks relatively minor for a volcano, that’s because it is. “The eruption is considered a small one and the eruption fissure is about 500-700 metres (1640-2300 feet) long,” said the Icelandic Meteorological Office (IMO) in a statement. “The lava is less than 1 square kilometre (0.4 square miles) in size.”

You can get a better sense of the scale of the thing in these images taken on Sunday below. They show crowds of hikers admiring the eruption, which is located around 40 kilometers west of the Icelandic capital of Reykjavik

  

 

 

This video below also shows you a before and after of the eruption site, which is nestled in a small valley in an uninhabited region of the country. News reports say there’s been no ash fall created by the eruption, but residents living downwind of the volcano have been told to close their windows due to possible gas emissions.

None of that has stopped Steinbekk from getting up-close-and-personal with Fagradalsfjall. And if you want to see more of his fantastic videos and images of Iceland from the air, you can check out his official Instagram. There are some truly wonderful shots to admire.

"JUST THE FACTS MA'AM"

US trial reports AZ Covid-19 jab safe and

effective, with no blood clot link

Darcy Jimenez

22 March 2021 

The US Phase III trial of AstraZeneca’s Covid-19 vaccine has demonstrated an efficacy of 79% at preventing symptomatic Covid-19, and 100% efficacy at preventing severe disease and hospitalisation.

The Phase III trial showed AZ’s Covid-19 vaccine to be reliably effective among those aged 65 years and over, in whom the jab demonstrated an efficacy of 80%. 

Credit: AstraZeneca

The US Phase III trial of AstraZeneca’s Covid-19 vaccine has demonstrated an efficacy of 79% at preventing symptomatic Covid-19, and 100% efficacy at preventing severe disease and hospitalisation.

A specific review of thrombotic events and cerebral venous sinus thrombosis during the trial, conducted by the independent safety monitoring board and an independent neurologist, found no increased risk of thrombosis among the 21,583 trial participants receiving at least one dose of the vaccine.

The review findings come after several European countries paused rollouts of the AstraZeneca-Oxford University vaccine, following reports of blood clotting events in a small number of those vaccinated.

The European Medicines Agency last week concluded that the vaccine is “safe and effective” following an investigation into a potential link between the jab and blood clots, while the World Health Organisation urged countries to continue administering the vaccine.

The randomised Phase III trial also showed the vaccine to be reliably effective among those aged 65 years and over, in whom the jab demonstrated an efficacy of 80%.

The results among older participants confirm the vaccine’s efficacy in those aged over 65. Earlier this year, numerous European countries decided to limit the AstraZeneca vaccine to under-65s, citing a lack of evidence for the vaccine in the older age group. Several of these countries, including Germany and France, have since approved the jab for use in older people in response to the publication of further safety and efficacy data.

In the Phase III study, around 20% of participants were aged 65 or older, and approximately 60% had co-morbidities associated with an increased risk for progression of severe Covid-19, such as diabetes, severe obesity or cardiac disease.

The trial involved a total of 32,449 participants – two-thirds of whom received the vaccine – across 88 sites in the US, Peru and Chile.

University of Rochester School of Medicine professor Ann Falsey, one of the principal investigators for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time.

“This analysis validates the AstraZeneca Covid-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

The new data, which AstraZeneca will continue to analyse, is set to be submitted to the US Food and Drug Administration for Emergency Use Authorisation in the coming weeks. The vaccine has already been approved for emergency use in the UK, European Union and many other countries globally.

AstraZeneca executive vice president of biopharmaceuticals R&D Mene Pangalos said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of Covid-19 and across all age groups.

“We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorisation.”

AZ Covid-19 vaccine trial: US data on safety and efficacy, no blood clot link (pharmaceutical-technology.com)

you are here: science media centre > roundups for journalists > expert reaction to press release from astrazeneca announcing interim data on safety and efficacy from the us trial of the oxford-astrazeneca covid-19 vaccine

MARCH 22, 2021

expert reaction to press release from AstraZeneca announcing interim data on safety and efficacy from the US trial of the Oxford-AstraZeneca COVID-19 vaccine

AstraZeneca has published a press release announcing that the Oxford-AstraZeneca COVID-19 vaccine US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis.

