Friday, January 29, 2021

 

Canada Seeking Exemptions From Biden’s ‘Buy American’ Provisions

Canada will seek exemptions to a U.S. effort to ensure federal agencies buy American-produced goods, Prime Minister Justin Trudeau said on Tuesday, as business groups expressed concern about the potential impact.

U.S. President Joe Biden vowed on Monday to leverage Washington’s purchasing power to strengthen domestic manufacturing by clamping down on foreign suppliers. That could hurt Canada, given how tightly the two nations’ economies are integrated.

Asked whether he would seek exemptions to the “Buy American” program when it is unveiled, Trudeau told reporters: “We will continue to be effective in advocating for Canada’s interests with this new administration.”

Canadian officials are already engaging U.S. counterparts, a government source said, to “discuss the importance of two-way trade to both the U.S. and Canada, and the nature of our shared supply chains.”

Many American companies have Canadian suppliers that risk losing business depending on how tightly the new rules are applied. Under a similar program launched by former President Barack Obama following the 2008 financial crisis, Canada won some waivers after many months of talks.

Canadian Foreign Minister Marc Garneau spoke to U.S. Secretary of State Antony Blinken by telephone on Tuesday, according to a statement from Ottawa.

“Minister Garneau emphasized the importance of cooperation in areas like the management of the border, vaccines, the movement of critical PPE and personnel, and uninterrupted supply chains so we generate economic growth and create jobs on both sides of the border,” the statement said.

“We are obviously concerned this could impact Canadian companies that work in the United States,” said Dennis Darby, chief executive officer of Canadian Manufacturers and Exporters.

“Canada can’t let down its push to make sure we get those waivers,” he said by phone.

Trudeau noted he had often successfully lobbied former President Donald Trump’s “unpredictable and protectionist” administration. With Biden, there is more common ground, he said, even though the new president on his first day in office last week canceled the Keystone XL oil pipeline project backed by Canada.

“President Biden has a lot of similar priorities to this government, to Canadians,” Trudeau said.

(Reporting by Steve Scherer and David Ljunggren; Editing by Peter Cooney)

 1%PARASITE QUE JUMPERS

Bill and Melinda Gates Point To a New Injustice COVID Pandemic Could ‘Unleash’

Bill and Melinda Gates are expressing their concerns about a new injustice the COVID-19 pandemic could potentially lead to.

“Bill and I are deeply concerned, though, that in addition to shining a light on so many old injustices, the pandemic will unleash a new one: immunity inequality, a future where the wealthiest people have access to a COVID-19 vaccine, while the rest of the world doesn’t,” they warned in their annual letter on Wednesday.

They continued, “Until vaccines reach everyone, new clusters of disease will keep popping up. Those clusters will grow and spread. Schools and offices will shut down again. The cycle of inequality will continue.”

The couple argued the future depends on “whether the world comes together to ensure that the lifesaving science developed in 2020 saves as many lives as possible in 2021.”

Bill Gates said the world “failed to prepare” for the COVID-19 pandemic, but there is hope.

“To prevent the hardship of this last year from happening again, pandemic preparedness must be taken as seriously as we take the threat of war,” Bill Gates wrote.

He acknowledged the cost of the pandemic and suggested the world needs to spend “billions to save trillions (and prevent millions of deaths).”

Bill Gates advocated for creating a global alert system to spot outbreaks as soon as they happen.

He is optimistic the world will be better prepared to take on the next pandemic for one reason.

“The world now understands how seriously we should take pandemics. No one needs to be convinced that an infectious disease could kill millions of people or shut down the global economy,” Bill Gates wrote.

He added, “The pain of this past year will be seared into people’s thinking for a generation.”

They predicted the pandemic will serve as “a testament to the remarkable leaders” who put their lives at risk to help others.

United States Drops in Global Corruption Index on Election Aftermath

“Serious departures” from democratic norms were a core factor in driving the United States to its lowest in eight years on a global corruption index in 2020, watchdog Transparency International said on Thursday.

The group’s annual report on business leaders’ perceptions of corruption – which gave the United States a score of 67 out of 100, down from 69 in 2019 – also cited weak oversight of the country’s $1 trillion COVID-19 relief package.

