Kids of those exposed to Chernobyl nuclear disaster show no genetic damage

By HealthDay News

A sign declaring "Halt! Prohibited Zone" is seen in the exclusion zone around the closed Chernobyl nuclear power plant in the Ilinci village, April 5, 2006. File Photo by Sergey Starostenko/UPI | License Photo

There's no evidence of genetic damage in the children of parents who were exposed to radiation from the 1986 Chernobyl Nuclear Power Plant disaster in Ukraine, researchers say.

Several previous studies have examined the risks across generations of radiation exposure from events such as this, but have yielded inconclusive results.

In this study, the investigators analyzed the genomes of 130 children and parents from families where one or both parents were exposed to radiation due to the Chernobyl accident, and where children were conceived afterward and born between 1987 and 2002.





There was no increase in gene changes in reproductive cells of study participants, and rates of new germline mutations were similar to those in the general population, according to a team led by Meredith Yeager of the U.S. National Cancer Institute, in Rockville, Md.

RELATED Researchers: NYC cancer cases may be tied to Chernobyl disaster

"This is one of the first studies to systematically evaluate alterations in human mutation rates in response to a man-made disaster, such as accidental radiation exposure," the authors wrote.

The "study does not provide support for a transgenerational effect of ionizing radiation on germline DNA in humans," the researchers concluded.

The study is one of two related to the Chernobyl disaster published Thursday in the journal Science.

RELATED Health effects of Hiroshima, Nagasaki bombs not as dire as thought

In the second, a team led by Lindsay Morton of the U.S. National Cancer Institute sought to learn more about the development of radiation-induced papillary thyroid cancers in Chernobyl survivors. These are among the most common cancers seen after the disaster.

The researchers compared thyroid tumors, normal thyroid tissue, and blood from hundreds of survivors to those of people who weren't exposed to radiation.

No unique radiation-related biomarker was identified, according to the report.

But the researchers did find radiation-related increases in DNA damage in human thyroid cancers of Chernobyl survivors. Radiation-related genomic changes were more pronounced in those who were younger when they were exposed to radiation.

The findings suggest that thyroid tumors that follow radiation exposure result from DNA double-strand breaks in the genome, the researchers said in a news release from the American Association for the Advancement of Science.

The study findings have implications for radiation protection and public health, particularly for low-dose exposure, the authors said.More information

The U.S. National Library of Medicine has more on radiation exposure.

Copyright 2021 HealthDay. All rights reserved.

Study Reveals Rapid Melting of Glaciers Has Shifted Earth's Axis

"Faster ice melting under global warming was the most likely cause of the directional change of the polar drift in the 1990s."

by Kenny Stancil, staff writer

A piece of the Perito Moreno glacier, part of the Southern Patagonian Ice Field, breaks off and crashes into Lake Argentina in the Los Glaciares National Park on April 5, 2019 in Santa Cruz province, Argentina. (Photo: David Silverman via Getty Images)

Since 1980, the planet's north and south poles have moved roughly four meters in distance, and new research shows that shifts in the Earth's rotational axis have accelerated since the 1990s as a result of the widespread melting of glaciers—a clear manifestation, scientists say, of the climate emergency.

"Faster ice melting under global warming was the most likely cause of the directional change of the polar drift in the 1990s," Shanshan Deng—a researcher from the Institute of Geographic Sciences and Natural Resources Research at the Chinese Academy of Sciences—told the American Geophysical Union (AGU) Thursday.

In a study published last month in the peer-reviewed journal Geophysical Research Letter, Deng and her co-authors found that changes in terrestrial water storage—particularly the accelerated loss of water stored on land due to melting glaciers—redistributed enough of the world's mass to drive "the rapid polar drift toward the east after the 1990s."

As The Guardian explained Friday:


The planet's geographic north and south poles are the point where its axis of rotation intersects the surface, but they are not fixed. Changes in how the Earth's mass is distributed around the planet cause the axis, and therefore the poles, to move.

In the past, only natural factors such as ocean currents and the convection of hot rock in the deep Earth contributed to the drifting position of the poles. But the new research shows that since the 1990s, the loss of hundreds of billions of tons of ice a year into the oceans resulting from the climate crisis has caused the poles to move in new directions.

The scientists found the direction of polar drift shifted from southward to eastward in 1995 and that the average speed of drift from 1995 to 2020 was 17 times faster than from 1981 to 1995.