 

Dr Peter English, Retired Consultant in Communicable Disease Control, Former Editor of Vaccines in Practice Magazine, Immediate past Chair of the BMA Public Health Medicine Committee, said:

“This press release provides more good news about vaccines in general and the Oxford/AstraZeneca vaccine in particular.1  It is consistent with previous studies of the vaccine.

“Part of the importance of the study it describes is that it will support the emergency use authorisation which is reportedly soon to be (if not already) being applied for in the United States.

“The press release describes a large phase III trial conducted in the US, Peru and Chile, with 32,449 participants of all ages and of different ethnicities, two-thirds of whom were given the active vaccine, and the other third a placebo vaccine (no doubt the full peer-reviewed papers will tell us what the placebo contained).  It gives us information from an interim analysis of data from these trials.

“The press release tells us that there were 141 cases of symptomatic disease in participants, and that the vaccine showed the following characteristics:

“79% vaccine efficacy at preventing symptomatic COVID-19

“100% efficacy against severe or critical disease and hospitalisation

“Comparable efficacy result across ethnicity and age, with 80% efficacy in participants aged 65 years and over”

“This is a large study, so these results can be expected to be robust.  They could be expected to be even more so if there were more cases to compare between the groups; but 141 is still a substantial number of cases.

“The press release also tells us that:

“Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.

“Approximately 20% of participants were 65 years and over, and approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.”

“The full, peer-reviewed paper will no-doubt provide more detailed information on the efficacy in these subgroups; but with only 141 cases, the numbers in different subcategories may be too small to detect small efficacy differences between subgroups, if they exist.  Nevertheless, it is reassuring to read that there was no obvious difference between them.

“Note that the vaccine showed “100% efficacy against severe or critical disease and hospitalisation”.  In other words, NO vaccine recipients had severe or critical disease, or was hospitalised (at least, not with Covid-19), so there is no way to distinguish between efficacy at preventing different subcategories of more severe disease, and we don’t know if the study distinguished between levels of severity greater than mild-to-moderate disease.

“This also means that there were no cases of the more severe forms of disease in people aged 65 years and over – in this age group, the vaccine had 100% efficacy at preventing such disease; 80% efficacy against any symptomatic disease in this age group. (The same concept applies to other subgroups.)

“The report also shows that there were no safety concerns.  It looked particularly at clotting (“thrombotic”) events and found no excess of cases in vaccine recipients.  It was unable to shed further light on the specific clotting event that has raised concerns recently, cerebral venous sinus thrombosis (CVST), other than to confirm that such events are very rare.  No CVST events were detected in either arm of the study, we are told, so it was unable to confirm or refute the suggestion that this particular condition may be more common following vaccination.

“The fact that there were no such events, however, does emphasise the rarity of this condition, and that even if there were to be an increase in the relative risk following vaccination, the absolute risk remains very low.

“(I have yet to see any explanation as to why this particular clotting event (CVST) might be more common post-vaccination when other clotting events are not.  If you look for enough rare events, one of them will, by chance, be more common in people who were vaccinated in the study population you used, without this being a causal relationship but just chance.  My strong suspicion is that this will prove to be the case for CVST.)

“The press release does refer to the prime-boost interval, stating:

“This AstraZeneca-led US Phase III trial included two doses administered at a four week interval. Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data. This evidence suggests administration of the second dose with an interval longer than four weeks could further increase efficacy and accelerates the number of people who can receive their first dose.”

“Decades of vaccine research tell us that a longer prime-boost interval is likely to increase vaccine efficacy, and, as they say this is supported by immunogenicity data; but it should be noted that the study the press release is describing used a four-week prime-boost interval.  There is nothing in the press release to suggest that the study examined vaccine efficacy with different prime-boost intervals.

“One thing that is not clear in this press release is whether the study provided any information on the real-world efficacy of the vaccine against different variants of the virus.  There is no information on whether genomic typing of the cases was undertaken, the prevalence of different variants in the study population, or the dates during which the data were collected (which would allow some inferences to be drawn on variant prevalence and thus vaccine efficacy against the variants).  We know from other work that the vaccine seems to be highly effective against many variants, in particular the more transmissible B.1.1.7 variant; but we do not know if the study will add to our knowledge on this.”