That put the United States behind Bhutan and Uruguay in 25th place, down from 23rd in 2019.

Referring to alleged conflicts of interest and abuse of office at the highest level, it described what it called the U.S. president’s attempts to pressure election officials and incite violence in order to change certified vote counts as “among the most serious departures from ethical democratic practice.”

Denmark and New Zealand continued to top the Corruption Perceptions Index (CPI), both with 88 points, while Syria, Somalia and South Sudan are still at the bottom.

Delia Ferreira Rubio, who chairs the global civil society group, said the COVID-19 pandemic was also a corruption crisis.

“The past year has tested governments like no other in memory, and those with higher levels of corruption have been less able to meet the challenge,” she said in a statement.

Transparency International noted that Uruguay, with the highest score in Latin America, invests heavily in health care, which has helped its response to COVID-19, while low-ranked Bangladesh has seen corruption flourish during the pandemic.

It also said that countries with more corruption had shown the worst record on the rule of law during the crisis, including the Philippines, where it said the response to COVID-19 had brought major attacks on human rights and media freedom.

The group said that 26 countries had significantly improved their scores since 2012, including Ecuador, Greece, Guyana, Myanmar and South Korea.

(Reporting by Emma Thomasson; editing by John Stonestreet)

Economics In Space


One of the most common definitions of economics is the study of the allocation of limited resources: how we use what we have, what we value, and why. There have been plenty of studies done on how economics works on earth. But what about in space?

We talk to NASA astronaut Doug "Wheels" Wheelock, who explains how the principles of economics guided trades of goods and services on the International Space Station. He also describes how his experiences changed how he values things often taken for granted on Earth, like birds, wind, and the rain.









NPR
THE INDICATOR FROM PLANET MONEY

January 21, 20215:31 PM ET

NASA/Getty Images
CAPITALI$M IN SPACE
1st Private Crew Will Visit Space Station. The Price Tag: $55 Million Each

January 27, 202112:38 PM ET
BILL CHAPPELLTwitter


The first private excursion to the International Space Station includes a crew of former NASA astronaut Michael López-Alegría (from left) along with Canadian Mark Pathy, American Larry Connor and Israeli Eytan Stibbe.Axiom Space


A crew of private astronauts will pay around $55 million each to spend about eight days at the International Space Station next January in what would be a new step for joint private-public space missions. Axiom Space, a Houston company, says the trip will be led by former NASA astronaut and space station commander Michael López-Alegría.

The proposed Ax-1 mission will use a SpaceX rocket to put three paying customers — American Larry Connor, Canadian Mark Pathy and Israeli Eytan Stibbe – into low-Earth orbit on the space station. All of the trio are wealthy entrepreneurs and investors. The group will be under the command of López-Alegría, who is now an executive at Axiom.

It would be the first time an entirely private mission sends astronauts to the International Space Station. Russia sold the first ride to the station to a private citizen, American businessman Dennis Tito, in 2001.



All of the private astronauts for the upcoming mission are far older than the average NASA astronaut's age of 34. The space agency does not have age restrictions for astronaut candidates, who generally range from 26 to 46 years old. At 70, Connor is surpassed in age only by John Glenn, who flew on the space shuttle when he was 77.

Under NASA's rules for private astronaut missions, Axiom must ensure its astronauts meet the space agency's medical standards. They must also undergo training and certification procedures required for crew members of the International Space Station.

While the paying customers represent a new era of space tourism, they will also perform research as the space station whizzes over the Earth.

Connor will work with the Mayo Clinic and Cleveland Clinic on research projects, Axiom says, while Pathy will collaborate with the Canadian Space Agency and the Montreal Children's Hospital. Stibbe plans to do experiments for Israeli researchers, working with the Ramon Foundation and Israel's space agency.

"We sought to put together a crew for this historic mission that had demonstrated a lifelong commitment to improving the lives of the people on Earth, and I'm glad to say we've done that with this group," Axiom Space President and CEO Michael Suffredini said as the company announced the crew.


Similar missions are planned for the future, Suffredini said. Axiom hopes to arrange up to two trips per year — and the company also wants to build its own privately funded space station. Under that plan, its modules would be attached to the space station as soon as 2024. And when the space station is retired, the Axiom modules would break off to continue in orbit on their own.