The AGU noted that "researchers have been able to determine the causes of polar drifts starting from 2002 based on data from the Gravity Recovery and Climate Experiment (GRACE), a joint mission by NASA and the German Aerospace Center, launched with twin satellites that year and a follow-up mission in 2018."

Data from the GRACE satellites has enabled scientists to "link glacial melting to movements of the pole in 2005 and 2012, both following increases in ice losses," The Guardian reported. "But Deng's research breaks new ground by extending the link to before the satellite's launch, showing human activities have been shifting the poles since the 1990s, almost three decades ago."

While Deng's team showed that the accelerated decline in water stored on land stemming from glacial losses "is the main driver" of polar drift since the 1990s, the researchers wrote that groundwater depletion in non-glacial regions has also contributed to the movements.

"Groundwater is stored under land but, once pumped up for drinking or agriculture, most eventually flows to sea, redistributing its weight around the world," The Guardian noted. "In the past 50 years, humanity has removed 18 trillion tons of water from deep underground reservoirs without it being replaced."

Vincent Humphrey, a climate scientist at the University of Zurich who was not involved in the study, told AGU that the new research "tells you how strong this mass change is—it's so big that it can change the axis of the Earth."

This shift in the Earth's axis, however, is too small to affect daily life, Humphrey added. It could change the length of day, but only by milliseconds.

Nonetheless, other climate experts such as Jonathan Overpeck of the University of Arizona, have said before that the mere fact that the climate crisis is driving polar movements demonstrates "how real and profoundly large an impact humans are having on the planet."

 

The rare black panther not seen in Africa for 100 years: Sony World Photography Awards 2021 - BBC Science Focus Magazine

An incredibly rare black panther (Panthera pardus) photographed in Laikipia Country, Kenya. The photographer spent more than a year photographing leopards in this location using a high-quality camera trap system that was developed to snap elusive and nocturnal wildlife. Prior to this project, a black panther had not been scientifically documented in Africa for more than 100 years.

 Will Burrard-Lucas/Sony World Photo Awards

 

Biden puts Erdogan under high pressure

Erdogan, who is besieged by crises, faces the prospect of Biden recognising the Armenian genocide after having excluded Turkey from the F-35 programme.

Friday 23/04/2021

A file picture shows a demonstrator holding a sign during a rally to commemorate the 1915 Turkish massacre of Armenians in Times Square in New York City. (AFP)

WASHINGTON/ ANKARA – The administration of President Joe Biden has dashed Turkey’s hopes for calmer days with the US, putting it under high pressure by officially removing it from a project to manufacture F-35 fighter planes, while expectations grow that Biden will announce Saturday formal US recognition of the historical responsibility of the Turks for the Armenian genocide.

This step that is likely to infuriate Turkey and exacerbate tensions between the two countries.

A US Defence Department official announced Washington has notified Turkey it is officially excluded from the F-35 fighter jet production programme.

The official said the US and eight other countries had cancelled a 2006 memorandum of understanding and signed a new one, but did not go into further details.

Ankara had ordered and manufactured parts of more than 100 F-35s. But it was removed from the programme in 2019 after it purchased Russian S-400 ground-to-air missile systems, which Washington says constitute a security threat for the F-35 fighters.

Analysts say the Biden administration took a serious second look at its relations with Turkey, which wants to be a member of NATO and at the same time an ally of Russia.

Washington is now telling Ankara that the new administration is different from the previous one and that Turkey will be forced to reassess its ambiguous policy of pursuing strategic military cooperation with Moscow and Washington at the same time.

Observers pointed out that the exclusion of Ankara from the stealth fighter project and the recognition of the Armenian genocide narrative are two steps that personally challenge the Turkish President Recep Tayyip Erdogan, who finds himself besieged by crises and unable to push his usual brinkmanship any further.

Erdogan has pledged to continue defending the case against those who, he maintains, for political reasons promote the “slander and lies” of the “Armenian genocide”, in reference to the US President’s decision to be announced on Saturday.

Washington’s resolve to remove Ankara from the F-35 project is likely to push Turkey closer  to Russia and further strain its relationship with NATO, especially considering the tensions shaking its ties with member countries, over a number of issues, including gas exploration in the eastern Mediterranean and the stance on Libya.

Before his confirmation as US secretary of state, Anthony Blinken described Ankara last January as a ” so–called strategic partner”.