References

1. AstraZeneca Press Office. AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis. AstraZeneca Press Release 2021; Updated 22 Mar 2021; Accessed: 2021 (22 Mar): (https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html).
2. Steenhuysen J. Exclusive: AstraZeneca to seek U.S. authorization for COVID-19 vaccine this month or early next – sources. Reuters 2021; Updated 13 Mar 2021; Accessed: 2021 (22 Mar): (https://www.reuters.com/article/us-health-coronavirus-astrazeneca/exclusive-astrazeneca-to-seek-u-s-authorization-for-covid-19-vaccine-this-month-or-early-next-sources-idINKBN2B42JN).

 

Dr Andrew Garrett, Executive VP, Scientific Operations, ICON Clinical Research, said:

“This is clearly stated as an AstraZeneca-led trial, and it more closely follows the large phase III vaccine trials reported by other sponsors.  In this respect it is a solid 30,000 plus participant study with a placebo control, and a simple 4 week dosing interval, such that interpretation is more straightforward than previous Oxford/AZ vaccine trials.  It has a good age mix with more than 6,000 participants aged >65 years and also wide ethnic representation.  Interim efficacy is clearly stated as being 79% against symptomatic COVID-19 and 100% effective against severe disease.  Detailed numbers are not provided at this time and the lower confidence limit is not stated.  Importantly the trial provides further support for efficacy in the elderly (80%) where previous clinical trial data, other than immunological data, had been lacking.  The study randomized two subjects to receive vaccine for every subject that received placebo providing a large safety database of 20,000 plus participants who received active vaccine.  As described, this has been used to investigate the potential association of the vaccine with thrombotic events and specifically cerebral venous sinus thrombosis, of which there were no cases detected.  Overall it was reported that there was no increased risk of thrombosis.  These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.

“The trial is directed at generating data to support emergency use in the US but also provides valuable data to other countries – both confirming efficacy using a 4-week dosing interval and re-enforcing vaccine safety.”

 

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“These results are not surprising given what we know now.  The US regulatory authorities are reluctant, even in a pandemic, to rely totally on data obtained outside the US, so this trial was done to provide convincing evidence of efficacy and safety in a sufficiently large number of US patients.  The benefits of these results will mainly be for the rest of the world where confidence in the AZ vaccine has been eroded, largely by political and media comment.  Once that happens, reporting of adverse effects becomes very biased and confidence can spiral downwards.  The rest of the world that will rely on this low-cost vaccine may be able to procced with vaccinating their populations.

“Vaccine development and rollout should be an international collaboration rather than nationalistic fervour whether in favour of, or against, a particular vaccine.  Assessment should be based on science alone.

“It is important also to realise that the “headline” efficacy numbers are valid for comparison between the groups in a trial, but great care is needed in comparisons between trials.  The way that events are assessed and counted as well as the context of a trial means that exact values for any between trial comparison are uncertain, not only because of statistical uncertainty, but also because of these other factors.

“It is clear this vaccine has very good efficacy (remember that 60% was, prior to any trials being started, regarded as a good target), and that this efficacy does not show a notable decline at older ages.  This was expected and the speculation that it was ineffective (or “quasi-ineffective”) at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided.”

 

 

AstraZeneca press release: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html

University of Oxford press release: https://www.ovg.ox.ac.uk/news/usa-chile-and-peru-interim-trial-data-show-oxford-astrazeneca-vaccine-is-safe-and-highly-effective

 

 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

 

 

Declared interests

Dr Peter English: “No conflicts of interest to declare.”

Dr Andrew Garrett: “I am employed by ICON which is a Contract Research Organization.  ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials. I am a member of the UK Statistical Authority’s (UKSA) Research Accreditation Panel. I have received one dose of the Oxford/AstraZeneca vaccine as part of the UK vaccination program.”

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.  I am a participant in the Oxford/Astra Zeneca trial, and on 13th January 2021 learnt I had received the active vaccine.”