NASA announced its plans to open the International Space Station to commercial activities in June 2019, saying it wants businesses to use innovation and ingenuity to speed up development of "a thriving commercial economy in low-Earth orbit."

The space agency has a plan to recoup the steep costs of a private citizen visiting the space station. Its pricing policy lists expenses such as a daily fee of $11,250 per person for "regenerative life support and toilet" and $22,500 per person for crew supplies such as food and air. The price sheet also includes a data plan, priced at $50 per gigabyte.







FACT CHECK
Pfizer and Moderna haven't proven their COVID-19 vaccines shield against new variants: analysts

by Arlene Weintraub |
Jan 28, 2021 

One infectious disease specialist said efforts to determine if existing vaccines will work against new COVID strains have left us "in a state of ignorance" due to incomplete data.
(Bill Oxford/Getty Images)

Just as the U.S. government is starting to ramp up purchases of Pfizer’s and Moderna’s mRNA vaccines to prevent COVID-19, a troubling question is emerging in the scientific community: Can these shots protect people against aggressive new variants racing through the U.K., South Africa and Brazil?


Several analysts have scoured the medical literature and interviewed infectious disease experts in an effort to answer that question. Their conclusion? There is no clear answer. At least not yet.


When it comes to SARS-CoV-2, the virus at the heart of the pandemic, “we are in a state of ignorance with incomplete data,” said SVB Leerink analyst Geoffrey Porges in a note to clients Wednesday. He reached that conclusion after interviewing an infectious disease specialist who is also an official with the FDA, he said.

Both Moderna and Pfizer have undertaken studies to try to understand how their vaccines affect the emerging variants. But they’ve taken different approaches, causing some confusion.

For example, Moderna analyzed the South African variant and found its vaccine produced sixfold fewer neutralizing antibodies against that strain than it did against the original virus. Then Pfizer followed with an analysis suggesting its vaccine was only slightly less effective against the South African strain.

Problem is, Pfizer’s analysis did not include all the mutations found in the South African variant of SARS-CoV-2, said Evercore ISI analyst Umer Raffat in a Wednesday note. In fact, it didn’t include a certain mutation that’s known to be problematic, he said. Therefore, because “the simultaneous co-mutations is where the neutralization activity starts to dip,” Pfizer’s analysis may not be entirely comprehensive, he said.

RELATED: Moderna to test different booster shot against South Africa coronavirus variant

In a separate note from SVB Leerink on Thursday, analysts pointed out vaccine makers have been testing their shots against new variants using assays that “are not validated to predict vaccine efficacy.” Typically, they’re isolating antibodies from people who received the vaccines and then testing them against “pseudoviruses” that have a single mutation from a new variant of the coronavirus.

Furthermore, it’s possible the immune system’s T cells could still mount a response against the mutant COVID strains, because they may respond to different types of protein fragments than the antibodies recognize, the analysts said. But this phenomenon has not been fully studied, therefore it’s impossible to quantify the contribution of T cells to the immune response, they wrote.

Moderna isn’t taking any chances with the emerging coronavirus variants, though. It has moved a booster vaccine that addresses the South African variant into preclinical studies and a phase 1 human trial, the company announced Monday. “As we seek to defeat the COVID-19 virus, which has created a worldwide pandemic, we believe it is imperative to be proactive as the virus evolves,” said CEO Stéphane Bancel, in a statement.

RELATED: Order up: U.S. calls on Pfizer, Moderna for 200 million more vaccine doses

Tuesday, Pfizer and its mRNA vaccine partner BioNTech followed suit, confirming they’re also working on booster shots that shield against the new COVID variants.

One advantage of the mRNA technology behind the Moderna and Pfizer products is that it allows for new vaccine constructs to be rolled out quickly, SVB Leerink’s Porges said. The FDA official he interviewed “confirmed that the development of ‘next generation’ vaccines containing the novel variant sequences could be very fast using the established platforms, potentially requiring only a ‘few hundred’ subjects that could be enrolled, vaccinated, and studied ‘in a matter of weeks.’”