And he  indicated that more sanctions could be imposed on Ankara for its purchase of Russian missile systems.

” “The idea that a strategic – so-called strategic – partner of ours would actually be in line with one of our biggest strategic competitors in Russia is not acceptable,” he said.

 

The firm American stance towards Turkey’s acquisition of the S-400 system coincides with a new escalation, that is unrelated the issue of military alliances.

It has to do instead with Biden’s intention to recognise that the massacre of Armenians at the hands of the Ottoman Empire during the First World War was an act of genocide.

.

Three US sources familiar with the matter said that Biden is likely to use the phrase “genocide” in a statement he will make on April 24 on the occasion of annual events commemorating the victims of the massacres.

“My understanding is that he took the decision and will use the word genocide in his statement on Saturday,” said a source familiar with the matter.

However, the sources cautioned that Biden may decide at the last minute not to use this term in light of the importance of bilateral relations with Turkey.

“I expect we will have more to say about Remembrance Day on Saturday,” White House press secretary Jen Psaki said Wednesday when asked about Biden’s commitment. “But I don’t have anything to get ahead of that at this point in time.”

“The recognition by the United States will be a moral beacon for many countries,” said Armenian Foreign Minister Ara Ayvazyan.

“This is not about Armenia and Turkey, this is about our commitment to recognise and condemn genocide in the past, present and future,” he added.

Turkish Foreign Minister Mevlut Cavusoglu said that any move by

Biden to recognise the 1915 mass killings of Armenians by the Ottomans as a genocide will further harm already strained ties between the NATO allies.

A year ago, when Biden was still a presidential candidate, he commemorated the anniversary of the 1.5 million Armenian men, women and children who lost their lives in the final days of the Ottoman Empire.

He pledged to support efforts to describe these killings as genocide.

The “New York Times” and “The Wall Street Journal” reported that Biden is scheduled to declare the massacres classified as “genocide” on Saturday on the occasion of the 106th anniversary of the mass killings that began in 1915 when the Ottoman Empire was fighting Tsarist Russia during World War I in the region known now as Armenia.

More than 100 members of Congress, led by the Democratic member Adam Schiff, the House Intelligence Committee chairman, have sent a letter to Biden urging him to fulfil his pledge to recognise genocide during his election campaign.

“For decades, as leaders around the world recognised the first genocide of the twentieth century, the president of the United States maintained his silence,” the letter said.

“Mr President, as you said last year in your statement of the 24th of April, silence is complicity. And the shameful silence of the United States Government on the historic fact of the Armenian Genocide has gone on for too long, and it must end.”

The massacres were already officially recognised by the US Congress as an act of genocide in December 2019 in an essentially symbolic vote.

Ian Bremmer, president and founder of the Eurasia Group, said Biden’s expected move reflects the deteriorating relationship between the two countries, but that Erdogan’s options will be limited.

“It is unlikely that Erdogan will provoke the United States with actions that could further undermine Turkey’s weak economy,” he added.

Turkey alarmed over Biden’s intent to recognise Armenian ‘genocide’

This formal recognition of the World War One killing of some 1.5 million Armenians is expected from Biden Saturday at the marking of the 106th anniversary of the start of the mass-killings and deportations. Ankara has limited option in this regard.

Thursday 22/04/2021

Demonstrators march towards the Turkish Consulate during a rally commemorating the anniversary of the Armenian genocide on in Los Angeles, California. (AFP)

WASHINGTON--US President Joe Biden is expected to honour a campaign pledge and become the first occupant of the White House to describe the wartime massacre of Ottoman Turkey’s Armenians as “genocide”.

This formal recognition of the World War One “genocidal” killing of some 1.5 million Armenians which started in 1915 on orders from the then Ottoman Turkish government, is expected from Biden Saturday at the marking of the 106th anniversary of the start of the mass-killings and deportations.

Successive Turkish governments, while admitting that many Armenians died in eastern Turkey, have always angrily denied that the massacres were planned and ordered by the Ottoman military from the  country’s then-capital Istanbul. Turks also point out that there had been an Armenian uprising behind the lines when Ottoman troops were fighting a losing campaign against Tsarist Russian forces driving out of the Caucasus.

President Recep Tayyip Erdogan is likely to furiously push back at Biden’s formal use of the word “genocide”. Clearly anticipating the development, Turkish Foreign Minister Mevlut Cavusoglu warned on Tuesday that it will further harm already strained ties between the NATO allies.