Meanwhile President Joe Biden’s administration is doing everything it can to speed up the pace of vaccinations. The government is negotiating with both Pfizer and Moderna to order an additional 200 million COVID-19 vaccine doses for delivery in the third quarter. That would bring the total number of doses available in the U.S. to 600 million.
Sanofi, after R&D setback, lends a hand to vaccine rival Pfizer for coronavirus shot production

by Eric Sagonowsky |
Jan 26, 2021 

Sanofi is teaming up with Pfizer and BioNTech to help produce mRNA coronavirus vaccines. (Sanofi/Vincent Moncorgé)

Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing.

After Sanofi's weak trial showing in December forced the company to delay its own vaccine development, the French drugmaker approached Pfizer and BioNTech about helping with mRNA shot production, CEO Paul Hudson said in an interview with Le Figaro newspaper.

A Sanofi spokesman confirmed the manufacturing partnership, saying Sanofi will provide BioNTech “access to our established infrastructure and expertise to produce over 100 million doses of COVID-19 vaccine in Europe in 2021.” The first batches will be delivered from Sanofi’s site in Frankfurt, Germany, by August, he said.

“While our utmost priority remains to advance our two COVID-19 vaccine programs, we recognize that some companies are facing challenges with their production,” he said. “Therefore, where we have the right manufacturing capabilities, without compromising other essential medicines and vaccines, and where we believe we can make a difference, we are stepping forward to do more for the fight against COVID and show solidarity across the industry.”

The company sees the partnership as “feasible” from a “technological and from a timing perspective,” he added.

RELATED: Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine

The news comes after Sanofi’s December disclosure that lackluster phase 1/2 data had forced the company and its adjuvant partner, GlaxoSmithKline, to delay their COVID-19 vaccine development. With the setback, the company pushed its anticipated launch to late 2021 rather than the middle of 2021 as originally expected.

Now, the partners are gearing up for a phase 2b study set to begin next month; investigators anticipate including a comparison against an existing authorized vaccine in the trial, according to Sanofi’s website. Earlier in the pandemic, the company teamed up with GSK to utilize that vaccine rival's adjuvant technology.

Aside from Sanofi’s GSK-partnered vaccine, the company has an mRNA vaccine in the pipeline through its partnership with Translate Bio. That vaccine has shown early promise in preclinical trials.

RELATED: COVID-19 mRNA vaccine candidate from Sanofi and Translate protects mice, monkeys: study

The Sanofi tie-up comes as mRNA partners Pfizer and BioNTech work to scale up production to 2 billion global doses in 2021. Amid that push, the companies temporarily reduced shipments to Europe this month, causing some countries to push back at the move. Meanwhile, AstraZeneca has suffered a manufacturing issue that will force it to reduce first-quarter deliveries to Europe.
PUBLIC OWNERSHIP OF BIG PHARMA
AstraZeneca, EU officials duke it out in the press as COVID-19 vaccine supply battle heats up

by Eric Sagonowsky |
Jan 27, 2021 

AstraZeneca CEO Pascal Soriot said the company's EU coronavirus vaccine supply deal carries no legal obligation to deliver doses on a specific timeline. (AstraZeneca)


Within days of AstraZeneca's surprise cut to first-quarter COVID-19 vaccine deliveries to Europe, a fierce debate between the drugmaker and government officials is playing out behind the scenes—and in the press.

CEO Pascal Soriot said the company has no legal obligation to deliver vaccines on a specific timeline. The EU maintains AZ’s new delivery schedule is “not acceptable.”

The sides were set to meet Wednesday, but an EU official told Politico the drugmaker had pulled out. AstraZeneca told Fierce Pharma via email it hadn't.

The back-and-forth comes as both sides seek to manage public opinion while salvaging their own relationship and getting deliveries back on track—and after AstraZeneca disclosed last week that a manufacturing problem would force a big reduction in Q1 supplies.

The company was originally set to deliver 80 million doses to Europe in the first quarter, but that number has been reduced to 31 million, according to Reuters. A spokesperson last week told Fierce Pharma the company plans to deliver "tens of millions" of doses to Europe in February and March.