“Statements that have no legal binding will have no benefit, but they will harm ties,” Cavusoglu warned. “If the United States wants to worsen ties, the decision is theirs,” he said, adding “ the US needs to respect international law”.

Biden’s move would be largely symbolic but would mean breaking away from decades of carefully-calibrated language from the White House and comes at a time when Ankara and Washington are already at loggerheads over a string of issues.

Biden is expected to use the word “genocide” as part of a statement on April 24 when annual commemorations for the victims are held around the world, three sources familiar with the matter said.

“My understanding is that he took the decision and will use the word genocide in his statement on Saturday,” said a source familiar with the matter. Sources cautioned that given the importance of bilateral ties with Turkey, Biden may still choose not to use the term at the last minute.

White House Press Secretary Jen Psaki on Wednesday told reporters the White House would likely have “more to say” about the issue on Saturday, but declined to elaborate.

The State Department referred queries on the issue to the White House and National Security Council had no comment beyond what Psaki said.

A year ago, while still a presidential candidate, Biden commemorated the 1.5 million Armenian men, women, and children who lost their lives in the final years of the Ottoman Empire and said he would back efforts to recognise those killings as a genocide.

“Today, we remember the atrocities faced by the Armenian people in the Metz Yeghern (Great Calamity) the Armenian Genocide. If elected, I pledge to support a resolution recognising the Armenian Genocide and will make universal human rights a top priority,” he said on Twitter at the time.

Turkey accepts that many Armenians living in the Ottoman Empire were killed in clashes with Ottoman forces during World War One, but contests the figures and denies the killings were systematically orchestrated and constitute a genocide.

At the time, one of the loudest protests over the Armenian massacres and forced death marches into Syria and Iraq came from the then US ambassador to Turkey, Henry Morgenthau.

For decades, measures recognising the Armenian genocide stalled in the US Congress and US presidents have refrained from calling it that, stymied by concerns about relations with Turkey and intense lobbying by Ankara.

Turkish President Tayyip Erdogan had established a close bond with former US President Donald Trump, but he has yet to speak to Biden since he became president in January

While Turkish and American officials have held talks since then, the Biden administration has stepped up pressure on Turkey by frequently expressing its discontent over Ankara’s human rights track record and the gap between the two sides over a host of issues including Turkey’s purchase of Russian weapons systems and policy differences in Syria remains.

Ian Bremmer, founder of the Eurasia Group research and consulting firm, said Biden’s expected move reflected the deteriorating relationship between the NATO allies, but Erdogan’s response would be likely limited.

“Erdogan is … unlikely to provoke the US with actions that could further undermine Turkey’s weak economy,” he said.

In 2019, the US Senate passed a non-binding resolution recognising the killings as a genocide, in a historic move that deeply angered Turkey.

Bi-partisan pressure 

Representative Adam Schiff and a group of 100 bipartisan lawmakers sent a letter to Biden this week urging him to follow through on his campaign pledge and “right decades of wrongs.”

“For decades, while leaders around the world recognise the first genocide of the 20th century, the president of the United States has remained silent,” the letter said, continuing ” ‘Silence is complicity.’ The shameful silence of the United States government on the historic fact of the Armenian Genocide has gone on for too long, and it must end”.

Dozens of other countries including France and Russia have already designated the Armenian killings as genocide. After the Dutch parliament passed a motion in February urging the government to recognise the genocide, Turkey said the move was “aimed at rewriting history based on political motives.”

Aram Hamparian, executive director of the Armenian National Committee of America has been prominent in the campaign to have Biden abandon long-standing US ambivalence and call the massacres a genocide.

“In the past, the arm twisting from Turkey was, ‘Well we’re such a good friend that you should remain solid with us on this,'” he said, “But they’re proving to be not such a good friend.”

Hamparian said he is hopeful that Biden will follow through. He noted that the stinging disappointment, when former President Barack Obama failed to honour  his own campaign pledge in 2008 to recognise the Armenian genocide, still lingers for many in the Armenian diaspora.

Samantha Power, who served as Obama’s United Nations ambassador and has been nominated by Biden to serve as USAID administrator along with deputy national security adviser Ben Rhodes both publicly expressed disappointment that Obama didn’t act on the matter. Obama was concerned about straining the relationship with Turkey, a NATO member whose cooperation was needed on military and diplomatic efforts in Afghanistan, Iran and Syria.

Power said in a 2018 interview with Pod Save the World that the administration was “played a little bit” by Erdogan and others invested in delaying a genocide declaration.

CEO Salaries for the Top 20 Pharma Companies by Market Cap


Published: Apr 23, 2021 By Alex Keown
https://www.biospace.com/


Executives at pharmaceutical companies are known for receiving large salaries. When bonuses and stock options are factored into the picture, their annual compensation can jump into the range of tens of millions of dollars, like Pfizer’s Albert Bourla, Alex Gorsky from Johnson & Johnson, and AstraZeneca’s Pascal Soriot.

Over the past several weeks, life sciences and biopharma companies have been filing year-end reports that include the total compensation for CEOs and other members of the executive teams received for 2020. As BioSpace reported earlier this month, CEOs of companies that have developed vaccines for the COVID-19 pandemic saw boosts in their annual compensation.

The bulk of the increases have come in the form of bonuses and stock options. For example, Ugur Sahin, CEO of Germany’s BioNTech, earned the majority of his $7.4 million compensation through stock options. Sahin is the sole shareholder of a German firm that controls an 18% stake in BioNTech.

After the vaccine developed by his company and Pfizer was authorized across the globe against COVID-19, Sahin became one of the world’s 500 richest people in the world. Sahin’s net worth increased to $5.1 billion after inking a developmental deal with Pfizer and vaccine distribution deals, making him the 493rd-richest person on the planet.

The BioSpace editorial team collected the most recent base salary information for CEOs of the top 20 biopharma companies based on market cap. The salaries ranged from a low of $591,710 for Vertex CEO David DeStefano to the $3,785,000 base salary for Severin Schwan, CEO of Swiss pharma giant Roche.

The chart below shows the change in base salary from the previous year in addition to the base salary. Some of the CEOs saw a slight increase of only a few percentage points. However, Novartis CEO Vas Narasimhan and Gilead Sciences CEO Daniel O’Day, whose company jumped due to early success with Remdesivir against COVID-19, saw significant boosts in their base salary, 29.8%, and 34.4%, respectively.

Two CEOs saw a decline in their base salary. Roche’s Schwan, who posted the highest base salary, saw a 12.5% decrease from 2019, and Illumina CEO Francis deSouza saw his base salary fall 2.1%.

J&J CEO Alex Gorsky is actually in line for a boost in his total compensation to $30 million if approved by shareholders later this month. However, several stakeholders in the company are opposed to that boost, mainly because of ongoing litigation related to the company’s opioid business. Those who oppose the CEO pay raise say Gorsky’s pay increases should not be shielded from billions of dollars lost in litigation.

Israel-based Teva is not in the top 20 for market cap, but its CEO Kåre Schultz is set for a significant boost in his annual compensation. His $2 million base salary remains the same as in 2019, but he is set to receive a $4 million boost in his stock holdings, a 35% increase. According to the company’s SEC filing, Schultz is set to receive total compensation of $15,724,518. This is despite the continued litigation the company faces over its role in the opioid crisis, as well as for manipulating generic drug prices.

Below is the base salary chart for the top 20 biopharma companies based on market cap.
COMPANY MARKET CAP (IN BILLIONS)**Market Cap as of April 21, 2021 CEO 2020 BASE SALARY (USD) BASE SALARY CHANGE FROM 2019
Johnson & Johnson $438.29 Alex Gorsky $1,650,000 0%
Roche $289.07 Severin Schwan $3,785,000 -12.5%
Pfizer $217.72 Albert Bourla $1,700,000 6.3%
Novartis $215.70 Vas Narisimhan $1,886,000 29.8%
Abbott $212.58 Robert B. Ford $1,298,462 6.3%
Merck & Co. $198.88 Kenneth C. Frazier $1,702,006 1.8%
AbbVie $192.42 Richard Gonzales $1,688,462 2.3%
Eli Lilly $182.76 David A. Ricks $1,483,333 7.0%
Amgen $148.67 Robert A. Bradway $1,647,538 2.9%
Bristol Myers Squibb $148.27 Giovanni Caforio $1,687,115 2.2%
AstraZeneca $139.15 Pascal Soriot $1,767,000 0%
Novo Nordisk $133.17 Lars Fruergaard Jørgensen $2,256,324 1.4%
Sanofi $131.30 Paul Hudson $6,707,717 Hired in 2019
GlaxoSmithKline $94.30 Emma Walmsley $1,648,677 8%
Gilead Sciences $83.76 Daniel O’Day $1,702,885 34.4%
Bayer $65.92 Werner Baumann $1,992,301 1.1%
Illumina $58.97 Francis deSouza $1,028,462 -2.1%
Moderna $67.16 Stéphane Bancel $950,000 2.7%
Vertex $56.57 David DeStefano $591,710 11.6%
Regeneron $54.20 Leonard Schleifer $1,425,300 3.5%