In a statement Monday, European Commissioner for Health and Food Safety Stella Kyriakides said the EU "pre-financed the development of the vaccine and the production and wants to see the return." She wrote a letter to the company raising "important and serious" questions, she added.

RELATED: AstraZeneca's surprise COVID-19 vaccine shortfall prompts Europe to press for answers

Meanwhile, Soriot told AstraZeneca's side of the story in an interview this week with Italian newspaper la Repubblica. The company isn’t contractually obligated to deliver doses on a specific timeline under its EU agreement, he said. Rather, the deal called for AZ to make its “best effort” to deliver on its promise.

OK, then, EU officials said after the interview, AstraZeneca should publicly release its contracts, Reuters reports. An EU official told the news service that the details Soriot disclosed were supposed to be confidential and the “best effort” clause was standard for agreements centering on products that don’t yet exist.

Soriot also said AstraZeneca owed the U.K. first. Britain finalized its deal with AstraZeneca three months before the European Union struck its own, Soriot added, giving AZ a “head start” to work through potential manufacturing issues in that supply chain. Soriot has rejected calls to divert U.K. doses to Europe, The Guardian reports.

The source of the trouble in Europe is a Novasep factory in Belgium the Wall Street Journal reported, citing sources. The facility has only been able to turn out about a third of the yield AZ had been expecting, the Journal said. Meanwhile, in the U.K., AstraZeneca has partnered with at least one local manufacturer, Wockhardt, which is turning out doses at a plant in Wales.

"Governments are under pressure,” Soriot told the la Repubblica newspaper. “Everybody is getting kind of a bit, you know, aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe.”

RELATED: Sorry, Europe: AstraZeneca follows Pfizer/BioNTech in cutting back EU vaccine delivery plans

AZ told Reuters in a statement that its COVID-19 vaccine supply chains were set up around individual agreements with countries or international organizations. Vaccines produced under the deals are "dedicated to the relevant countries or regions" and the deals rely on "local manufacturing wherever possible," the company said.

As if to support that argument, Serum Institute of India said its manufacturing is on track; it's set to supply multiple countries with vaccines, including its home country, Brazil and Saudi Arabia. Overall, AstraZeneca has set up deals with 20 different manufacturing partners around the world.

As AstraZeneca works through its manufacturing issues, the mRNA vaccine team of Pfizer and BioNTech are working to scale up their global supply chain—an effort that caused a temporary glitch in European and Canadian deliveries.

But on Tuesday, vaccine giant Sanofi said it's also stepping in to help. After the company's own vaccine took a hit in phase 2 testing, Sanofi approached Pfizer and BioNTech about a manufacturing partnership. Sanofi is now set to produce 100 million doses of the Pfizer/BioNTech mRNA vaccine for Europe this year.
Novartis says it's ready to pitch in on manufacturing rivals' COVID-19 vaccines, diagnostics

by Eric Sagonowsky |
Jan 28, 2021 9:57am

Novartis is looking into manufacturing partnerships to boost coronavirus vaccine and diagnostic supplies, a spokesman said. (Novartis)


Right after Sanofi stepped in to help produce Pfizer/BioNTech coronavirus vaccines in Europe, Novartis is exploring whether it can deploy its own manufacturing network to boost COVID-19 supplies. Separately, the U.S. is weighing the Defense Production Act to compel drugmakers to produce Pfizer or Moderna mRNA vaccines.

Novartis is "currently in discussions with several companies with a view to supporting the manufacturing of vaccines and components for tests for Covid-19," a spokesman said.

Novartis sees controlling the pandemic as "one of the most pressing concerns for leaders, businesses and individuals all across the world," he said, so the company is "exploring ways in which we can collaborate with our partners in the industry, and leverage our manufacturing capacity and capabilities to contribute to the pandemic effort."

Though Novartis isn't at the forefront of COVID-19 vaccine or drug development, it is involved in the fight. Last year, Novartis' gene therapy outfit AveXis signed up to produce an early-stage COVID-19 gene therapy being investigated by researchers at Massachusetts General Hospital and Massachusetts Eye and Ear, for instance.