Justin Trudeau and wife Sophie receive AstraZeneca vaccine in wake of damning newspaper story

by Charlie Smith on April 23rd, 2021 

GEORGIA STRAIGHT



Media captured the moment when the Trudeaus received their first COVID-19 vaccinations.CPAC

The prime minister of Canada has taken what one health writer derided last month as the Edsel of pandemic age.

The decision of Justin Trudeau and his wife, Sophie Grégoire Trudeau, to receive the AstraZeneca vaccine today came as the vaccine's Baltimore manufacturer is under fire.

The National Post reported that more than half of Canada's AstraZeneca vaccine supply came from a plant that had quality-control problems, according to the U.S. Food and Drug Administration.

That prompted University of Ottawa health and legal specialist Amir Attaran to declare that the doses must be recalled and not used.

In March, the Globe and Mail's Andre Picard described the AstraZeneca as a "good vaccine".

However, Picard also compared its rollout and the company's missteps to that of the infamous Ford car that was sold from 1958 to 1960.

In B.C., Premier John Horgan took the AstraZeneca vaccine when it was only available in pharmacies to those between 55 and 65 years old.

At that time, there were vaccines sitting in pharmacies unused, but demand has spiked sharply since the age limit was lowered to 40 in B.C.

Here's what Trudeau said last night over Twitter.

He followed it up this morning with another call for people to get vaccinated.

“If you’re eligible for your vaccine like we are, make sure you get your dose as soon as possible,” Trudeau told reporters today.

You can see him receiving his shot in the video below.

The Trudeau's appear at 6:15 of this video.

Meanwhile, Ontario has reported first case of an AstraZeneca vaccine–based blood clot.

Also known as vaccine-induced immune thrombotic thrombocytopenia, it occurred in an Ontario man in his 60s who received the AstraZeneca/COVIDSHIELD vaccine, which was manufactured in India.

“The patient has received treatment and is recovering at home," Ontario's chief medical officer of health, David Williams, said. "Additional details will not be publicly released to protect the patient’s privacy.”

It's the fourth such case in Canada from more than 1.1 million doses that have been given.

The chance of a blood clot from COVID-19 vastly exceeds the change of a blood clot from the AtraZeneca vaccine, as the tweet below indicates.

ANOTHER FORM OF TRADE DUMPING

More than half Canada's AstraZeneca vaccine came from U.S. plant accused by FDA of quality-control problems

Close to two thirds of the AstraZeneca COVID-19 vaccine imported into Canada came from a U.S. factory that American authorities say was rife with quality-control issues, Health Canada confirmed Thursday.

 Provided by National Post The Emergent BioSolutions plant in Baltimore, Maryland.

The U.S. Food and Drug Administration said this week it will not allow the release of any vaccine made under contract at the Emergent Biosolutions plant in Baltimore, Md. — and still in the U.S.— until it’s been tested further.

But Health Canada said AstraZeneca has assured the government a contamination event at the Emergent plant that led to a recent FDA inspection had no impact on the 1.5 million doses of its vaccine shipped here.

“All products in Canada met authorized specifications before they were released to the market,” Anna Madison, a spokeswoman for the department, said in a statement.

U.S. removes AstraZeneca from plant that ruined 15 million doses of COVID-19 vaccine

White House says removal of AstraZeneca vaccine from U.S. plant will not affect dose output

“COVID-19 vaccines are subjected to the same independent, rigorous scientific reviews, quality standards, testing and post-market surveillance as all other vaccines approved for use in Canada.”


Madison said the last of the 1.5 million doses of AstraZeneca vaccine made at the Emergent plant were distributed to the provinces the week of April 5.

Though uptake on that particular shot was slow at first, its use has surged in recent days after some provinces made it available to a broader age range of Canadians. B.C. authorities said Thursday they had all but expended their allotment.

Canada also obtained 500,000 AstraZeneca doses made under contract by a company in India, and 300,000 manufactured in South Korea through the COVAX project.

AstraZeneca said in a statement Thursday the vaccine it sent to Canada in March was done so at the request of the U.S. government and “met the stringent requirements” the firm must follow.

“Required safety tests and quality control measures are carried out at each step of the production process,” the company said. “All checks were met prior to the release of the batches.”

The Food and Drug Administration released a report Wednesday that outlined a number of issues with Emergent’s Bayview plant in Baltimore that it said could potentially affect the quality of the products it made.

They ranged from inadequate training of staff to not cleaning equipment at appropriate intervals to “prevent contamination that would alter the safety, identity, strength, quality or purity of the drug substance.”

Emergent had earlier agreed with the agency to halt production at the plant until the problems are fixed.

In the meantime, the FDA said that none of the vaccine made at the factory so far would be distributed in the United States.

“For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution,” the agency said in a news release. “We will not allow the release of any product until we feel confident that it meets our expectations for quality.”

Amir Attaran, a law professor and drug-policy expert at the University of Ottawa, said any of the Emergent-made vaccine not already administered in Canada should now be shelved.

And he said he’s not even sure if potential problems could be uncovered by an inspection after the fact.

“It is impossible to “inspect in” high quality to a product that started life as low quality,” charged Attaran. “There is absolutely no option but to throw these doses away, like the other doses manufactured in that factory which the Americans are not allowing to be used. No way should Canadians be offered these doses.”

Emergent has manufactured vaccine under contract for both AstraZeneca and Johnson & Johnson.

Controversy first erupted in March when it was revealed that cross-contamination at the Baltimore plant had ruined 15 million doses of the J&J product.

U.S. media reports indicated that the contamination came from the harmless virus used in the AstraZeneca vaccine being manufactured in the same facility.

The companies agreed after the incident to no longer make AstraZeneca’s shot at the plant to avoid any cross-contamination, while the FDA carried out an extensive inspection of the facility that finished on Tuesday.

The resulting report outlined a number of issues around the company’s investigation into the Johnson & Johnson incident, saying it had failed to thoroughly probe the “unexplained discrepancies.”

But the report, citing security camera footage and other evidence, also detailed several other, broader concerns about how the facility operated.

It said the building was not maintained in a “clean and sanitary condition,” saying for instance that waste is not properly decontaminated before being taken through the warehouse for disposal.

There were also areas of peeling paint and damaged wall boards, which would undermine Emergent’s ability to clean and disinfect the area.

The warehouse was also overcrowded with materials destined for the manufacturing process and samples for quality control, said the report.

Provided by National Post A bottle of the AstraZeneca COVID-19 vaccine.

Among other concerns, it also said Emergent had failed to adequately train workers involved in manufacturing, quality control and other areas to “prevent cross contamination of bulk drug substances.”

AstraZeneca’s vaccine has been clouded somewhat by suspicions it is linked to a rare blood-clotting problem. But scientists say the benefits of taking the shot — and avoiding seriously COVID-19 illness — easily outweigh slim risks.

BACK

FDA pens stinging report on Emergent COVID vaccine plant

April 22, 2021

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. 

The US regulator says it completed an inspection of the Bayview plant run by the contract manufacturing organisation (CMO) which uncovered a string of violations including that the building was “not maintained in a clean and sanitary condition”.

The inspectors found peeling paint and damaged floors and walls that would prevent adequate cleaning, and waste materials that weren’t properly decontaminated before being shipped to other areas of the facility.

Some employees were observed throwing unsealed bags of medical waste into a service elevator leading to the plant’s warehouse, for example, and there were also failings in the plant’s size and design, worker training and handling of raw materials.

The FDA’s closeout letter refers specifically to the cross-contamination incident that led to 15 million doses of the J&J shot being jettisoned when ingredients destined for AstraZeneca’s AZD1222 shot were accidentally mixed into vials of the J&J product.

As a result, J&J said it had assumed “full responsibility” for making the COVID-19 vaccine material at the plant, while AZ pulled out of using the facility altogether. At the time, Emergent suggested that one batch of the vaccine failed quality controls, and no contamination took place.

The report notes that the cross-contamination was not investigated properly, which raises concerns that other batches may have also been affected.