Meanwhile, the U.S. government is considering tapping drug manufacturers who aren’t already making vaccines to produce doses of either the Pfizer or Moderna mRNA shots via the Defense Production Act, Reuters reports. Both vaccines carry FDA emergency authorizations, but limited supply and logistics hurdles have complicated their rollouts.

RELATED: Sanofi, after R&D setback, lends a hand to vaccine rival Pfizer for coronavirus shot production

At a media briefing this week, White House senior COVID-19 advisor Andy Slavitt said he didn’t want to “talk about specific names," as quoted by the news service, but he said the administration is “not afraid to explore every option to get more vaccines to the public as quickly as possible." Before taking office, President Joe Biden’s advisors said the new president would invoke the Defense Production Act to boost vaccine supplies.

The talks come right after the French drugmaker Sanofi signed up to produce 100 million doses of the Pfizer/BioNTech vaccine for Europe. After Sanofi late last year suffered an R&D setback for its own vaccine program, the company reached out to rival Pfizer to see if it could help with manufacturing. The first batches will be delivered from Sanofi’s site in Frankfurt, Germany, by August, a spokesman said.

Even as the Biden team considers the Defense Production Act, experts recently raised concerns to Kaiser Health News about the legality of the plan and complexity of mRNA vaccine production. Converting an existing pharma manufacturing plant would require significant time, rigorous cleaning, converting equipment and training staff, they said. Plus, there’s no way to be sure vaccines that come from the new plant are safe and effective without testing, one expert told KHN.

RELATED: Order up: U.S. calls on Pfizer, Moderna for 200 million more vaccine doses

In a separate move to address supply concerns, the Biden administration this week ordered another 200 million mRNA vaccine doses from Pfizer and Moderna, taking the U.S. total haul up to 600 million doses. That supply, when it’s delivered, will be enough to vaccinate 300 million people, or almost the entire U.S. population. The new doses are on tap to be delivered this summer.

The administration is also weighing bringing more distributors on board to bolster deliveries, Reuters reports.

PANDEMIC PROFITEERING

Pfizer – Consensus Indicates Potential 11.5% Upside

Broker Ratings

Pfizer with ticker code (PFE) now have 20 analysts covering the stock with the consensus suggesting a rating of ‘Hold’. The target price ranges between 53 and 36 and has a mean target at 41.59. Now with the previous closing price of 37.31 this would indicate that there is a potential upside of 11.5%. The day 50 moving average is 37.76 and the 200 moving average now moves to 36.18. The company has a market capitalisation of $202,215m. Visit the company website at: http://www.pfizer.com

Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including cardiovascular metabolic and pain under the Eliquis, Chantix/Champix, and Premarin family brands; biologics, small molecules, immunotherapies, and biosimilars under the Ibrance, Sutent, Xtandi, Xalkori, Inlyta, Braftovi + Mektovi brands; and sterile injectable and anti-infective medicines under the Sulperazon, Medrol, Vfend, and Zithromax brands. The company also provides medicines and vaccines in various therapeutic areas, such as pneumococcal disease, meningococcal disease, and tick-borne encephalitis under the Prevnar 13/Prevenar 13 (pediatric/adult), FSME-IMMUN, Nimenrix, and Trumenba brands; biosimilars for chronic immune and inflammatory diseases under the Xeljanz, Enbrel, Inflectra, and Eucrisa brands; and amyloidosis, hemophilia, and endocrine diseases under the Vyndaqel/Vyndamax, BeneFIX, Genotropin, and Refacto AF/Xyntha brands. In addition, the company is involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration agreements with Bristol-Myers Squibb Company, Astellas Pharma US, and Myovant Sciences Ltd.; a licensing agreement with Akcea Therapeutics, Inc; a strategic alliance with Verily Life Sciences LLC; collaboration agreements with Merck KGaA and Valneva SE; a clinical trial collaboration and supply agreement with IDEAYA Biosciences; collaboration agreement with BioNTech SE; a clinical supply collaboration with Jiangsu Alphamab Biopharmaceuticals Co., Ltd; a research collaboration and license agreement with BioInvent International AB; a drug discovery collaboration with Sosei Group Corporation; and collaboration with LianBio. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

Pfizer - Consensus Indicates Potential 11.5% Upside - DirectorsTalk Interviews