Production at the facility has been halted while the company works with the FDA to try to resolve the deficiencies, and all stocks of the J&J vaccine already produced – said to be around 62 million doses – will have to be re-tested for quality before they can be distributed.

The plant reportedly also had to destroy millions of doses of AZ’s vaccine between October 2020 and January 2021 due to suspected contamination.

As the plant hadn’t been approved to supply the J&J vaccine none of the shots have been used in the US vaccination programme, which has been placed on hold while the US investigates a link between the shot and blood clotting side effects. AZ’s vaccine meanwhile has yet to be approved in the US.

The EU regulator said this week that the benefits of the vaccine outweigh a very small risk of clots, clearing the way for the rollout of the one-shot vaccine to resume. An FDA decision is expected tomorrow.

Award of federal contract probed

The problems at the Emergent plant have also prompted an investigation by Democrat members of the House Committee on Oversight and Reform into the award of a federal contract to make the vaccines.

The CMO’s chief executive – Robert Kramer – has been asked to testify before the group’s coronavirus subcommittee.

Reps Carolyn Maloney and James Clyburn say they are investigating “reports that Emergent received multi-million-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues”.

They note that the company received $628 million in June 2020 to establish the main US facility for making the J&J and AZ vaccines, and in particular are interested in the role played by Dr Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under President Trump and previously worked as a consultant for Emergent.

They say Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfil the contract”.

https://www.biospace.com/

The Cryogenic Hydrogen Powertrain That Will Transform Propulsion
Caroline Delbert 
POPULAR MECHANICS

4/23/2021

© Airbus/Handout Airbus’s new powertrain could help electric propulsion systems perform better in low-emission aircraft. The secret is using liquid hydrogen.

Airbus’s new powertrain could help electric propulsion systems perform better in low-emission aircraft.

The secret is using liquid hydrogen to supercool engine parts to a superconducting state.
For now, the system is in ground-based demonstrations.

In the ongoing fight against carbon emissions, air travel has a particularly bad position because of the industry’s reliance on high speeds, light weights, and fossil fuels. But Airbus’s new superconducting powertrain, which is cooled by super cold liquid hydrogen, may solve some of those pressing problems.

The new system—named Advanced Superconducting & Cryogenic Experimental powertrain Demonstrator (ASCEND)—is in ground-based demonstrations. The three-year project“aims to show that an electric- or hybrid-electric propulsion system can be more than 2 to 3 times lighter than a conventional system without compromising a 97 [percent] powertrain efficiency,” Airbus says.

If it works, ASCEND could be a landmark achievement in future-looking aeronautics. The snag facing electric aircraft designs mostly comes down to a matter of weight. On the ground, cars can add up to 1,000 pounds worth of batteries. But in the sky, that could mean the difference between an aircraft flying or sinking. Passenger planes in particular are already a very finely balanced system.

Airbus’s hydrogen powertrain is made up of a superconducting distribution system, a cryogenically cooled motor control unit, and a superconducting motor. The overall goal is to put the entire powertrain into a superconducting state, meaning with virtually no electrical resistance.

At that point, its power density could greatly exceed the burden of the added weight of electrical power. That’s why liquid hydrogen is key, Airbus says:
“[I]f a cold source at 20°K (-253.15°C), such as liquid hydrogen, is available on board, it can be used to cool the electrical systems. The superconducting components can then work to significantly improve the power density of the electric-propulsion systems.”

© Airbus/Handout ascend infographic

How did this all come about? Well, liquid hydrogen is already considered the leading candidate to transition commercial airliners away from fossil fuels. That’s for several reasons, but liquid hydrogen is able to slot into existing engineering in a way electric propulsion hasn’t before now.

What Airbus is suggesting is a marriage of hydrogen and electric. Liquid hydrogen has to be supercooled to be used at all, and Airbus realized that cold hydrogen itself became a new available resource. It’s like air-cooled car engines, which utilize the air rushing through the engine anyway and turn it into an asset.

For now, the system is only on the ground as engineers work on it for demonstrations. If ASCEND makes it to primetime, it will approach parity with traditional fossil fuel aircraft, Airbus says. Airliners are a special case, but Vancouver-based Harbour Air is working on electrifying its fleet of small local planes. It’s possible to do—it’s just difficult or impossible to scale up to jumbo jets.

Certainly no“regular” electric plane can compete with something that runs on superconducting electrics, so if Airbus brings ASCEND into its fleets in future decades, the manufacturer will essentially have the sky to itself.